Wondering how to get ISO 9001:2015 certification? When should you start your organisation’s transition to the new 2015 version of the ISO 9001 quality management system standard? Answers to those common questions and many others below.
What is the first thing that ISO 9001:2008 certified organisations should be doing?
Firstly, remember that the three-year transition deadline for ISO 9001:2015 is September 2018, after which all ISO 9001:2008 certificates will be invalid.
The clock is ticking – more than a year has already passed on the transition timeline, so don’t risk your existing ISO 9001 certification by waiting any longer to begin your transition journey.
In parallel, research and read the communications from ISO and LRQA to understand the proposed transition guidance. ISO has published transition guidance, as well as guidance for the interpretation and implementation of ISO 9001:2015.
Then, have a look at how your organisation already manages your existing quality or integrated management system. You should already begin thinking about an outline plan, and timings for when and how you will review your management system to understand how well it relates to the new areas within ISO 9001:2015.
Also, consider how your key stakeholders’ knowledge and skills may need to be developed to help your organisation through the changes, and if they might benefit from third-party training from LRQA.
Is it too late to be thinking about ISO 9001:2015 training?
It’s never too late. In fact, training is typically a good place to start rolling out your transition plan, to deliver a common organisation-wide understanding around the new standard, and to obtain buy-in from your top management.
During the planning process, you may also find that training for yourself, and your key people involved in the management system, might be necessary in order to upgrade existing expertise and techniques to accommodate the changes within ISO 9001:2015.
A lot has changed since the last significant revision to ISO 9001 more than 15 years ago. Therefore, training to understand the new direction and topics introduced within ISO 9001:2015 should benefit both the individual and the organisation.
LRQA’s training courses deliver against a wide range of needs, from introductory briefings to specialised role-based courses. Click here to learn more about our most popular courses.
What are the new and revised areas in ISO 9001:2015?
By now, you should have already heard about the introduction of the new High Level Structure, Annex SL, which is the single biggest change contained within the ISO 9001:2015 document. Annex SL establishes a consistent structure featuring 10 clauses as well as common terminology and definitions applicable to all ISO Management System Standards (MSS).
Other changes that are new to ISO 9001:2015 include:
a] organisational context (clause 4), b] knowledge (clause 7), c] the control of externally provided products and services (outsourcing, clause 8) and d] the formal introduction of a risk based approach (several clauses), among others.
Areas of the standard that have been revised or now contain more specific information include:
a] increased emphasis on top management engagement with ISO 9001 (clause 5) b] managing change (clause 6) c] performance and evaluation (clause 9) d] management review (clause 9) and e] repeat references to the process approach (several clauses).
How are the changes likely to impact smaller organisations?
The potential organisational impact of the revised ISO 9001:2015 standard is dependent upon the organisation and their individual QMS.
Factors such as the maturity and complexity of their existing QMS, the existence of other management systems (such as ISO 14001 or OHSAS 18001) and the organisation’s current evaluation and management of risk will all heavily influence the degree of change that an organisation will need to undertake in order to meet these requirements of ISO 9001:2015.
For smaller companies, all the new and changed requirements may well apply, and the approach to a management system varies more. However, the intent and outcome expected remains the same i.e. that customer and applicable regulatory requirements are met.
Who in my organisation needs to know about the revised expectations of ISO 9001:2015?
With the removal of the designated management representative, responsibilities still remain and can be delegated by Top Management to the System Manager.
Top Management needs to understand and engage with the leadership elements of the revised standard.
Process Owners need to understand their obligations to managing their defined processes and associated indicators.
Internal Governance teams such as Internal Auditors and Audit Programme Managers also need to ensure that they understand specific requirements around context, leadership and performance.
What is your advice to an organisation with an integrated management system?
As the newly revised ISO 14001:2015 also has Annex SL as its core text and high level structure, any learning you undertake in preparing for ISO 9001:2015 is also likely to help you through the changes within ISO 14001:2015. In the future when ISO 45001 (the new ISO standard for occupational health & safety, set to replace OHSAS 18001) is issued, it will also use the same core text and high level structure in Annex SL.
At first glance, Annex SL appears to make the standard writers lives ‘much easier’ but in reality, as organisations begin to understand and appreciate the value of different management systems all speaking a common language, it will be organisations and in turn the consumer who stand to be the true beneficiaries.
Talk to LRQA. As a member of the Independent International Organisation for Certification (IIOC), we are a member of all the major ISO technical committees helping to shape the new standards. We not only understand the revisions, but more importantly, we know what the revisions mean to your QMS and wider organisation and how to apply it to best effect.
Engage with LRQA to find out how a gap analysis and training on specific areas of ISO 9001:2015 can benefit you personally, as well as your organisation.
Focus on the areas that are completely new or have been revised. Those are the areas that are likely to be included in your transition plan. Also, make sure that quality managers and internal auditors understand the differences that Annex SL (common text and structure) will bring to the design, operation and performance of your QMS and any other management system standards in your organisation.
Begin formalising a transition plan and process and ensure that top management is involved from the start.