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ISO 9001:2008 Implementation

Ray Ness

As of November 15. We’ll start with a brief review of the changes published in ISO 9001:2008.1 Notes 2 & 3 explain outsourced processes. 2008.1. 4. these are in the form of “notes” at the end of certain elements/clauses.com 1 . Until then. as well as the concepts of Customer Satisfaction and the Process Approach.c & .f Added clarification of documents for control.3.2. no new requirements have been introduced. Compared to ISO 9001:2000. we’ll go through a case study example of “Review and Refresh” implementation. you’ll be introduced to a useful process auditing tool for evaluating your QMS. The following is a brief outline of the most significant changes: Clause Revision 4. detailed list of the changes from ISO 9001:2000. Also note 1. Information marked “NOTE” is not a requirement to be audited – it is guidance in understanding or clarifying the associated requirement. The organization has to control outsourced processes. they may still require you to update your quality management system (QMS). Finally.intertek. certificates to ISO 9001:2000 will be considered equal to certificates to ISO 9001:2008. ISO 9001:2008 Implementation Introduction While the changes in the ISO 9001:2008 standard are minor in nature. 2009.d Added “Records” for documentation requirements.2. Annex B of ISO 9001:2008 has a full. 2010. With this article. all audits must be performed against the requirements of this new version of the standard. Any remaining ISO 9001:2000 certificates will become invalid on November 15. The changes in ISO 9001:2008 ISO 9001:2008 was published on November 15. www. you’ll gain insight and information that will help you prepare for a seamless transition. Next. Most of the changes are for ease of use and improved compatibility with ISO 14001:2004. 4.

2.5.3 Word change and note added. 7. See the Normative reference. 7.com 2 .2.5.4 Note on clarification of work environment.3. 6.2.2 Clarification of who can be the management representative.3.5.2.b Added “achieve necessary competence for personnel.f Reviewing effectiveness of corrective action.3. 7. 8.1 Note on sources for customer satisfaction.2. The QMS helps to measure and www. 7.2.3 Note on product preservation. (See 6.5.4 Note on personal property from customer to be protected.c Added information systems as pertaining to the product.2.3 Added clarification of identification of product from receiving to shipping.6) 6.1.c & 7.6. (See 7.3.e Reviewing effectiveness of preventive action. 8. 8.1 Note word added and clarification of post delivery activities. ISO 9001:2008 Implementation Clause Revision 5. status of equipment identified and note on use of software for conformity of product. 7.” 6. Key concept: Customer satisfaction Customer satisfaction is defined as: The ability to consistently provide a product or service that meets customer and applicable statutory and regulatory requirements.5 Wording change on preservation of product for conformity.d Added NC product after delivery. 8.intertek.1 Note on what is verification & validation. Implementation of these changes should be easy and “transparent” to the organization and auditors. 7.c) 8.5. The purpose of ISO 9001 is to enhance customer satisfaction through the application of a quality management system. 7.2.c Word changes.3.5.2 Added corrections and corrective actions for Internal Audits and records of results of audits now required. 8.a & .

Processes describe how work is performed and evaluated to the customer’s and organization’s expectations. Both of these factors have to be balanced in order to achieve success. to run the business efficiently for the owners. By better understanding this “horizontal” interaction of the groups within your organization. • Internal from shareholders and managers. and measurable quality objectives. usually including a “top down” hierarchy of reporting and responsibilities (organizational chart). Key concept: The process approach The process approach is a more holistic business approach to auditing. compared to the more traditional clause-based approach. Customer satisfaction can be measured from both from an External and an Internal viewpoint: • External from customers and interested parties. It recognizes that while organizations are aligned by functional departments. customer complaints. management review. customer satisfaction reports.com 3 . including: • Inputs: how many and from where? • Outputs: how many and where to? • Evaluation criteria: is this process working effectively for the business? • Competent personnel • Method or sequence to be followed www.intertek. ISO 9001:2008 Implementation manage customer satisfaction through the use of tools such as internal audit. you can ensure that all of their functions create real value for the customer. those departments and functions come together to perform the work required – providing activities that form processes. continual improvement.

and a refresher for those who have already completed implementation. Be creative with your own implementation. Process interaction Our sample organization has identified the following processes: Planning.” www. Resource Procurement supports all of the processes by obtaining the resources (materials. Assessment & Action. ISO 9001:2008 Implementation “Review and refresh” implementation: A sample case study The following is a composite case study based on the experience of Intertek auditors and clients. and is then linked to… Product Design is the stage of determining what is to be produced. it needs to meet the needs of your business. personnel. evaluate how those processes interact with one another: Planning is the beginning.intertek. A diagram is not required. “service” could be substituted for “product. Process Design. linked to… Assessment & Action is the feedback mechanism for evaluation of compliance for external and internal satisfaction. and Resource Procurement. outside services. linked to… Process Design reveals the details of how to produce. suppliers.) required for achieving the planned results of the processes. Such a diagram might look like this: * Note that in this implementation example. linked to… Production & Service is the actual creation of the product by the design. Now. equipment. You may notice that the process interaction mapped above is descriptive in nature. etc. since in the end. Product* Design. Production & Service. although some people can find them helpful. The intent is to provide guidance and understanding for an initial review of implementation.com 4 .

and specifications. open mgr. & test equipment. Mgr. instructions. An example follows: Process Inputs Outputs Effectiveness Competent Sequence Personnel Planning Market analysis. Warranty. ion. evaluate each process based on the process approach outlined above: Inputs. quote. and Sequence. Kickoff mtg. BOM. floor issues resolved. and approval of measuring design. assignments. timing plan Design statement of work. mgr. engineering techs. Design objectives. Manufacturing. product testing purchasing mgr. flow chart. mgr.. after production. Outputs.... customer development completion.. issues resolved. specifications. obtain mfg. equipment for equipment. create maint. review records. Q. quotes accepted. & BOM. estimates. test productivity is process engineer. process test methods. Design & Timing plan Engineering Mgr. Engineering. Quotes on time. equipment. Maint.. Senior Mgt. and calibration/verificat estimates.A. decision. assessment. resources. equipment acceptable to mfg. timing Customer reliability goals. of changes. open design engineers. Timing plan Mfg.intertek.com 5 . and install equipment. mgr. log time.. Process Design Mfg. program.. feasibility requirements. ISO 9001:2008 Implementation Individual process evaluation Next. drawings. Product Design goals. allocate floor space.A.. no open issues Marketing/Sales. & & CATIA drawings. test requirements. & approval/denial customer reports. results analysis. work completion. Mgr. respond to and request for customer quote. plant review design. plan. select reliability targets. Design product. review specifications. Evaluation of Effectiveness. production goals. plant Review inputs requirements for quality plan. www. create & product function material accepted and on Q. Competent Personnel.. test plan. Finance. finances statement of work available. from design. and parameters. Form team.

. provide employee Qualified Human accidents. and Materials mgr. you should focus efforts to correct any issues. or third-party – are used as an assessment of your system.. effectiveness. and conforming workers. Audits – whether internal. flow chart. and scrap costs production packaging. mgr. records. Service instructions. www.. and sources.intertek.. If you have too many processes. An audit will show you if a process is not performing “up to par” – and if that is the case. ups. approve Procurement requirements. Customer Customer Senior managers. evaluations of attained. and follow improvement. completion per processes. internal objectives measures of all plant mgr.. you might end up spending too much time on maintaining unnecessary documentation. work product meeting variances. processes. On time delivered Labor & material Plant Mgr. all other processes. shipping. equipment. tool makers. non. satisfaction performance General mgr. material & tool set instructions. maint. internal & Action customer achieved and reports. test requirements. performance Business plan metrics reports. requirements from plan. second-party. training records. ISO 9001:2008 Implementation Process Inputs Outputs Effectiveness Competent Sequence Personnel Production & Mfg. sources. Select & evaluate equipment to all affected performance.R. set up customer’s premium freight... reports. engs. Management Review will be the key for actions and prevention measures. turnover. representative.. product tests. Management Review. Purchasing mgr. Inputs/Outputs/Personnel/Sequence should be easy and simple. ensure that the process evaluations are close to the business objectives. & internal audits. training. and issue requirements & resources to all training resources to training. and processes. Resource Material and Physical resources Supplier H. Senior mgrs. Assessment Production data. status progress of objectives. processes. and of corrective continual system actions. and packaging. and review of external reports. personnel.. Test on-time delivery. Review and Refresh During this review. internal management performance. up. Review customer & costs to mfg. process production run. Schedule issue. Be flexible! “More” is not always “better” – start small and add processes as necessary in the future. and business processes. quality plans. Mgr. mfg. supvs.com 6 .

It takes into account all of the characteristics of each process. ISO 9001:2008 Implementation Process auditing tool This matrix is one of many methods that can be used to aid in the evaluation of the QMS. and helps to analyze the risk to the customer at each step.intertek. With What? Impact to the With Who? customer Are physical resources Does the process owner present? What are the risks for know the process? Are they maintained? customer satisfaction? Are people qualified and trained? INPUTS PROCESS OUTPUTS Where do they originate? Does the sequence operate What are they? Can you find evidence of as documented? Where do they go? all inputs? Where do the support Is there an acceptance processes contribute? criteria? How Many? Support processes How? Are the metrics tracked? Who supports and how? What is used to control this process? Do they have goals? Are they linked to other processes? What are the monitoring Are there actions for goals methods? not achieved? Have you checked the linkages? What are the records? Remote sites? www.com 7 .

Unlike other registrars.com to learn more. and aerospace industries.com 8 . ISO 14001. www. and ISO/TS 16949 standards.Build Stage 2 .intertek. Visit our website at www. With over 40 years of experience in the automotive. Intertek: Your partner beyond the moment of certification At Intertek. Purchasing & Supplier Management.Improve We partner with you to plan for Our expert auditors work with you Insightful audits help you find and certification.Conform Stage 3 . Intertek is dedicated to providing audit results that address your business needs and benefit the organization. and Process Engineering. Plant Management.intertek. commercial. we give you more than a certificate – we give you the tools to improve your business. to assessing your performance against your own objectives. find management to align the audit results with implement best practices for system gaps and their impact on customer requirements and your continual improvement your business business needs and objectives From sharing best practices and new industry requirements. He is a certified lead auditor for the ISO 9001. his areas of expertise include Automotive Quality Systems. we look beyond “Stage 1 and Stage 2” to be your business partner at every stage of your management system’s life cycle: Stage 1 . ISO 9001:2008 Implementation About the author Ray Ness is a lead auditor and project manager for Intertek.