ISO 9001:2015 benefits of early transition WHITE PAPER. Copyright 2016 Advisera Expert Solutions Ltd. All rights reserved.

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1 ISO 9001:2015 benefits of early transition WHITE PAPER Copyright 2016 Advisera Expert Solutions Ltd. All rights reserved. 1

2 Table of Contents Executive summary... 3 Introduction... 3 What are the changes in ISO 9001:2015?... 4 Benefits of early transition... 5 Transition timing... 6 The transition steps... 7 Conclusion... 9 Sample documentation templates

3 Executive summary With the release of ISO 9001:2015, companies have been given three years to finish their transition to the new standard. In any case, numerous organizations are transitioning early to drive expanded business advantages and increase their upper hand. Early transition provides organizations with tangible benefits for driving business improvements and supply chain efficiency, as well as improved internal and external interested party engagement. The revisions affect the scope, design, and maintenance of the management system; hence, it is crucial to start planning early and develop a clear transition plan to ensure a smooth transition process. Introduction In case you didn t know already, ISO 9001 was revised in 2015 to reflect the current market and expectations from customers. All organizations currently certified against ISO 9001:2008 will need to transition to the new requirements by September This means that after the end of September 2018, a certificate based on ISO 9001:2008 will no longer be valid. So, why change now if it can wait until 2018? Time is the most important factor. Most organizations transition successfully; however, if you wait until near the deadline, there will be less time to correct problems increasing the chances of not being certified on time. So, transition early, to reduce the risks and costs to your business. 3

4 What are the changes in ISO 9001:2015? Although the new version brings some significant changes, the good news is that many of the requirements we have become familiar with in previous versions of the ISO 9001 standard will remain the same. There are now seven principles instead of the eight in the 2008 revision, but the essence is the same. The new version has 10 instead of the eight clauses in the old version, and instead of six mandatory procedures, there are now six mandatory documents that don t have to be in the form of a procedure. This can be little confusing at the beginning, but the intention was to provide more liberty in documenting the Quality Management System. For more information, see: List of mandatory documents required by ISO 9001:2015. There are some new requirements, but the most significant are Context of the organization (Clause 4) and Actions to address risks and opportunities (Clause 6.1). The idea behind these new requirements is to make the QMS (Quality Management System) a part of everyday business activities, and vice versa. Of course, some old requirements are history now: Quality Manual, management representative, and preventive actions are no longer part of ISO Only time will tell which of these will survive now that they are no longer a requirement. To learn more about changes in ISO 9001, attend this webinar: ISO 9001:2015 vs. ISO 9001:2008 The main changes. 4

5 Benefits of early transition If you dismiss the normal human feeling to oppose change, then there is no motivation to hold up before executing the transition. The ISO committee has taken counsel from all segments of the business community in numerous nations, and numerous experts have given input. The changes are all intended to enhance your business, and its odds of survival, profitability, and development. Transitioning to the new standard early can give various key advantages to an organization: Better business performance The new structure of the standard is to guarantee the management system is totally adjusted to the business procedures of the organization. Utilized as a business management tool, this will enhance performance and drive real value, embedding healthy performance processes into the organization earlier. Your reputation Put quite simply, implement early and be the envy of your suppliers, customers, and competitors! Early implementation also shows diligence and can only help in tenders, bids, and existing business relationships, too. Adopting risk-based thinking Introduction of risk and opportunity management into your management system will shift your system from reactive to proactive, and will reinforce its use as a governance tool, as well as a performance accelerator. This will ensure that your organization will be able to identify risks and opportunities more effectively, thereby improving operational efficiency and reducing duplication, saving both time and money. More pragmatic approach Early transition to the new version of the standard means you can benefit quickly from the less prescriptive requirements of the revised standard, i.e., reduced documentation, saving time and resources. Improved integration Some of the other standards, like ISO and ISO 14001, have also adopted the new common structure, and other management system standards are sure to follow. This will ensure that you can integrate more than one system into your organization smoothly, without investing a lot of extra time and money. 5

6 Transition timing According to ISO, the transition period will last three years, meaning that you can become certified or have surveillance audits according to the old version until September 23, Some of the biggest certification bodies announced that they will stop issuing new certificates according to the old version by September If you became certified before September 23, 2015, you will have your surveillance audits according to the 2008 revision, but your recertification audit will be conducted according to the 2015 revision. If you get your certificate according to the 2008 revision after September 23, 2015, you will have to transition to the new version by September New ISO 9001 is published on September 23 rd, September 23 rd, 2018, is the ultimate deadline for the transition; the organizations that don t meet the deadline will lose their certificates. 6

7 The transition steps Looking at all the benefits and the timing for the transition, you are probably asking yourself whether you need to implement the whole standard all over again. That is far from the truth; the current QMS simply needs to be updated to meet the new requirements of the standard. 1) Define context of the organization. This is a new requirement and requires special attention, because it provides the basis for your new QMS (Quality Management System). For more information, see: How to identify the context of the organization in ISO 9001: ) List all interested parties. Although it belongs to the same clause as Context of the organization, it is something new and should be considered carefully. Having all interested parties and their expectations identified will help the organization to adjust its strategic direction. To learn more about interested parties, see: How to determine interested parties and their requirements according to ISO 9001: ) Review the scope of the QMS. The transition is a good time to consider the existing scope of your QMS, since the credibility of your Quality Management System depends on it. For more information about the scope, see: How to define the scope of the QMS according to ISO 9001: ) Demonstrate leadership. The requirements are almost the same as those for management commitment in the previous version, and the new version puts even greater emphasis on the leadership. Demonstrate leadership through taking accountability for the QMS, providing resources, and establishing a Quality Policy and quality objectives. For more information, see: How to comply with new leadership requirements in ISO 9001: ) Align QMS objectives with the company s strategy. Your QMS must be compatible with the strategic direction of the company, and quality objectives must aim in the same direction as other activities in the company. The plans for achieving the objectives must be created, and that is the requirement of the new version. 6) Assess risks and opportunities. According to the new version, the risks and opportunities must be addressed. They focus on the ability of the organization to achieve the intended results, but also on other parts of the system such as context of the organization and compliance obligations. After the assessment of risks and opportunities, there should also be some plans for addressing them. For more information, see: How to address risks and opportunities in ISO ) Control of documented information. This new term refers to both procedures and records. Besides aligning your old procedures to the new clause numbers, the transition process should be used for improving your existing documentation. The requirements for preventive actions do not exist anymore (preventive actions basically became a part of the risk assessment process), so you can decide whether 7

8 to delete that procedure or not. You can use this free ISO online tool for handling your documentation, i.e., using it as a document management system (DMS). 8) Operational control. The new version requires better control of the processes, including operating criteria and implementing controls of processes according to the criteria. 9) Review the design and development process. Design and development need to be defined in more detail. You need to define responsibilities, controls, inputs, and outputs, and also how you will handle the changes in the design and development process, meaning who will review the results of the changes, who is authorized to make the changes, and what actions will be taken to prevent adverse impacts. 10) Control of external providers. Purchasing in the current version is now called Control of externally provided processes, products and services. You need to ensure that externally provided processes, services, and products are compliant with your requirements. This means that you will need to determine controls, their type and extent, and information to be provided to the supplier. Basically, you need to undertake all activities necessary to ensure that your provider will deliver what you expect from him. For more information, see: How to control outsourced processes using ISO ) Performance evaluation. This means that you need to determine what needs to be monitored, how, and how often. The purpose is to evaluate the performance and effectiveness of your Quality Management System. If you are familiar with key performance indicators, this change will be easy on you. To learn more about Key Performance Indicators, see: How to define Key Performance Indicators for a QMS based on ISO ) Measurement and reporting. The new version of the standard strongly emphasizes the importance of measurement and reporting, especially regarding the above-mentioned performance evaluation, but also the internal audit and the management review need to be aligned with the new version of the standard. Although the techniques for conducting them remain the same, there are changes in the input elements of the management review and requirements to be audited during the internal audit. For more information, see: Analysis of measuring and monitoring requirements in ISO 9001:2015. And, this is it it might seem like a lot, but probably within the one-year period this won t take more than a couple of hours per month to achieve. This is especially true because these changes really do make sense they will not only bring your QMS closer to the needs of your business, but you will also have a system in place to show the usefulness of your quality management. 8

9 Conclusion The new ISO 9001 is here to stay, and other management system standards will follow the same path if they haven t already gone through the revision. Adopting the new standards early also sends a clear message to existing and prospective customers it shows you are taking a leading, innovative, and proactive approach to quality management through new management systems. By embedding healthy performance processes into the organization earlier, you will enhance your reputation overall. It is better to start working on the transition sooner rather than later to gain early benefits of the new standard and improve business performance. Sample documentation templates Here you can download a free preview of the ISO 9001 Transition Toolkit in this free preview, you will be able to see the Table of Contents of each template, as well as a few sections from each document. 9

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