QMS Level of Reference Document Planned Process Completion (Name / Rev. Question / Requirement Completion Responsibility NSF-ISR Lead Auditor Review Comments Related to 0=Not Started OR Date 10=Completed & Requirement Records Implemented (Process Name) QMS Documentation Clause 4.1 General requirements – Updates required: Documentation • ALL Increased regulatory and risk based • approach; Outsourced processes; • Change management; • Validation of software. • Clause 4.2 Documentation – requirements Updates required: Clauses 6, 7 and 8; • Medical device file; • Controls related to document and • record amendment, security and integrity Clause 5 Management Responsibility – Increased focus on regulatory • requirements; Documented procedures for • management review; documented planned intervals Evidence of : Clause 6.2 – resources Updates required: Documented processes for • competence, awareness and training Risk based training effectiveness • Evidence of : Clause 6.3 – Infrastructure Updates required: Processes for preventing product • Information systems infrastructure; • Maintenance intervals for production or • monitoring equipment. Evidence of: Clause 6.4 Work – environment Updates required: Documentation requirements for work • environment; Contamination controls for sterile • medical devices. Evidence of : Clause 7.1 Planning of – product realization Updates required; Processes for risk management; •
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. OR Records NSF-ISR Lead Auditor Review Comments QMS Documentation Clause 4.1 – General requirements Updates required: • Documentation • Increased regulatory and risk based approach; • Outsourced processes; • Change management; • Validation of software. ALL Clause 4.2 – Documentation requirements Updates required: • Clauses 6, 7 and 8; • Medical device file; • Controls related to document and record amendment, security and integrity Clause 5 – Management Responsibility • Increased focus on regulatory requirements; • Documented procedures for management review; documented planned intervals Evidence of : Clause 6.2 – resources Updates required: • Documented processes for competence, awareness and training • Risk based training effectiveness Evidence of : Clause 6.3 – Infrastructure Updates required: • Processes for preventing product • Information systems infrastructure; • Maintenance intervals for production or monitoring equipment. Evidence of: Clause 6.4 – Work environment Updates required: • Documentation requirements for work environment; • Contamination controls for sterile medical devices. Evidence of : Clause 7.1 – Planning of product realization Updates required; • Processes for risk management;
isr_13485_delta_checklist.docx