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Table of Contents 2 2 Introduction 2 The Standard 3 The Transition 5 Key Elements and Changes 10 SAI Global Support Introduction For many industries and organizations around the world, ISO 9001 has evolved to become the foundational quality standard on which their complete quality management system is built. However, as the integration of technology has changed many aspects of systems and operations in recent years, a degree of inflexibility and rigidness in the current ISO 9001:2008 standard was exposed. This latest revision-----due to be published in September, 2015-----will allow organizations to be more flexible in how they apply the standards and practices of ISO9001 in the context of their unique processes, technologies and business needs. The following questions and answers have been chosen for inclusion in this FAQ and organized by topic to facilitate organizations understanding of the changes afoot and how they will impact their business. The Standard Where can I get access to the ISO 9001:2015 FDIS? The Final Draft International Standard (FDIS) is the last draft before publication of the final version of ISO 9001:2015. The FDIS is scheduled for July 2015 release. You may purchase the full version of the FDIS then or the DIS version now from SAI Global by calling 1 (201) 986-1131 or uspubsales@saiglobal.com Where can I learn about the new structure of ISO 9001:2015? SAI Global has produced an infographic and published a whitepaper that includes an overview and analysis of the new high-level structure of ISO 9001, Annex SL. The whitepaper is available for download /iso-9001-2015-revision We also have a series of interactive webinars already scheduled, and public training courses on the transition all over North Americas. http://www.saiglobal.com/ training/assurance You may also contact SAI Global with any questions at certification.americas@saiglobal.com or call 1 (877) 426-0714.
3 When will the final version of ISO 9001:2015 be published, and where can I get a copy? SAI Global will offer the full document package for purchase when the new standard is published, scheduled currently for September, 2015. The Transition What is the timeline for publication and implementation of ISO 9001:2015? July -- October 2014: Comments on DIS submitted July 2015: Final Draft International Standard FDIS issued September 2015 (estimate): ISO 9001:2015 issued September 2015 - September 2018: Transition period. All current registrations to ISO 9001:2008 must be transitioned to the 2015 revision by this time, or they will lapse. Will there be an implementation guide published for ISO 9001:2015? Yes, it will be titled ISO/TR 9002:2015. As things progress, we will publish additional information on our website (/resourcelibrary/quality/ ) When should I start transitioning to ISO 9001:2015, and what should I do to prepare? hold off on taking any major action until the standard is published and the transition officially begins in September, 2015. One thing you can do is start taking inventory of your current processes and comparing them to the new high level structure proposed in the DIS. How much longer will ISO 9001:2008 compliance be recognized? Conformance to the current standard will be recognized through the end of the three-year transition period, which is due to end September, 2018. Organizations can request to be audited to the FDIS when it is issued. The issuance of certificates is an Assurance Group decision All organizations must transition to the new standard by the end of the transition period. Can I upgrade during my scheduled recertification in 2016? Yes, as long as your systems conform to the standards set forth in ISO 9001:2015. It would be prudent to begin planning discussions now based on the DIS, but
4 I m currently implementing or considering certification to ISO 9001:2008. What should I do? You should continue as planned; you have three full years to achieve certification to ISO 9001:2015 after its planned final publication in September, 2015. We would recommend familiarizing yourself with the new high-level structure, so you can build in or revise your systems with an eye toward the future. We also have a series of interactive webinars already scheduled, and public training courses on the transition all over North America. http://www. saiglobal.com/training/assurance Will the transition require additional time or budgetary resources? Most likely, but this will depend upon the current status of your management system. The areas that will be mostly impacted item will be personnel time developing or modifying current systems and processes to meet the new requirements. If you would like to know in more details how the ISO 9001:2015 might impact your organization, we offer GAP Analysis services that can help showing you if or where the audit against the revised standard will differ from your current audit. When may I begin transitioning? Do I need to wait until my Surveillance Audit? How do I measure my progress in the transition process? SAI Global can work closely with to develop an approach that will enable you to track your progress towards the new standard and ensure you are properly trained and supported every step of the way. If you are implementing the standards for the first time, then you would create a project plan and work to the dates and tasks as defined. When will auditor training be available for ISO 9001:2015? Lead and internal auditor training classes will be available following publication of the FDIS in 2015; the rules and requirements have not yet been finalized. If your organization has a robust internal audit process, the auditing techniques should not change. However, the criteria you audit against and the scope of your audits will definitely be affected. SAI Global will provide customers with additional information as it becomes available. We also have a series of interactive webinars already scheduled, and public training courses on the transition all over North America. http://www.saiglobal.com/training/assurance We also have a series of interactive webinars already scheduled, and public training courses on the transition all over North America. http://www.saiglobal.com/training/assurance You may begin the transition process as soon as the official three-year transition begins. If you wish to do it outside of your regular audit, you may do so, however it would be more efficient to do an upgrade audit to ISO 9001:2015 during one of your regular surveillance audits.
Key Elements and Changes 5 Is Plan-Do-Check-Act (PDCA) still a part of the ISO 9001 structure in the new version? Yes, the new standard is still built around the PDCA cycle. It s featured on page 8 of the Draft International Standard, and the final version will include more detailed information on this approach. Will FMEA s and Control Plans be required under ISO 9001:2015? Although very valuable tools, FMEA s and Control Plans are not required by ISO 9001:2015. Your organization could apply these tools as their approach to meet the requirements. Properly developed Control Plans would satisfy many of the requirements for section 8. FMEA s are a useful tool to identify areas of risk required in section 6. However, you will need to broaden the approach to cover all aspects of your business, not just the manufacturing processes. Is the final version of ISO 9001:2015 expected to differ significantly from Draft International Standard? It is reasonable to expect some requirements in the finalized ISO 9001:2015 will change from what s in the DIS. The finalized standard will address comments from over 150 countries, so we can t say for sure. However, we can say that the new high-level structure, outlined in the DIS, its clause numbering and additional elements around organizational context and leadership will be retained. The DIS does not require a management representative. How will this affect our relationship with SAI Global and how we manage SAI Global visits? The management system still needs a champion and a spokesperson, but it does not automatically mean that this is the quality manager-----or any one person. Optimally, these responsibilities would be shared by a member(s) of the leadership team. Once the management system has been implemented, this person s role should transform into being a facilitator of continual improvement. It should be noted that while the requirement for a designated Management Representative has been removed from the DIS, the responsibilities that were attributed to this position are still retained in the standard. What tips do you have for organizations that might want to start preparing for the new version of ISO 9001:2015? - Review your current systems management approach against the DIS to map out where changes will likely need to be made - Begin a dialogue with managers that will be affected by the proposed changes. Help them gain a comprehensive understanding of the issues at hand and help them begin to strategize an action plan for implementation - If you have certification to more than one standard, look at where management system integration might be possible and beneficial
6 - Read the introduction of the DIS; it offers some valuable guidance on the driving concepts of standard, which will very likely be retained in one form or another in the final version - Talk to one of our representatives and ask how we can support your organization prepare for the new version at certification.americas@saiglobal.com or call 1 (877) 426-0714 I have an integrated management system based on ISO 14001 and OHSAS 18001-----how will the revisions to ISO 9001 and these standards affect me? The changes will make system integration much easier as there will be greater alignment among these standards. But with differing projected publication dates and transitional periods, you should plan your transitions carefully to retain certification on each. It may be beneficial to acquire a copy of PAS 99, It offers valuable guidance on the design and structure of an integrated management system. What kinds of changes are coming to the requirements for Design and Development of Products and Services and will there be requirements for Process Design? Technically, manufacturing process design is not included. However, a note at the end of section 8.3.1 encourages organizations to apply these same principles to process design and development. Can you summarize the new approach to Preventative Action in ISO 9001:2015 DIS? The DIS requires organizations to understand their organization s business context (Clause 4.1) and determine the risks and opportunities that need to be addressed (Clause 6.1). One of the key purposes of a quality management system is to act as a preventive tool. Consequently, the new standard does not have a separate clause or sub-clause titled Preventive Action. Instead, the concept of preventive action is expressed through a risk-based approach to formulating quality management system requirements. This has resulted in a reduction of prescriptive requirements, which have been replaced by performance-based requirements. Although risks and opportunities have to be determined and addressed, there is no requirement for formal risk management or a documented risk management process. The implication is the entire management system, properly implemented, should function as a preventive tool. Much of what is now required under ISO 9001:2015 was implied and would have been considered good practices under ISO 9001:2008. Section 8.3 Design and Development of Products and Services enhances the requirements found in section 7.3 of ISO 9001:2008, which dealt with product design. Some of the requirements have been reorganized (i.e. verification and validation have been consolidated in one section 8.3.4 Design and Development Controls.)
7 What is meant by output in the ISO 9001:2015 DIS? Here are two definitions from ISO 9001:2015 DIS that explain what is meant by output: 3.12 Process A set of interrelated or interacting activities which transforms inputs into outputs (3.46) - Inputs to a process are generally outputs (3.46) of other processes. - In some processes, some inputs become outputs (3.46) without any transformation e.g. a blueprint used in a manufacturing process or a catalyst in a chemical process. - Processes in an organization (3.01) are generally planned and carried out under controlled conditions to add value. - A process where the conformity (3.18) of the resulting output (3.46) cannot be readily or economically validated is frequently referred to as a special process. 3.46 Output Result of a process (3.12) - There are four generic output categories, as follows: services (e.g. transport); software (e.g. computer program, dictionary); hardware (e.g. engine mechanical part); processed materials (e.g. lubricant). Many outputs comprise elements belonging to different generic output categories. Whether the output is then called service, product, software, hardware or processed material depends on the dominant element. For example, a car consists of hardware (e.g. tires), processed materials (e.g. fuel, cooling liquid), software (e.g. engine control software, driver s manual), and service (e.g. operating explanations given by the salesman). - In some processes, some inputs become outputs (3.46) without any transformation e.g. a blueprint used in a manufacturing process or a catalyst in a chemical process. - The ownership of a product can usually be transferred. This is not necessarily the case for a service. What are the guidelines like for internal audits under ISO 9001:2015 DIS what new factors should we be considering? Let s look at the requirements of section 9.2.2 Internal Audit. 9.2.2 The organization shall: a) plan, establish, implement and maintain an audit programme(s) including the frequency, methods, responsibilities, planning requirements and reporting, which shall take into consideration the quality objectives, the importance of the processes concerned, customer feedback, changes impacting on the organization, and the results of previous audits; b) define the audit criteria and scope for each audit; c) select auditors and conduct audits to ensure objectivity and the impartiality of the audit process - These requirements have been clarified from those in 9001:2008. Audits are still required to be conducted at planned intervals. Organizations need to establish their reasoning to support their decisions on the frequency of audits in each area/ function within the quality management system. A number of factors go into the development of an audit program, risk is only one of them. Other things to consider: complexity of the process; current state of the process or area (customer issues,
8 nonconforming product); potential impact on customers, costs, reputation to the business; changes in the area (personnel, equipment, volume, new products); results of the previous audits, etc. Will there be a requirement for a quality manual in ISO 9001:2015? ISO 9001:2015 does not require a quality manual. The question each organization should consider is whether or not having one is beneficial to the organization. If it is used as intended in 9001:2008-----an introduction to the management system that acts as a guide or roadmap to the overall system-----then by all means have one. Would meeting the risk management requirements in ISO 31000 satisfy the risk management requirements in ISO 9001:2015? An organization could certainly apply the full requirements of a risk management system as defined in ISO 31000 and more than meet the requirements for risk based thinking in ISO 9001:2015. The standard does not require a full risk management approach but rather the organization must identify, understand and consider their business environment in a broad sense and the potential risks they face. Equipped with this information, the organization should then design and implement a management system to eliminate, minimize and control these risks. Both standards will be utilizing the same high-level structure defined in Annex SL. Approximately 30% of the language in the two management system standards will be the same. ISO 14001:2015 FDIS is scheduled for issue in February - March, 2015 which represents a delay in the original scheduling. The standard ISO 14001:2015 should be issued in September 2015 along with ISO 9001:2015 if everything goes according to plan. How are the industry-specific standards for the automotive (ISO/TS 16949:2009) changing as a result of the updates to ISO 9001? The automotive industry does not look favorably on the revisions to ISO 9001. At this time, they are opting out of participating in the revision process in favor of creating their own standard. The automotive group could certainly change their position between now and when the standard is finally issued in September 2015, but whether that happens remains to be seen. We are certified to AS 9100. Are there any plans to revise this standard to accommodate new ISO 9001:2015 requirements? AS 9100 will adopt the requirements of ISO 9001:2015 when the new standard is revised in 2016. ISO 14001 is also being revised along with ISO 9001. How will the changes affect organizations using both standards? ISO 9001:2015 and ISO 14001:2015 will be more closely aligned than ever.
9 How is the medical device standard (ISO 13485) changing as a result of the updates to ISO 9001? The draft ISO 13485:2015 is based on the clause structure in ISO 9001:2008, not the new requirements and clause structure of ISO 9001:2015 using Annex SL. Tables correlating ISO 9001 and the previous version of ISO 13485 have been included in the document. As with ISO 9001:2015, there will be a transition period for organizations to transition from the 2003 revision to the ISO 13485:2015 standard. The details of the ISO 13485 transition have not been announced as yet. Whether this will be influenced by the ISO 9001:2015 transition period, which has already been announced as three years from the date of issue, is unknown at present. Also, the supplementary Annex Z in support of the European Medical Devices Directives has been included in anticipation of the next revision of ISO 13485 being harmonized under the three Medical Device Directives. This means ISO 13485 and EN ISO 13485 would be published in a similar timeframe. Organizations can then use the Harmonized Standard within Europe which provides for the Presumption of Conformity under the applicable clauses of the Directives. This revision has also been drafted recognizing that it will have to support the existing European Medical Devices Directives and the proposed European Medical Device Regulations when they are published in the future. Some of the content has therefore been specifically drafted to accommodate this requirement. Please check back on our website as we will update the information as it becomes available. Are there any discussions happening on what the new ISO 9001:2015 requirements will mean to API Q2? Presently, there have been no formal discussions regarding API Q2 and the ISO 9001:2015 requirements. As you may be aware, API determined that registration to ISO 9001:2008 did not provide sufficient confidence to customers and organizations that their work processes were operating in a controlled manner and all operational risks had been identified, evaluated and effective countermeasures implemented where required. ISO 9001:2015 encourages organizations to take a much broader and holistic approach to how it conducts its business. Given the goals of API Q2, it would seem ISO 9001:2015 is now on the same path. As additional information becomes available, we will post it on our website. Will ANSI E4 also be revised and continue to be considered equivalent to ISO 9001? While there have been no specific discussions regarding ANSI E4, it would be logical to assume that once the 9001:2015 standard is finalized and issued in September 2015, it will be reviewed and revised to continue to be in alignment with ISO 9001. As you are aware, E4 is accepted as an equivalent to ISO 9001. It would make sense to revise E4 to continue that relationship. Is there a summary of the changes available between ISO 9001:2008 and 9001:2015? Yes. We provide this summary and discuss it at our training courses, both classroom and interactive webinars. www.saiglobal.com/training/assurance For more information please contact us at 1 (877) 426-0714 or training.americas@saiglobal.com
SAI Global Support 10 How can SAI Global provide support through the transition process? SAI Global will have the latest upto-date information on the ISO 9001 revision all the way up to the planned publication in September, 2015. Upon publication, we can advise you on what to do to meet the new requirements. Ultimately, it is up to you to plan and implement the changes, but SAI Global will provide all the support you need to make the best possible decisions. I have questions about my certification I need to answer right now. Who should I call? 1 (800) 465-3717 or e-mail us at certification.americas@saiglobal.com What training will be available? Yes, we have a series of interactive webinars already scheduled, and public training courses on the transition all over North America. http://www. saiglobal.com/training/assurance For more information please contact us at 1 (877) 426-0714 or training.americas@saiglobal.com For more information on SAI Global Assurance Services VISIT: OR CONTACT: Certification Inquiries (800) 465-3717 certification.americas@saiglobal.com Training Inquiries (877) 426-0714 Training.americas@saiglobal.com