ISO Revisions Moving from ISO 9001 2008 to ISO 9001 2015

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ISO 9001 Quality Management System Transition Guide. Successful businesses understand the value of an effective Quality. Management System that ensures the organization is focussed on. meeting customer requirements and ensuring that they are satisfied. with the products and services that they receive from you. This guide has been designed to help you meet the Integrate with other management systems. requirements of the new international standard for Provide an integrated approach to organizational. Quality Management Systems QMS management,ISO 9001 2015 which replaces the previous. version ISO 9001 2008 It specifies the Reflect the increasingly complex environments in. requirements for establishing implementing which organizations operate. maintaining and continually improving a QMS for Enhance an organization s ability to satisfy it s. any organization regardless of type or size customers. NB This transition guide is designed to be read in. So why is it changing conjunction with the latest available version of. All ISO management system standards are subject ISO 9001 Quality Management Systems. to a regular review under the rules by which they are Requirements with guidance for use It does not. written Following a substantial ISO user survey the contain the complete content of the standard and. committee decided that a review was appropriate should not be regarded as a primary source of. and created the following objectives to maintain its reference in place of the published standard itself. relevance in today s market place and in the future. bsigroup com,Why adopt a Quality Management,System standard. Manage quality whatever the size of your business with a standard that s. recognized the world over and used by over one million organizations. With ISO 9001 Quality Management you can These are some of the benefits that our customers tell us they have. received as a result of adopting and implementing a system that. Consistently meet customers expectations meets the requirements of ISO 9001. Differentiate your company and win more business The standard allows. Improve company performance increasing efficiency and bottom You to become a more consistent competitor in your marketplace. line Better quality management helps you meet customer needs. An ISO 9001 quality management system will help you to continually More efficient ways of working will save time money and resources. monitor and manage quality whether you run a single site operation. Improved operational performance will cut errors and increase. or a global business As the world s most widely recognized quality profits. management standard it outlines ways to achieve as well as. benchmark consistent performance and service Motivate and engage staff with more efficient internal processes. Win more high value customers with better customer service. Broaden business opportunities by demonstrating compliance. Implementing ISO 9001, ISO 9001 is part of a family of quality management related standards You may find this section. useful for further reference in addition to ISO 9001. 1 ISO 9000 Quality management systems Fundamentals and 5 ISO 10004 Quality management Customer satisfaction. vocabulary Guidelines for monitoring and measuring. 2 ISO 9004 Managing for the sustained success of an organization 6 ISO 10014 Quality management Guidelines for realizing. A quality management approach financial and economic benefits. 3 ISO 10001 Quality management Customer satisfaction 7 ISO 19011 Guidelines for auditing management systems. Guidelines for codes of conduct for organizations, 4 ISO 10002 Quality management Customer satisfaction. Guidelines for complaints handling in organizations. ISO 9001 Quality Management System Transition Guide. Comparing the latest version of,ISO 9001 with ISO 9001 2008.
ISO 9001 2015 will be based on Annex SL the new high level Figure 1. structure HLS that brings a common framework to all ISO. management systems This helps to keep consistency align different. management system standards offer matching sub clauses against. the top level structure and apply common language across all. 5 Leadership,standards 10 Improvement,6 Planning, With the new standard structure in place organizations will find it 4 Context of the. easier to incorporate their quality management system into the core organization. business processes and get more involvement from senior 9 Performance. management evaluation, Based on Annex SL Fig 1 shows how the clauses of the new high CHECK DO. level structure could also be applied to the Plan Do Check Act cycle 8 Operation. The PDCA cycle can be applied to all processes and to the quality. management system as a whole,New updated concept Comment. Context of the organization Consider the combination of internal and external factors and conditions that can have an. effect on an organization s approach to its products services and investments and interested. Issues Issues can be internal or external positive or negative and include conditions that either. affect or are affected by the organization, Interested parties Can be a person or organization that can affect be affected by or perceive themselves to be. affected by a decision or activity Examples include suppliers customers or competitors. Leadership Requirements specific to top management who are defined as a person or group of people. who directs and controls an organization at the highest level. Risk associated with threats Refined planning process replaces preventive action and is defined as the effect of. and opportunities uncertainty on an expected result. Communication There are explicit and more detailed requirements for both internal and external. communications, Documented information Replaces documents and records.
Performance evaluation The measurement of quality performance and the effectiveness of the QMS covering the. methods for monitoring measurement analysis and evaluation as applicable to ensure valid. Nonconformity and corrective More detailed evaluation of both the nonconformities themselves and corrective actions. action required, Management Review More detailed requirements relating to inputs and outputs of the review. bsigroup com, Clause 4 Context of the organization process and the approach taken to manage reduce or transfer the. This is a new clause that establishes the context for the QMS Firstly. the organization will need to determine external and internal issues Finally the clause places requirements on top management to assign. that are relevant to its purpose i e what are the relevant issues both QMS relevant responsibilities and authorities but must remain. inside and out that have an impact on what the organization does or accountable for the effectiveness of the QMS. that would affect its ability to achieve the intended outcome s of its. management system, It should be noted that the term issue covers not only problems. Clause 6 Planning, which would have been the subject of preventive action in previous This clause works with Clauses 4 1 and 4 2 to complete the new way. standards but also important topics for the management system to of dealing with preventive actions The first part of this clause. address such as any market assurance and governance goals that concerns risk assessment whilst the second part is concerned with. the organization might set risk treatment The organization will need to plan actions to address. both risks and opportunities how to integrate and implement the. The final requirement in clause 4 is to establish implement maintain actions into its management system processes and evaluate the. and continually improve the QMS in accordance with the effectiveness of these actions. requirements the standard, Clause 5 Leadership Act incorporate Plan the process.
Interaction with other processes,Interaction with other processes. This clause places requirements on top management which is the improvements extent of planning. person or group of people who directs and controls the organization as necessary depends on risk. at the highest level The purpose of these requirements is to. demonstrate leadership and commitment by leading from the top. Top management now have greater involvement in the management Inputs Outputs. system and must ensure that the requirements of it are integrated Do carry out the. into the organization s processes and that the policy and objectives process. are compatible with the strategic direction of the organization In the. same context they need to have a grasp of the organization s. internal strengths and weaknesses and how these could impact on. Check monitor measure, the ability to deliver their products or services This will strengthen. the concept of business process management including the need. process performance, now to allocate specific responsibilities for processes and. demonstrate an understanding of the key risks associated with each. ISO 9001 Quality Management System Transition Guide. Clause 7 Support Clause 10 Improvement, This clause begins with a requirement that organizations shall Due to the new way of handling preventive actions there are no. determine and provide the necessary resources to establish preventive action requirements in this clause However there are. implement maintain and continually improve the QMS Simply some new corrective action requirements The first is to react to. expressed this is a very powerful requirement covering all QMS nonconformities and take action as applicable to control and. resource needs The clause continues with requirements for correct the nonconformity and deal with the consequences The. competence awareness and communication second is to determine whether similar nonconformities exist or. could potentially occur, Finally there are the requirements for documented information This.
is a new term which replaces the references in the 2008 standard The requirement for continual improvement has been extended to. to documents and records cover the suitability and adequacy of the QMS as well as its. effectiveness but it no longer specifies how an organization achieves. Clause 8 Operation, The change has brought some changes to the terminology used as. This clause deals with the execution of the plans and processes that shown in the table below. enable the organization to meet customer requirements and design. products and services It includes much of what was previously referred Major differences in terminology between ISO 9001 2008 and. to in Clause 7 of the 2008 version ISO 9001 2015, Clause 9 Performance evaluation ISO 9001 2008 ISO 9001 2015. Performance evaluation covers many of the areas previously featured in Products Products and services. Clause 8 of the 2008 version Exclusions Not used see Annex 4 for clarification of. applicability, Requirements for monitoring measurement analysis and evaluation are. Documentation records Documentated information, covered and you will need to consider what needs to be measured methods. employed when data should be analyzed and reported on and at what Work environment Environment for the operation of processes. intervals Purchased product Externally provided products and services. Supplier External provider, Internal audits must also be conducted at planned intervals with.
management reviews taking place to review the organization s management. system and ensure its continuing suitability adequacy and effectiveness. bsigroup com,Documented information, As part of the alignment with other management system standards a Where ISO 9001 2008 would have referred to records this is now. common clause on Documented Information has been adopted The expressed as a requirement to retain documented information. terms documented procedure and record have both been replaced Requirements to maintain documented information are detailed. throughout the requirements text by documented information throughout the standard and some examples are given Please read. Where ISO 9001 2008 would have referred to documented the standard carefully particularly 7 5. procedures e g to define control or support a process this is now. expressed as a requirement to maintain documented information. 4 3 Scope of the QMS 8 4 Control of externally provided products and services. 4 4 QMS and its processes 8 5 1 Production and service provision. 5 2 QMS policy 8 5 2 Identification and traceability. 6 2 QMS objectives 8 5 6 Control of changes, 7 1 5 Monitoring and measuring resources 8 7 Control of non conforming processes. 7 2 Evidence of competence 9 1 Control of monitoring measurement analysis and. 7 5 Documented information determined by the evaluation. organization as being necessary for the effectiveness of 9 2 Evidence of the audit programme s and the audit results. the QMS 9 3 Evidence of the results of management reviews. 8 1 Operational planning and control 10 1 Evidence of the nature of the nonconformities and any. 8 2 Determination of requirements for products and subsequent actions taken. services 10 3 Evidence of continual improvement,8 3 5 Design and development. Mapping table, The table below is a clause by clause comparison between the requirements of the proposed 2015 version and the current 2008 standard. ISO DIS 9001 ISO 9001 2008,4 Context of the organization 1 0 Scope.
4 1 Understanding the organization and its context 1 1 General. 4 2 Understanding the needs and expectations of 1 1 General. ISO Revisions ISO 9001 Transition guide Successful businesses understand the value of an effective Quality Management System that ensures the organization is focussed on meeting customer requirements and ensuring that they are satisfied with the products and services that they receive from you This guide has been designed to help you meet the requirements of the new international standard

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