I am quite sure that you have heard that ISO 9001 has an updated version, available now. So after 7 years of getting used to the present requirements it’s all change again. Most of us don’t like change so I am sure many people will be asking lots of questions starting with when, what and why. In this blog I will try to answer some of the questions and hopefully allay any panic. Having been involved with QHSE for over 25 years I have seen many changes to quality management and remember good old BS 5750: 1979 which can trace its roots back even further to the publication of the United States Department of Defence MIL-Q-9858 standard in 1959 (who knew it went that far back and originated in the USA). So enough looking back; let’s look forward.
When will it be available?
- The final approved version of ISO 9001:2015 is now available from the BSI website.
How long will ISO 9001:2008 continue to be recognized and audited to?
- The current standard will be recognized and can be audited to until the end of the 3 year transition period for ISO 9001:2015 (expected late 2018).
What are the main changes then?
- There are now 10 clauses not 8 as before; but don’t panic there are 2 more new ones on top of the old 8, as the clauses are better organized round a new 10 clause structure which all the other management system standards will follow in the future (including ISO 14001 and ISO 45001; previously known as OHSAS 18001 and I will cover those standards in future blogs).
ISO 9001:2015 promotes the process approach beyond the existing requirements of ISO 9001:2008. Clause 4.4 (Quality management system and its processes) of the DIS provides specific requirements for adopting a process approach.
- Context of the organisation. This effectively means that your organisation needs to review, identify and monitor its compliance with external requirements such your customers’ requirements, legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional or local. Furthermore your organisation must consider internal issues related to values, culture, knowledge and performance of the organization.
- In the 2008 version it refers to Products but in 2015 it now refers to Products and Services; so no big deal there then!
- The procedure is dead; long live the process! The quality management system is now to be structured with interrelated processes. This will enable the organization to optimize its performance through its processes, resources, controls and interactions, rather than standalone segmented procedures. Remember the old Plan, Act, Do, Check, well the Do bit is the carrying out of the process.
- Documents and records are history; the organisation now has documented information! Basically semantics, as it really means the same thing; it simply now recognises that most organisations have record and information in many mediums not just on paper.
- The new standard does not make any reference to exclusions. However it does clarify that the organization cannot decide a requirement to be not applicable if it falls under the scope of its QMS. Also non-applicability is not allowed if that could lead to failure to achieve the conformity or to enhance customer satisfaction. This may cause some organisations some issues; however, if your QMS has been written to satisfy the business and its clients first and foremost rather than getting a certificate on the wall then you should not have any issues here.
- No Quality Manual needed, yes you read that right. You won’t need one soon. You are now asking Why? The easy answer is that it had minimal value to the organisation and its personnel as a process approach focuses on the work method that people need to follow rather a high level definition.
- There is now a requirement for a more proactive leadership role but at the same time there is no longer a requirement for a management representative. So senior management have to demonstrate that they take an interest and play a part in the QMS rather than simply signing the policy. They must also ensure that QMS requirements have been integrated into business processes. So QA Managers can stop panicking now; you are still needed as a focal point and to police the QMS.
- You need to take into account the context of the organisation in your Quality Policy which will mean some minor changes.
I have left one of the most significant changes till last:
- One of the main reasons for a quality management system is for it to act as a preventive tool, however the formal requirement related to preventive action is no more and is being replaced with a risk based approach and requires organisations to determine and address risks. Risk-based thinking has been introduced in all of the clauses in the standard and effectively means that hazard identification, risk evaluation and controls needs to be embedded throughout all aspects of the managements system and is can’t be bolt on or something dealt with separately.
There are many more minor changes to the new ISO 9001 standard including lots of small changes to words, phrases and terms which have varying negligible impacts; however, in this blog I have tried to focus on some of the more significant changes.
If you wish to know more or gain a better understanding on the changes and impacts on your management system then contact Agility Systems today on (+44) 01224 33 00 00.
Next time I will explain the changes coming to ISO 14001.
Alan McInnes, CMIOSH, CIQA, MIIRSM