FDIS ISO 9001:2015 changes and update(英文资料）
FDIS ISO 9001:2015 changes and update--------------------------------------------------------
Last updated:17th April2015
ISO9001:2015 changes are well underway with the Draft International Standard (DIS) ISO 9001:2015 released for comment in May this year.Feedback resulting from reviewing the DIS has been considered by Technical Committee 176 and the DIS has been approved although some countries did oppose it. An initial Final Draft International Standard (FDIS) was released November 2014 and is scheduled for approval August 2015. The new standard ISO 9001:2015 is planned for publication in September 2015 although I'm hearing it may be delayed.Here in the UK, as of 17th April 2015 UKAS has still not issued guidance on how Certification Bodies shall address the new version of the Standard.
The changes are far more significant than the last revision from ISO 9001:2000 to ISO 9001:2008 and are on a par with, if not greater than, the changes made to ISO 9001:2000.The main changes (as currently understood) are outlined below.However, it should be borne in mind that other changes may occur prior to publication.Main ChangesStructural Change:The structure of the new Standard has aligned itself with Annex SL. Annex SL is an ISO document prescribing the high level structure for all ISO management system standards e.g. ISO 14001; ISO 27001, ISO 9001.As ISO management system standards are updated they will all follow the same structure and use the same high level language.The new and current structures are shown below;
ISO 9001:2015 (DIS)ISO 9001:2008
0. Introduction1. Scope2. Normative references3. Terms and definitions4. Context of the organization5. Leadership6. Planning7. Support8. Operation9. Performance evaluation10. Improvement0. Introduction1. Scope2. Normative references3. Terms and definitions4. Quality management system5. Management Responsibility6. Resource Management7. Product Realization8. Measurement, analysis and improvement
Risk based approach: There is more emphasis on risk based thinking when setting up the quality management system (QMS). It will be a requirement to identify and understand risks and opportunities from external as well as internal factors and take these into account when setting up the management system. However, there is no requirement to have a formal risk assessment process in place.Terminology: There are changes to terminology throughout the Standard to facilitate interpretation and/or to recognise that the way business is conducted and managed has changed over the last decade e.g. IT, communications, storage and access of information and acquisition of materials and services.The main terminology changes are;
ISO 9001:2015 (DIS)ISO 9001:2008
Products and servicesDocumented informationEnvironment for the operation of processesExternally provided products and servicesExternal providerProductsDocumentation and RecordsWork environmentPurchased productSupplier
Management Representative: There is no longer a specified requirement for a management representative to be nominated. Instead, there will be an increased demand on top management to demonstrate organisational leadership.Exclusions: There will no longer be a requirement to specify and justify Exclusions. Currently a statement has to be prepared stating and justifying the clauses that do not apply to the QMS e.g. businesses who do not perform design activities exclude ISO 9001 clause 7.3 Design and Development.Only 7 Quality Management Principles: The existing eight quality management principles are being reduced to seven and are set out in Annex B of the Standard. The principle of "A systems approach to management" has been dropped (probably because it was considered answered by having the QMS in the first place). The last principle "Relationship Management" replaces the previously titled "Mutually beneficial supplier relationships" and broadens its scope to encompass relationships with all interested parties, not just suppliers.Documentation requirements: There is no specified requirement for a "Quality Manual". This reflects the fact that nowadays many businesses manage their documentation (policies, procedures, instructions, forms, records etc) electronically e.g. shared drives, public folders, intranet etc.There is no longer a set of specified mandatory procedures. The requirement to have "documents" (in whatever medium is appropriate) is specified throughout the standard. Where there is a requirement, it will be stated along the lines of "retain documented information" or in the case where evidence (records) are required "maintain documented information". ISO 9001:2015 clause 4.4 Quality management system and its processes currently states "organizations shall maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are being carried out as planned". The nature of those documents will be in context to the type of business, its approach to its QMS and the need to demonstrate compliance with the Standard, statutory, regulatory and contractual requirements.Process approach: The requirements for applying the process approach have become a key emphasis in ISO 9001:2015. A whole sub-section within the Introduction section is dedicated to explaining the Process Approach and it has its own clause, 4.4. Itrequires businesses to systematically define and manage not just their processes, but also the interaction between them.Companies who currently have simply written procedures for each clause of the Standard will have some work to do.Planning: This now has its own section (6) and requires risks and opportunities to be taken into account when planning the QMS. Other requirements for planning i.e. planning to achieve quality objectives and changing the QMS in a planned manner have been carried forward from ISO 9001:2008.Preventive action: This requirement has been removed. It is considered to be suitably covered by taking the risk based approach to quality management which will be one of the primary objectives of the QMS.Annex A of the Standard currently states that "one of the key purposes of the QMS is to act as a preventive tool".Purchasing: This now refers to the "external provider" as opposed to the "supplier" to help clarify that activities (products and services) which are outsourced e.g. subcontract treatments, services and hire are included and must be controlled as appropriate.Previously the emphasis was on controlling purchased product.Compliance: There is a general requirement throughout the Standard for businesses to know and understand what statutory and regulatory requirements (and any requirements from interested parties e.g. customer contractual requirements etc) it must comply with and ensure supplied products and services comply accordingly. Transition PlanningFor companies already ISO 9001:2008 certified, the current standard will be recognized and can be audited against until the end of the three year transition period, likely to be September 2018. For companies seeking new certification, ISO 9001:2008 certificates can be issued up to the Standard's expiry date but Certificates must not exceed the expiry date of the Standard.After this date all new certifications will be to ISO 9001:2015. Companies currently certified to ISO 9001:2008 do not need to panic or do anything yet (the Standard has not been finalised) other than perhaps think about existing systems and how they may have to change. However, don't leave everything to the last minute either and risk last minute fixes and re-visits resulting in additional Certification costs and poorly designed systems.
Due to the quality management system model developed and currently being used by SHA it is not envisaged that the transition will be a major upheaval or difficult task as a number of the changes are already adopted e.g. SHA's model has never included a Preventive Action procedure per se. SHA is formulating a plan to convert existing and new clients' quality management systems to the new Standard in a simple, hassle free manner and will be happy to discuss and support transition with any client either through site visits or remotely. Please contact SHA for further information and/or to discuss your requirements.
ISO 9001:2015 TimelineAccording to the draft design specification, the revised ISO 9001:2015 standard should (among other things) :
[*]Provide a stable core set of requirements for the next 10 years or more
[*]Remain generic, and relevant to all sizes and types of organisation operating in any sector
[*]Maintain the current focus on effective process management to produce desired outcomes
[*]Take account of changes in quality management systems practices and technology since the last major revision in 2000
[*]Reflect changes in the increasingly complex, demanding and dynamic environments in which organisations operate
[*]Apply Annex SL of the ISO Directives to enhance compatibility and alignment with other ISO management system standards
[*]Facilitate effective organisational implementation and effective conformity assessment by first, second and third parties
[*]Use simplified language and writing styles to aid understanding and consistent interpretations of its requirements
The ISO timetable for development is as follows:
DateISO 9001 development stage
Apr 2013CD (Final draft)
Jun 2013CD ballot opens
Jul 2013CD ballot closes
May 2014DIS released
Jul 2014DIS ballot opens
Aug 2014DIS ballot closes
Mar 2015FDIS released
Jul 2015FDIS ballot opens
Aug 2015FDIS ballot closes
Sep 2015ISO 9001: 2015 Publication
Useful linksISO
目前，我还未见到正式发布的ISO 9001 FDIS 版本，包括网上和线下，电子或纸质的。 拭目以待，结构变化挺大。 等公布后再学习也不迟 英文版的看起来有点难度，呵呵～ 变化挺大的，这样一变有些侧重点都更加明显了:D
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