Overview of Quality Management Systems and ISO 9001

1. Overview of Quality Management Systems and ISO 9001

2. Why is ISO 9001 so popular? The scope of the Standard specifies requirements intended to: • demonstrate organization’s ability toconsistentlyprovide productmeeting customer & applicable regulatory requirements • enhance customer’s satisfaction througheffective application of the system including processes for its continual improvement and assurance of conformity to customer and applicable regulatory requirements

3. New Structure & Focus Why is ISO 9001 so popular? • Significantly less emphasis on procedures and records. • Significantly more emphasis on management involvement and a system that works to achieve the goals of your business.

4. The ISO 9000 “Family” • ISO 9000:2005 Quality management - Fundamentals and vocabulary • ISO 9001:2000 Quality management systems - Requirements • ISO 9004:2000 Quality management systems - Guidelines for performance improvements • ISO 10006:2003 Quality management - Guidelines for quality management in projects • ISO 10007:2003 Quality management systems - Guidelines for configuration management • ISO 10012:2003 Measurement management systems - Requirements for measurement processes and measuring equipment • ISO 19011:2002 Guidelines for quality and/or environmental management systems auditing

5. Relationship with ISO 9004 • ISO 9001 & ISO 9004 - consistent pair • Designed to complement each other • Different scope - same structure • ISO 9001 can apply for certification or contractual purposes and focuses on effectiveness • ISO 9004 aims on improving performance and efficiency

6. The Use of ISO 9004 as a Management Tool • ISO 9004 includes all of ISO 9001 plus additional items to consider for improvement ideas. • ISO 9004 should be regularly used throughout the organization to lead beyond the basics of ISO 9001 and improve the QMS. • There is a possibility that we may offer ISO 9004 “certification” for clients seeking to achieve results beyond ISO 9001

7. New Structure & Focus • The ISO 9001 Standard is modelled for Quality Management with 5 Major clauses: • Quality Management System (QMS) • Management Responsibility • Resource Management • Product Realization • Measurement, Analysis & Improvement

8. System Approach of ISO 9k2k C U S T O M E R S C U S T O M E R S Continual Improvement of the Quality Management System S a t I s f a c t I o n Management responsibility R e q u I r e m e n t s Resource management Measurement, analysis, improvement Product Product Input Output

9. The Deming Cycle

10. The Deming Cycle for improvement is the cornerstone of all Management Systems

11. PLAN: Design or revise business process components to improve results • DO: Implement the plan and measure its performance • CHECK / STUDY: Assess the measurements and report the results to decision makers • ACT: Decide on changes needed to improve the process

12. Every organization’s management systems are comprised of various processes, each with their own set of metrics, goals, targets and initiatives. The key is to align each process’ PDCA cycle with the overall strategic effort of the organization.

13. As your Management Systems mature, effective use of the Deming Cycle will ensure continual improvement

14. System Approach of ISO 9k2k C U S T O M E R S C U S T O M E R S Continual Improvement of the Quality Management System S a t I s f a c t I o n Management responsibility R e q u I r e m e n t s Resource management Measurement, analysis, improvement Product Product Input Output

15. PERFORMANCE SELL IT! RISK WASTE VARIATION THE VALUE ADDED AUDITING APPROACH PROCESS AUDITS

16. 8 Management Principles

17. New Structure & Focus • The intent of ISO 9001 is based on the 8 Management System Principles described in ISO 9004: • customer focus • leadership • involvement of people • process approach • system approach • continual improvement • factual approach to decision making • mutually beneficial supplier relationships

18. Customer Focus

19. Customer Focus Customer Focus “Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.”

20. System Approach of ISO 9k2k C U S T O M E R S C U S T O M E R S Continual Improvement of the Quality Management System S a t I s f a c t I o n Management responsibility R e q u I r e m e n t s Resource management Measurement, analysis, improvement Product Product Input Output

21. Customer Focus • Information on Customer perception as to whether the organization has met their requirements must be collected, reviewed and appropriately acted upon (8.2.1). • The methods of doing this are not prescribed by the standard but should be objective, representative of the customer base, and ADD VALUE.

22. Customer Focus • The most common methods of collecting Customer Satisfaction data are customer surveys and customer report cards (when provided). • Other methods include measuring repeat orders, market share, industry benchmarking, capturing info. from sales visits, focus groups, and hiring consulting firms. • A good system will use multiple methods and compare data from multiple sources to comprehensively understand customer perceptions and balance out any potential biases.

23. Customer Focus Additionally, the organization must demonstrate that effective arrangements for communicating with customers are in place in relation to:

24. Customer Focus Product Information (7.2.3-a): • How well do you communicate your product information to your customers? • Consider the experiences of using your favorite store Catalogue, or browsing Amazon.com or ebay... • Were you satisfied with these experiences? • How do you know what your customers think about your ability to communicate information that they are looking for?

25. Customer Focus Enquiries, contracts, and order handling, including changes (7.2.3-b): • Now consider the “buying experience” with these same companies and ask the same questions… • How do you think your customers feel about the ordering experience with your company? What about your quoting and order amendment processes?

26. Customer Focus Customer feedback, including complaints (7.2.3-c) • Consider that a customer can be more loyal when you handle their problems to their satisfaction (or delight) vs. them never having a problem at all. • Your want to know whether your customers are satisfied with how you handle their feedback (even positive) and complaints.

27. Process and System Approach

28. The Process Approach Process Approach “A desired result is achieved more efficiently when activities and related resources are managed as a process.”

29. The System Approach to Management System Approach “Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives.”

30. ISO 9000 – 2.4 The Process Approach Any activity, or set of activities, that uses resources to transform inputs to outputs can be considered as a process. For organizations to function effectively, they have to identify and manage numerous interrelated and interacting processes. Often, the output from one process will directly form the input into the next process. The systematic identification and management of the processes employed within an organization and particularly the interactions between such processes is referred to as the “process approach”.

31. ISO 9000 – 2.8.1 Evaluating processes within the quality management system When evaluating quality management systems, there are four basic questions that should be asked in relation to every process being evaluated. a) Is the process identified and appropriately defined? b) Are responsibilities assigned? c) Are the procedures implemented and maintained? d) Is the process effective in achieving the required results? The collective answers to the above questions can determine the result of the evaluation.

32. Process InteractionsInputs and Outputs

33. Controls (procedures, inspections, training, etc.) Process Activities + Resources Inputs Outputs

34. Process A Process C Process B Process D Input Output Controls Management Systems – must define the sequence and interactions of processes

35. Process A Process C Process B Process D A Quality Management System is focussed on meeting customer requirements. Customer requirements Customer Satisfaction

36. Process A Process C Process B Process D Other Management Systems (Environmental, Safety, SOX, etc.) are mainly focussed on meeting regulatory requirements. Regulatory requirements Regulatory Compliance The Process Approach can be used for all Management Systems!

37. Process A Process C Process B Process D Ultimately every Management System must be seen by Top Management as an effective method for ensuring financial performance (even though it’s not a requirement). Investment Profitability

38. Compatibility with other management systems • Standard is intended to be compatible with other systems • It is aligned with ISO 14001 and 18001 to enhance compatibility • Standard does not include requirements for other management systems such as EMS, OHSM, or financial management • Integration of management systems is possible

39. The ultimate goal of any organization is to fully integrate all • customer • shareholder • regulatory • and any other requirements? (discuss) into ONE Business Management System.

40. BMS QMS OHSMS EMS Ideal scenario: Our clients’ Quality, Health & Safety and Environmental Management Systems operate within their Business Management System Their BMS = • QMS+ • FMS+ • OHSM+ • EMS+ • ERP+ • HR

41. BMS QMS OHSMS EMS All too common scenario that we need to help change: Their QMS, OHSMS and EMS are seen as the “ISO systems” and operate mostly outside of their BMS. Management does not see the value of these. “It’s something that we have to do for ISO”

42. Process A Process C Process B Process D This example clearly defines the sequence of processes but does it clearly define their interactions?How should process interactions be defined? Sequence versus Interactions

43. Interaction should be defined using inputs and outputs • Graphical representations such as process maps / flowcharts are perhaps the most easily understandable methods of describing interaction between processes, however not a specific requirement. • Interaction can be described with words if desired • At a minimum, the processes of the organization need to be identified as per 4.1a and their interaction needs to be clearly defined in the manual as per 4.2.2c. Interaction of Processes

44. Common methods used to define process interactions: • Flowcharting • SIPOC diagrams (Six Sigma method) • Process Turtles (ISO 9001 method) • Value Stream Mapping (Lean Manufacturing method) NOTE: How many times have your processes been defined in how many ways? Are all process definitions linked and do they complement each other (no redundancy)?

48. Most importantly, does Top Management use their process definitions to effectively manage their business (not just for audits)?

49. Every process has an owner.The process outputs are their job description!The process measures are their performance review!

50. Evidence to find and communicate: • Organization charts are process based and show clear process ownership • Business metrics are process based and ensure transparent accountability for process performance • Facility floor plans can be linked to processes • Business plans and budgets align with their process definitions. • Management reviews of “process performance” include ALL processes at some frequency