MANAGEMENT SYSTEMS · DIN EN ISO 9001:2015

Revision of the DIN EN ISO 9001:2015 –Changes and Their Impact

The international quality management standard ISO 9001, under revision since 2012, waspublished in September 2015 and replaces the 2008 version. Quality management according
to ISO 9001 is an issue of relevance for companies of all sizes across the world and across allindustries, and therefore companies are bound to have questions about the standard. Whatchanges are coming? What do I need to consider?

What changes does the new standard bring with it?
With the revision, the scope of the standard does notchange; it will continue to apply to all companies. One
substantial change affects the structure of ISO 9001. The
revision follows the so-called “high-level” structure.
This guarantees an identical definition and structure forall management systems as well as the uniform use of coretexts and terms. Having a uniform structure as the basis ofcertification for management systems improves standards
comprehension and facilitates the implementation andcertification of integrated management systems (i.e. theIn addition to the customer, the new ISO 9001 takes into
account other “interested parties” as well. Nowadays,companies often find themselves in a complex, dynamicenvironment which presents new challenges. This change
is also reflected in ISO 9001:2015, with such topics asrisk management, change management and knowledge
management playing an important role. The processoriented approach is maintained and “risk-based thinking”
is required. Furthermore, there is a guide to ISO 9001:2015
which will be published as ISO/TS 9002.

integration of quality and environment).

Objectives of the new ISO 9001:2015
 Provide a stable framework of requirements for the next ten years.
 Be sufficiently generic, yet still relevant to all types and sizes of organizations, regardless of their industry or sector.
 Maintain the present focus on effective process management in order to achieve the desired results.
 Take into account changes to QM practice and technology since the last major revision in 2000.
 Reflect changes in the increasingly complex and dynamic working environment in which organizations operate.
 Apply the uniform structure, core texts and definitions (high-level structure) laid down in Annex SL of the ISO directives in order to ensurecompatibility and conformity with other ISO management systems (e.g. ISO 14001).
 Simplify effective implementation in organizations and effective compliance reviews.
 Use simple phrasing to ensure common understanding and consistent interpretation of the requirements.

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MANAGEMENT SYSTEMS · DIN EN ISO 9001:2015
Transition period for ISO 9001
The first official draft of ISO/DIS 9001:2015 was publishedin mid-May 2014 and the final draft (ISO/FDIS 9001) in July
2015. The standard was then published in September 2015.
The transition period will last three years. This means thatfor most certified companies the rescheduling of the recertification audit can be planned.

Examples of requirements
 Identification of internal and external topics (pt. 4.1.)
 Understanding expectations and needs of interested
parties. (pt. 4.2)
 Process-oriented approach: explicit naming of input, output
and those responsible for processes is required.(pt. 4.4)
 Handbook: no formal requests for a handbook; requests
with regard to content remain unchanged. (pts. 4.4 & 7.5)
 Quality management representatives: Functional
requirements exist but not regarding their position within
the company. The requirement “member of management”
does not exist. (Pt. 5.3)
 Implementation of quality goals: when planning theachievement of quality goals, the organization must
determine who is responsible, when the procedure should
be completed and how the results should be evaluated.
(Chap. 6.2)

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www.tuv.com/iso-9001-2015(Status: September 2015)

The ten sections of ISO 9001:2015
1.      Scope

6.    Planning

2.     Normative references

7.      Support

3.     Terms und definitions

8.     Operation

4.     Environment of the organization

9.     Performance evaluation

5.     Management

10.  Improvement

 Dealing with risks: Organizations must identify risks
which could affect the achievement of product and process
goals. The company must plan measures to counter theserisks and evaluate their effectiveness. (Chap. 6.1)
 Communication: the organization must determine about
what, when, with whom and how communication shouldtake place. (Chap. 7.4)
 Development: a development process must be introduced
that is capable of ensuring the availability of products andservices. (Chap. 8.3.1)
 Outsourcing: “Externally provided goods” are now treatedthe same as “externally provided services.” (Chap. 8.4)