Editable ISO 15189- 2022 Documents

ISO 15189:2022

Accreditation

Documentation Kit

(Manual, Procedures, Audit Checklist)

What is ISO 15189:2022

Documentation Kit?

The standard ISO 15189:2022 is developed for use by medical laboratories in developing their quality management systems and assessing their own competence. The ISO 15189 standard's fourth edition was published in December 2022. The ISO 15189:2022 standard edition has been totally revised and is now in accordance with the ISO/IEC 17025 standard.

Quality Manual

It covers sample copy of quality manual for ISO 15189:2022 standard. It describes how all requirement of ISO 15189:2022 standard requirements. It covers list of procedures as well as overview of organization and covers tier1 of ISO 15189:2022 documents.

Quality Procedures

Sample copies of mandatory quality procedures as per ISO 15189:2022 are provided, which cover all the details like purpose, scope, responsibility, how procedure is followed as well as the list of exhibits, reference documents and formats.

❖ List of Quality Procedures

• Procedure for maintaining impartiality

• Procedure for personnel and training

• Procedure for equipment acceptance procedure

• Procedure for equipment calibration

• Transportations of samples

• Procedure for monitoring the validity of results

• Procedure for reporting the results

• Procedure for control of documents

• Procedure for control of records

• Procedure for risk assessment

Exhibits

It covers Skill requirements, Codification system, Calibration periodicity, Secrecy rules, Recommended conditions for sample collection, transport and storage for conventional cytogenetic analysis, Minimum retention period for identified records, Impartiality policy, Patient’s right etc.

❖ List of Exhibits

• Skill requirements

• Codification system

• Calibration periodicity

• Secrecy rules

• Recommended conditions for sample collection, transport and storage for conventional cytogenetic analysis

• Minimum retention period for identified records

• Impartiality policy

• Patient’s right

Standard Operation Procedures

It covers sample standard operating procedures covering all the specific practice areas and provides details for operation of training organization.

❖ List of SOPs

• SOP for Collection and transportation of sample

• SOP for Specimen acceptance & rejection criteria

• SOP for Treatment and disposal of biomedical waste

• SOP for Housekeeping

• SOP for Use of PPE and personal safety

• SOP for Examination by lateral flow method

• SOP for Examination of COVID–

19 by CT Value

Blank Sample Formats

It covers sample copy of blank forms required to maintain records as well as establish control and make system in the organization. The samples given are as a guide and not compulsory to follow and organization is free to change the same to suit own requirements.

❖ List of Blank Formats

• Sample collection register

• Request for examination

• Customer feedback form

• Complaint report

• Equipment history card

• Preventive maintenance schedule

• Goods inward register

• Stock register

• Corrective action report

• Internal audit non–conformity report

• Improvement log

• Skill matrix

Job Description

Sample copies of job description as per ISO 15189:2022 are provided. The list of sample job description provided in the kit is given below.

❖ List of Job Description

• Job description for Director

• Job description for Quality Manager

• Job description for Technical Manager

• Job description for Lab Technicians / Microbiologist

• Job description for Sampling

Technicians

• Job description for Receptionist

Advantages of Documentation Kit

• Customizable Templates

• Fully Compliant with Standards

• More Cost & Time Efficient

• Developed by Experts

• Quick BUY Options

How Useful is This Documentation?

• The users / ISO 15189 consultant can modify readymade templates as per their working system and they can create their own documents for quick accreditation.

• It saves a lot of time and cost in document preparation. It gives value for money to customers and the number of payback is very low.

• Ready to use templates in .doc format will reduce your time in the documentation process as well as useful in giving training to staff.