QAI CSTE flashcards
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32 cards. Read the term and the definition here. The deck at the top of this page is optional.
- ISO/IEC 17065
- International standard specifying requirements for certification bodies that certify products, processes, or services; covers impartiality, scheme design, evaluation, decision, and surveillance.
- Certification decision
- The formal action by which a certification body grants, maintains, extends, suspends, or withdraws certification; must be made by a person not involved in the evaluation.
- Certification scheme
- A documented set of requirements, rules, and procedures for certifying products; includes the standard, evaluation methods, surveillance, and decision rules.
- Surveillance in certification
- Planned ongoing activities after certification to confirm continued conformity; frequency and methods are defined by the scheme and must be documented.
- Suspension vs withdrawal
- Suspension temporarily removes certification while issues are resolved; withdrawal permanently terminates certification and requires the client to stop using the mark.
- Scope of certification
- The products, standards, and schemes covered by a certificate; extending scope requires evaluation against the additional requirements before the decision.
- Impartiality in certification
- The certification body must identify and manage risks to impartiality; it cannot be owned or controlled by a party with a financial interest in the certification outcome.
- Public directory of certificates
- A list maintained by the certification body showing certified products, scopes, and status; required for transparency and to allow verification by interested parties.
- ISO/IEC 17025
- International standard for testing and calibration laboratories; covers competence, method validation, measurement uncertainty, equipment, reports, and impartiality.
- Method validation
- Confirmation by examination and provision of objective evidence that a method is fit for its intended use; required for non-standard, modified, or out-of-scope methods.
- Measurement uncertainty
- A parameter characterizing the dispersion of values attributed to a measurand; must be evaluated and reported when required by the client or the specification.
- Decision rule
- A documented rule describing how measurement uncertainty is accounted for when stating conformity or non-conformity with a specification; must be agreed with the client.
- Proficiency testing
- Evaluation of laboratory performance against pre-established criteria using interlaboratory comparisons; used to demonstrate and maintain competence for specific tests.
- Test report content
- Must include laboratory identification, unique report number, method, results with units, and a statement that the report shall not be reproduced except in full.
- Equipment calibration
- The set of operations establishing the relationship between values indicated by an instrument and the corresponding values of a reference standard; required before use.
- Sampling in testing
- A defined procedure for selecting a portion of a product for testing; the plan must be documented and the sampling details included in the test report.
- ISO/IEC 17020
- International standard for inspection bodies; defines competence, independence, inspection methods, reporting, and handling of complaints and appeals.
- Type A inspection body
- An inspection body that is independent of the parties involved and provides third-party inspection; must not be part of an organization that supplies the inspected items.
- Type B inspection body
- An inspection body that is part of an organization involved in the design, manufacture, supply, installation, or maintenance of the items inspected; subject to specific restrictions.
- Type C inspection body
- An inspection body that is part of the organization that supplies the inspected items; may only inspect items from that organization and must meet defined independence criteria.
- Inspection report
- A document recording inspection findings, including identification of the item, the requirements, the method, and the conformity determination; must be accurate and unambiguous.
- Inspection sampling plan
- A documented plan defining sample size, selection method, and acceptance criteria; forms the basis for the inspection decision and must be recorded.
- Inspection personnel competence
- The demonstrated ability of inspection staff to apply knowledge and skills; includes product knowledge, standard requirements, and inspection techniques, maintained through training.
- Complaints and appeals
- A documented process for receiving, evaluating, and deciding on complaints and appeals from clients and other parties; decisions must be made by independent personnel.
- ISO/IEC 17011
- International standard for accreditation bodies; covers impartiality, competence, accreditation process, assessment, decision, and surveillance of conformity assessment bodies.
- Accreditation
- Third-party attestation by an accreditation body that a conformity assessment body is competent to perform specific tasks; distinct from certification of products.
- Accreditation assessment
- The on-site evaluation of a conformity assessment body by an accreditation body to verify competence, including document review, interviews, and witnessing of activities.
- Accreditation scope
- The specific standards, methods, and activities for which accreditation is granted; published by the accreditation body and used to define the body's competence.
- Mutual recognition arrangement
- An agreement among accreditation bodies (e.g., ILAC MRA, IAF MLA) to recognize each other's accreditation, facilitating acceptance of results across borders.
- Code evaluation
- Conformity assessment activity that examines code (building, product, or software) against specified requirements; evaluators must be competent in the code and method.
- Nonconformity in assessment
- A failure to meet a requirement identified during accreditation assessment; must be corrected within a defined timeframe, and major nonconformities may require follow-up.
- Accreditation decision
- The formal action by which an accreditation body grants, maintains, extends, suspends, or withdraws accreditation; made by competent persons independent of the assessment team.