ISO 9001 - 2015 - Avoiding Nonconformities During The Transition

ISO 9001:2015: Avoiding Nonconformities During the Transition
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Randall DAmico | 08/05/2015
Story update 8/6/2015: Paragraph 14 of this article stated "many

organizations are ill-equipped to develop an effective risk
management assessment process," implying, to some, that a risk
management system is required, which as stated in paragraph 8
of this article, it is not (nor was that the author's intent).
Paragraph 14 has been updated to avoid confusion. --Editor
The anticipated release later this year of the revised version of ISO
9001:2015Quality management systemsRequirements, has
many organizations asking what the revision will mean for them.
Specifically, what are the key changes required for existing ISO
9001-compliant quality management systems (QMS) to achieve
compliance with the revised standard? Also, what areas are likely to
present the greatest challenges for avoiding nonconformities during
the certification audit?
In this article, well attempt to answer these and other questions to
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help you transition to ISO 9001:2015 smoothly and successfully.

Background
The current review and revision process for ISO 9001 is a routine
part of the ISOs efforts to ensure that the requirements of its
internationally accepted standards keep pace with changes in
technology and remain relevant to the market. At the same time,
ISO Technical Committee 176 (TC 176), the committee responsible
for the ISO 9001 revision also wanted to reorganize the standard to
better align with the overall structure of other management systems
standards, such as ISO 14001 (environmental management
systems) and ISO 27001 (information security management
systems). By adopting a common framework, ISO TC 176 hopes to
make ISO 9001 more compatible with other management systems
standards, and make it easier and more efficient for organizations
to concurrently maintain and manage multiple management
systems.
A draft version of the revised standard, ISO/DIS 9001:2015, was
originally distributed in May 2014 for review and comment to ISO
member country representatives. This initial draft elicited about
3,000 separate comments, but the draft was ultimately approved by
80 percent of voting members during a preliminary vote. On July 9,
2015, ISO TC 176 released the final draft international standard
(FDIS) for a final vote and approval. If all goes as planned, the final
version of ISO 9001:2015 is scheduled to be released by the end of
September 2015 with no further technical changes incorporated.
A summary of the key changes
ISO 9001:2015 includes a number of significant changes that must
be considered by organizations certified to the current version of
the standard. Those changes include:
The importance of stakeholders. The revised standard
adopts a stakeholder approach to quality management, and focuses
on stakeholder relationship management (SRM). As such,
organizations are required to identify the issues and requirements
of relevant stakeholders when developing their QMS. The concept
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of SRM can extend beyond customers to include employees,

suppliers, partners, and even regulatory authorities.
Expanded role for leadership. By expanding the scope of
what it terms management responsibilities, the revised standard
clearly places overall responsibility and accountability for an
organizations QMS with senior leadership. While leadership may
appoint a representative to manage quality system-related
activities, they retain ultimate responsibility for implementation
consistent with the standards requirements.
A risk-based approach to quality. ISO 9001:2015 adopts a
risk-based approach to various requirements throughout the
standard. However, it doesnt require the application of a
standardized risk management approach, and contains no clauses
that detail specific requirements for preventive measures.
An increased emphasis on process. ISO 9001:2015
strengthens the importance of applying a process approach in
developing, implementing, and improving the effectiveness of an
organizations QMS. As such, organizations will now be required to
define inputs and expected outputs of each process, and to identify
key performance indicators.
Greater documentation flexibility. The terms documents
and records are being replaced with the term documented
information. This change is intended to provide organizations with
greater flexibility in describing their QMS. In addition, the current
requirement for documented procedures will no longer be
mandatory.
Potential nonconformities and other challenges
Organizations currently certified to the 2008 version of ISO 9001
will have up to three years to modify their current QMS to comply
with the requirements of the revised standard and to achieve
recertification. However, adopting to the changes in the revised
standard is likely to pose a number of specific challenges, including
the following:
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Getting leadership involved. The requirement for increased

leadership oversight and accountability for an organizations quality
management system may well represent the biggest challenge.
Meeting the threshold of this requirement involves the full
engagement of leadership team members, as well as an
understanding of the role that a commitment to quality plays in
achieving organizational goals, and training on the particulars of an
effective QMS.
Addressing root cause issues. The increased emphasis on
process requires a significant effort to identify and investigate root
cause issues that affect performance and require corrective actions.
However, most organizations arent sufficiently trained in root
cause analysis, and may struggle to develop and implement
processes that uncover the underlying basis for nonconformities
that are identified.
Implementing risk management practices.The revised
standard requires organizations to adopt a risk-based approach to
quality, but provides few details on how to achieve this. Some
organizations may need to look more closely at how they address
risk in order to be in compliance.
Documentation and recordkeeping. The revised
documentation requirements are actually likely to impose a
different kind of recordkeeping burden on organizations. Although
there will be greater flexibility in the types of documentation that
are permitted, that flexibility will be offset by the need to provide
evidence of a robust recordkeeping system that provides a thorough
history of all quality management activities.
Recommendations
According to the International Accreditation Forum (IAF), there are
a number of recommended actions that organizations can take to
successfully transition to the new requirements of ISO 9001:2015.
These include:
Conduct a gap analysis. Identifying the gaps between current
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practices and the new requirements is the most effective way to

evaluate the changes that are required in your current QMS.
Develop an implementation plan and timetable. A formal
implementation plan and schedule will help your organization
address the required changes within the anticipated three-year
transition period.
Provide appropriate training for all parties. Ongoing
education and training for all relevant personnel are critical to
achieving the goals of your transition plan. More important,
educated stakeholders are vital in ensuring ongoing compliance
once the transition is complete.
Update existing QMS documentation. As noted above, clear
and thorough documentation is essential to demonstrate
compliance with the requirements of the revised standard and to
help reduce the risk of nonconformities.
Involve your certification partner early in the process.
An experienced certification body can provide invaluable assistance
in the process of transitioning to the requirements of ISO
9001:2015. Its early involvement can help your organization save
time and money.
Conclusion
TV SD America, in cooperation with Quality Digest, will host a
free webinar, ISO 9001:2015Avoiding Nonconformities During
Transition, live on Tues., Aug. 11, 2015, at 2 p.m. Eastern. Intended
for organizations currently holding ISO 9001 certification, as well
as those contemplating certification, the webinar will discuss the
transition to ISO 9001:2015, and provide guidance for complying
with the new requirements. For more information, or to register, go
to (include link here).
TV SD has also launched an online resource page dedicated to
the 2015 revision of ISO 9001. Access it here.
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For more information about the ISO 9001 standard, see the
Quality Digest knowledge guide, What Is ISO 9001:2015?
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ISO 9001:2015: Avoiding Nonconformities During the Transition

Randall DAmico | 08/05/2015

Story update 8/6/2015: Paragraph 14 of this article stated "many

In this article, well attempt to answer these and other questions to