ISO 15189

Accreditation for
Medical Laboratory

By Global Manager Group

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.
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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.

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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 accelerates the
process of certification.

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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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 Global Manager Group
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