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. This document is applicable to all organizations performing laboratory activities, regardless of the number of personnel.
Standard is suitable 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
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.
This revision cancels and supersedes the previous edition and has made three main changes:
1. A definition of “laboratory” has been added.
2. Risk-based thinking has been applied, enabling some prescriptive requirements to be replaced by performance-based requirements.
3. There is greater flexibility in the requirements for processes, procedures, documented information and organizational responsibilities.
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