What is this standard about?
This standard is used to confirm or recognize the competence, impartiality and consistent operation of laboratories.
It applies to all organizations performing tests and/or calibrations, including first, second and third-party laboratories.
Who is this standard for?
- Laboratories where testing and/or calibration is part of inspection or product certification
- Laboratory customers
- Testing organizations
- Regulatory authorities
- Accreditation bodies
- Organizations and schemes using peer assessment
Why should you use this standard?
It specifies general requirements for the competence, impartiality and consistent operation of laboratories. It looks at all of the requirements that testing and calibration laboratories and testing organizations have to meet to prove that they operate a quality system; are technically competent; and can generate technically valid results. It applies to all organizations performing laboratory activities, regardless of the number of personnel.
What’s changed since the last update?
This standard had not been revised since 2005. This technical revision cancels and supersedes the previous edition and has made three main changes:
- the risk-based thinking applied in this edition has enabled some reduction in prescriptive requirements and their replacement by performance-based requirements;
- there is greater flexibility than in the previous edition in the requirements for processes, procedures, documented information and organizational responsibilities;
- a definition of “laboratory” has been added.
This standard looks at all of the requirements testing and calibration laboratories and testing organizations have to meet to prove that they operate a quality system, are technically competent and can generate technically valid results.