What Documentation Necessary for ISO 9001:2015?

Page 1

ISO 9001:2015 Documentation Kit

for Quality Management System

By Global Manager Group


What is Quality Management System? A quality management system is a management technique used to communicate to employees what is required to produce the desired quality of products and services and to influence employee actions to complete tasks according to the quality specifications.

ISO 9001:2015 specifies the requirements for a quality management system. Organizations use the ISO 9001:2015 standard to specify the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 and the only www.Globalmanagergroup.com standard of the series to which organizations can be certified.


Principles of ISO 9001:2015 - QMS

 Customer Focus  Leadership  Involvement of People  Process Approach  System Approach to Management  Continual Improvement  Factual Approach to Decision - Making.  Mutually Beneficial Supplier Relationship

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Key Benefits of ISO 9001:2015 Certification

 Allows you to become a more consistent competitor in your marketplace

 Better quality management helps you meet customer needs  More efficient ways of working will save time, money and resources

Improved operational performance will cut errors and

increase profits

Motivate and engage staff with more efficient internal

processes

Win more high value customers with better customer

service

Broaden

www.Globalmanagergroup.com business opportunities by

demonstrating


ISO 9001:2015 Documentation Requirements The ISO 9001:2015 documents basic requirements for an organization to establish, document, implement, and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard. There are specific ISO 9001:2015 documentation requirements that need to be fulfill which provides better control over implemented QMS system. List of such requirements for better understanding quality system as per ISO 9001:2015 are as below:       

Quality Manual Quality Procedures Process Approach Standard Operating Procedures Exhibits Sample Forms and Templates ISO 9001:2015 Audit Checklist www.Globalmanagergroup.com


Quality Manual The QMS system documentation standard prescribes the minimum requirements for the content of a quality manual. The standard recognizes that the structure and format of the manual will depend on the size, culture and complexity of the organization. The ISO 9001:2015 Manual is designed to implements best quality management system as well as accelerates documentation process.

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Quality Procedure The Quality Procedures are the essence of the ISO 9001:2015 documentation. The ISO 9001 quality procedures explicitly describe how certain key processes within the company must be performed, and who is responsible for them. Ideally, the quality procedures and the quality manual are combined in a single user-friendly document.      

Procedure Procedure Procedure Procedure Procedure Procedure

for for for for for for

documented information corrective action internal audit management review Risk Management Training www.Globalmanagergroup.com


Process Approach Process Approach covers guideline for processes, flow chart and process model useful for process mapping. It covers process flow chart and activities of all the main and critical processes with input - output matrix and reference of documented information

generated

by

process

for

manufacturing

organization. It helps any organization in process mapping as well as preparing process documents for own organization. In Input and output matrix process wise risk and opportunity as well as mitigation plan for risk is given.

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Standard Operating Procedures Standard

Operating

Procedures

provide

step

by

step

instructions for performing a single activity. It helps to ensure consistency, accuracy and quality of the organization. A Standard Operating Procedure describes how to undertake a specific part of a function, or activity. It is similar to a procedure but is characterized by increased focus and further detail on a particular task. A SOP is mandatory, and must be subordinate to a procedure.

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Exhibits The ISO 9001:2015 Exhibits are very helpful tool to teach all employees

and

staff

about

how

to

implements

and

improvements quality requirements for organization and get number of benefits. Following are list of Exhibits covering all the details of ISO 9001:2015 requirements.       

Skill requirements Multi skill requirements Disposal Of Non – Conforming products Operation control plan Quality Plan – Incoming Inspection and Testing Material specifications Document Identification and Codification System www.Globalmanagergroup.com


Sample Forms and Templates Forms and templates are a way of documenting that the policies, procedures, and work instructions have been followed. Records may be forms that are filled out, a stamp of approval on a product, or a signature and date on some type of document, such as routing sheet. Records are used to provide traceability of actions taken on a specific product or batch of products. They provide data for corrective actions and a way of recalling products, if necessary.

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ISO 9001:2015 Audit Checklist The ISO 9001:2015 Audit Checklist is a good tool or the internal to

make

audit

questionnaire

while

auditing

and

make

effectiveness in auditing. It covers sample audit questions based on all the ISO 9001:2015 requirements. It also covers department

wise

questions

production,

quality

control,

like

marketing,

engineering

purchase,

and

utility,

maintenance, top management, stores, packing & dispatch, administration & training, research and development and M.R. areas and It can be used as a very good tool for logically auditing during internal audit for quality management system's certification. www.Globalmanagergroup.com


ISO 9001:2015 Documentation Kit Global Manager Group provides ISO 9001:2015 Documentation kit that having sample documents required for ISO 9001:2015 Certification. It contains all documents that covers all such requirements standard. The ISO 9001:2015 manual to ISO 9001:2015 audit checklist are provided in editable format that serves as the primary source of documentation.

The ready to use ISO 9001:2015 Documentation Kit is taking care of all clauses defined in quality management certification standard as well as it satisfies governing general requirements to create own documents for their company in couple of days. www.Globalmanagergroup.com


Global Manager Group Global Manager Group is the first company that introduces Online

Consultancy

by

offering

International

System

Certification Documentation and Auditor Training Packages available on website @ www.Globalmanagergroup.com

For further inquiry contact us : sales@Globalmanagergroup.com

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