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ISO 13485 Noz


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ISO 13485 Noz

  1. 1. ISO 13485
  2. 2. 2 Scope 1. Understanding1. Understanding 2. Quality Management System2. Quality Management System 3. Management Responsibility3. Management Responsibility 4. Resource Management4. Resource Management 5. Product Realization5. Product Realization 6. MEASUREMENT, ANALYSIS AND IMPROVEMENT6. MEASUREMENT, ANALYSIS AND IMPROVEMENT 7. Implementation7. Implementation
  3. 3. 3 Understanding 1. Based on the ISO 9001:2008 process model 2. Meets the quality system requirements of various global regulations 3. Has not been adopted by the FDA, but can easily meets the FDA QSR requirements 4. Was written as a tool for maintaining the effectiveness of processes 5. Risk management is a very key element
  4. 4. 4 ISO 9001:2008 process model C U S T O M E R R E Q U I R E M E N T S C U S T O M E R S A T I S F A C T I O N Continual Improvement of the Quality Management System Management Responsibility Resource Management Measurement, Analysis & Improvement Product Realization Product Input Output
  5. 5. 5 Additional Requirements  Design controls  Process controls (including environmental controls)  Special processes (relevant product and service oriented technical standards )  Traceability matrix  Record retention  Regulatory actions
  6. 6. 6 Quality Management System  Process Approach- Establish a QMS which identifies and manages processes  Regulatory requirements- Greater emphasis on understanding and controlling processes and Combines process and compliance auditing  Outsourcing- Responsible for controlling outsourced activities and processes  Objectives- Quality Policy should be a framework of objectives and All objectives must be measurable  Documentation- All required procedures must be implemented and maintained
  7. 7. 7 Management Responsibility  Commitment to the QMS by Top Management  Ensure there are available resources to support the QMS, and conduct management reviews  Ensure that regulatory and customer requirements are determined and met  Objectives must have top management support  Periodic review and control
  8. 8. 8 Resource Management  Adequate resources for an effective QMS that is capable of meeting customer and regulatory requirements  Management of work environment to ensure there is no adverse impact on product quality
  9. 9. 9 Product Realization  Risk management- Greater emphasis on documented risk management  Customer and regulatory requirements- Proactive approach  Design and Development:  Design Inputs  Design outputs to be verified as suitable for manufacturing  Safety according to intended use  Design Reviews and formal verification  Validation to be completed before delivery or clinical evaluation
  10. 10. 10 Product Realization (Cont.(  Purchasing- Qualification and re-evaluation  Production- Sterilization processes must be validated and records maintained (traceable to each production batch)  Process Validation- Process validation and verification (keeping with the QSR requirements of the FDA)  Product Identification and Traceability - Required throughout product realization
  11. 11. 11 Monitoring & Measurement of processes  Customer satisfaction  Internal audits  Monitoring and measurement of product  Control of Non-conforming product  Complaint handling  Analysis of data  Corrective and Preventive actions  Improvements
  12. 12. 12 Realization Requirements  7.1 Control realization planning  Product quality objectives and requirements.  Product realization needs and requirements.  Product realization risk management requirements.  Product realization record keeping requirements.
  13. 13. 13 Realization Requirements (Cont.(  7.2 Control customer processes  Requirements that customers want you to meet.  Requirements that are dictated by the product's use.  Requirements that are imposed by external agencies.  Requirements that your organization wants to meet.  Review customers' product requirements.  Communicate with your customers
  14. 14. 14 Realization Requirements  7.3 Control product design and development  Plan design and development (Stages, Controls, CM)  Define design and development inputs (Intended Use, Spec, RM, DRs).  Generate design and development outputs.  Carry out design and development reviews.  Perform design and development verifications.  Conduct design and development validations.  Manage design and development changes.
  15. 15. 15 Realization Requirements  7.4 Control your purchasing function  Approved suppliers  Control purchasing process  Document product purchases.  Verify purchased products.
  16. 16. 16 Realization Requirements  7.5 Manage production and service provision  Control production and service provision.  Validate production and service provision.  Identify and track your products.  Protect property supplied by customers.  Preserve your products and components.
  17. 17. 17 Realization Requirements  7.6 Control monitoring devices  Identify monitoring and measuring needs.  Select monitoring and measuring devices.  Develop monitoring and measuring procedures.  Calibrate your monitoring and measuring devices.  Safeguard your monitoring and measuring devices.  Validate your monitoring and measuring software.  Use your monitoring and measuring devices.
  18. 18. 18 Implementation  Detailed Gap Analysis  Detailed Work Plan  Registration  Procedures and Records  Comments from SII and corrective actions  Implementation  Comprehensive internal audits  Corrective actions  External audit and certification
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