Suitability of packaging systems; • Recording of measuring equipment • adjustments. Evidence of:: Clause 8 Measurement, – analysis and improvement Clause 8.2 Monitoring and measuring – Updates required: Linkages from customer feedback into • risk management; Documented processes for ascertaining • whether customer requirements have been met; Procedures for complaint handling; • Processes for informing third parties of • complaints; Plans for internal audits at defined • intervals; Processes for the identification of test • equipment. Clause 8.3 Control of non-conforming – product Updates required: Processes for communication with • external parties regarding product; Controls for managing concessions; • Linkages between rework and • regulatory requirements. QMS Level of Reference Document Planned Process Completion (Name / Rev. Level) Question / Requirement Completion Responsibility NSF-ISR Lead Auditor Review Comments Related to 0=Not Started OR Date Requirement 10=Completed & Records Implemented (Process Name) : Clause 8.4 Analysis of data – Updates required: Sources of data for analysis, such as • service records and audits; Procedures that cover the application • of statistical techniques; Linkages between the analysis and • improvement processes. :Clause 8.5 Improvement – Updates required: Actions are without undue delay; • Evaluation of actions for adverse effects • on regulatory requirements and product safety and performance. Organization confirmation that the QMS now complies with all
• Suitability of packaging systems; • Recording of measuring equipment adjustments. Evidence of:: Clause 8 – Measurement, analysis and improvement Clause 8.2 – Monitoring and measuring Updates required: • Linkages from customer feedback into risk management; • Documented processes for ascertaining whether customer requirements have been met; • Procedures for complaint handling; • Processes for informing third parties of complaints; • Plans for internal audits at defined intervals; • Processes for the identification of test equipment. Clause 8.3 – Control of non-conforming product Updates required: • Processes for communication with external parties regarding product; • Controls for managing concessions; • Linkages between rework and regulatory requirements. Question / Requirement Level of Completion 0=Not Started 10=Completed & Implemented QMS Process Related to Requirement (Process Name) Planned Completion Date Responsibility Reference Document (Name / Rev. Level) OR Records NSF-ISR Lead Auditor Review Comments : Clause 8.4 – Analysis of data Updates required: • Sources of data for analysis, such as service records and audits; • Procedures that cover the application of statistical techniques; • Linkages between the analysis and improvement processes. :Clause 8.5 – Improvement Updates required: • Actions are without undue delay; • Evaluation of actions for adverse effects on regulatory requirements and product safety and performance. Organization confirmation that the QMS now complies with all
isr_13485_delta_checklist.docx