Professional Documents
Culture Documents
Accreditation for
Medical Laboratory
www.globalmanagergroup.com
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.
www.globalmanagergroup.com
Documentation of ISO 15189
www.globalmanagergroup.com
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
www.globalmanagergroup.com
1. Quality Manual
www.globalmanagergroup.com
2. Procedures
www.globalmanagergroup.com
3. Standard Operating Procedures
www.globalmanagergroup.com
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.
www.globalmanagergroup.com
5. Sample Forms and Templates
www.globalmanagergroup.com
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.
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.
Contact us : Follow us :
www.globalmanagergroup.com
sales@globalmanagergroup.com