The standard was developed by the International Organization for Standardizations’ 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
ISO 15189 Accreditation Services
- 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.
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 be 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 labs
- can be determined.
- Quality control checks will be carried out periodically by which system is always maintained.
- National and international recognition
- 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
