All companies that are currently certified to ISO 9001:2008 need to transition to the new ISO 9001:2015 in order to stay certified. We show you what is needed and how you can achieve the transition easily and inexpensively.
The new ISO 9001:2015 was published on September 23, 2015. With its publication, a 3-year transition period started during which both ISO 9001:2008 and ISO 9001:2015 remain valid. During the transition period, existing ISO 9001:2008 registrations should gradually be upgraded to ISO 9001:2015. By the end of the transition period on September 15, 2018, all existing ISO 9001:2008 certifications must have been upgraded to ISO 9001:2015 in order to remain valid ISO 9001 registrations.
The re-certification to ISO 9001:2015 requires an audit by your registrar. It is most economic and efficient to schedule your transition audit at the time of a scheduled surveillance audit. This approach will require only a minimum of additional audit time added to the time of your surveillance audit in order to verify compliance with the new requirements of ISO 9001:2015. Upon successful completion of the transition audit, your registrar will upgrade your certification to ISO 9001:2015 certification.
In case you do not have your upgrade audit by September 15, 2018, you will lose your ISO 9001 certification and you will need to start over with an initial certification audit. While this is not the end of the world, it still means that at least temporarily you cannot advertise your ISO 9001 certification until you achieve certification to ISO 9001:2015. Also, the cost of a certification audit is about three times the cost of an upgrade audit.
The best time to start with your transition to the new ISO 9001:2015 is now. We recommend that you don't delay the upgrade. Please start now to avoid any last minute rush. As there are over a million companies worldwide that need to transition to ISO 9001:2015, auditors and registrars will get increasingly busy towards the end of the transition period, and your preferred dates may not be available. Again, please start now.
There are several approaches that you can take to achieve the transition to ISO 9001:2015 and stay certified. Here a listing of three basic approaches:
Do-It-All-Yourself from Scratch: This approach is ideal for those who have an intimate understanding of ISO 9001:2015 and want to set up the most individualized system possible. Expertise and much time are required, as well as some flexibility to allow for mistakes and subsequent changes.
Templates: Customizing prewritten templates according to detailed customization instructions is an inexpensive and quick way to transition to ISO 9001:2015. No expertise and only some time is required; the quality of the templates and customization instructions are decisive factors.
Consultant: An ISO 9001 consultant may write the documentation necessary to transition to ISO 9001:2015; the consultant will also train staff in the new requirements. This approach requires the least staff involvement but by far the biggest budget.
The 9001Simplified system is based on the use of templates and detailed instructions. No matter which approach you prefer, please read on as this article explains the steps necessary to upgrade your ISO 9001 certification. To learn more about the changes that the new ISO 9001:2015 introduces, please review our article "ISO 9001:2015 - What is New?".
Before doing anything else, you need to decide if you want to make the least possible modifications to your existing quality management system, or if you want to rewrite your entire ISO 9001 documentation.
ISO 9001:2015 introduces several modifications to the previous revision, as well as some completely new requirements. While the text of the new ISO 9001:2015 reads differently from the previous revision, most of the actual requirements remain the same. Though the new standard uses different wording and a different structure, the International Organization for Standardization (ISO) specifically states that you are neither required nor encouraged to adopt the new wording and structure if your current setup works well for you. This means that you are only required to make some modifications and additions to your current ISO 9001 quality management system, while keeping most of your current documentation and processes in place.
On the other hand, ISO 9001:2015 has adopted a new, uniform structure that will be common to all ISO management standards. If your company intends to integrate ISO 9001 with ISO 14001 or another ISO standard, it may be easier to adopt the new structure and numbering system. In this case, you would rewrite your existing ISO 9001 documentation either from scratch or modify its structure with the help of a correlation matrix.
Lastly, you may want to consider the quality of your current ISO documentation and processes. If you are not satisfied with the performance of your current ISO 9001 system, you may want to take the required transition to ISO 9001:2015 as an opportunity to completely redesign your entire ISO 9001 quality management system. The new revision of ISO 9001 clarifies existing requirements as well as the intent of existing requirements, which means that the new ISO 9001:2015 may add many benefits to your ISO 9001 system beyond the added and the modified requirements. Note that if you have been using the 9001Simplified system in the past, you don't need to be concerned as our materials have always reflected the the correct interpretations and intent of all ISO 9001 requirements.
No matter what you decide here, the 9001Simplified system has you covered. Choose the ISO 9001:2015 Upgrade Package and select the option for small documentation upgrade or for complete redesign.
Follow our transition steps to upgrade your existing ISO 9001 system and stay certified. But before you do anything else and start the transition to ISO 9001:2015, please consider the following:
Don't change what's working for you!
Don't make changes merely to please the auditor or make auditing easy. It is the auditor's job to establish how your ISO 9001 system meets the requirements of ISO 9001:2015.
Consider the value to your company. ISO 9001 is supposed to be a real business tool for companies, and every part of your ISO 9001 system should add value. That's the core of the 9001Simplified system.
Keep things simple!
Don't read too much into the changes when looking at the ISO 9001:2015 standard. There may be new words but that doesn't mean that the requirements have changed.
Some people will be perfectly fine using our materials, others may prefer a training course to learn more about ISO 9001:2015 and its new concepts. Particularly top management may benefit from some training in those key ISO 9001 requirements for which they will be directly responsible (ISO 9001:2015 significantly expanded the involvement of top management in ISO 9001). In any event, it will be worthwhile to at least consider taking some training.
As mentioned earlier, is is ideal to schedule the transition audit at the time of a scheduled surveillance audit. Please discuss dates, details and costs with your registrar. You may also discuss your transition plan. Last but not least, ISO 9001:2015, section 4.3 requires that you have your products and/or services explicitly listed in the ISO 9001 scope statement. Please check with your registrar which updates to the scope statement on your ISO 9001 certificate are necessary.
Updating the ISO 9001 documentation is generally considered the biggest step in the transition process. ISO 9001:2015 includes several completely new requirements as well as modifications to existing requirements.
The following clauses of ISO 9001:2015 introduce completely new requirements that have not been part of any previous version of ISO 9001. As a result, completely new procedures and forms are needed:
clause 4.1 "Understanding the Organization and its Context"
clause 4.2 "Understanding the Needs and Expectations of Interested Parties"
clause 4.4 "Quality Management System and its Processes"
clause 5.1 "Leadership and Commitment"
clause 6.1 "Actions to address Risks and Opportunities"
clause 6.3 "Planning of Changes"
clause 7.1.6 "Organizational Knowledge"
The most important of the new requirements in ISO 9001:2015 is the focus on risk management in clause 6.1. While previous versions had a section on preventive action, the new 2015 version expands upon preventive action to create a complete clause on risk management. This new requirement will be of great value for many small businesses that had previously not properly managed the internal and external risks to their very existence.
The following clauses include changes to existing ISO 9001:2008 requirements. As a result, modifications to your existing procedures, forms and flowcharts are needed:
Scope of the quality management system (as shown on your ISO 9001 certificate)
Quality management processes (process flowchart)
Control of Documents (section 4.2.3 in ISO 9001:2008)
Management Commitment (section 5.1 in ISO 9001:2008)
Customer Focus (section 5.2 in ISO 9001:2008)
Management Review (section 5.6 in ISO 9001:2008)
Human Resources (section 6.2 in ISO 9001:2008)
Customer Property (section 7.5.4 in ISO 9001:2008)
Corrective Action (section 8.5.2 in ISO 9001:2008)
Preventive Action (section 8.5.3 in ISO 9001:2008)
Most would consider the updates to the ISO 9001 documentation to be the biggest step in the transition process. The 9001Simplified system makes this step particularly easy on you as our ISO 9001:2015 Upgrade Package contains all new procedures, forms and flowcharts in form of templates with detailed customization instructions; the package also contains step-by-step instructions on any necessary modifications to your existing ISO 9001 documentation in order to allow you to keep changes to a minimum.
Carefully review the changes that you made to your ISO 9001 documentation and jot down who will be affected by the changes. Risk-based thinking, for example, will somewhat impact all managers.
Meet up with individual department managers to introduce them to the changes. Introduce the new ISO 9001 documentation and any pertinent forms.
As the concept of the process approach has been expanded to include risk- based thinking and change management, it is necessary to review all existing processes and work work instructions. Therefore, ask the managers to look at all their processes and pay particular attention to these issues:
Authorities (who can assign responsibilities in the process?)
Risks (what could cause the process to lead to an undesirable output?)
Opportunities (what could improve the process?)
Change (have a plan for reviewing, adapting and improving the process)
Based on the answers to the four points above, process owners may need to update any related work instructions and process flow charts.
It is necessary to conduct a complete internal audit of the entire ISO 9001 quality management system and correct any audit non-conformities prior to the registrar being able to upgrade your certification. The internal audit will show you how well all changes have been implemented.
Don't forget that your ISO 9001 system has changed and, therefore, your internal auditor(s) need to be trained accordingly. The changes to your ISO 9001 system are rather small so it will be possible to conduct an ISO 9001:2015 internal audit if you introduce your auditor(s) to all the changes and provide new audit checklists. You may, however, consider an entire ISO 9001:2015 auditor training course (for example, the online course ISO 9001:2015 Internal Auditor Training) as it will teach your auditor(s) not only the changes in ISO 9001:2015 but also refresh their knowledge of the entire ISO 9001 standard.
As mentioned earlier, the upgrade audit is best done as part of a scheduled surveillance audit. The external auditor will hereby focus on the new and modified requirements. As with all audits, you will have the opportunity to address all audit nonconformities through corrective action. Once your registrar is satisfied that your company meets the requirements of ISO 9001:2015, your company's ISO 9001 certification will be upgraded to the new ISO 9001:2015.