1. ISO

2. What is a standard? Standards are written guidelines which help to do things, or make things, more efficiently or more safely. Standards are written guidelines which help to do things, or make things, more efficiently or more safely. They are written through a formal prescribed process which involves consultation with relevant bodies and reaching consensus across all interested parties so that the final document meets the needs of business and society. They are written through a formal prescribed process which involves consultation with relevant bodies and reaching consensus across all interested parties so that the final document meets the needs of business and society. All standards take the form of either: specifications, methods, vocabularies, codes of practice or guides. All standards take the form of either: specifications, methods, vocabularies, codes of practice or guides.

3. What is ISO? International Organization for Standardization. International Organization for Standardization. An International-Standard setting body. An International-Standard setting body. Founded on 23 February 1947. Founded on 23 February 1947. promulgates worldwide proprietary industrial and commercial standards. promulgates worldwide proprietary industrial and commercial standards. headquarters in Geneva, Switzerland. headquarters in Geneva, Switzerland. non-governmental organization. non-governmental organization. two official languages, English and French. two official languages, English and French. ISO has 158 (of 195) national members. ISO has 158 (of 195) national members.

4. About… Name and abbreviation. Name and abbreviation. main products are the International Standards. main products are the International Standards. ISO also publishes Technical Reports, Technical Specifications, Publicly Available Specifications, Technical Corrigenda, and Guides ISO also publishes Technical Reports, Technical Specifications, Publicly Available Specifications, Technical Corrigenda, and Guides International Standards are identified in the format ISO[/IEC][/ASTM] [IS] nnnnn[:yyyy] Title International Standards are identified in the format ISO[/IEC][/ASTM] [IS] nnnnn[:yyyy] Title (IEC for International Electrotechnical Commission) (IEC for International Electrotechnical Commission) - the std. is a work of ISO/IEC JTC1 (the ISO/IEC Joint Technical Committee).

6. ISO documents are copyrighted. ISO documents are copyrighted. Not Open source. Not Open source. About…

7. List of some ISO Standards ISO 1 Standard reference temperature for geometrical product specification and verification ISO 1 Standard reference temperature for geometrical product specification and verification ISO 1 ISO 1 ISO 1000 SI units and recommendations for the use of their multiples and of certain other units ISO 1000 SI units and recommendations for the use of their multiples and of certain other units ISO 1000SI ISO 1000SI ISO 9000 Quality management system in production environments ISO 9000 Quality management system in production environments ISO 9000 ISO 9000 ISO 9001 Quality management ISO 9001 Quality management ISO 9001 ISO 9001 ISO 10006 Quality management — Guidelines to quality in project management ISO 10006 Quality management — Guidelines to quality in project management ISO 10006 ISO 10006 ISO 14001 Environmental management standards ISO 14001 Environmental management standards ISO 14001 ISO 14001 ISO/IEC 20000:2005 IT Service Management System (based on BS15000) ISO/IEC 20000:2005 IT Service Management System (based on BS15000) ISO/IEC 20000:2005 ISO/IEC 20000:2005 ISO 31000 — Risk Management ISO 31000 — Risk Management ISO 31000 ISO 31000 ISO/IEC 80000 — Quantities and Units ISO/IEC 80000 — Quantities and Units ISO/IEC 80000 ISO/IEC 80000

8. ISO 9000 ISO 9000 is a family of standards for quality management systems. ISO 9000 is a family of standards for quality management systems. maintained by ISO. maintained by ISO. administered by accreditation and certification bodies. administered by accreditation and certification bodies. Companies are "ISO 9001 certified" or "ISO 9001 registered". Companies are "ISO 9001 certified" or "ISO 9001 registered".

9. ISO 9000 series of standards includes:- ISO 9001:2008 Quality management systems – Requirements (also – 9000 series like 9002, 9003) ISO 9001:2008 Quality management systems – Requirements (also – 9000 series like 9002, 9003) ISO 9004:2000 Quality management systems - Guidelines for performance improvements ISO 9004:2000 Quality management systems - Guidelines for performance improvements ISO 9001: Version includes – 1987 1987 1994 1994 2000 2000 2008 2008 ISO 9001:2000 combines the three standards 9001, 9002, and 9003 into one, called 9001

10. ISO 9001:2008 Quality management systems — Requirements Page iv: Foreword Page iv: Foreword Pages v to vii: Section 0 Introduction Pages v to vii: Section 0 Introduction Pages 1 to 14: Requirements Pages 1 to 14: Requirements Section 1: Scope Section 1: Scope Section 2: Normative Reference Section 2: Normative Reference Section 3: Terms and definitions (specific to ISO 9001, not specified in ISO 9000) Section 3: Terms and definitions (specific to ISO 9001, not specified in ISO 9000) Pages 2 to 14 Pages 2 to 14 Section 4: Quality Management System Section 4: Quality Management System Section 5: Management Responsibility Section 5: Management Responsibility Section 6: Resource Management Section 6: Resource Management Section 7: Product Realization Section 7: Product Realization Section 8: Measurement, analysis and improvement Section 8: Measurement, analysis and improvement

11. ISO 9001:2008 Quality management systems — Requirements The standard specifies six compulsory documents: Control of Documents (4.2.3) Control of Documents (4.2.3) Control of Records (4.2.4) Control of Records (4.2.4) Internal Audits (8.2.2) Internal Audits (8.2.2) Control of Nonconforming Product / Service (8.3) Control of Nonconforming Product / Service (8.3) Corrective Action (8.5.2) Corrective Action (8.5.2) Preventive Action (8.5.3) Preventive Action (8.5.3) Also, Quality Policy & Quality Manual

12. Summary of ISO 9001:2008 in informal language See also, http://www.praxiom.com/iso-9001.htm http://www.praxiom.com/iso-9001.htm http://www.praxiom.com/iso-9001.htm

13. Elements of QMS Organizational structure Organizational structure Responsibilities Responsibilities Procedures Procedures Processes Processes Resources Resources

14. Auditing Two types of auditing: Two types of auditing: Internal Audits & External Audits

15. "compliance auditing" Tell me what you do (describe the business process) Tell me what you do (describe the business process) Show me where it says that (reference the procedure manuals) Show me where it says that (reference the procedure manuals) Prove that that is what happened (exhibit evidence in documented records) Prove that that is what happened (exhibit evidence in documented records) Non-Compliance Non-Compliance

16. Corrective Action Preventive Action CAPA is part of the overall quality management system (QMS). CAPA is part of the overall quality management system (QMS). CAPA focuses on the systematic investigation of discrepancies (failures and/or deviations) in an attempt to prevent their recurrence (for corrective action) or prevent from occurrence (for preventive action). CAPA focuses on the systematic investigation of discrepancies (failures and/or deviations) in an attempt to prevent their recurrence (for corrective action) or prevent from occurrence (for preventive action). Both fit into the Plan Do Check Act philosophy Both fit into the Plan Do Check Act philosophyPlan Do Check ActPlan Do Check Act

17. PDCA PDCA ("Plan-Do-Check-Act") is an iterative four-step problem-solving process typically used in business process improvement. It is also known as the Deming Cycle, Shewhart cycle, Deming Wheel, or Plan-Do-Study-Act. PDCA ("Plan-Do-Check-Act") is an iterative four-step problem-solving process typically used in business process improvement. It is also known as the Deming Cycle, Shewhart cycle, Deming Wheel, or Plan-Do-Study-Act.

18. The PDCA Cycle

19. Example

20. Questions?