ISO 9001:2015 REVISION

10 THINGS TO KNOW

September 2014
Timothy Woodcome
Director, NQA USA
2014 NQA, USA

ISO 9001:2015 - #1
ISO 9001 is currently under revision
As per the regular review cycle, ISO is in process of updating the ISO 9001
standard (current version 2008). ISO standards are typically reviewed
approximately every 5 to 7 years. Depending upon user input, some revisions are
more or less substantial than others. The current revision appears to be fairly
significant, primarily due to changes in structure, along with some additional
concepts/requirements.

2014 NQA, USA

ISO 9001:2015 - #2
The ISO Revision process is phased - The usual phases include the
following:

2014 NQA, USA

ISO 9001:2015 - #3
Certified Organizations will have additional time to transition to the new
standard.
It is expected that organizations will have up to three years from the ISO release
date upon which to transition their existing certification (e.g. late 2015 to late
2018). Transitioning will require organizations to meet the revised requirements
and demonstrate effectiveness of their processes. Certification bodies such as
NQA will be actively communicating and facilitating these transitions for
customers.

2014 NQA, USA

ISO 9001:2015 - #4
Transition audits may require additional time.
NQA will strive to offer low or no-cost transition options (such as phased
transitions across multiple audits), however additional audit time may be
necessary for organizations looking to achieve 2015 certification in some
instances (e.g. special visit, single visit, etc.). Additionally, Accreditation Body
oversight may specify additional time requirements that Certification Bodies will
need to comply with in order to provide suitable audit coverage of revised
requirements. (This has yet to be determined at this time...)

2014 NQA, USA

ISO 9001:2015 - #5
ISO 9001:2015 will have a new structure
ISO has developed a High Level Structure (aka Annex SL) to be utilized by the
various ISO management system standards moving forward. This structure will
allow for more consistency and better alignment across management system
disciplines such as quality, environmental, information security, etc. The new
structure is set up with 10 clauses vs. the 8 clauses in ISO 9001:2008. There is
no requirement to have organizations re-number any documents or processes per
se, however some organizations may find value in doing so. Further detail on the
new structure can be found in documents reviewing Annex SL.

2014 NQA, USA

ISO 9001:2015 - #6
Risk is made an explicit requirement
The inclusion of risk and related topics(e.g. opportunities, consequences, controls) is likely the mostdiscussed change to be seen in 9001:2015. As examples, Actions to address risks and opportunities
can be found in section 6, and evidence of risk can also be see in requirements for the QMS and its
processes (4.4), Customer focus (5.1.2), and Management review (9.3). Related references to impacts,
consequences, controls, etc. can be found in virtually every section of ISO 9001:2015 requirements.
The term Risk-Based Thinking has been coined to help the concept of risk pervade throughout the
QMS, and risk has also been incorporated into the process approach model. While many organizations
may already practice some level of risk-based thinking, the challenges within 9001:2015 may include
the ability to demonstrate such an approach within their QMS.
Additional reading on risk can be found in these related documents:
ISO 9001:2015 Risk Based Thinking (ISO/TC 176/SC 2/N1221)
Risk in ISO 9001:2015 (ISO/TC 176/SC 2/N1222)

2014 NQA, USA

ISO 9001:2015 - #7
Additional requirement changes to be aware of include:

2014 NQA, USA

ISO 9001:2015 - #8
Some specific requirements have been dropped from ISO 9001: 2008 ISO
9001:2015 may not be as prescriptive in requiring certain documents or
specific roles. As examples:

It should be noted that these changes do not require organizations to

eliminate existing documents, roles, etc. if they are found to be effective or
necessary for operation of the QMS, but do provide additional flexibility.

2014 NQA, USA

ISO 9001:2015 - #9
Client Competence and Awareness needs
No specific ISO requirement will tell organizations what competencies or
familiarity will be required of them for ISO 9001:2015, nor specifically how to
gain such knowledge. However as a change relevant to the QMS (6.3, 9.3.1)
and thus pertinent to the implementation and maintenance of the QMS,
organizations would be advised to review and ensure appropriate levels of
competence and awareness around the 9001:2015 standard. Means to do so may
include external training, internal training, self-guided study (or combinations
thereof) so long as evidence confirming competence is retained (7.2).

2014 NQA, USA

ISO 9001:2015 - #10

Dual Compliance to ISO 9001: 2008/2015
Organizations should plan to remain compliant to the ISO 9001:2008 standard
while preparing for and implementing changes for ISO 9001:2015. Early disassociation from 2008 requirements may leave organizations without a valid ISO
9001 certification should their 2015 transition not go as planned. Organizations
should consider themselves ISO 9001:2008 certified/compliant until such time as
they have their ISO 9001:2015 certificate in hand; only then should they consider
disassembling any 2008-required framework no longer mandated by ISO
9001:2015.

2014 NQA, USA

ISO 9001:2015
NQA has already released a series of communications for clients in an awareness-building effort
of this coming transition. Much of NQAs ISO 9001:2015 content may be found at www.nqausa.com via the ISO 9001:2015 Revision logo. Additional communications will include web
content, newsletter articles and face to face client conferences.
Additional publically-available resources include:
ISO/DIS/FDIS standard
www.iso.org
www.asq.org
www.ansi.org
ISO Technical Committee TC176 guidance documents
www.iso.org/tc176/sc2
Go to Public Information folder in the Library section
NQA-USA
http://www.nqa-usa.com/services/iso9001
Connects to various downloads, articles and content feeds

2014 NQA, USA