Meaning
Formal addenda are attached to a laboratory’s certificate of accreditation to specify the precise testing methods and standards they are authorized to perform. The ISO 17025 Scope Annex defines the specific testing boundaries, such as voltage limits, mechanical load capacities and chemical analysis procedures, that the laboratory has proven its competence to execute. It allows cell manufacturers to verify if a test house is qualified to perform a particular test.
This sheet defines the legal limit of the laboratory’s certified capability.
Formal Schedule
Each listing identifies the specific international standards and testing limits of the accredited laboratory. If a test method is not explicitly named in the ISO 17025 Scope Annex, any data produced for that method is considered unaccredited. This distinction is critical for sourcing teams who need to verify compliance with strict regional cell safety laws.
It protects the data from rejection by regulatory bodies.
Testing Competence
Continuous audits by national accreditation bodies are mandatory to keep these documents active and updated. The assessment process verifies that the laboratory utilizes calibrated testing systems and trained operators. This verification ensures that testing reports are accepted by global regulatory authorities.
Acceptance Criteria
Regulatory bodies and quality engineers depend on these schedules to evaluate the validity of test certificates during product audits. By comparing the testing requirements against the limits stated in the ISO 17025 Scope Annex, teams can ensure that the testing was carried out under authorized conditions. This practice minimizes the risk of receiving test reports that are invalid or rejected during compliance audits, which avoids expensive testing delays during international product launches.