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ISO 15189 Documentation


Global Manager Group has prepared presentation to provide information about Medical Laboratory Accreditation Standard - ISO 15189 and about Documentation kit. All the documents like quality manual, procedures, SOPs, audit checklist, etc that required for the ISO 15189 Certification process. are described in details in this presentation. – PowerPoint PPT presentation

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Title: ISO 15189 Documentation

ISO 15189
Accreditation for
Medical Laboratory
By Global Manager Group
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.
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
  • 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
Benefits of ISO 15189
  1. National International Recognition.
  2. Recognizes The Technical Competence Of Laboratory
  3. Assures The Client That Results Are Technically
  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
  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.
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.
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
  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
  • 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
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
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
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
  • 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.
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
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
  • 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.
Global Manager Group
Global Manager Group is the first company that
introduces Online Consultancy by offering
International System Certification Documentation
and Auditor Training Packages.
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