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ISO 13485:2002 Forecast

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ISO 13485:2002 Forecast

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    1. ISO 13485:2002 Forecast ISO 9000:2000 and 9001:2000 Revisions Pierre Landry Medical Devices Bureau 8th Conference on the Global Harmonization Task Force Ottawa, 2000/09/22

    3. Medical Devices Quality System Requirements

    4. 9000 family - Before and After Existing 8402 - Vocabulary 9000-1 Selection/Use 9001, 9002, 9003 - QMS Requirements 9004-1 - QMS Guidelines 10011 - QMS Audit Process 2000 Revisions 9000 - Fundamentals and vocabulary 9001 - QMS Requirements 9004 - QMS Guidelines 19011 - QMS / EMS Audit Process

    5. Timeline for Introduction ISO 9000:2000 family by end of 2000 Including a Product Introduction Package ISO 19011:2001 ??? QMS and EMS Auditing process replacing 10011 ISO 13485:2002 and ISO 13488:2002 Not sure to update ISO 9000-2:1997 Guideline on the application of 9001 9000-2 was the base for 14969 (for medical devices) ISO 14969:2003 ??? Guideline for the application of 13485

    6. 9000:2000 family - 3 Changes Terminology and fundamental concepts 9000 Fundamentals clause (informative) 9000 Vocabulary clause (normative) Requirements (concept and layout) 9001 with clause 1.2 re. permissible exclusions rather than tier 9001/2/3 9001 process model - continual improvement Auditing process i.e. tie quality QMS with environmental EMS

    7. Fundamentals in 9000:2000 Narrative “informative” not “normative” and replaces 9000-1 Rationale for QMS 8 quality management principles Process Approach (from 20 elements in 1994 to 5 processes in 2000) Role of top management Documenting the QMS Continual Improvement Role of statistical techniques

    8. Vocabulary in 9000:2000 Normative and replaces 8402:1994 Usually adopted “as is” e.g. Clause 2 of ISO 13485:1996 Concise, precise, in 10 thematic groupings 82 definitions as opposed to 67 in 8402:94 quality, management, organization, process and product, characteristics, conformity, documentation, examination, audit, QA of measurement process ISO/TC 37 Terminology methodology

    9. 9000:2000 - Documentation Concept Diagram

    10. 9000:2000 - Documentation Concept Diagram

    11. Example 9000:2000 clause 3.7.3 3.7.3 Specification: document (3.7.2) stating requirements (3.1.2)

    12. Example 9000:2000 clause 3.7.5 cont’d Quality Plan - Definitions 8402 document setting out the specific quality practices, resources and sequence of activities relevant to a particular product, project or contract 9000:2000 document specifying which procedures and associated resources shall be applied by whom and when to a specific project, product, process or contract

    13. 9001:1994 Requirements 1 Scope 2 Normative Reference 3 Terms and Definitions 4.1 to 4.20

    14. 9001:2000 Requirements 1 Scope 2 Normative Reference 3 Terms and Definitions 4 Quality Management System 5 Management Responsibility 6 Resource Management 7 Product Realization 8 Measurement, Analysis and Improvement Note: see comparison table between 9001:1994 and 9001:2000

    15. 9001:2000 Requirements cont’d PIP (Product Introduction Package) Modules will assist in understanding of 9001:2000 Permissible exclusion (for comments ISO/176 SC2N524) Documentation (for comments ISO/176 SC2N525) Terminology (for comments ISO/176 SC2N526) Self Assessment (to be developed) Process Approach (to be developed) Transition 1994 to 2000 (to be developed)

    16. 9001:2000 Requirements cont’d Quality Plan Requirement 9001:1994, clause 4.2.3 Q. Planning the supplier shall give consideration to the following … in meeting specified requirements for product, projects or contract: a) preparation of quality plan… 9001:2000, clause 7.1 …organization shall plan and develop the processes needed for product realization... Note: A document specifying the processes of the QMS (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred as a quality plan

    17. 9001:2000 Requirements Clause 1.2 “Permissible Exclusions” in replacement of the tier 9001/2/3:1994 Applicable to all product categories hardware, processed material, software and service New layout based on the process approach, fully compatible with 9004 Aim to enhance customer satisfaction via processes for continual improvement of the QMS

    18. 9001:2000 Requirements cont’d Permissible Exclusion Organization may exclude parts of clause 7 dealing with product realization processes 7.1 Planning of product realization 7.2 Customer-related processes 7.3 Design and development 7.4 Purchasing 7.5 Production and service provision 7.6 Control of monitoring and measuring devices

    19. 9001:2000 Requirements cont’d Permissible Exclusion Condition: Exclusions do not affect ability and responsibility to provide product that fulfils customer and regulatory requirements Could be “fuzzy” at time of conformity assessment ISO/TC 210 prefers the ISO 13485/13488 approach - 13485:2002 should not adopt this provision of 9001:2000

    20. Thank you for your interest and participation Questions

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