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품질경영(QMS) 15개 항목

ISO 9001:2015 Control of Production & Service Provision Checklist (Clause 8.5.1)

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A checklist for implementing production and service provision under controlled conditions, covering documented information, monitoring, infrastructure, competence, and validation per ISO 9001:2015 Clause 8.5.1.

ISO 9001:2015

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Documented Information & Characteristics

  • Is documented information available that defines the characteristics of the products to be produced or services to be provided? *
  • Is documented information available that defines the results to be achieved? *
  • Are work instructions and reference standards accessible at the point of use? *

Monitoring & Measuring Resources

  • Are suitable monitoring and measuring resources available and used at appropriate stages? *
  • Are monitoring and measurement activities implemented to verify that acceptance criteria have been met? *
  • Are monitoring and measuring resources calibrated or verified and controlled where used for acceptance? *

Infrastructure, Environment & Competence

  • Is suitable infrastructure and a suitable process environment used for the operation of processes? *
  • Are competent persons, including any required qualification, appointed to the process? *
  • Is evidence of personnel qualification for special or safety-related processes retained? *

Process Validation & Human Error

  • For processes where output cannot be verified by subsequent monitoring, has the ability to achieve planned results been validated and periodically revalidated? *
  • Are actions implemented to prevent human error? *
  • Is the effectiveness of error-prevention measures monitored and improved?

Release, Delivery & Post-Delivery

  • Are release, delivery, and post-delivery activities implemented as planned? *
  • Is evidence of conformity with acceptance criteria retained before release? *
  • Process / line reviewed

ISO 9001:2015 Control of Production & Service Provision Checklist (Clause 8.5.1) 체크리스트 전체 다운로드

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