Pharmout device qms pack demo by info@pharmout.net

Information Guide

How to Prepare Device QMS Documents Thank you for purchasing the PharmOut Device Quality Management System (QMS) documents. This information guide will help you get started on generating the QMS documents using the templates provided.

ÂŠ 2016 PharmOut. This document has been prepared solely for the use of PharmOut and its clients. Copying is prohibited.

Page 1 of 12

Version - 02

How to Prepare Device QMS Documents

Introduction The PharmOut QMS templates are primarily based on ICH Q10 and the PIC/S requirements for Good Manufacturing Practice (GMP) but can also be adapted for regional GMP requirements. Our experience has shown the ISO 13485 framework is an excellent, practical model. ICH Q10 provides a harmonised model for a device QMS throughout product lifecycles and is intended to be used together with regional GMP requirements. The quality system elements and management responsibilities described in these templates are intended to encourage the use of science and risk based approaches at each lifecycle stage, thereby promoting continual improvement across the entire product lifecycle. The content of the templates prompts for the requirements of the: 

PIC/S Code of Good Manufacturing Practice



ICH Pharmaceutical Quality System Q10



ISO 13485:2016 Medical Devices- Quality Management Systems



ISO 14971:2007 Medical Devices – Application of Risk Management to Medical Devices



21CFR Part 820 Quality System Regulation (CSR)

The QMS templates are only a guide and are not intended to cover all circumstances unique to your company. Consequently, they may be altered or additional sections or procedures may be added. PharmOut recommends careful consideration of the relevant compliance standards before removing any sections from the Quality Manual document. Note: This guidance document does not provide instructions for implementing the processes and procedures required by the relevant quality standard within your company. Should you require this, PharmOut is able to help (refer to How PharmOut can help).

PharmOut QMS support PharmOut offers 2 hours free phone or email support with the purchase of the documents within 12 months of the purchase date. Please quote the reference number included with the document purchase invoice. Additional support is available upon request if further help is required. Refer to the PharmOut website for contact details (www.pharmout.net) or email on info@pharmout.net.

Page 2 of 12

Version - 03

How to Prepare Device QMS Documents

Managing the QMS files in your system Unzip the files Unzip the document files obtained from PharmOut and save them either to an appropriate network drive or a hard disk. A list of the files that you should have received as part of the QMS document package is listed below. Document Type

Document Number

Title

File Format

Manual

QM001

Quality Manual

Word

Procedure

QP401

Control of Documents

Word

Procedure

QP402

Device Master Record

Word

Procedure

QP403

Control of Records

Word

Procedure

QP404

Information and Records

Word

Procedure

QP501

Management Review

Word

Procedure

QP601

Training, Awareness and Competency

Word

Procedure

QP602

Equipment Maintenance

Word

Procedure

QP603

Production and Work Environment

Word

Procedure

QP701

Production Planning and Risk Management

Word

Procedure

QP702

Order Processing and Review

Word

Procedure

QP703

Design Control

Word

Procedure

QP704

Control of Design and Process Changes

Word

Procedure

QP705

Supplier Evaluation and Monitoring

Word

Procedure

QP706

Purchasing

Word

Procedure

QP707

Verification of Purchased Product

Word

Procedure

QP708

Production Work Order and History Record

Word

Procedure

QP709

Cleanliness and Control of Product

Word

Procedure

QP710

Validation of Processes and Software

Word

Procedure

QP711

Installation and Servicing

Word

Procedure

QP712

Product Identification and Traceability

Word

Procedure

QP713

Labelling and Packaging

Word

Procedure

QP714

Storage and Distribution

Word

Procedure

QP716

QMS Change Control

Word

Procedure

QP715

Measuring and Monitoring Equipment

Word

Procedure

QP801

Feedback and Customer Satisfaction

Word

Procedure

QP802

Internal Quality Audits

Word

Procedure

QP803

In-process Inspections

Word

Procedure

QP804

Final Acceptance Inspection

Word

Procedure

QP805

Control of Non-Conforming Product

Word

Procedure

QP806

Analysis of Data

Word

Procedure

QP807

Continuous Improvement

Word

Procedure

QP808

Device Recall and Advisory Notices

Word

Continued next pageâ&#x20AC;Ś ÂŠ 2016 PharmOut Pty Ltd

Page 3 of 12

Version - 03

How to Prepare Device QMS Documents

Continued from previousâ&#x20AC;Ś Document Type

Document Number

Procedure

QP809

Customer Complaints

Word

Procedure

QP810

Corrective and Preventative Action

Word

Procedure

QP811

Statistical Process Control

Word

Procedure

QP812

Device Risk Management

Word

Form

FM401-1

Controlled Document Master List

Word

Form

FM402-1

Device Master Record Index

Word

Form

FM501-1

Quality Objectives Record

Word

Form

FM601-1

Training Record

Word

Form

FM603-1

Cleaning and Maintenance Log

Word

Form

FM702-1

Order Form

Excel

Form

FM703-1

Medical Device Design Project Plan

Word & Excel

Form

FM704-1

Engineering Change Request

Word & Excel

Form

FM708-1

Production Work Order

Word

Form

FM711-1

Medical Device Service Record

Word

Form

FM716-1

QMS Change Control Form

Word

Form

FM802-1

Internal Audit Plan

Word

Form

FM802-2

Audit Non-Conformity Report

Word

Form

FM805-1

Product Non-Conformity Report

Word

Form

FM809-1

Complaints Register

Excel

Form

FM810-1

Corrective Action Request

Word

Form

FM812-1

Risk Assessment Spreadsheet

Excel

Master Template

MAS01

Manual master template

Word

Master Template

MAS02

Policy master template

Word

Master Template

MAS03

Site Master File master template

Word

Master Template

MAS04

Procedure master template

Word

Master Template

MAS05

Work Instruction master template

Word

Master Template

MAS06

Specification master template

Word

Master Template

MAS07

Portrait Form master template

Word

Master Template

MAS08

Landscape Form master template

Word

Master Template

MAS09

Excel

Master Template

MAS10

List master template

Word

Master Template

MAS11

Log master template

Word

Master Template

MAS12

Blank Procedure master template

Word

ÂŠ 2016 PharmOut Pty Ltd

Title

Page 4 of 12

File Format

Version - 03

How to Prepare Device QMS Documents

Document control during drafting Once drafting begins, PharmOut suggests saving the QMS files with a document control suffix in the file name and in a separate folder to the original files. This ensures that the original templates are always available and helps track draft/review stages. Some examples may include: 

Track the draft version - QM001 Quality Manual_v01a, b, c etc



Track the date of review (1st Jan 2016) – QM001 Quality Manual_010116



Track a reviewer – QM001 Quality Manual_JBloggs



A combination of the above

It is important to maintain consistency in the document control mechanism you decide to use during the drafting process. Once the QMS documents are completed and are ready to be implemented, save the files according to your document control procedure (QP401) with the document revision number in the file name.

Page 5 of 12

Version - 03

How to Prepare Device QMS Documents

Starting the QMS documents QMS document requirements A company requiring GMP and/or ISO compliance must establish, document, implement and maintain a QMS, as well as maintain its effectiveness, in accordance with the required quality standard. QMS documents require the following elements: 

documented statements of a quality policy and quality objectives



a Quality Manual that includes: -

the scope of the QMS including details of, and justification for exclusions

documented procedures for the QMS or reference to them

a description of the interactions between the processes of the QMS



documented procedures required by the compliance standard (if not located within the Quality Manual)



documents needed by the organisation to ensure effective planning, operation and control of its processes



records required by the compliance standard such as evidence of conformity to requirements and the effective operation of the QMS

Where do I start? To achieve the above elements, PharmOut recommends that you use the following steps. You may also use the QMS Preparation Checklist at the end of this guide to ensure that the documentation requirements have been met. 1. Identify your company’s key processes, existing procedures, and management and control systems needed for the QMS. 2. Map the key processes so that you understand their sequence and interaction. The map should highlight what processes and procedures will need to be documented and also ensures that the QMS is structured to reflect the services you supply and the processes and specific practices you use. 3. Draft your Quality Manual using your document map created in Step 2. Use the prompts within the template as a guide to the contents. Include: 

the scope of the QMS, details and justifications of exclusions



the documented procedures established for the QMS



a description of the interaction between the processes of the QMS



the documentation structure of QMS documents

4. Draft all procedures and forms required for the QMS highlighted in Step 1 and Step 2 using the templates. General consistency should be present within the documents, i.e. The name of a piece of equipment, a role, etc., once defined, should not be varied. 5. Ensure the content of all QMS documents are reviewed by appropriate subject matter experts (SMEs).

Page 6 of 12

Version - 03

How to Prepare Device QMS Documents

6. Prepare hard copies of all QMS documents and obtain the appropriate approval as dictated by the compliance standard. 7. Maintain these QMS documents as described by the relevant QMS procedures. The Change History section of the document must be completed and have a valid reference to the Quality system (change control, CAPA, etc.) raised to revise the document in accordance with site procedures.

Using the PharmOut QMS templates The PharmOut QMS templates have been prepared to meet the requirements of the compliance standards for PIC/S GMP, ICH Q10, ISO 13485 and 14971.

Document Hierarchy The QMS templates are structured in the following hierarchy. Document Type

Description

Quality Manual

This is the high level document that provides policy on a company’s processes (that is, how your company’s QMS works). It details:

Procedures



QMS requirements



management responsibilities



management of resources for all aspects of the company



how manufacture will be designed, validated and conducted



customer-related processes



Quality Assurance processes

Details all procedures required by the company to plan, operate and control its processes. Additional procedures to those supplied with the PharmOut QMS templates can be generated using the Blank Procedure template. Procedures for smaller/simpler QMS may also be incorporated into the Quality Manual or multiple procedures may be combined (where appropriate).

Forms

Captures records for all data/information required to support or confirm a company’s processes. Additional forms to those supplied with the PharmOut QMS templates can be generated using the Blank Form template. Forms may also be in MS Word or Excel format. A company may prefer to capture forms either as separate controlled documents or within the appropriate procedure document. Refer to the attachment section at the back of the PharmOut Blank Procedure template as a guide to inserting forms within a procedure.

Note: Additional controlled document types may also be used at the discretion of your company depending on requirements or preferences. These may include: 

work/operating instructions



manuals



lists, logbooks or templates

Page 7 of 12

Version - 03

How to Prepare Device QMS Documents

Document numbering The QMS templates have been pre-numbered so that the procedures and forms reflect the relevant section of the Quality Manual. The QMS documents have the following numbering convention. Document Type

Document Number

Quality Manual

QM001

Numbering Convention QM - Quality Manual Note: Typically, there is only one Quality Manual so sequential numbering is not required.

Procedure

QPNXX

QP - Quality Procedure N - Section number from the Quality Manual XX - Next sequential number Example: QP401 is the first procedure associated with Section 4 of the Quality Manual.

Form

FMNXX-Y

FM - Form N - Section number from the Quality Manual XX - Number corresponding to that of referenced procedure. Y – Next sequential number of forms referenced from the procedure. Example: FM401-1 is the first form associated with Section 4 of the Quality Manual and Procedure QP401.

This numbering convention may be changed to reflect your company’s QMS requirements.

Using MS Word functions The PharmOut QMS templates assume that the Preparer is familiar with some intermediate MS Word functions such as styles, fields, referencing etc. The templates are prepared in MS Word 2013 (although some Forms are prepared in Excel 2013). The following section suggests the functions to be used within the templates. Help for specific problems or different versions of MS Word should be sourced from the Microsoft Help function. Note: PharmOut offers introductory help as part of the purchase of the QMS templates (see How PharmOut can help).

Page 8 of 12

Version - 03

How to Prepare Device QMS Documents

Using document styles The Styles function within MS Word applies a set of formatting characteristics to a document, such as font name, size, colour, paragraph alignment and spacing. The PharmOut QMS templates use document styles so that: 

the same set of styles are available to generate all QMS documents



consistent formats can be quickly and easily applied throughout the document



MS Word features like header numbering, table of contents and the document map are easily generated and then maintained during editing and review

Apply your choice of styles to your text using the Styles functionality of MS Word.

Using fields MS Word uses fields to perform a variety of functions, including: 

inserting the date and time, footnotes, tables of contents



inserting information to multiple places within the text (e.g. Company Name



performing mail merges

You should use the Document Properties to add specific fields to the templates such as your company name, document title, references, author etc. This allows the Preparer to insert this information only once within the document and it is automatically populated to each location where the field is inserted.

Instructions in the text The PharmOut templates contain red instructional text to help you prepare the content of your QMS documents. This red text should be deleted when the document is nearing completion and before pagination. Text highlighted in green represents the changes required by the ISO 13485:2016 update. Note: PharmOut templates do not use hidden text to provide instructions.

Using the cross referencing function The MS Word Citations & Bibliography function may be used to insert citations and to generate a list of references. This function may be used to form a list of procedures referenced in the Quality Manual. The citations and references should be tailored to your company’s requirements and preferred formats. The PharmOut QMS templates do not specify the use of this function although references and citations may be inserted in this manner. Refer to the MS Word Help function for further instructions on using Citations & Bibliography. Citations and references are inserted manually in the PharmOut templates.

Page 9 of 12

Version - 03

How to Prepare Device QMS Documents

Using page breaks Page breaks should be reviewed when you paginate your document. Insert a page break rather than pressing the Enter key multiple times to break information to the next page. This ensures that subsequent changes in the text appearing before a page break do not alter the pagination.

Using section breaks Section breaks have not been used in the PharmOut templates although they may be applied as required. These allow the document to be divided into separate sections containing different layout (e.g. portrait versus landscape page orientation) or formatting (e.g. different section headers/footers). Important: Headers and footers can be linked or separated from one section to another. Deleting a section break before breaking the link can alter headers/footers linked to the previous header/footer throughout the document.

Using bulleted lists Always use a stem sentence to start a bulleted list. Donâ&#x20AC;&#x2122;t allow a bulleted list to continue to a second page; keep the stem sentence and bullets on the same page. Refer to an Australian style guide for punctuation requirements.

Using numbered lists Reserve numbered (or lettered) lists when it is necessary to show priority or chronology. Use bulleted lists for all other options.

ÂŠ 2016 PharmOut Pty Ltd

Page 10 of 12

Version - 03

How to Prepare Device QMS Documents

QMS Preparation Checklist The following checklist may be used during the preparation of QMS documents. Step

Description

Identify your company’s key processes, existing procedures, and management and control systems needed for the QMS.

Map the key processes and procedures so that their sequence and interaction is clear. Highlight any area that is missing a process or procedure that is required as part of the QMS.

Draft the Quality Manual using the document map.

Draft the remaining procedures and forms required for the QMS.

Review the content of all QMS documents with subject matter experts (SMEs) with respect to their sequence and interaction.

Finalise the QMS documents before approval. Ensure:



company name, logo etc. has been inserted into each document



all red instructional text has been removed from each document



all Procedures and Forms are cross-referenced as appropriate in the Quality Manual. References to compliance/quality standards have been included where required



all styles are consistent within the QMS documents

Completed? ( / )

Obtain the appropriate document approval signatures required by the compliance standard and as dictated by your QMS procedure.

Page 11 of 12

Version - 03

How to Prepare Device QMS Documents

About PharmOut PharmOut is a boutique consultancy to the Pharmaceutical, Medical Device and Veterinary drug industries. PharmOut specialises in GMP compliance, validation and continuous improvement consulting and training.

How PharmOut can help We offer a range of services to help companies achieve compliance to GMP and ISO standards.

Compliance gap analysis audits We will visit your site and perform an audit to determine where you need to improve your processes, documentation and operations.

Quality management systems We can help you create and implement a QMS or bring your current system into compliance.

Technical writing We can help you write plain English documents (policies, manuals, procedures, work instructions, forms, etc.) that are compliant and your staff can easily use and follow.

ISO and GMP consulting We can provide practical recommendations and advice on the implementation of the code of GMP, ISO 9001 for Pharmaceuticals or ISO 13485 for Medical Device Quality Management Systems. We can help you obtain approval from international regulatory authorities (FDA, MHRA and TGA). This includes Part 11 and Annex 11 compliance to FDA and TGA requirements.

Training We run onsite and classroom training on GMP, validation and documentation writing. We also develop eLearning modules on topics such as Good Record Keeping that you can use for your ongoing training needs.

www.pharmout.net

ÂŠ 2016 PharmOut Pty Ltd

Page 12 of 12

Version - 03

Insert logo here Quality Manual

Document ID:

QM001

Revision No.:

Effective Date:

<date>

Quality Manual

Document information, authorship and approvals Author signs to confirm technical content Prepared by:

Job title:

Signature:

Date:

Subject matter expert reviewer signs to confirm technical content Reviewed by:

Job title:

Signature:

Date:

Quality representative signs to confirm document complies with quality management system Authorised by:

Job title:

Signature:

Document is current if front page has â&#x20AC;&#x153;Controlled copyâ&#x20AC;? stamped

Date:

Page 1 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

Table of Contents Update the Table of Contents (TOC) during drafting by clicking anywhere on the TOC and pressing F9. 1.

Scope

1.1.

Introduction

1.2.

Quality policy

1.3.

Application

1.4.

Exclusions

References

2.1.

Regulatory codes and guidelines

2.2.

Standards

Terms and definitions

Quality management system

4.1.

General requirements

4.2.

Documentation requirements

Management responsibility

5.1.

Management commitment

5.2.

Customer focus

5.3.

Quality policy

5.4.

Planning

5.5.

Responsibility, authority and communication

5.6.

Management reviews

Resource management

6.1.

Provision of resources

6.2.

Human resources

6.3.

Infrastructure

6.4.

Work environment

Product realisation

7.1.

Planning for product realisation

7.2.

Customer-related processes

7.3.

Design and development

7.4.

Purchasing

7.5.

Production and service operations

Document is current if front page has â&#x20AC;&#x153;Controlled copyâ&#x20AC;? stamped

Page 2 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

7.6. 8.

Control of monitoring and measuring devices

Measurement, analysis and improvement

8.1.

General

8.2.

Monitoring and measurement

8.3.

Control of non-conforming product

8.4.

Analysis of data

8.5.

Improvement

Document Information

Document is current if front page has â&#x20AC;&#x153;Controlled copyâ&#x20AC;? stamped

Page 3 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

This Quality Manual has been formatted on the requirements of ISO 13485:2016, ISO 9001:2015, ICH Q10, PIC/S and 21 CFR Part 820. Where differences arise, these have been noted in the text. Compliance with ISO 13485:2016 does not infer compliance with ISO 9001, and vice versa. Each standard has some specific requirements which must all be addressed to comply with both international standards. References to clauses or sections of standards are to parts of ISO 13485:2016, unless specified otherwise. While populating this manual with your information, reference these regulatory/compliance documents and others such as the Australian Code of Good Manufacturing Practice (GMP). Ensure that your QMS is compliant to these regulations and is detailed in the quality manual. Additional detail not included in this template may need to be included for unique, company-specific requirements.

Scope

1.1.

Introduction Provide a general description of the company, its location, operations, the products it produces or roles it undertakes as part of the device life-cycle. Roles can include manufacturer, authorized representative, importer or distributor as defined in Section 3 and should consider design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support). Describe which quality systems apply and identify any exclusion from ISO 13485:2016. <Company Name> develops and manufactures [or other roles] medical devices that are sold in [Australia, the United States of America and the European Union]. This quality manual, which is based on AS/NZS ISO 13485:2016, FDA 21 CFR Part 820 quality system standards and regulation clauses, addresses the requirements for a Quality Management System (QMS) for the development and manufacture [or other roles] of these products. It addresses the quality standards used to comply with regulatory requirements where the products are developed, manufactured and distributed. It references relevant policies, procedures and other documentation that form the QMS. This quality manual also defines the authorities and responsibilities of management and personnel involved in operation of the QMS. This manual presents the QMS to customers, suppliers, regulators and other external interested parties, informing them what specific controls are in place to assure quality. Amend the following standards as appropriate. This QMS complies with the following Australian and international standards: • AS/NZS ISO 13485:2016: Medical devices–Quality management systems– Requirements for regulatory purposes • AS/NZS ISO 9001:2015: Quality management systems–Requirements • US FDA Code of Federal Regulations, Part 820, Quality System Regulation. Education in the elements that make up the Quality Management System (QMS) shall be managed via a training program and compliance to the QMS via an internal audit schedule.

Document is current if front page has “Controlled copy” stamped

Page 4 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

1.2.

Quality policy Write the company’s quality policy here. It should embody both the process and the required outcome(s). <Company Name> is committed to consistently meeting customer requirements and expectations and regulatory requirements by delivering products that meet or exceed relevant quality standards through continual improvement of its products, services and the QMS. It is the responsibility of Senior Management to ensure that the Quality Policy is implemented. The Senior Management team will: • implement and maintain a formal QMS • ensure these requirements are always met • review this quality manual at least annually to ensure the objectives are appropriate and that it is effective and suitable • ensure this quality manual is communicated and understood by all employees, contractors and suppliers to ensure a culture committed to quality

1.3.

Application The QMS described in this manual applies to the development, manufacture and distribution of medical devices supplied by <Company Name> and the monitoring, maintaining, and controlling of outsourced processes. Identify the products (devices) and services which are to be covered by this quality system. As appropriate, include manufacture, delivery, design, development, distribution, installation, servicing, or other organization roles. Identify any processes that are applicable to the organization, but are not performed by the organization. These are also the responsibility of the organization and are accounted for in the quality management system by monitoring, maintaining, and controlling the processes. Also identify those products (or groups or types of products) to which the system does not apply. Any exclusion should be justified in this manual.

1.4.

Exclusions Organisations may, if the applicable regulatory requirements permit, claim exclusions from various requirements that do not apply to their operations (e.g. design requirements, customer property). Any exclusion must be explained and justified in writing and identify who made the decision and by who it was approved. The QMS described in this quality manual relates to <Company Name>, its products, customer requirements and regulatory obligations. The company excludes QMS requirements only if the exclusion: • does not affect the company’s ability nor remove its responsibility to provide product that meets specified requirements • does not affect the company’s ability to carry out corrective action • applies to quality requirements in section 6, 7 and 8 only

Document is current if front page has “Controlled copy” stamped

Page 5 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

The quality assurance manager is responsible for identifying requirements that do not apply and proposing to high-level management that they be excluded from the scope of the QMS. Processes which are applicable to the product but are performed by outside contractors, do not qualify for exclusion. They are accounted for in this quality manual to ensure adequate controls are in place. Any exclusion should be documented in this section of the manual. Excluded requirements must be precisely identified with reference to specific clauses and/or statements in ISO 13485:2016. Provide a brief justification as to why the exclusion is taken and why it is appropriate. Following are two examples of exclusions and their justification: Example 1 Exclusion: ISO 13485:2016, Section 7.3, Design and Development (including all subsections) Justification: <Company Name> does not design or develop products. All principal product characteristics are specified by the customers or their consultants. Our engineering activities are limited to developing methods and means of production, fabrication, or installation. Example 2 Exclusion: ISO 13485:2016, Section 7.5.4, Customer Property Justification: <Company Name> does not receive from customers any tangible or intellectual property that is intended for incorporation into, or in any way associated with the medical device(s). The next paragraph is not mandatory and may be deleted. High-level management evaluates the proposed exclusions and determines whether they are appropriate. The evaluation and approval of exclusions is conducted within the framework of management reviews of the QMS. Refer to Procedure QP501: Management Review.

References List any relevant international, national, regulatory or industry, quality system related regulations, standards or guidelines. Add to or delete from the following list as appropriate.

2.1.

Regulatory codes and guidelines Table 1: Regulatory codes and guidelines Reference

Title

US FDA 21CFR Part 820

Quality System Regulation

United States Food and Drug Administration, Title 21 of the Code of Federal Regulations (US FDA 21CFR) Part 11

Electronic Records; Electronic Signatures

Document is current if front page has â&#x20AC;&#x153;Controlled copyâ&#x20AC;? stamped

Page 6 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

Add/delete as appropriate

2.2.

Standards Table 2: Standards Reference

Title

ANSI/ASQC M1–1996

American National Standard for Calibration Systems

AS/NZS ISO 10006:1997

Quality Management–Guidelines to Quality in Project Management

AS/NZS ISO 10007:1995

Quality Management–Guidelines for Configuration Management

AS/NZS ISO 10013:1995

Guidelines for Quality Manuals

AS/NZS ISO 9000:2000

Quality Management Systems–Fundamentals and Vocabulary

AS/NZS ISO 9001:2000

Quality Management Systems–Requirements

AS/NZS ISO 9004:2000

Quality Management Systems–Guidelines for Performance Improvements

AS/NZS ISO 13485:2016

Medical devices–Quality management systems–Requirements for regulatory purposes

AS/NZS ISO 14971:2007

Medical Devices – Application of Risk Management to Medical Devices

Add/delete as appropriate

Terms and definitions Add or delete definitions as appropriate. Define company or Industry specific abbreviations and acronyms. The following definitions are from ISO 13485:2016 and may be changed to comply with national regulations, if necessary. Delete those definitions that do not apply. To comply with 21 CFR 820, include relevant definitions from 21 CFR 820.3, Definitions. Any additional requirements that are over and above ISO 13485:2016 should be added here, for example, items from ISO 9001 such as quality, non-conformity, process, etc. Define company specific abbreviations and acronyms. Table 3: Terms and definitions Term

Definition

Advisory notice

Notice issued by the organisation, subsequent to delivery of the medical device, to provide supplementary information and/or to advise on corrective or preventive action to be taken: • in the use of a medical device, • modification of a medical device, • return of the medical device to the organisation that supplied it or • destruction of a medical device

Authorised representative

Natural or legal person established within a country or jurisdiction who has received a written mandate from the manufacturer to act on his behalf for specified tasks with regard to the latter’s obligations under that country or jurisdiction’s legislation

Clinical evaluation

Assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer

Document is current if front page has “Controlled copy” stamped

Page 7 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

Term

Definition

Complaint

Written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety or performance of a medical device that has been released from the organization’s control or related to a service that affects the performance of such medical devices

Distributor

Natural or legal person in the supply chain who, on his own behalf, furthers the availability of a medical device to the end user Note 1: More than one distributor may be involved in the supply chain. Note 2: Persons in the supply chain involved in activities such as storage and transport on behalf of the manufacturer, importer or distributor, are not distributors under this definition.

Implantable medical device

Medical device which can only be removed by medical or surgical intervention and which is intended to: •

be totally or partially introduced into the human body or a natural orifice, or

•

replace an epithelial surface or the surface of the eye, and

•

remain after the procedure for at least 30 days

Note: This definition of implantable medical device includes active implantable medical device Importer

Natural or legal person in the supply chain who is the first in a supply chain to make a medical device, manufactured in another country or jurisdiction, available in the country or jurisdiction where it is to be marketed

Labelling

Label, instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device, but excluding shipping documents

Life-cycle

All phases in the life of a medical device, from the initial conception to final decommissioning and disposal

Document is current if front page has “Controlled copy” stamped

Page 8 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

Term

Definition

Manufacturer

natural or legal person with responsibility for design and/or manufacture of a medical device with the intention of making the medical device available for use, under his name; whether or not such a medical device is designed and/or manufactured by that person himself or on his behalf by another person(s) Note 1: This “natural or legal person” has ultimate legal responsibility for ensuring compliance with all applicable regulatory requirements for the medical devices in the countries or jurisdictions where it is intended to be made available or sold, unless this responsibility is specifically imposed on another person by the Regulatory Authority (RA) within that jurisdiction. Note 2: The manufacturer’s responsibilities are described in other GHTF guidance documents. These responsibilities include meeting both premarket requirements and post-market requirements, such as adverse event reporting and notification of corrective actions. Note 3: “Design and/or manufacture”, as referred to in the above definition, may include specification development, production, fabrication, assembly, processing, packaging, repackaging, labelling, relabelling, sterilization, installation, or remanufacturing of a medical device; or putting a collection of devices, and possibly other products, together for a medical purpose. Note 4: Any person who assembles or adapts a medical device that has already been supplied by another person for an individual patient, in accordance with the instructions for use, is not the manufacturer, provided the assembly or adaptation does not change the intended use of the medical device. Note 5: Any person who changes the intended use of, or modifies, a medical device without acting on behalf of the original manufacturer and who makes it available for use under his own name, should be considered the manufacturer of the modified medical device. Note 6: An authorized representative, distributor or importer who only adds its own address and contact details to the medical device or the packaging, without covering or changing the existing labelling, is not considered a manufacturer. Note 7: To the extent that an accessory is subject to the regulatory requirements of a medical device, the person responsible for the design and/or manufacture of that accessory is considered to be a manufacturer.

Document is current if front page has “Controlled copy” stamped

Page 9 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

Term

Definition

Medical device

Material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of: •

diagnosis, prevention, monitoring, treatment or alleviation of disease;

•

diagnosis, monitoring, treatment, alleviation of or compensation for an injury;

•

investigation, replacement, modification, or support of the anatomy or of a physiological process;

•

supporting or sustaining life;

•

control of conception;

•

disinfection of medical devices;

•

providing information by means of in vitro examination of specimens derived from the human body;

and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means Note: Products which may be considered to be medical devices in some jurisdictions but not in others include: •

disinfection substances;

•

aids for persons with disabilities;

•

devices incorporating animal and/or human tissues;

•

devices for in vitro fertilization or assisted reproduction technologies.

Medical device family

Group of medical devices manufactured by or for the same organization and having the same basic design and performance characteristics related to safety, intended use and function

Performance evaluation

Assessment and analysis of data to establish or verify the ability of an in vitro diagnostic medical device to achieve its intended use

Post-market surveillance

Systematic process to collect and analyse experience gained from medical devices that have been placed on the market

Document is current if front page has “Controlled copy” stamped

Page 10 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

Term

Definition

Product

Result of a process Note 1: There are four generic product categories, as follows: • services (e.g. transport); • software (e.g. computer program, dictionary); • hardware (e.g. engine mechanical part); • processed materials (e.g. lubricant). Many products comprise elements belonging to different generic product categories. Whether the product is then called service, software, hardware or processed material depends on the dominant element. For example, the offered product “automobile” consists of hardware (e.g. tyres), processed materials (e.g. fuel, cooling liquid), software (e.g. engine control software, driver’s manual), and service (e.g. operating explanations given by the salesman). Note 2: Service is the result of at least one activity necessarily performed at the interface between the supplier and customer and is generally intangible. Provision of a service can involve, for example, the following: •

an activity performed on a customer-supplied tangible product (e.g. automobile to be repaired);

•

an activity performed on a customer-supplied intangible product (e.g. the income statement needed to prepare a tax return);

•

the delivery of an intangible product (e.g. the delivery of information in the context of knowledge transmission);

•

the creation of ambience for the customer (e.g. in hotels and restaurants).

Software consists of information and is generally intangible and can be in the form of approaches, transactions or procedures. Hardware is generally tangible and its amount is a countable characteristic. Processed materials are generally tangible and their amount is a continuous characteristic. Hardware and processed materials often are referred to as goods. Purchased product

Product provided by a party outside the organization’s quality management system Note: The provision of product does not necessarily infer a commercial or financial arrangement.

Risk

Combination of the probability of occurrence of harm and the severity of that harm

Risk Management

Systematic application of management policies, procedures and practices to the tasks of analysing, evaluating, controlling and monitoring risk

Sterile barrier system

Minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at the point of use

Sterile medical device

A category of medical device intended to meet the requirements for sterility

Document is current if front page has “Controlled copy” stamped

Page 11 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

Quality management system To satisfy ISO 13485:2016 it is common to include a “Plan-Do-Check-Act” diagram in the QMS (refer Fig. 1). This depicts the quality system process, sequence and interrelations.

4.1.

General requirements This QMS is designed as a system of interrelated processes. It sets out the processes and procedures that together provide the mechanisms required to implement the Quality Policy. The systems’ main activities are defined as Quality System Processes (QSPs) and are grouped into six categories, as listed in Figure 1: • Customer requirements • Product realisation • Measurement, analysis and improvement • Management responsibility • Resource management • Continual improvement

Document is current if front page has “Controlled copy” stamped

Page 12 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

Figure 1: QSP Map 1.

Production Product info, quotes & orders

A. CUSTOMER REQUIREMENTS CUSTOMERS

Customer Communication

12 Human Resources 13 Plant, facility & equipment 14 Information resources (document control) 15 Measuring/monitoring devices

2 Product development 3. Production & quality planning

10 Management policies, planning & commitments

E. RESOURCE MANAGEMENT

11 Management review

4. Purchasing & receiving 5 Production

B. PRODUCT REALISATION

D. MANAGEMENT RESPONSIBILITY F. (16) CONTINUAL IMPROVEMENT –

C. MEASUREMENT, ANALYSIS & IMPROVEMENT

Risk assessments Corrective & Preventive Action

7 Monitoring of manufacturing processes measurement of product 6 Labelling, packaging, shipping, distribution

8. Monitoring/measurement of QMS (internal audits) 9 Monitoring customer satisfaction

CUSTOMERS

Note: Detailed process descriptions are provided in the Quality System Process Matrix.

Where applicable, delete the contents of Figure 1 and insert a customised diagram for your company. The Quality System Process Matrix may be a separate document listing the relationship of key compliance processes and sub-processes. This could be controlled documentation of the document map generated during the drafting stage of the QMS (refer to the How to Prepare QMS Documents guide supplied by PharmOut with the QMS templates). However, a QMS could also use the documents tabled in section 4.4.2. Ensure accurate cross referencing of names and locations for the Quality System Process Matrix used by your company.

Document is current if front page has “Controlled copy” stamped

Page 13 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

4.3.

Influences on QMS design Provide a brief summary of the organizational influences that determine the specific design of the quality management system. In particular, describe: • organizational environment, changes in that environment, and the influence that the organizational environment has on the conformity of the medical devices • regulatory requirements applicable to the organization’s activities • The required “risk based approach to the control of the appropriate processes needed for the quality management system.”

4.4.

Documentation requirements This section describes the scope of the quality system and related documentation, sets out general policies regarding this manual and references operational procedures for document control and quality records.

4.4.1.

General

The last three types of documents are similar to those in the Device Master Record (DMR). However, the list identifies documents that need to be controlled rather than those that should be in the DMR. All DMR documents must be controlled but not all controlled documents are in the DMR Each quality system sub-process is controlled by documented procedures (refer to Table 4). The QMS at <Company Name> contains appropriate documentation to ensure effective operation and control of processes and keeping of records, and includes this quality manual and the quality policy.

4.4.2.

Quality Manual

This Quality Manual details the: • quality policy of <Company Name> • process by which the policy will be implemented • the scope of the quality system, including details and justification for any exclusion(s) • the organisational structure of <Company Name> • procedures for the QMS • the overall quality system, its processes, sequence and interaction • high-level management responsibilities to achieve compliance. Secondary documentation details the QMS processes and procedures. Secondary documents

Description

Procedures

describe and explain processes and define what records must be maintained to document the results

Document is current if front page has “Controlled copy” stamped

Page 14 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

Secondary documents

Description

Forms, templates or matrices

recording raw data or information

Work instructions

Details specific tasks, such production processes (process operator instructions), handling products, calibrating measuring equipment, conducting tests or inspections

Device, labelling and packaging specifications

If templates are not used at the company then delete from above bullet point.

•

Component, subassembly, assembly and packaging drawings and specifications

•

Bills of materials (or lists of ingredients); compositions

•

Formulations

•

Wiring and piping diagrams

•

Software specifications

•

User manual, packaging artwork

•

Other such documents defining the medical device and its packaging.

All of these documents shall be included in the DMR. Refer to these documents as is customary in the company. For example, specifications may be called data sheets and they may be drawings, not diagrams. Whatever the format and names, this clause refers to documents defining the company’s medical devices. If such documents are not received from the customer, delete the last sentence (above). Manufacturing, installation and servicing specifications

•

Process flow charts

•

Process/assembly lines diagrams

•

Specifications for equipment, tools and moulds

•

Manufacturing environment specifications

•

Setup procedures

•

Operator instructions

•

Machine maintenance procedures

•

Blank work orders (job travellers), non-conforming product / process forms and other reporting forms

•

Other such documents defining the manufacturing processes and the manner of production.

Delete items that are not applicable. For example, if process flowcharts are not used, delete references to flowcharts. Quality Assurance/Control procedures and specifications

•

Process control specifications / charts

•

Control plans, instructions and acceptance criteria for incoming, inprocess and finished device inspection and testing

•

Procedures and acceptance criteria for the verification of packaging, labelling, installation and servicing activities

•

Blank forms for inspection/testing reports and other device history records

•

Release document review list

•

Other such documents defining how products and manufacturing processes are controlled and verified.

Delete items that are not applicable. For example, if SPC is not used, delete references to process control.

Document is current if front page has “Controlled copy” stamped

Page 15 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

Secondary documents Standards and codes

Description •

International, national and local regulations

•

Standards and codes that define operational, quality and product requirements.

The DMR is not an additional category but a compilation of device-specific documents. Relevant document from any category may be included in the DMR. A DMR is a term for a file with similar requirements to the Medical Device File described in the ISO13485:2016 code. For simple devices, the DMR may be a collection of engineering and production documents specific to that device. For more complex devices, the DMR may be an index or reference list of relevant documents, including their revision status and location. In this QMS, the DMR is treated as an index and there is a procedure for establishing and maintaining DMRs. Modify this section to reflect the company’s procedures. The Device Master Record (DMR) includes engineering, manufacturing, quality specifications, production methods and other specific documentation. The DMR may be actual documents or an index referencing these documents, their revision status and location. When a DMR document is withdrawn or superseded a copy of the old document is retained (archived) for at least the life of the medical device and no less than two years from product release. In the event of conflict, local regulatory requirements shall take precedence. Refer to Procedure QP402: Device Master Record. Measures to prevent loss or deterioration of records must be implemented as per [enter procedure reference]

4.4.3.

Control of documents

This section will vary depending on whether documents are distributed and controlled as hard copies or electronically. Requirements are the same for both systems but the means of control will differ. The text in this section assumes the company has both hard and electronic systems. Modify this section, and Procedure QP401 to reflect the company’s systems and practices. All documents required by the QMS are controlled. <Company Name> uses both hard copies and electronic copies of documents. Approval of and changes to these documents is the responsibility of the quality manager. The following processes are in place: • unique identification of controlled documents (including revision and change status) • a review and approval (and if necessary a re-approval) process to ensure documents are adequate and approved prior to release • identification of personnel to approve, issue and register controlled documents • allocation and distribution of controlled documents • control of changes to controlled documents • control, removal and archival of obsolete documents, including a system to prevent their unintended use • identification and management of documents produced by external organisations used by the company in GxP Document is current if front page has “Controlled copy” stamped

Page 16 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

maintenance of a master file of all current and superseded controlled documents (whether internal or external) Refer to Procedure QP401: Control of Documents. •

4.4.4.

Control of records

ISO 13485:2016 discusses records and documents in the same section, however, they differ in some important respects. Records are not reviewed and approved and should not be revised. Documents are for instruction or information; records are a statement of facts or events and provide complete evidence of product and process conformity and of the conformity and effectiveness of a quality system. Records can be paper or electronic and methods for control will depend on the media. This section relates to paper records. Modify to reflect company conditions. Records are established and maintained to provide evidence of conformity to requirements and of the effective operation of the QMS. All records that give evidence of conformity to product quality requirements are retained. These are retrievable in human readable form, uniquely identifiable and legible. A procedure is defined for the identification, storage, protection, retrieval, retention and deposition of records. Records are organised into the following five categories: • Design History File (DHF) • Device Master Record (DMR) • Device History Record (DHR) • Quality System Record (QSR) • Complaint Files ISO 13485:2016 is quite general in its requirements and allows companies to tailor to their needs. However, the above five groups are explicitly required in 21 CFR Part 820 Subpart M. Refer to Procedure QP403: Control of Records. Table 4: Documentation Confirm documents listed are in use for your system. Include additional document references that you have generated to describe unique, company-specific procedures. Sub-processes

Related document no. and title

Information resources (document control)

QP401 Control of Documents QP402 Device Master Record QP403 Control of Records QP716 Change Control Procedure FM716 Change Control Form

Measuring and monitoring devices

QP715 Measuring and Monitoring Equipment

Continual improvement (Corrective and preventative action)

QP501 Management Review QP806 Analysis of Data QP807 Continual Improvement QP809 Customer Complaints QP810 Corrective and Preventative Action QP812 Device Risk Management

Management responsibility This section follows ISO 13485:2016 Clause 5.1 requirements a) through e). It demonstrates management commitment and points to those sections of the manual and procedures where corresponding activities are defined and explained

5.1.

Management commitment <Company Name> high-level management will ensure the company is continually striving to meet its quality objectives by: • communicating formally and regularly to the organisation, the importance of meeting customer, legal and regulatory commitments • promoting awareness of the QMS • establishing and maintaining the QMS • ensuring the availability of resources • conducting regulatory quality audits and management reviews High-level management periodically review the QMS to ensure its continuing appropriateness, adequacy and effectives. The status and performance of the system is evaluated, and actions for improvement initiated. Refer to Procedure QP501: Management Review.

5.2.

Customer focus Determination of customer requirements is addressed more specifically and in more detail in ISO 13485:2016 Clause 7.2.1. The principal objective of the QMS is to focus the organisation on the customer. The key to achieving high customer satisfaction is an accurate determination of customer requirements and an effective verification that the requirements are met. High-level management ensures that customer requirements are determined and are well understood. This is done through the process of order and contract review. High-level management ensures that customer requirements are met by inspecting and testing products at various stages of production and upon completion.

Document is current if front page has “Controlled copy” stamped

Page 19 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

5.3.

Quality policy This section describes requirements for the quality policy and the process for its formulation and review. The quality policy itself is documented at the beginning of this manual. <Company Name>’s quality policy is described in Section 1.2. The quality policy is established by the CEO and: • is appropriate to the purpose of the company • is committed to complying with requirements • is continually improving the effectiveness of the QMS • provides a framework for establishing specific quality objectives • provides direction for the continual improvement effort The use of the quality policy to set quality objectives and facilitate continual improvement is addressed in this manual. The quality policy is: • periodically reviewed as part of management review of the QMS. This ensures its continual relevance and suitability • posted throughout the company and its role is explained and discussed at general orientation training provided to all employees • communicated to customers, consumers and other interested parties. For this purpose, it is displayed in the reception area and posted on the <Company Name> internet site External communication of the quality policy is not required. Delete the last two bullet points of this clause if not appropriate. Refer to Procedure QP501: Management Review and Procedure QP807: Continual Improvement.

5.4.

Planning ISO 13485:2016 addresses quality planning in several clauses. This section relates to Clauses 5.4.1 and 5.4.2 and addresses planning of the quality system and achievement of quality objectives. Clause 7.1 addresses requirements for planning of manufacturing processes, product verification and validation.

5.4.1.

Quality objectives

This documentation includes a specific system for establishing, documenting and implementing quality objectives. Quality objectives are established throughout the organisation to: • implement the quality policy • meet requirements for products and processes • improve quality system and quality performance Quality objectives are established during management reviews of the QMS. Management reviews can also initiate and monitor projects for achieving quality objectives. Refer to Procedure QP501: Management Review.

Document is current if front page has “Controlled copy” stamped

Page 20 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

5.4.2.

Quality management system planning

Quality system processes are planned to ensure that the system is appropriate for its intended purpose, and that it is effective and efficient. The purpose of the quality system is to: • comply with the quality policy • ensure and demonstrate the company’s ability to provide products that consistently meet customer and applicable regulatory requirements • ensure a high level of customer satisfaction • facilitate continual improvement • comply with requirements of ISO 13485:2016 standard and applicable regulatory requirements The output of quality system planning comprises this quality manual, associated operational procedures and referenced documents. Changes to the QMS may be in response to product, process, capacity, operational or organisational changes and are made to improve the effectiveness and efficiency of the QMS. Changes are discussed during management reviews of the QMS. Refer to Procedure QP501: Management Review.

5.5.

Responsibility, authority and communication 5.5.1.

Responsibility and authority

Refer to Figure 2 for the organisational structure that directs, manages and delivers the QMS. Figure 2: Organisational structure Insert organisational structure High level management ensures that personnel have sufficient independence and authority to perform their allotted tasks, in particular, internal auditors and personnel responsible for monitoring and reporting adverse events. For the purpose of the QMS, high level management includes the CEO, quality manager, chief engineer, production manager, marketing manager and accounting/finance manager. Every employee within <Company Name> has a responsibility to meet the intent of the Quality System by following approved procedures and accurately documenting their activities. All departments and functions in the company are responsible for implementing, maintaining and improving the QMS. Authorities and responsibilities for specific processes of the QMS are defined: • throughout this quality manual • in operational procedures • where the specific quality system processes or activities are documented • in job descriptions

Document is current if front page has “Controlled copy” stamped

Page 21 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

5.5.2.

Management representative

The regulatory affairs and/or Quality Assurance manager is typically the management representative. However, anyone from the management team may be appointed, irrespective of responsibilities. It is not necessary that the representative be involved in daily operation of the QMS. Table 5 details individual responsibilities responsible for the establishing, implementing and maintaining the QMS. Table 5: Roles and responsibilities Role

Responsibilities

High-level management

Quality manager

Departmental managers

5.5.3.

•

Ensuring all personnel are nominated to manage, perform and to supervise activities within the quality system

•

Ensuring that responsibilities of personnel are clearly defined

•

Nominating a quality management representative

•

Review of the quality system at planned intervals

•

Assessing opportunities for improvement of the quality system

•

Identifying the need to change the quality system

•

Establishing, developing, implementing and maintaining the quality management system

•

Managing the quality process

•

Reporting to high-level management on the performance of the QMS

•

Promoting awareness of the customer’s requirements and this QMS throughout the organisation

•

Approving quality related documentation

•

Verifying the implementation of corrective and preventative processes

•

Identifying deficiencies relating to the quality system

•

Initiating preventative and corrective actions to prevent reoccurrence of non-conformances

•

Identifying training requirements

•

Training personnel, visitors, contractors and if necessary suppliers, including induction of new staff in the requirements of the QMS

•

Developing and approving controlled documentation

•

Implementing preventative and corrective actions

•

Addressing and resolving technical problems

•

Managing equipment and product related issues

•

Updating personnel training plans and registers to reflect current procedures and policies

Internal communication

ISO 13485:2016 Clause 5.5.3 requires that "Top management shall ensure that appropriate communication processes are established within the organisation and that communication takes place regarding the effectiveness of the quality system". The standard outlines methods for communicating this information and references appropriate procedures, in particular those pertaining to document control, training and management reviews. Document is current if front page has “Controlled copy” stamped

Page 22 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

Although an operational procedure for internal communication is not explicitly required, such procedures are useful and sometimes expected in a larger organisation, i.e. refer to more specific communication methods such as weekly production meetings, monthly newsletters or a bulletin board or intranet site where appropriate. Internal communication regarding the quality system flows two ways: Flow

Type

Management communicates to the organisation

The organisation communicates to management

•

the quality policy and objectives

•

customer and regulatory requirements

•

product and process specifications

•

verification and validation requirements

•

instructions on how to implement and use the quality system

•

information and data regarding quality performance

•

effectiveness of the quality system

Note that there is no requirement for customer satisfaction or continual improvement in ISO 13485:2016. The information is communicated through: Edit the following list to remove those methods that are not used in <Company Name>. • paper or electronic documents such as manuals, procedures, instructions, drawings, specifications, quality records, reports, etc. • emails, memos and meetings • bulletin boards, the intranet site and newsletters • training and awareness programs • employee suggestions, surveys and feedback Management review meetings have a special role in ensuring proper communication between high-level management and the organisation. The meeting provides the framework for the organisation to report on the status of quality-related issues and activities and for management to formulate and communicate policies and directives to change and/or improve the quality system. The quality assurance manager has the overall responsibility for ensuring that pertinent documents, reports and records are distributed to appropriate departments and that information and data about quality performance and the effectiveness of the quality system are reported to high-level management. Refer to Procedure QP501: Management Review.

5.6.

Management reviews 5.6.1.

General

Managers will review the effectiveness of the QMS and advise high-level management of recommended improvements to the system. These reviews are performed at least annually. More frequent reviews are scheduled in periods when organisational, technological, product or other changes require increased attention and input from the high-level management. The purpose of management reviews is to: Document is current if front page has “Controlled copy” stamped

Page 23 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

• evaluate the suitability, adequacy and effectiveness of the QMS • consider changes to the QMS, quality policy and quality objectives Modify the following and QP501 Section 3 to suite the structure of <Company Name>. Management reviews are chaired by the CEO and are attended by managers representing quality assurance, marketing, sales, engineering, production, purchasing and human resources. Refer to Procedure QP501: Management Review.

5.6.2.

Review input

The QMS review takes into account: • findings of audits carried out since the last management review • customer feedback and complaints • changes in policy and standards • changes in work practices and organisational structures • monitoring and measurement of product and processes • status of corrective and preventative actions • follow up on previous management review actions • reporting to regulatory authorities • new or revised regulatory requirements • recommendations for improvement • other changes that could affect the QMS

5.6.3.

Review output

This section of the manual summarises procedure QP501, Management Review. It can be further abbreviated if required. The output from management reviews include: • improvements needed to maintain effectiveness of the quality management system • initiating actions for improvement of product relating to customer requirements • resource requirements to maintain QMS effectiveness and continuous improvement of product • changes needed in response to an applicable new or revised regulatory requirements. Results of management reviews are documented in minutes of the review meeting. The minutes include improvement actions and assign responsibilities and allocate resources for implementation of these actions.

Resource management

6.1.

Provision of resources The high-level management of <Company Name> ensures that adequate resources are available to implement and maintain and improve the quality systems and to meet regulatory and customer requirements. Resources required for implementing, maintaining

Document is current if front page has “Controlled copy” stamped

Page 24 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

and improving the QMS include personnel, infrastructure, work environment, equipment, materials, information and financial resources. Determination of resource needs for specific activities is integrated with the process of defining and initiating the activity. It may take the form of personnel assignments, allocation of space or equipment, training, procurement decisions, budgets, etc. Depending on the type and nature of the operation or activity, resource requirements are defined in: • the quality manual, operational procedures and work instructions • product and process drawings and specifications • production plans • job descriptions, competence matrixes and training programs • minutes of management reviews • quality objective records • corrective and preventive action requests High-level management has the responsibility and authority for provision of resources. Management reviews of the QMS are the principal forum for determining and providing adequate resources for maintaining and improving the quality system. References to "improvement" and "customer satisfaction" are not required for ISO 13485:2016.

6.2.

Human resources 6.2.1.

General

All personnel have the appropriate education, training, skills and experience to perform their duties. Human Resources are responsible for training and awareness programs for company-wide participation, such as general orientation, rules and regulations, quality systems, safety and other company-wide systems and issues. Departmental managers are responsible for identifying competency requirements and for providing specific training in their departments. Departmental training is primarily focused on increasing skills in operating equipment and processes, conducting inspections and testing, using analytical and statistical techniques and other such skills as appropriate for particular positions and jobs. Refer to Procedure QP601: Training, Awareness and Competency.

6.2.2.

Competence, awareness and training

The company: • assesses resource needs • employs personnel (including consultants and contractors) with appropriate qualifications, skills and experience • provides on-going training to ensure that personnel retain a high level of expertise in their fields • maintains up-to-date training plans for all personnel • maintains records of training received Senior staff will: Document is current if front page has “Controlled copy” stamped

Page 25 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

• assess and identify training requirements • establish competence of personnel • ensure awareness of personnel Methods used will include on-the-job training, discussion groups and where required, formal in-house training or external courses. Means of assessment may include interviews or supervisor evaluation of performance. Appropriate records, resumes, job descriptions and training logs are maintained. Refer to Procedure QP601: Training, Awareness and Competency.

6.3.

Infrastructure ISO 13485:2016 Clause 6.3 applies to any facility, equipment and supporting services having direct impact on product conformity, for example, production equipment or processes. This documentation takes a minimalist approach but does cover buildings, infrastructure and services, etc., that may impact product quality. The facilities are located at [insert address] and includes premises, services and equipment that has been designed to support the QMS. The infrastructure required for prevention of product mix-ups, orderly handling of product and achieving conformity to product requirements is documented in report [insert report reference].

6.3.1.

Buildings, workspace and associated utilities

Infrastructure and facilities, such as buildings, workspaces and associated utilities are appropriate and properly maintained to achieve conformity to product requirements. Departmental managers are responsible for identifying the needs and requirements for new and/or modification/repair of existing infrastructure and facilities in their departments. Requests for changes and/or expansions of facilities are submitted to the high-level management for review and approval. External contractors perform maintenance of buildings and facilities. This includes regular scheduled maintenance of lighting systems, air conditioning, heating systems, landscaping and cleaning (modify as appropriate). Repairs to buildings and other such facilities are contracted as needed. Purchasing is responsible for coordinating and managing maintenance contracts. Refer to Procedure QP706: Purchasing.

6.3.2.

Process equipment

Procurement of new and/or modification of existing process equipment (including hardware and software) is planned in conjunction with development of manufacturing processes, as defined in Section 7.1.

6.3.3.

Supporting services

Supporting services required by <Company Name> include transportation, communication and IT services: Document is current if front page has “Controlled copy” stamped

Page 26 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

• • •

6.3.4.

transportation services are purchased from parcel delivery, courier services and trucking or other approved transport companies communication services are provided by telephone, wireless and internet access companies installation, management and operation of IT systems, infrastructure and applications

Equipment maintenance

Key process equipment, machines, hardware and software are regularly maintained in accordance with approved maintenance plans specified by equipment manufacturers, engineering or responsible departmental managers. Refer to Procedure QP602: Equipment Maintenance.

6.4.

Work environment 6.4.1.

Human factors

This section addresses general requirements for the work environment as applied to an ISO 9001 system. ISO 13485:2016 emphasises controlling the physical environment of production areas rather than the "workplace" environment. This section can be deleted if compliance with ISO 9001 is not required. Human resources and departmental managers are responsible for ensuring suitable physical, social and psychological conditions in the workplace including temperature, lighting, cleanliness and interaction between employees. Production and quality assurance are responsible for identifying operations where extreme environmental conditions could impact product quality. Where appropriate, limits of exposure and/or mitigating measures are defined and implemented for these operations. For legal reasons, it is preferable to keep Health and Safety management systems separate from quality management. Edit this section to reflect how H&S is administrated in <Company Name>. The health and safety management system is independent from the QMS. It is administrated by human resources and is documented in the Health and Safety manual.

6.4.2.

Work environment in production and storage areas

This section is based on ISO 13485:2016 clauses 6.4 a) through b). Delete any that don't apply. However, issues such as general cleanliness, clothing and contamination control apply to most workplaces. Coordinate this section with procedure QP603. The work environment is properly controlled in areas where environmental conditions could adversely affect product quality. The following are controlled and requirements are documented: • Health, cleanliness and clothing of personnel where contact between personnel and product or the work environment could adversely affect product quality. Requirements for health, cleanliness and clothing of personnel are established and documented. • Conditions where the work environment can adversely affect product quality. Requirements for environmental conditions and monitoring are defined and Document is current if front page has “Controlled copy” stamped

Page 27 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

documented. Environmental control systems are periodically inspected to verify that the systems and equipment are adequate and functioning properly. The last sentence is from CFR 820.70(c) and ISO 13485:2016 clause b) • Contaminated product where special arrangements are established and documented for control of contaminated or potentially contaminated product in order to prevent contamination of other products, the work environment and/or personnel. • For sterile medical devices, the organization shall document requirements for control of contamination with microorganisms or particulate matter and maintain the required cleanliness during assembly or packaging processes. • Training where personnel who work under special environmental conditions are appropriately trained. Personnel who work or temporarily enter controlled areas are trained in appropriate procedures or are supervised by a trained person. Refer to Procedure QP603: Production and Work Environment.

Product realisation

7.1.

Planning for product realisation The term "design transfer" is used in this heading to establish a link to CFR 820.30(h) Design Transfer. However, this is actually used in CFR 820 Subpart C - Design Controls. ISO 13485:2016 is not specific about how the manufacturing and inspection/testing program is planned and documented but it does require that it is planned and documented is some form. Planning for production processes and product verification activities include the determination of: • requirements and quality objectives for products and processes • the need to develop production processes; establish process specifications, operator instructions and other such documentation; provide resources specific to the product, including infrastructure and work environment; and provide training to process operators • required product verification, measurement, inspection and test activities, handling, storage, distribution, traceability, and the criteria for product acceptance • records needed to provide evidence of product and process conformity This manual uses the Work Order (a job traveller) to define the manufacturing processes and inspection/ testing activities necessary to produce and verify product. If Work Orders are not used, develop an alternative system, for example, process flow charts, control plans, etc. for each product (or family of products).

7.1.1.

Risk Management

Risk management is a new requirement of ISO 13485:2016. Procedure QP701 describes this activity. Risk analysis studies are conducted for key manufacturing and product realisation processes. This identifies high-risk activities and focuses controls on those higher risk areas to reduce the risk. Refer to the following procedures: Document is current if front page has “Controlled copy” stamped

Page 28 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

• • •

7.2.

Procedure QP812: Device Risk Management Procedure QP708: Production Work Order and History Record Procedure QP701: Production Planning and Risk Management.

Customer-related processes 7.2.1.

Determination of requirements related to the product

The company determines customer requirements by identifying the following: • requirements specified by the customer • requirements not stated by the customer but necessary for intended use • statutory and regulatory requirements • any user training needed to ensure specified performance and safe use of the medical device • any additional requirements determined by <Company Name> Refer to Procedure QP702: Order Processing and Review.

7.2.2.

Review of requirements related to the product

The company reviews the requirements of the product prior to commitment to supply. These reviews ensure: • the product requirements are defined • differences in order requirements are resolved • applicable regulatory requirements are met • any user training identified in accordance with 7.2.1 is available or planned to be available • the product can be supplied to the time, budget and quality requirements The confirmation would typically be by e-mail or fax or by repeating the order requirements back to the customer (refer to procedure). Delete below if verbal orders are not taken. When the customer provides no documented statement of requirements (e.g. verbal orders), the customer requirements are confirmed before acceptance. Changes or amendments to orders are processed and reviewed using the same procedures as for initial orders. Changes to orders are communicated to all functions within the company that may be affected. Refer to Procedure QP702: Order Processing and Review.

7.2.3.

Communication

There are no specific requirements for personnel communicating product information to customers however there is a requirement to plan and document arrangements for any communications. Modify this clause to reflect the practices of <Company Name>. Marketing is responsible for developing and controlling the <Company Name> brochures, catalogues, internet site and other forms of promotional and product information. These communications are based on technical specifications developed by design engineering. Only designated personnel from marketing, sales, customer service and engineering are authorised to communicate with customers regarding product information, enquiries, contracts, order handing, including amendments, customer feedback and complaints or Document is current if front page has “Controlled copy” stamped

Page 29 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

issuing advisory notices. The customer service manager is responsible for designating which personnel are authorised and for supporting them with training and current product information. Refer to the following documents: • Procedure QP702: Order Processing and Review • Procedure QP801: Feedback and Customer Satisfaction • Procedure QP809: Customer Complaints. The organization shall communicate with regulatory authorities in accordance with applicable regulatory requirements.

7.3.

Design and development 7.3.2.

Design and development planning

If <Company Name> does not design products, an exemption can be claimed from ISO 13485:2016 Clause 7.3. Remove this section and document reasons in the exclusions section of this manual. Each product is designed by the chief engineer to an agreed development plan. The plan determines, controls and documents: • the design and development stages • the review(s) needed at each design and development stage • verification, validation and design transfer activities appropriate to each stage • personnel responsible for each stage • the methods to ensure traceability of design and development outputs to design and development inputs • the resources needed, including necessary competence of personnel.

7.3.3.

Design and development inputs

Design input requirements are developed by design engineering from product concepts and include: • product briefs • sketches • models • prototypes Design inputs requirements are reviewed, verified or validated and approved before they are used in design. Refer to QP703: Design Control Procedure

7.3.4.

Design and development outputs

Design outputs include: • documents • samples • models • mathematical data Document is current if front page has “Controlled copy” stamped

Page 30 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

• software Products are considered developed when they: • meet the input requirements • provide appropriate information for purchasing, production and service provision • contain or reference product acceptance criteria • specify the characteristics of the product for its safe and proper use Developed products are registered by the regulatory agency in the country or territory in which they are to be sold. The information required to register the product will be documented (and such documentation approved) by suitably trained and experienced product development and regulatory affairs staff. Design output documents are approved before release to production. Design output documents are organised in a DMR. Refer to Procedure QP401: Document Control and Procedure QP402: Device Master Record.

7.3.5.

Design and development review

Design reviews are performed at appropriate development stages in accordance with the design project plan. The purpose of the design reviews is to evaluate the ability of the design to meet design input requirements and to identify any problems and propose necessary corrective actions. Participants in design reviews include representatives of functions concerned with the design stage being reviewed, and other specialist personnel as appropriate. All design reviews are documented and must include and include the identification of the design under review, the participants involved and the date of the review.

7.3.6.

Design and development verification

Transfer of product manufacture to production includes technology transfer, validation, verification and scale-up to production quantities of the final product. Product and process acceptance criteria are set so that they can be measured to assure product quality. Document verification plans that include methods, acceptance criteria and, as appropriate, statistical techniques with rationale for sample size. If the intended use requires that the medical device be connected to, or have an interface with, other medical device(s), verification include confirmation that the design outputs meet design inputs when so connected or interfaced. Records of the results and conclusions of the verification and necessary actions are maintained.

7.3.7.

Design and development validation

Validation of each product is performed using approved test plans, test protocols and checklists as described in the <Company Name> validation policy. Validation activities are performed prior to delivery or implementation of the product and records are maintained. Records of the results of device design verification and validation, and any necessary actions are maintained. The organization shall document validation plans and results. Document is current if front page has “Controlled copy” stamped

Page 31 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

Refer to Procedure QP710: Validation of Processes and Software.

7.3.8.

Design and development transfer

Transfer of design and development outputs to manufacturing is documented through Procedure QP703 Design Control. Design and development outputs are verified as suitable for manufacturing before becoming final production specifications and that production capability can meet product requirements.

7.3.9.

Control of design and development changes

Design and development changes, including changes to the product specification, acceptance criteria or manufacturing process are captured using the change control process as per Procedure QP716: Change Control. The change control process will determine the significance of the change and include an evaluation of the effect of the change on existing processes. Design changes are reviewed, verified, validated as appropriate, and approved before implementation. Refer to Procedure QP703: Design Control.

7.3.10.

Design and development files

A design and development file for each medical device type or medical device family is maintained in the Device Master Record (DMR) as per section 4.4.2. This file shall include or reference records generated to demonstrate conformity to the requirements for design and development and records for design and development changes.

7.4.

Purchasing This selection details evaluation and monitoring of suppliers, purchasing and verification of purchased product. These elements are covered by procedures QP705: Supplier Evaluation and Monitoring, QP706: Purchasing and QP707: Verification of Purchased Product. Modify the procedures as required and then ensure this section matches.

7.4.1.

Purchasing process

<Company Name> ensures that purchased product and materials conform to specified purchase requirements by internal and external inspections and/or qualification of received goods. Purchasing and quality assurance conduct initial supplier evaluations, continual monitoring and re-evaluations and those who meet requirements are added to or remain on the approved supplier list. Quality assurance monitors supplier quality performance. Suppliers with inadequate performance are requested to implement corrective actions. If corrective actions are not implemented and/or are not effective, the supplier may be removed from the approved supplier list. Purchasing maintains the approved supplier list. Orders for materials, components and subcontracted services are only placed with vendors on the list. The ability of suppliers to meet the company’s requirements determines the level of control and supervision in place. Each supplier is evaluated and selected on their ability to meet the company’s requirements. Where necessary, a risk-based approach is used to determine the level of control. Document is current if front page has “Controlled copy” stamped

Page 32 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

Refer to the following documents: • Procedure QP705: Supplier Evaluation and Monitoring • Procedure QP706: Purchasing An approved supplier list is not explicitly required by ISO 13485:2016 but communicating supplier status within the organisation is required and records of the results of evaluation, selection, monitoring and re-evaluation of supplier capability or performance and any necessary actions arising from these activities shall be maintained. Refer procedure QP705.

7.4.2.

Purchasing information

Review and approval of purchasing documents is not explicitly required in ISO 13485:2016 but there is a requirement to ensure adequacy of specified requirements contained in purchase orders and notification of any changes to purchased items. Refer procedure QP706. The purchasing department prepares purchasing documents. <Company Name> ensures that the purchased product conforms by providing relevant documentation to the supplier including relevant specifications, procedures and processes to determine conformance. Purchasing documents are reviewed and approved by the company before release to the supplier. A supplier must provide written agreement to advise <Company Name> of any changes to purchased product. Refer to Procedure QP706: Purchasing.

7.4.3.

Verification of purchased product

Purchased products are inspected prior to use in production and/or dispatch. Quality assurance is responsible for selecting appropriate methods for purchased product verification and acceptance. Testing and inspection are performed to approved specifications and procedures. Delete below if not applicable. When verification of purchased product is to be performed at a supplier's premises, purchasing documents specify the intended verification arrangements and method of product release. Refer to Procedure QP707: Verification of Purchased Product.

7.5.

Production and service operations 7.5.1.

Control of production and service provision

Device manufacturing and provision of associated services are carried out under controlled conditions. The specific requirements and controls are identified below. The following clauses correspond to ISO 13485:2016 Clause 7.5.1 a) through f). Control of each item is demonstrated by referencing activities and related procedures. Retain the format of this section to ensure all sections are covered. Ensure this also reflects the company’s activities and any changes. 7.5.1.1. General Requirements a) Product and process information and work instructions - information and instructions specifying product characteristics and manufacturing processes are communicated to Document is current if front page has “Controlled copy” stamped

Page 33 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

process operators in the form of work orders, drawings, specifications, samples, work instructions and/or product-specific templates and tooling. Information is developed during product design and in production and quality planning. b) Process equipment - process equipment, machines, hardware and software are selected on their ability to consistently produce products and provide services that meet specified requirements. Selection and maintenance of process equipment is documented. Refer to Procedure QP701: Production Planning and Risk Management, Procedure QP812: Device Risk Management and Procedure QP602: Equipment Maintenance. c) Monitoring and measuring devices - requirements for measuring and monitoring devices are determined in accordance with product and process monitoring and measurement programs defined in product realisation planning. The system for managing and controlling measuring and monitoring devices is documented. Refer to Procedure QP715: Measuring and Monitoring Equipment. d) Monitoring and measurement activities - monitoring and measurement of product is implemented through receiving, in-process and final inspection, as defined in procedures. Refer to Procedure QP707: Verification of Purchased Product, Procedure QP803: In-process Inspection and Procedure QP804: Final Acceptance Inspection. e) Product release and delivery - products are released for delivery only after all specified production activities have been satisfactorily completed and conformity of the product and associated Device History Record has been verified. Refer to Procedure QP804: Final Acceptance Inspection and Procedure QP714: Storage and Delivery. If installation and servicing do not apply, delete or edit clause f. (following) accordingly and delete and/or edit the associated procedure. f) Installation and servicing - device installation and servicing specifications and instructions are developed as part of the device design project, subject to applicable controls specified. The system for controlling installation and servicing operations is defined in a procedure. Refer to Procedure QP711: Installation and Servicing and Procedure QP703: Design Control. g) Labelling and packaging - labelling and packaging are considered to be part of the device itself. All components, processes and activities related to labelling and packaging meet the same requirements that apply to the design and manufacturing of the device. Application of quality system controls to labelling and packaging are documented. Refer to Procedure QP713: Labelling and Packaging. 7.5.1.2. Cleanliness of product and contamination control Documented requirements for cleanliness of product are established when product cleanliness is of significance, and when the product is to be cleaned for any reason and at any time prior to use or if it cannot be cleaned before sterilization or use. A procedure is in place to define who is responsible for defining these requirements, and how cleaning processes are developed, validated and implemented. Devices that may have been biologically contaminated are labelled ‘BIO HAZARD’ and are immediately moved to a special decontamination area. A procedure defines how to identify, handle, segregate and decontaminate such devices. This applies to devices that have been used by customers or in trials or demonstrations, and may be contaminated (typically with blood or other bodily fluids). Delete this clause if it does not apply. Document is current if front page has “Controlled copy” stamped

Page 34 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

For other types of contaminants that do not create a bio-hazard, products that are suspected of being contaminated are handled, identified and processed accordingly. Refer to Procedure QP805: Control of Non-Conforming Product and Procedure QP709: Cleanliness and Contamination of Product. 7.5.1.3. Installation activities Installation may be not applicable, performed by <Company Name> or agent prior to "delivery" or performed by customer/user after delivery. This section describes the third case (refer QP711). However, modify to reflect <Company Name> practices. Product installation instructions are developed as part of the product design project, subject to applicable controls and published in a booklet enclosed with the product. Development, validation and control of installation instructions are documented. Refer to Procedure QP711: Installation and Servicing and Procedure QP703: Design Control. 7.5.1.4. Servicing activities If servicing (either directly or indirectly) of products is not performed, state that servicing of products is not performed by <Company Name>. If servicing is subcontracted, explain the procedures, selection of sub-contractors and controls (including customer feedback and corrective actions). Servicing is concluded by verifying that the servicing meets specified requirements. Checklists, inspection instructions and test procedures are documented and servicing personnel are trained in their use. Servicing diagnosis, repairs and verification results are recorded in a service report. As a minimum, the report includes the: This list is from CFR 820.200, delete or edit as applicable. • name of the product serviced • product serial or batch number • date of service • technician servicing the device • service performed • test and inspection data Service reports are analysed to determine if the information is to be handled as a complaint or as an input to process improvement. Service reports should also be analysed with appropriate statistical methods to identify any systematic failures and quality problems that need to be addressed. Service requests associated with allegations of serious injury or death are automatically considered as complaints and recorded and investigated, in accordance with, to determine whether the complaint represents an event which must be reported to the TGA. Refer to Procedure QP711: Installation and Servicing and Procedure QP809: Customer Complaints. 7.5.1.5. Particular requirements for sterile medical devices Insert as appropriate or delete.

Document is current if front page has “Controlled copy” stamped

Page 35 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

7.5.2.

Validation of processes for production and service provision

Production, engineering and quality assurance are responsible for identifying, validating and documenting processes for production and services. Examples of special processes are: joining of materials by welding, soldering, splicing, gluing; moulding and casing of metals, plastics or cements; coating with paints, epoxies, metals, plastics or other materials; heat, radiation or chemical treatment of materials; etc. Delete if sterilisation does not apply. This section includes requirements for clause 7.5.7. The sterilisation process or sterile barrier systems are validated and qualified using a documented validation protocol and records maintained. Validation occurs prior to implementation and after product or process changes Computer software is validated prior to use if it controls production processes. This also applies to software used in quality control (equipment or instruments). The specific approach and activities associated with software validation and revalidation shall be proportionate to the risk associated with the use of the software. Refer to Procedure QP710: Validation of Processes and Software. 7.5.2.1. Particular requirements for sterile medical devices Insert as required or delete.

7.5.3.

Identification and traceability

7.5.3.1. Identification Materials, components and finished devices are identified throughout all stages of production and in storage. This may be a regulatory requirement for some devices. Refer to the following documents: • Procedure QP712: Product Identification and Traceability • Procedure QP708: Production Work Order and History Record • Procedure QP713: Labelling and Packaging 7.5.3.2. Traceability Traceability is maintained when required by applicable laws and regulations or when specified internally to facilitate corrective actions. Traceability is based on identifying the finished devices or batches with unique numbers. Procedures and activities related to maintaining and recording traceability are required to be documented. Refer to Procedure QP712: Product Identification and Traceability and Procedure QP708: Production Work Order and History Record. If traceability is not applicable, a claim for exemption from this clause can be made. However, if traceability is a requirement, refer procedures QP712 and QP708. Ensure these procedures and this section match. In this documentation, detailed instructions for identification of inspection status are provided directly in the referenced inspection and product verification procedures. Include particular requirements for active implantable medical devices and implantable medical devices

Document is current if front page has “Controlled copy” stamped

Page 36 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

7.5.3.3. Status identification Amend as required. A documented procedure describing the process of allocation of status to product throughout production is required. This ensures only compliant product or components are released for use. Refer to Procedure QP712: Product Identification and Traceability.

7.5.4.

Customer property

If products are not received from customers, an exemption may be claimed (then delete this section). Customer property includes samples, materials, components and parts intended for production, returnable packaging materials, manufacturing equipment and tooling, special gauges, templates, measuring and testing equipment or software and engineering drawings and specifications. Customer-supplied products are received and inspected following the same procedure that applies to purchased products. In the event the supplied products fail inspection or are not suitable for any other reason, the customer is contacted. Marking, storage, handling and preservation of customer-supplied products follow the same procedures that apply to the purchased products. Refer to the following documents: • Procedure QP712: Product Identification and Traceability • Procedure QP714: Storage and Distribution • Procedure QP707: Verification of Purchased Product Refer to any other procedures that would apply to customer's products. Customer-owned tooling, gauges and returnable packaging are permanently marked so that ownership of each item is apparent. Customer's software, documents and other intellectual property are protected to the same extent, as would internal documents of similar content. Additional measures may be required if there are contractual requirements for special measures to protect the customer's intellectual property. When specified in a contract, special handling instructions from customers will take precedent over <Company Name>'s standard procedures. For example, customers may require that their products be segregated and identified in a special way. Customers are immediately informed in the event of loss, damage, deterioration, or unsuitability of their products.

7.5.5.

Preservation of product

During internal processing and final delivery to the customer, the company will ensure adequate handling, storage, labelling and protection for all materials to: • preserve quality • safeguard from loss or theft • safeguard against damage or alteration Document is current if front page has “Controlled copy” stamped

Page 37 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

Production is responsible for product handling and preservation and in particular: • for ensuring that containers holding products are suitable and are in good condition • that equipment used for internal transportation of products is well maintained and is properly operated • that products are adequately protected during production and storage Refer to Procedure QP709: Cleanliness and Contamination of Product and Procedure

QP714: Storage and Distribution.

Storage, stockrooms and storage, staging and holding areas: • are controlled by the department that brings in new stock or uses the area • are appropriate to ensure adequate preservation and protection of product Procedures and/or work instructions are established for control of product with limited shelf-life or requiring special storage conditions (Procedure QP714: Storage and

Distribution).

Primary packaging includes boxes, bags or other packaging in which products are presented to the customers and patients. Primary packaging and labelling are considered to be part of production processes and are controlled as defined in a procedure (Procedure QP713: Labelling and Packaging). Secondary packaging includes cardboard boxes, crates or additional packaging intended to contain and protect products for shipping and transportation. Modify clause to accurately identify the nature of primary and secondary packaging, as used at <Company Name>.

7.6.

Control of monitoring and measuring devices This section is a brief summary of procedure QP715. Review and modify QP715, as required, then adjust this section accordingly. Appropriate measuring and monitoring devices are selected to ensure that their measurement capability is consistent with the measurement requirements. Devices used for ensuring and verifying product conformity are calibrated against an appropriate, traceable standard. Refer to Procedure QP715: Measuring and Monitoring Equipment.

7.6.1.

Measuring and monitoring devices calibration and maintenance

The scope of calibration control extends to measuring and test equipment, comparative reference hardware (e.g. gauges, templates) and software used for: • setup and monitoring of production processes • monitoring of environmental conditions • verification of product conformity • operations where defined accuracy of a measurement is required to assure product conformity Quality assurance is responsible for calibrating and maintaining measuring and monitoring devices. All active devices are inventoried in a controlled list, indicating their calibration status and location.

Document is current if front page has “Controlled copy” stamped

Page 38 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

Measuring devices are checked, adjusted and re-adjusted as necessary and are calibrated at specified intervals (or prior to use) against measurement standards traceable to international or national standards. Calibration is recorded in a calibration certificate and the calibrated devices are labelled with a calibration sticker to identify their calibration status. Measuring and monitoring devices are safeguarded from adjustments that would invalidate the measurement result. Measuring and monitoring devices are protected from damage and deterioration during handling, maintenance and storage.

7.6.2.

Validity of measurements made with non-conforming devices

When measuring equipment is found not to conform to requirements, previous measuring results are reassessed and appropriate action taken on the equipment and any product affected.

7.6.3.

Validation of software

Inspection, test, and monitoring software developed in-house is validated before it is used for product assurance or verification. Commercial software is purchased with validation certificates where available. Software is revalidated or recertified when conditions for which it was initially validated are materially changed.

Measurement, analysis and improvement

8.1.

General Measurement and monitoring activities to ensure and verify product conformity are defined in engineering specifications and drawings, production work orders, inspection and testing procedures and process control procedures. Refer to the following documents: • Procedure QP707: Verification of Purchased Product • Procedure QP803: In-process inspections • Procedure QP804: Final inspection Edit to reflect the types of activities at <Company Name>. Delete references to QP803 if not relevant. The conformity and effectiveness of the QMS is monitored by internal audits and measuring quality performance. Results of these activities are reported to high-level management and are used to identify opportunities for improvement. Activities related to internal audits and to measuring customer satisfaction and quality performance are defined in procedures. Refer to Procedure QP802: Internal Quality Audits and Procedure QP801: Feedback and

Customer Satisfaction.

8.1.1.

Statistical analysis

As applicable, statistical techniques may be applied to the following types of activities: Add or delete as applicable. Document is current if front page has “Controlled copy” stamped

Page 39 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

• testing and validation of designs • set up of process equipment • testing and validation of processes • control of process stability and performance • establishment of sampling plans for inspections and testing • evaluation of measurement systems • analysis of quality performance and other company-level data Departmental managers are responsible for identifying the need for using statistical techniques in their departments and in other activities for which they are responsible. Quality assurance may be called upon to assist other departments in selecting and documenting specific techniques. This clause reflects CFR 820.250 Statistical Techniques. The regulation requires that sampling plans be documented and be based on valid statistical rationale. Procedures must exist to control the establishment, use and changes to sampling plans. This documentation does not have a specific procedure for controlling sampling plans but rather considers them as part of inspection/testing procedures.

8.1.2.

Sampling plans

Sampling plans for inspections, testing and other product and process acceptance activities are documented. Sampling plans are reviewed and approved by quality assurance to ensure they are based on valid statistical rationale and are appropriate. Sampling plans are issued and controlled as work instructions and are either included with the inspection/testing instructions to which they pertain or are issued as independent documents. Sampling plans are reviewed and re-evaluated when there is a significant change in reject rates or when a non-conforming product is shipped or otherwise identified after passing its acceptance inspection. Re-evaluation of a sampling plan is carried out within the framework of the pertinent corrective action and the plan is revised and reissued.

8.2.

Monitoring and measurement 8.2.1.

Feedback

Some regulators require companies to gain experience from the post-production phase. If appropriate, expand on this section and the associated procedure to define the use of post-production feedback. Customer satisfaction is a requirement of ISO 9001 only. To comply with ISO 13485:2016 only, simplify the second part of this section to focus on collecting information about customer requirements and ensure its use in risk management rather than the broader customer satisfaction. The post-production feedback system provides early warning of quality problems and input into the corrective and preventive action processes. The following sources of information are used: Edit to coordinate with Procedure QP801. • customer, user and patient complaints • defective or otherwise non-conforming product returned by customers • servicing records Document is current if front page has “Controlled copy” stamped

Page 40 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

• monitoring orders for spare parts • clinical evaluations • reviews and articles in trade and professional publications Information and data pertaining to customer satisfaction is collected from several sources, including: • customer complaints and other feedback • customer satisfaction surveys • product returns and warranty claims • repeat customer rates • market share Data will also be collected from production activities. All feedback is used as potential risk management input for corrective and preventative actions or process and product improvements. Coordinate this list with Procedure QP801 Refer to Procedure QP801: Feedback and Customer Satisfaction and Procedure QP809: Customer Complaints.

8.2.2.

Complaint handling

The organization shall document procedures for timely complaint handling in accordance with applicable regulatory requirements. Refer to Procedure QP809: Customer complaints

8.2.3.

Reporting to regulatory authorities

Where applicable, regulatory requirements may require notification of complaints. Issuance of advisory notes and recalls will also require communication with regulatory authorities. All records of reporting to regulatory authorities shall be maintained. Refer to Procedure QP808: Device Recall and Advisory Notices.

8.2.4.

Internal audit

Quality assurance is responsible for conducting internal audits to determine whether the QMS: • conforms to quality plans • conforms to management system requirements as defined in this quality manual and operational procedures • conforms to the requirements of the ISO 9001, ISO 13485:2016 and 21 CFR 820 • is effectively implemented and maintained Internal audits are performed according to the status and importance of the activities and areas, and take into consideration performance in previous audits. The audit scope, frequency, criteria and methods are defined.

Document is current if front page has “Controlled copy” stamped

Page 41 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

Appropriate corrective actions are taken by management personnel responsible for the areas where non-conforming processes and/or practices are identified. Auditors follow up to ensure that actions taken are implemented and effective. Refer to Procedure QP802: Internal Quality Audits.

8.2.5.

Monitoring and measurement of processes

ISO 13485:2016 Clause 8.2.3 applies to "QMS processes". Some include product realisation processes in this. ISO 9001 Clause 3.2.3 defines a QMS as "management system to direct and control an organisation with regard to quality." On this basis product realisation processes are not considered in this section. QMS processes are monitored by a variety of approaches and techniques, as appropriate for a particular process and its importance. These include: Items in this list are mandatory as they are specified elsewhere in the standard. Further, process specific items may be added. • conducting internal audits of the QMS • monitoring trends in corrective and preventive action requests • measuring product conformity • monitoring other quality performance data and trends To meet ISO 13485:2016 only, the following dot-point may be changed to "monitoring information related to meeting customer requirements." • monitoring information related to meeting customer requirements When a quality system process does not conform to requirements, quality assurance initiates a corrective action request to address the problem. Refer to Procedure QP810: Corrective and Preventative Actions.

8.2.6.

Monitoring and measurement of product

This section summarises the three inspection procedures QP707 Verification of Purchased Product, QP803 In-process Inspections and QP804 Final Acceptance Inspection. Edit these procedures to reflect <Company Name> practices then modify this section appropriately. Products are defined in drawings and specifications, work orders, purchasing documents and inspection and testing procedures. Documents defining the inspection and testing program are collectively referred to as control plans. Modify to include the types of documents relevant to <Company Name>. Ensure coordination of this with Section 7.6. All purchased products are subjected to a visual inspection. Some designated products are subjected to a detailed and technical quality control inspection. Processes and test equipment for performing these inspections are documented. Refer to Procedure QP707: Verification of Purchased Product. Coordinate with Procedure QP707. In-process inspections are in the form of first article inspections, operator and quality control inspections, continuous product verification by automated inspection equipment and SPC [Statistical Process Control]. The focus is on defect prevention rather than detection. Systems for performing in-process inspections are documented.

Document is current if front page has “Controlled copy” stamped

Page 42 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

Refer to Procedure QP803: In-process Inspections and Procedure QP811: Statistical Process Control. List only the types of in-process inspections that apply. If statistical process control is not use, delete references to SPC. A procedure for in-process inspections is not explicitly required in the standard and may not be necessary or relevant. Refer QP803. Finished products are subjected to the final quality control inspection. Inspectors verify that all specified receiving and in-process inspections have been carried out satisfactorily. Remaining inspections and tests necessary to complete the evidence of product conformity are then performed. Only devices that pass final inspection are distributed. Results of inspections and tests are recorded and filed. Devices are released for distribution when all specified activities have been satisfactorily completed and conformity of the product has been verified. Only personnel performing final product inspections and tests have the authority to release products. The identity of the person authorising product release is recorded. Refer to the following documents: • Procedure QP804: Final Acceptance Inspection • Procedure QP708: Production Work Order and History Record • Procedure QP403: Control of Records

8.3.

Control of non-conforming product The review and disposition of non-conforming product is the responsibility of quality assurance. When non-conforming product is identified, it is evaluated to determine whether it should be reworked, accepted or rejected. To prevent non-conforming products being shipped, they are labelled appropriately. Actions required depend on whether a non-conformance is detected before or after delivery. If reworking is required, this is documented in written rework instructions that undergo the same authorisation and approval as the original work. Reworked products are reinspected to demonstrate conformity to original requirements. These verification activities are carried out in accordance with applicable inspection instructions and procedures. To prevent a re-occurrence of a problem, an investigation into the cause of the nonconformance is undertaken. This is documented via the corrective and preventative actions procedure and recommendations are followed up to ensure that action has been taken. When processes affecting product conformity are outsourced, special controls are implemented to ensure these processes meet specified requirements. Such controls include, as appropriate: Modify this list to reflect what is used in <Company Name>. • evaluation and pre-qualification of suppliers • assessment of subcontractor's manufacturing processes • assessment of subcontractor's quality system • assessment of customer (contract) requirements • monitoring of supplier quality performance • requirements for process control, inspection, testing or other records demonstrating product conformity • verification of the supplied product

Document is current if front page has “Controlled copy” stamped

Page 43 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

The company takes full responsibility to ensure outsourced processes conform to all customer and regulatory requirements. Refer to the following documents: • Procedure QP803: In-process Inspections • Procedure QP805: Control of Non-Conforming Product • Procedure QP810: Corrective and Preventative Actions

8.4.

Analysis of data Quality Assurance coordinates the collection and analysis of appropriate data to demonstrate the suitability and effectiveness of the QMS and to identify opportunities for improvement. Refer to Procedure QP806: Analysis of Data. The quality performance data focuses on providing information relating to: • feedback • conformity to product requirements • characteristics of processes and products • supplier quality performance • audits • service reports.

8.5.

Improvement Continuous improvement of the QMS is a requirement of ISO 9001 only. ISO 13485:2016 only requires that its suitability is maintained. The minimalist approach is to edit this section and the associated procedure to reflect this difference. In practice, maintenance is not very different from improvement. The following clause explain how the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management reviews are used to implement continual improvement and to reference relevant operational procedures.

8.5.1.

General

Continual improvements are identified via the quality policy, quality objectives, audit results, analysis of data, corrective and preventative actions and management review. All changes are managed via the change control procedure. Internal audit results and quality performance data are analysed by management to assess the effectiveness of the QMS and current organisational performance. Opportunities and priorities for improvement are identified by comparing present quality performance to goals defined in the quality policy. Refer to Procedure QP501: Management Review.

8.5.2.

Device recall and advisory notices

The recall committee, including the CEO, quality assurance manager and production manager, is responsible for decisions regarding device recalls and issuing of advisory notices. In an emergency, and when there is no time to assemble the full committee, the CEO or quality manager is authorised to initiate a recall.

Document is current if front page has “Controlled copy” stamped

Page 44 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

Planning of the recall, receipt of the recalled devices, communication with regulatory authorities and other activities related to recall and to issuing of advisory notices are documented. Refer to Procedure QP808: Device Recall and Advisory Notices.

8.5.3.

Customer complaints

Customer complaints that allege deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a distributed device are logged and documented. Complaints that involve a possible failure of a device, labelling or packaging to meet specifications and/or complaints representing an event which must be reported to regulatory authorities are always investigated and the results of the investigation documented. Refer to Procedure QP809: Customer Complaints.

8.5.4.

Corrective action

In this manual, corrective actions and preventive actions are addressed in one section and there is only one operational procedure covering both. This is appropriate provided there are different procedures for identifying the need for corrective action and the need for preventive action. The difference between the two lies in the criteria for identifying the need, not in the implementation. Corrective actions are taken, without undue delay, to eliminate causes of actual nonconformities in order to prevent their recurrence. The process for taking corrective actions includes: • reviewing non-conformities and potential non-conformities • determining causes for actual and potential non-conformities • evaluating the need for action to ensure that non-conformities do not recur and that potential non-conformities are prevented • determining and implementing actions needed, including, updating documentation • verifying the actions do not adversely affect the medical device • recording results of any investigations and of actions taken • reviewing corrective actions taken and their effectiveness. Refer to Procedure QP810: Procedure Corrective and Preventative Actions.

8.5.5.

Preventative action

Preventive actions are implemented to eliminate causes of potential non-conformities in order to prevent their occurrence. Refer to QP810: Procedure Corrective and Preventative Actions.

Document is current if front page has “Controlled copy” stamped

Page 45 of 46

Insert logo here

Document ID:

QM001

Revision No.:

Quality Manual

Document Information Revision History Revision

Modified by

Change Control No.

Description of Change

Complete the above fields for each revision of this document. Ensure that there is sufficient description of changes so that the change history of this document can be followed. Additional columns can be added to include document/change tracking numbers generated by your company’s systems if required (eg. change control). Associated forms and procedures Doc. No.

Document Title

List all controlled procedural documents referenced in this document (for example, policies, procedures, forms, lists, work/operator instructions Associated records Doc. No.

Document Title

List all other referenced records in this document. For example, regulatory documents, inhouse controlled documents (such as batch record forms, reports, methods, protocols), compliance standards etc. DOCUMENT END

Document is current if front page has “Controlled copy” stamped

Page 46 of 46