ISO 9001:2015 FAQs

ISO 9001 is currently at FDIS stage of the revisions process and the final FDIS is expected to be published in July 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 organizations 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 organization 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 organization through any changes.

Who in my organization needs to know about the revised expectations of ISO 9001?

ISO 9001:2015 who needs to know?

Within your organization, there are a number of key stakeholders who need to be aware of and understand the ISO 9001 revisions:

– With the removal of the designated management representative, responsibilities still remain and can be delegated by Top Management to the System Manager.

– Top Management need 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 need to ensure that they understand specific requirements around context, leadership and performance.

You mentioned new and revised areas in ISO 9001:2015; what are these?

Annex SL is the single biggest change to the ISO 9001:2015 document. Other topics that are new to ISO 9001 include:

a] organizational 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.

Amongst the areas of the standard that have been revised or now contain more specific information, organizations should pay attention to:

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 organization 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 organizations 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 training for the ISO 9001 revision?

It’s never too late to begin understanding topics that can make your management system more effective and provide even greater benefit for your organization. This revision to ISO 9001 is bringing the requirements up-to-date with good management practice. 

A lot has changed in 15 years since the last significant revision to ISO 9001. Indeed, many organizations have progressed beyond the requirements of ISO 9001:2008 because their organization and their interested parties have expected more. 

So training to understand the new direction and topics introduced within ISO 9001:2015 should benefit both the individual and the organization. And, if your organisation would like to be amongst the first organisations to be certified to ISO 9001:2015, then we suggest you start thinking about this training now.

Who are the most important internal interested parties for large and medium size organizations 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 organizations?

For smaller companies, all the new and changed requirements may well apply. The contextual nature of ISO 9001:2015 means that the approach and degree of formality should be appropriate to the organization’s operating environment. To put it simply, an organization should not be doing more than it needs to do to meet its customer and product/service regulatory requirements but should be achieving this through a management systems approach based on ISO 9001.

The approach to a management system varies more in small companies. 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 organizations – irrespective of their size or geographical location - the same way?

The potential organizational impact of the ISO 9001 revision is dependent upon the organization 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 organization’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 future requirements of ISO 9001:2015.

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

No, not at all. The transition guidance from ISO shows that organisations have three years from publication to transition to the new standard, so they can choose to transition at any point within this period. Some may choose their next certification cycle, although many will want to be ‘among the first’ given the increased functionality that ISO 9001:2015 will deliver, along with the bonus of a clear commitment to best practice being demonstrated to their interested parties.

Starting the transition planning early, including setting and communicating a transition date, will enable you and your organisation to pro-actively manage the transition at your pace.

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 organization.

Talk to LRQA; as a member of the Independent International Organization 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 DIS, but more importantly, we know what the DIS means to your QMS and wider organization - 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 organization. Begin formalising a transition plan and process and ensure that top management is involved from the start.

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