ISO 15189

What is ISO 15189?

ISO 15189 Medical laboratories — Particular requirements for quality and competence specify the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardisation’s Technical Committee 212 (ISO/TC 212). ISO/TC 212 assigned ISO 15189 to a working group to prepare the standard based on the details of ISO/IEC 17025:1999 General requirements for the competence of testing and calibration laboratories. This working group included provision of advice to users of the laboratory service, the collection of patient samples, the interpretation of test results, acceptable turnaround times, how testing is to be provided in a medical emergency and the lab’s role in the education and training of health care staff.

While the standard is based on ISO/IEC 17025 and ISO 9001, it is a unique document that takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to patient care.

Benefits of ISO 15189 accreditation :-

  • Improved national and global reputation and image of the laboratory.
  • Continually improving data quality and laboratory effectiveness.
  • Having a basis for most other quality systems related to laboratories, such as Good Laboratory Practices.
  • Mutual Recognition Agreement (MRA) amongst various countries test report is acceptable without repetition of analysis.
  • Customer satisfaction is achieved through introduction of Quality Management System which is a part of ISO 15189.
  • All test equipment will be calibrated and traceable to National Standards so that accuracy of results will be ascertained & maintained.
  • Laboratory will be participating in Inter laboratory Comparison program so that quality level of the lab with respect to other accredited lab can be determined.
  • Quality control checks will be carried out periodically by which system is always maintained.
  • National and international recognition (eg CTs)
  • Assurance to clients of good laboratory practice
  • Meets purchaser or regulatory specifications
  • Decision makers can rely on test results
  • Improves staff motivation and esteem
  • Ensure better support in the event of legal challenge
  • Saves money by getting it right the first time

Requirements of ISO 15189 :-

Management Requirements (Clause 4) – 15 Management Requirements

  • 4.1: Organisation and Management
  • 4.2: Quality Management System
  • 4.3: Document Control
  • 4.4: Review of Contracts
  • 4.5: Examination by Referral Laboratories
  • 4.6: External Services and Supplies
  • 4.7: Advisory Services
  • 4.8: Resolution of Complaints
  • 4.9: Identification and Control of Nonconformities
  • 4.10: Corrective Action
  • 4.11: Preventive Action
  • 4.12: Continual Improvement
  • 4.13: Quality and Technical Records
  • 4.14: Internal Audits
  • 4.15: Management Review

Technical Requirements (Clause 5) – 8 Management Requirements

1. Personnel
2. Accommodation and environmental conditions
3. Lab equipment
4. Pre-examination procedures
5. Examination procedures
6. Assuring quality of examination procedures
7. Reporting of results
8. Post-examination procedures


What we offer for ISO 15189 accreditation?

With a team of highly competent Certification and technical experts, you are sure to kick start your ISO 15189 accreditation journey with us in full confidence.

We provide you the following services for your ISO 15189 accreditation project :-

  • Awareness training
  • Gap analysis of your existing system
  • Process mapping and process definition
  • Documentation including manuals, procedures, work instructions, test instructions, check lists, formats etc.
  • Assistance in proficiency testing, inter laboratory comparison and measurement of uncertainty
  • Assistance in documentation implementation
  • Internal auditor training and conduct of internal audit
  • Pre assessment audit and pre certification audit.
  • Assistance during the entire phase of accreditation audit
  • Post certification assistance in system maintenance.

Contact us today at to get ISO 15189 accreditation for your laboratory and achieve sustainable competitive advantage in the market.



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