ISO 15189 Documentation

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ISO 15189
Accreditation for
Medical Laboratory
By Global Manager Group
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What is ISO 15189?
ISO 151892012 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 151892012 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 ISO151892012
  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 151892012 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 151892012 requirements.
• 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.

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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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introduces Online Consultancy by offering
International System Certification Documentation
and Auditor Training Packages.