ISO 9001:2008 Implementation

Ray Ness

2008. As of November 15. Any remaining ISO 9001:2000 certificates will become invalid on November 15. Added “Records” for documentation requirements. We’ll start with a brief review of the changes published in ISO 9001:2008. Also note 1. detailed list of the changes from ISO 9001:2000.2.d 4. The organization has to control outsourced processes. Added clarification of documents for control. www. The changes in ISO 9001:2008 ISO 9001:2008 was published on November 15. you’ll gain insight and information that will help you prepare for a seamless transition. these are in the form of “notes” at the end of certain elements/clauses. 1 .1.ISO 9001:2008 Implementation Introduction While the changes in the ISO 9001:2008 standard are minor in nature. 2009.c & .f Revision Notes 2 & 3 explain outsourced processes. you’ll be introduced to a useful process auditing tool for evaluating your QMS. Most of the changes are for ease of use and improved compatibility with ISO 14001:2004. we’ll go through a case study example of “Review and Refresh” implementation. Information marked “NOTE” is not a requirement to be audited – it is guidance in understanding or clarifying the associated requirement. Finally. they may still require you to update your quality management system (QMS).2.intertek. as well as the concepts of Customer Satisfaction and the Process Approach. no new requirements have been introduced. Until then. 2010. certificates to ISO 9001:2000 will be considered equal to certificates to ISO 9001:2008. Annex B of ISO 9001:2008 has a full. With this article. The following is a brief outline of the most significant changes: Clause 4. Compared to ISO 9001:2000. all audits must be performed against the requirements of this new version of the standard.1 4.

3.3. Added corrections and corrective actions for Internal Audits and records of results of audits now required.d 8.3 8. 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 2 . Note on personal property from customer to be protected.6.5 Added “achieve necessary competence for personnel. status of equipment identified and note on use of software for conformity of product.” Added information systems as pertaining to the product.1. Reviewing effectiveness of corrective action.b 6.3 7. Implementation of these changes should be easy and “transparent” to the organization and auditors.2. The purpose of ISO 9001 is to enhance customer satisfaction through the application of a quality management system.5.5.c) Note on sources for customer satisfaction.2 6. The QMS helps to measure and www.a & .c 6. Note on what is verification & validation.4 7.5.c & 7. Note on product preservation. Wording change on preservation of product for conformity. (See 6.1 7.2.e 8. Reviewing effectiveness of preventive action. Note word added and clarification of post delivery activities. (See 7.1 8.c 7.3.4 7. See the Normative reference.5.3. Added NC product after delivery.intertek.3. Word change and note added. Word changes. Added clarification of identification of product from receiving to shipping.3 7.2 8.6) Note on clarification of work environment.ISO 9001:2008 Implementation Clause Revision Clarification of who can be the management representative.

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

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

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

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

and helps to analyze the risk to the customer at each step. With What? Are physical resources present? Are they maintained? Impact to the customer What are the risks for customer satisfaction? With Who? Does the process owner know the process? Are people qualified and trained? INPUTS PROCESS OUTPUTS What are they? Where do they go? Is there an acceptance criteria? Where do they originate? Does the sequence operate as documented? Can you find evidence of all inputs? Where do the support processes contribute? How Many? Are the metrics tracked? Do they have goals? Are there actions for goals not achieved? Support processes How? Who supports and how? What is used to control this process? Are they linked to other processes? Have you checked the linkages? Remote sites? What are the monitoring methods? What are the records? www. 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 7 .intertek.

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

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