ISO 15189 Documentation Kit

ISO 15189 Accreditation for Medical Laboratory

What is ISO 15189?

ISO

15189:2012

specifies

requirements

for

quality

and

competence in medical laboratories. ISO 15189 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for

confirming

or

recognizing

the

competence

of

medical

laboratories by laboratory customers, regulating authorities and accreditation bodies.

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Purpose of ISO 15189  Laboratories accredited to ISO 15189 are formally recognized to be competent, thus providing a ready means for customers to identify and select medical testing and clinical analysis services. 

ISO 15189 Certification aids the laboratories to determine

whether

they

are performing their work

correctly

and

to

appropriate standards, and provides them with a benchmark for maintaining that competence. 

Compliance to ISO 15189 is an effective marketing tool for

medical and clinical laboratories and a passport to submit tenders to contractors that require independently verified laboratories. www.globalmanagergroup.com

Benefits of ISO 15189 1. National & International Recognition.

2. Recognizes The Technical Competence Of Laboratory Staff.

3. Assures The Client That Results Are Technically Valid.

4. Provides Comparability In Measurements.

5. Decision Makers Can Rely On Test Result.

6. Improves Staff Motivation.

7. Ensures Better Support In The Event Of Legal Challenge.

8. To Assist In The Development Of New Programmes.

9. To Reduce Technical Barriers In Trade.

10. Saves Money By Getting It Right First Time.

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Documentation of ISO 15189 ISO 15189:2012 Documentation should contains principles and requirements for the competence, consistency and impartiality of the medical laboratories. ISO 15189 documents is mandatory for the consistent application of ISO 15189 by the medical laboratories for Quality Management System – ISO 15189 Certification that helps while accreditation to meet customer requirements.

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Contents of ISO 15189 Documentation 1. Quality Manual 2. Mandatory Procedures 3. Standard

Operating

Procedures 4. Exhibits 5. Sample Forms and Templates 6. Audit Checklist

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1. Quality Manual 

ISO 15189 Manual specifies requirements and policy for

laboratories used to address customer satisfaction, to meet customer and applicable regulatory requirements and to meet ISO15189:2012 requirements. 

It is expected to provide an adequate description of the

Management intention to fulfill system requirement while serving as a permanent reference for implementation and maintenance of the system. It should include how ISO 15189 system is implemented in the organization. www.globalmanagergroup.com

2. Procedures  It covers sample copy of mandatory procedures covering all the details like purpose, scope, responsibility, how procedure is followed, reference documents and formats. 

The ISO 15189 procedures are designed to help the

organization in developing effective procedures formed as per ISO 15189:2012

standard

requirements,

which

process of certification.

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accelerates

the

3. 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.  It covers SOP and tables for guideline to staff for working. It covers standard operating procedures and guidelines to make good system. It is useful for process control and establishes effective management system with good practices culture.

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4. Exhibits  The ISO 15189 Exhibits are very helpful tool to teach all employees and staff about how to implements and improvements quality requirements for medical laboratories and get number of benefits.  Following are list of Exhibits covering all the details of ISO 15189:2012 requirements.

1.Skill Requirements 2.Codification System 3.Calibration Periodicity 4.Secrecy Rules 5.Recommended conditions for sample collection, transport and storage for conventional cytogenetic analysis 6.Minimum retention period for identified records.

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5. Sample Forms and Templates 

It covers sample copy of blank forms required to maintain

records as well as establish control and make system in medical laboratories. The samples given are as a guide and not compulsory to follow and medical laboratories is free to change the same to suit own requirements

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6. Audit Checklist  The ISO 15189 audit checklist is a good tool for the auditor to make audit question to make effective ISO 15189 internal audit for their medical laboratories. It covers sample audit questions based on all the ISO 15189 requirements.  It helps the auditor to make own audit checklist for quick and perfect auditing to ensure all the ISO 15189 requirements are fulfilled by the medical laboratories.

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