QAI CSTE cheat sheet

Certification is a third-party attestation (ISO/IEC 17065) that a product conforms to specified requirements; it is distinct from testing (17025) and inspection (17020).

ISO/IEC 17065 requires the certification body to have a documented certification scheme, impartiality analysis, and a legally enforceable agreement with the client.

The certification process sequence: application review, evaluation (testing/inspection/assessment), review of evaluation results, certification decision, and surveillance.

The certification decision must be made by a person or group not involved in the evaluation; the decision-maker cannot be the evaluator.

Surveillance is required to confirm continued conformity; the scheme defines frequency, and ISO/IEC 17065 requires surveillance activities to be planned and documented.

A certificate must include: identification of the certified product, the standard/scheme, the certification body, and the validity period; it must not imply approval of a production lot beyond the scope.

Scope of certification is defined by the product, the standard, and the scheme; extending scope requires re-evaluation against the new requirements.

Suspension, withdrawal, and reduction of scope are certification body actions; suspension is temporary, withdrawal terminates the certification, and reduction narrows the scope.

The certification body must maintain a public directory of certified products and a procedure for handling complaints and appeals from clients and other parties.

ISO/IEC 17025:2017 requires a laboratory to have a quality management system, documented procedures, and a management review at planned intervals.

Method validation is required for non-standard methods, laboratory-developed methods, and standard methods used outside their intended scope; validation confirms the method is fit for purpose.

Measurement uncertainty must be evaluated for each method and reported when the client requires it or when it affects conformity to a specification.

Decision rules (e.g., ISO/IEC 17025 and ILAC G8) define how uncertainty is handled when stating conformity or non-conformity; the rule must be agreed with the client.

Test reports must include the laboratory name and address, unique report identifier, method used, results with units, and a statement that the report shall not be reproduced except in full.

Proficiency testing (ISO/IEC 17043) is used to demonstrate laboratory competence; participation is required where available and appropriate.

Equipment must be calibrated or verified before use, and calibration status must be recorded; reference standards are calibrated by an accredited body where possible.

Sampling plans and sampling procedures must be documented when the laboratory performs sampling; the sampling plan is part of the test report when relevant.

Confidentiality and impartiality are mandatory; the laboratory must identify risks to impartiality and document actions to eliminate or minimize them.

Inspection (ISO/IEC 17020) is the examination of a product, process, or service and determination of conformity to specific requirements; it may include visual, dimensional, and functional checks.

ISO/IEC 17020 defines three types of inspection bodies: Type A (independent, third-party), Type B (part of an organization that also supplies the item), and Type C (part of the organization that supplies the item).

Type A inspection bodies must not be part of an organization that designs, manufactures, supplies, installs, or maintains the items inspected; Type B and C have specific restrictions.

Inspection methods and procedures must be documented, and inspection results must be recorded in an inspection report that identifies the item, the requirements, and the findings.

Sampling for inspection must follow a documented plan; the plan defines sample size, acceptance criteria, and the basis for decisions.

Inspection personnel must be competent; competence includes knowledge of the product, the standard, and the inspection technique, and must be maintained through training and evaluation.

Inspection reports must be accurate, clear, and unambiguous; they must not include recommendations that could compromise impartiality unless the scheme permits it.

Inspection bodies must have a procedure for handling complaints and appeals, and must maintain records of inspection activities for a defined retention period.

When inspection is used for certification, the inspection body and certification body must have a documented agreement defining responsibilities and information flow.

Accreditation (ISO/IEC 17011) is third-party attestation by an accreditation body that a conformity assessment body is competent to perform specific tasks.

ISO/IEC 17011 requires the accreditation body to have a documented accreditation scheme, impartiality policy, and a process for granting, maintaining, extending, suspending, and withdrawing accreditation.

The accreditation process: application, document review, assessment (on-site), review of findings, accreditation decision, and surveillance/reassessment.

Assessors must be competent and independent of the conformity assessment body; the assessment team must include technical experts for the scope being assessed.

Code evaluation (e.g., building code, product code, or software code) is a conformity assessment activity; the evaluator must be competent in the code and the evaluation method.

The accreditation body must maintain a public list of accredited bodies and their scopes; the scope defines the standards and activities covered.

Mutual recognition arrangements (e.g., ILAC MRA, IAF MLA) rely on accreditation to facilitate acceptance of results across borders.

Nonconformities identified during assessment must be corrected by the conformity assessment body within a defined timeframe; major nonconformities may require a follow-up assessment.

Accreditation is not certification of products; it is attestation of the competence of the body performing testing, inspection, or certification.