Overview of Quality Management Systems and ISO 9001

2 28-January-2008 Why is ISO 9001 so popular? The scope of the Standard specifies requirements intended to: demonstrate organizations ability to consistently provide product meeting customer & applicable regulatory requirements enhance customers satisfaction through effective application of the system including processes for its continual improvement and assurance of conformity to customer and applicable regulatory requirements

3 28-January-2008 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 28-January-2008 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 28-January-2008 Relationship with ISO 9004 ISO 9001 & ISO 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 28-January-2008 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 28-January-2008 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 28-January-2008 CUSTOMERSCUSTOMERS CUSTOMERSCUSTOMERS Management responsibility Resource management Measurement, analysis, improvement Product Continual Improvement of the Quality Management System RequIrementsRequIrements SatIsfactIonSatIsfactIon Input Output System Approach of ISO 9k2k

The Deming Cycle

10 28-January-2008 The Deming Cycle for improvement is the cornerstone of all Management Systems

11 28-January PLAN: Design or revise business process components to improve results 2.DO: Implement the plan and measure its performance 3.CHECK / STUDY: Assess the measurements and report the results to decision makers 4.ACT: Decide on changes needed to improve the process

12 28-January-2008 Every organizations 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 28-January-2008 As your Management Systems mature, effective use of the Deming Cycle will ensure continual improvement

14 28-January-2008 CUSTOMERSCUSTOMERS CUSTOMERSCUSTOMERS Management responsibility Resource management Measurement, analysis, improvement Product Continual Improvement of the Quality Management System RequIrementsRequIrements SatIsfactIonSatIsfactIon Input Output System Approach of ISO 9k2k

15 28-January-2008 WASTE VARIATION SELL IT! PERFORMANCE RISK THE VALUE ADDED AUDITING APPROACH PROCESS AUDITS

8 Management Principles

17 28-January-2008 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

Customer Focus

19 28-January-2008 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 28-January-2008 CUSTOMERSCUSTOMERS CUSTOMERSCUSTOMERS Management responsibility Resource management Measurement, analysis, improvement Product Continual Improvement of the Quality Management System RequIrementsRequIrements SatIsfactIonSatIsfactIon Input Output System Approach of ISO 9k2k

21 28-January-2008 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 28-January-2008 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 28-January-2008 Customer Focus Additionally, the organization must demonstrate that effective arrangements for communicating with customers are in place in relation to:

24 28-January-2008 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 28-January-2008 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 28-January-2008 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.

Process and System Approach

28 28-January-2008 Process Approach A desired result is achieved more efficiently when activities and related resources are managed as a process. The Process Approach

29 28-January-2008 System Approach Identifying, understanding and managing interrelated processes as a system contributes to the organizations effectiveness and efficiency in achieving its objectives. The System Approach to Management

30 28-January-2008 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 28-January-2008 ISO 9000 – 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.

Process Interactions Inputs and Outputs

33 28-January-2008 Process Activities + Resources Inputs Outputs Controls (procedures, inspections, training, etc.)

34 28-January-2008 Management Systems – must define the sequence and interactions of processes Process A Process D Process B Process C Input Output Controls

35 28-January-2008 Customer requirements Customer Satisfaction Process A Process D Process B Process C A Quality Management System is focussed on meeting customer requirements.

36 28-January-2008 Regulatory requirements Regulatory Compliance Process A Process D Process B Process C Other Management Systems (Environmental, Safety, SOX, etc.) are mainly focussed on meeting regulatory requirements. The Process Approach can be used for all Management Systems!

37 28-January-2008 Investment Profitability Process A Process D Process B Process C Ultimately every Management System must be seen by Top Management as an effective method for ensuring financial performance (even though its not a requirement).

38 28-January-2008 Compatibility with other management systems Standard is intended to be compatible with other systems It is aligned with ISO and 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 28-January-2008 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 28-January-2008 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 BMS QMS OHSMS EMS

41 28-January-2008 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. Its something that we have to do for ISO BMS QMS OHSMS EMS

42 28-January-2008 This example clearly defines the sequence of processes but does it clearly define their interactions? How should process interactions be defined? Process A Process D Process B Process C Sequence versus Interactions

43 28-January-2008 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 28-January-2008 Common methods used to define process interactions: 1.Flowcharting 2.SIPOC diagrams (Six Sigma method) 3.Process Turtles (ISO 9001 method) 4.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)?

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48 28-January-2008 Most importantly, does Top Management use their process definitions to effectively manage their business (not just for audits)?

49 28-January-2008 Every process has an owner. The process outputs are their job description! The process measures are their performance review!

50 28-January-2008 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

51 28-January-2008 Quality Manual ISO 9001, clause requires: The organization shall establish and maintain a quality manual that includes A) the scope of the quality management system, including any details of and justification for any exclusions B) the documented procedures established for the QMS, or reference to them C) a description of the interaction between the processes of the QMS

52 28-January-2008 Quality Manual A QM that simply regurgitates the ISO clauses is not acceptable! A QM that includes a process map showing sequence only is not acceptable! The QM must define the process interactions (outputs & inputs)!

53 28-January-2008 Quality Manual – potential uses To manage the business as a key input to organizational planning, resource allocation, goal setting, problem solving, etc. The training material for employee orientation, especially managers! A communication tool for external parties (customers, corporate management, board of directors, regulatory bodies, etc.)

Process Measurement and Objective Deployment

55 28-January-2008 Factual Approach to Decision Making Effective decisions are based on the analysis of data and information.

56 28-January-2008 Analysis of Data & Measurement Food for Thought: Consider all the records and data that you collect and store in your company... How are each of these used for analysis, training, and improvement purposes? If you cant answer this question for nearly every record you spend time and money collecting then why do you do it?

57 28-January-2008 Analysis of Data & Measurement The organization shall determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources. The analysis of data shall provide information relating to customer satisfaction (see 8.2.1), conformity to product requirements (see 7.2.1), characteristics and trends of processes and products including opportunities for preventive action, and suppliers.

58 28-January-2008 Continual Improvement Continual improvement of the organizations overall performance should be a permanent objective of the organization.

59 28-January-2008 Continual Improvement The organization shall implement actions necessary to achieve planned results and continual improvement of the QMS processes (4.1-f). Top management shall provide evidence of its commitment to the development and implementation of the QMS and continually improve its effectiveness (5.1).

60 28-January-2008 ISO 9000 – 2.11 Quality management systems and other management system focuses The quality management system is that part of the organization's management system that focuses on the achievement of results, in relation to the quality objectives, to satisfy the needs, expectations and requirements of interested parties, as appropriate.

61 28-January-2008 ISO Auditing the quality management system Audit findings are used to assess the effectiveness of the quality management system and to identify opportunities for improvement.

62 28-January-2008 WASTE VARIATION SELL IT! PERFORMANCE RISK THE VALUE ADDED AUDITING APPROACH PROCESS AUDIT

63 28-January-2008 Process Monitoring and Measurement

64 28-January-2008 Processes must be monitored and measured - Measurement categories that need to be considered are: Quality: Does the process consistently produce desired outputs? Delivery: Does the process consistently deliver the outputs on time? Efficiency: Does the process produce and deliver the outputs using the least amount of resources necessary Others such as Cost, Safety, Regulatory Compliance, etc. Too often only one of these categories is applied and that misleads management into thinking that everything is alright.

65 28-January-2008 How does a company implement their BUSINESS PLAN? The process approach is one of the best methods to implement a business plan

66 28-January-2008 Policy Management System (Business) Objectives Process Objectives Project / Product / Sub-process objectives Top Management Process Owners Operators Top Management Effective Planning and Communication Effective policy deployment through measurement is required by all ISO 9001 based standards.

67 28-January-2008 OTD Order Review Process Warehouse Process/ Inventory Management Maintenance Process Purchasing Process Production Planning & Scheduling Process We try to focus our audits on: The linkage of the measures and objectives to customer satisfaction and business results The planning and resource allocation activities that are necessary to achieve any improvement objective The leadership and communications activities that engage the entire organization in this process The effective use of the PDCA cycle in every process that is focused on company objectives

68 28-January-2008 Policy – Defect free product, on time to the customer at a reasonable price and continually improving all processes in accordance with the requirements. Organizational objective – 98% on time to customer promise date Process objectives established to meet organizational goal Order review processes – all orders processed within 2 days of receipt Warehouse process – 100% compliance with FIFO, 18 inventory turns Maintenance Process – 97% uptime, no past due scheduled items Purchasing process – 95% of tier 1 suppliers on time and within window Production Scheduling – all shop routers completed within 1 day of receipt and all orders scheduled to be completed 2 days prior to required ship date

Management Communication and Employee Awareness

70 28-January-2008 Leadership & Involvement of People Leadership and Involvement of People Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organizations objectives. People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organizations benefit.

71 28-January-2008 Leadership & Involvement of People Top Management shall ensure that appropriate communication processes are established within the organization… (5.5.3) Specific requirements for communicating information regarding the effectiveness of the QMS and the importance of meeting customer and regulatory requirements (5.5.3 & 5.1-a).

72 28-January-2008 Leadership & Involvement of People The organization shall ensure that all personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives (6.2.2-d).

73 28-January-2008 Imagine the power of an organization that has truly achieved Unity of Purpose?

74 28-January-2008 Is this enough information to ensure that everyone clearly understands what must be done to achieve the improvement goal?

75 28-January-2008 Too often management only communicates partial information. To understand the complete path to improvement everyone needs to know the following: Where are we now (measure) and where do we want to be (goal)? Why are we here (causes of failure)? What are we doing to improve (plan)? How am I personally involved?

76 28-January-2008 TasksResp.Due% ContributionStatus Increase PM frequencies on key machines Joe K.2/23/085075% complete, Need more resources Increase buffer inventories of critical parts Janice Q.4/1/083050% complete, no issues Plan for Improvement

77 28-January-2008 EFFECTIVE Communication Too often management only communicates in one way (think - quarterly all employee meeting) Does this communication effectively reach everyone (think - kids in the back of the room)? To truly achieve unity of purpose shouldnt there be multiple communication methods happening all the time? Will management have to adjust their communication methods and frequencies or do they normally achieve perfection on the first try? Can management communication be considered a process with clear outputs (employee understanding, satisfaction, unity of purpose, etc.) and measures?

Summary

79 28-January-2008 What is the role of an auditor? Especially 3 rd party pros

80 28-January-2008 To make sure that an organization is doing the right things, the right ways, all the time. To find evidence that what the organization does is conforming, effective and efficient. To add value by: Identifying potential problems before they happen Helping to solve existing problems, and Identifying opportunities for improvement.

81 28-January-2008 Hierarchy of Quality Quality Management Quality Assurance Quality Control Advanced Auditing covers QA and QM more effectively Basic conformance auditing covers QC level

82 28-January-2008 Its not about the paperwork… Its all about if it works! Course Summary

83 28-January-2008 The majority of the efforts needed to demonstrate conformance to ISO 9001 lie with Top Management. Course Summary

84 28-January-2008 Run properly, by management, your QMS will help you achieve your business goals. Course Summary