Both ISO 9001:2008 and ISO 17025:2005 are standards that contribute to maintain high quality standards in your laboratory. It is important to have clarity on these and understand the differences between the two so that you can decide which one to adopt.
Evolution of ISO 9001:2008
- ISO 9001:2008 sets out requirements for Quality Management Systems. It is implemented in over 1 million organizations across several countries.
- ISO 9001 is the generic standard for the implementation and certification of quality management systems in the ISO 9000 series
- It was initially published in 1987 and comprised 3 standards -ISO 9001, ISO 9002 and ISO 9003
- Subsequently in 2000 all the three standards 9001, 9002 and 9003 were amalgamated into ISO 9001:2000
- ISO 9001:2005 defines fundamentals and vocabulary
- ISO 9001:2008 provides the frame work on Quality Management Systems which became a global bench mark in quality management
Evolution of ISO 17025:2005
- ISO 17025 is the first internationally accepted standard for laboratory quality systems that provides a basis for accreditation
- It evolved out of revision of ISO guide 25
- ISO 17025 compliments ISO 9001
- ISO 17025:1999 incorporates the requirements of ISO 9001:1995 and ISO 9002:1994 which were relevant to the scope of testing and calibration services and subsequently replaced both these two standards
- ISO 17025:2005 is the current version. Laboratories seeking accreditation of their services must comply with its requirements
Comparison between ISO 9001 and ISO 17025
- ISO 9001 is the overall standard for quality management systems and ISO 17025 provides specific guidance on applications of ISO 9001 to test and calibration laboratories
- ISO 17025 includes several steps to establish technical competence of laboratories to produce valid data specially required for testing and calibration laboratories
- ISO 9001 specifies quality system requirements on a laboratory’s capacity to provide product (s) to its clients. ISO 17025 prescribes a combination of quality requirements and also its technical competence to provide such services
- ISO 9001 certification focuses on compliance to quality management systems whereas ISO 17025 additionally focuses on proficiency of testing . This proficiency of testing is verified at different time intervals by the accreditation body
- ISO 17025 is necessary for the formal recognition of the laboratory for specific tests or measurements relevant to acceptable specifications within defined limits of uncertainty.
- The specific tests fall into the scope of testing and calibration services such as chemical, mechanical, biological, etc. ISO 17025 provides accreditation against such specified fields
- ISO 17025 further includes participation in proficiency testing, adherence to documented validated test procedures and technical competence of its laboratory personnel
Does a Laboratory require both ISO 9001 and ISO 17025?
- Both standards follow quality management systems specified under ISO 9000 but ISO 17025 is essential for testing and calibration laboratories that are seeking accreditation of their services
- A commercial testing laboratory selling its services to outside clients requires accreditation with the ISO 17025 standard
- In -house quality control laboratories routinely test products for their own manufacturing units and can be certified under ISO 9000. However if services are extended to outside clients, for a fee, then they have to be accredited under ISO 17025