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ISO 13485:2016 Quality System PlanPurpose:To define the implementation plan for revision and updates to the quality system in order to comply with the 2016 version of ISO 13485. Advanced planning will ensure that the risks of change implementation are considered and the implementation plan is approved. The plan will also include monitoring and quality objectives to ensure that unanticipated side-effects are quickly identified and corrective actions are taken in a timely manner.Note: This plan is based upon DIS2 that was released in February 2015. The final draft is expected to be released in early 2016.Description of proposed changes:The following table identifies the procedural changes that are being proposed to the quality management system. The specific changes to each controlled document are identified by redlined version of the procedures.Document No.Description of ChangesPOL-001Quality manual is being updated to reflect the updated outline structure of the ISO 13485 standard and the updated version of the standard is referenced. References to new required procedures for UDI labeling (SYS-039) and complaint handling (SYS-018) were added.POL-003Additional terms and definitions were added to the glossary.FRM-022The organization chart was expanded to identify external entities that also participate in the quality system (e.g., importers, distributors, contract manufacturers).LST-001The master document list was updated to identify the process owner for each procedure.SYS-001The control of documents external origin and provisions for backup and recovery of controlled documents was clarified and improved.SYS-002The methods of safeguarding confidential health information (i.e., HIPPA compliance) was added to the procedure.SYS-003The management review procedure was modified to require documentation of the justification for the frequency of management reviews as an output of each management review meeting. The changes needed to address new and revised regulatory requirements was also added as a required output of management review meetings.SYS-004A requirement for documenting training effectiveness and competency for each employee was added to the procedure.SYS-006The process for change control was revised to include specified guidelines and methods of communicating significant changes to regulatory authorities for organizational changes, quality system changes, product changes and changes to the supply chain.SYS-007The process for customer-related processes was revised to include requirements for user training to ensure specified performance and safe product use.SYS-007Updated the requirements for planning of product development. A requirement to document the rationale for sample size in verification and validation testing was added. Requirements for design transfer were clarified. Requirements for validation, review, approval and documentation of design changes were added. Requirements for documentation of the design history file were specified.SYS-011Supplier qualification and on-going supplier evaluation methods were clarified with the addition of risk-based requirements and the need to determine process capability.SYS-013The requirement for analysis of service data was clarified--including the requirement for statistical analysis of the data.SYS-014The process validation procedure was updated to include a requirement for review and approval of process changes--including the need to perform revalidation and document the revalidation in a master validation plan. Requirements for packaging revalidation of sterile products was also added to the procedure.SYS-027Requirements for product acceptance, procedures, processes and equipment were added to purchasing information to be communicated in purchase orders. In addition, the requirement for a written supplier quality agreement was added.SYS-033Requirements for verification of purchased product and monitoring of product conformity were clarified in the receiving inspection procedure.SYS-039A procedure for UDI labeling was added and references to this new procedure are found in the quality manual (POL-001) and the procedure for identification and traceability (SYS-032).All proceduresA new subsection was added to all the procedures under the section of monitoring and measurement of the process. A subsection for quality objectives was added to encourage the process owner to specify quality objectives for each process. These quality objectives are linked to risk management of product realization where possible. A new subsection was also added to all the procedures under the section of training. The subsection requires the process owner to specify the methods for documenting training effectiveness and competency for each procedure.Resources needed:As part of the changes to the organization chart (FRM-022) and the master document list (LST-001), the new process owners identified are responsible for making redlines to procedures and initiating document change notices for each revised and updated controlled document. In addition, updated training requirements will be documented by each process owner to address the requirements for evaluating effectiveness of training and competency. Monitoring implementation of quality system changes:A project schedule shall be created with target due dates for review and approval of revised documents as well as personnel training. Each process owner will be responsible for developing a quantitative or semiquantitative method for estimating completion. The status of the implementation plan and progress of the overall project shall be communicated to top management as part of each management review until the project is completed.Due to the interaction between processes, processes and procedures will be organized into groups and the process owners for each group will meet as a team on a weekly basis to communicate the status of their processes and to request assistance with revisions, training and to resolve conflicts as they arise.A full quality system audit will be performed prior to the certification upgrade audit and the audit results will be reviewed by top management in a management review. Any remaining quality issues shall be addressed by initiation of an action item in the management review output.Training of personnel:The training presentations for ISO 13485 will be updated to reflect the changes in the 2016 version of the standard. The exam for training effectiveness will be updated. All personnel will be responsible for completing the required training and passing the updated exam. Lead auditors, audit team members and process owners will need training first on the changes to ISO munication of changes to customers and regulatory authorities:Planned changes to the quality system will be communicated to customers and regulatory authorities prior to implementation. Upgrading of quality system certification will be planned in advance and the date of the certification upgrade audit will be coordinated with the registrar. For any products that have a Canadian Medical Device License, Health Canada will need to be notified of the certificate changes within 30 days. ................
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