ISO 9001:2015 FAQs

ISO 9001:2015 was published on September 2015. Find out the answers to common questions to help you and your organisation prepare for transition to ISO 9001:2015.

What is the first thing that ISO 9001:2008 certified organisations should be doing?

Firstly, start by obtaining a copy of the Standard.

The introduction of Annex SL, which establishes a consistent structure featuring 10 clauses as well as common terminology and definitions applicable to all ISO Management System Standards (MSS), is the biggest change contained within the ISO 9001:2015 document.

In parallel, research and read the communications from ISO and LRQA to understand the proposed transition guidance. ISO is intending to publish further transition guidance and also guidance for the interpretation and implementation of ISO 9001:2015.

Look at how your organisation already manages the new and significantly changed areas and how this relates to your quality or integrated management system.

Begin thinking about an outline plan and timings for when and how you will review your management system to gain a view of how well it relates to these new areas.

Think about training for yourself and your key people involved in the management system and about how their knowledge and skills may need to be developed to help your organisation through any changes.

Who in my organisation needs to know about the revised expectations of 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).

What is your advice to an organisation with an integrated management system?

As ISO 14001 is under revision and will also have Annex SL as its core text and high level structure, any learning you undertake in preparing for the revision to ISO 9001:2015 is also likely to help you through the revision to ISO 14001. 

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.

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.

Who are the most important internal interested parties for large and medium size organisations for the ISO 9001 revision?

Probably the most important internal interested party is top management. ISO 9001:2015 requires greater understanding of the external environment, addressing risk and greater top management ‘quality leadership’ responsibility tied to closer links between the management system and product/service quality.

There is more emphasis on their direct involvement or oversight for the design, implementation, structure and performance of the organisation’s management system and to ensure the QMS is an integral part of the organisation’s business processes. 

When this is done well, the QMS provides a valuable mechanism for top management to meet their responsibilities for internal governance and control as well as providing an excellent source of performance data for use in decision making forums.

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.

Will the ISO 9001 revision affect organisations – irrespective of their size or geographical location - the same way?

The potential organisational impact of the ISO 9001 revision 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.

Do we have to be ready to transition to the revised standard straight away?

The transition period will be three years from the publication date of the standard itself, organisations have until September 2018 to transition.

In order to maximise the benefits offered by ISO 9001:2015, it is recommended that you plan your transition as soon as your organisation is able. Should something happen to delay your transitional assessment, your existing approval will still remain valid.

Could things still change before the final ISO 9001:2015 is issued?

The publication of the Draft International Standard (DIS) is an important stage for any standard. The revision process so far has consulted with users through surveys and discussions with industry groups to gain their views on what needed to stay the same and what needed to change. 

National Standards Bodies and external interested parties will make comments that the standards developers will have to consider, and take action where deemed relevant and necessary. A significant amount of change in this revision is through the incorporation of Annex SL core text and high level structure. Here the standards writers have little freedom to change this text even if it receives comments in those areas. 

Given that LRQA is part of the technical committee that has helped to develop the revised ISO 9001, we have seen three versions of this document prior to publication, but the main change topics have remained.

Next steps

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.

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 FDIS, but more importantly, we know what the FDIS means 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. Begin formalizing a transition plan and process and ensure that top management is involved from the start.

Begin formalizing a transition plan and process and ensure that top management is involved from the start.