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;
• 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
meeting applicable regulatory requirements. — New requirements added related to monitoring and of suppliers, and action to be when purchasing requirements are not met. — Provides addition details related to the content of the records. 7.4.2 Purchasing information — New requirement added to include notification of changes in purchased product. 7.4.3 Verification of purchased product — New requirements added on the extent of verification activities and action to be taken when the organization becomes of any changes to the purchased product. 7.5.1 Control of production and service provision — Adds details related to the controls for carrying out production and service provision. 7.5.2 Cleanliness of product — Added a requirement to the list. 7.5.4 Servicing activities — New requirement for analysis of records for servicing activities. 7.5.6 Validation of processes for production and service provision — Added requirements to the list — Adds details related to situations requiring procedures. — Relates the specific approach to software validation to the risk associated with the use of the software. — Adds requirements related to the validation records. 7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems — Added requirements for sterile barrier systems. 7.5.8 Identification 7.5.8 Identification — Added requirement for unique device identification. — New requirement for a documented procedure for product identification and regarding identification and product status during production 7.5.11 Preservation of product — Adds details as to how preservation can be accomplished. 8.2.1 Feedback — Indicates that feedback should come from production and post-production activities. — Adds a requirement to utilize feedback in risk management processes in order to monitor and maintain product requirements. 8.2.2 Complaint handling — New sub-clause. 8.2.3 Reporting to regulatory authorities — New sub-clause. 8.2.6 Monitoring and measurement of product — Adds requirement to identify the test equipment used to perform measurement activities. 8.3 Control of nonconforming product — Added details related to kinds of controls that shall be documented. — Generalized the requirement to include any investigation and the rationale for decisions. — Adds requirements related to concessions. — Separated requirements for nonconformities detected before delivery, detected after
delivery and rework. — Adds requirements for records related to the issuance of advisory notices. 8.4 Analysis of data — Adds the requirement to include determination of appropriate methods, including statistical techniques and the extent of their use. — Adds detail to list of inputs. 8.5.2 Corrective action — Adds the requirement to verify that the corrective action does not have an adverse effect. — Added requirement for corrective action to be taken without undue delay. 8.5.3 Preventive action — Adds the requirement to verify that the preventive action does not have an adverse effect. Appendix A ISO 13485: 2016 vs. ISO 13485: 2003 Comparison Table Amendment Record Version # Submitted Date Summary of Changes 1 10/2016 Initial issue 2 3