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Questions and Answers about
the Revision of ISO 9001
Our experts have answered the most frequently asked
questions about the ISO 9001 Revision. Would you like tolearn more? Get in touch with our experts!

1. H OW TO T R A N S I T I O N F R O M T H E F O R M E R V E R S I O N O F I SO 9 0 01 TO
THE NEW VERSION?

For certificates and audits under accreditation, the following transitionalarrangements and deadlines apply:
A transitional period of three years was granted after the publication of ISO
9001:2015 (September 15, 2015). After September 14, 2018, all accredited
certificates according to ISO 9001:2008 will become invalid.
Certificates may only be issued after an audit and after the accreditation of thecertifier.
Audits in conjunction with monitoring or recertification are expected to require
additional time.

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2T I M E TA B L E F O R T H E C H A N G E TO I S O 9 0 01 : 2 01 5

P U B L I C AT I O N O FREVISION

Sept. 15, 2015

END OF TRANSITION PERIODF O R C E R T I F I C AT E R E V I S I O N

C A R RY O U T G A P A N A LYS I STransitional period for the conversion to the revised certiﬁcate

2 01 62 017

Sept. 14, 2018

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Companies certified according to the new version of ISO 9001 can take thefollowing measures:
BEISPIEL 1
Identify
gaps in the new standard. Use the standard as a checklist and checkrequirements for their fulfillment. We would like to support you as a first stepBeispiel Zertiﬁkatslaufzeit 9001:2008: 30.09.2017
Die Organisation kann zum Überwachungsaudit oder zum
towards the secure
conversion to the new ISO
9001:2015 with a GAP analysis.
Re-Zertiﬁzierungs-AuditÜberwachungsaudit
Re-Zertiﬁzierungs-Audit auf die ISO 9001:2015 umstellen.
Ende derSollte die Organisation bei dem Re-Zertiﬁzierungs-Audit erneut
Develop an implementation plan.
Zertiﬁkatslaufzeit
die alte Version anwenden, ist dieses Zertiﬁkat maximal biszum 14.09.2018 gültig.
Ensure proper training and awareness of all parties that influence theBEISPIEL 2
performanceof your organization.
Inform all parties involved in the quality management process in time for theBeispiel Zertiﬁkatslaufzeit 9001:2008: 30.11.2016
conversion to the newISO 9001:2015 and the resulting
changesand effects. wird empfohlen.
Umstellungzum Re-Zertiﬁzierungs-Audit
Re-Zertiﬁzierungs-Audit
Sollte die Organisation bei dem Re-Zertiﬁzierungs-Audit
Ende system
derUpdate your current quality management
toerneut
meet
theVersion
additional
die alte
anwenden,or
ist dieses Zertiﬁkat
Zertiﬁkatslaufzeit
maximal bis zum 14.09.2018 gültig.
changed requirements and verify the performance ofthe system.
2 01I6O N G U I D E ?
3 . I S T H E R E A N I M P L E M E N TAT

2 017

Currently, there is an ISO/TS 9002 English-language guide for theimplementation of ISO 9001:2015. The guide from the International Organizationfor Standardization (ISO) provides examples that are intended to illustrate theapplication of the new ISO 9001.
4 . W H AT G O A L S D O E S T H E I S O 9 0 0 1 R E V I S I O N P U R S U E ?

The revision of ISO 9001 aims at adapting itself better to the dynamic, complex
market conditions in which many companies are moving today, with content
enhancements and structural changes. The ISO 9001 Revision also has thefollowing goals:Creation of a stable requirement framework for the next ten years.
Consideration of changes in quality management practice, technology andthe increasingly complex and dynamic work environment for more practicalproximity.
Pursue a generic approach on the condition that relevance is given to allcompany sizes and types of organization, regardless of industry or sector.
Focus on effective process management.

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3··Implementation of the „High Level Structure“ (uniform structure, text blocks

and definitions). This ensures structural compatibility with other management
standards such as ISO 14001 for environmental management or ISO 50001 forenergy management.
Simplify the implementation in organizations and the conformity assessment.
Simplification of the formulations to ensure the same understanding andconsistent interpretation of requirements.

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5 . W H Y A R E M A N A G E M E N T R E P R E S E N TAT I V E S ( M R ) N O T M E N T I O N E D
IN THE NEW VERSION?

The quality management system is a tool for the executive management
to implement concepts and ideas. It is a clear management tool and theresponsibility for it remains with management. The new version of ISO 9001
reflects this approach even more strongly than before. However, the tasksand duties of the MR remain and must be fulfilled. In this respect, the MR cancontinue to be entrusted with tasks so that the project „Quality Management“
can be advanced and improved by a central office in the company.
6 . I S T H E Q M M A N U A L I N T H E N E W V E R S I O N A C T U A L LY O M I T T E D ?

Many companies that use a QM system according to ISO 9001 have alreadyprovided their manual electronically in the form of various documents. You cankeep this as long as this is, for you, purposive and properly documented in thisform. For companies that start with the new ISO 9001:2015, it is recommended
to follow the new version. That is, the manual as such is not required, but thecontent is. It is only optional as to how a company collects and consolidates
these documents or not. Again, it is sensible to deal with the documents in sucha way that it is appropriate for the respective company.
7. W H AT D O E S R I S K A N D R I S K M A N A G E M E N T M E A N A C C O R D I N G T O I S O
9 0 01: 2 015?

The standard defines „risk“ as the effect of uncertainty on an expected
outcome. Basically, the new version requires more risk awareness. Companies
should identify and assess possible risks. Once the company identifies,evaluates and prioritizes risks, it can decide, for example, whether the risk istolerated or avoided or whether appropriate measures should be developed tominimize the impact of this risk.
8 . W H AT D O E S I T M E A N T O V I E W R I S K M A N A G E M E N T Q U A L I TAT I V E LY ?

Companies have an average of 15 to 25 processes represented in the process
map. The standard does not specify the number of risks a company must haveper process or total. An auditor who examines these processes in terms of risk
management would ask questions such as: Where are risks in the respective
processes? Can you name the identified risks? On what basis did you identify
these risks? How do you assess the probability of these risks? How do you dealwith these risks? If the answers are plausible and corresponding documentation
is provided, this requirement of the standard is fulfilled.

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9 . H O W C A N A G A P A N A LY S I S H E L P W I T H T H E N E W I S O 9 0 0 1 : 2 0 1 5 ?

GAP analysis forISO 9001:2015
The International
GAP analysis
Accreditation Forumfor ISO 9001:2015(IAF) recommends a GAPanalysis as a first step
towards the conversion
to the new ISO 9001
standard. With a GAP analysis of your existing quality management system, you
are taking the first step towards the successful conversion to ISO 9001:2015.
The analysis helps you to confirm the conformity of already implemented
procedures as well as to recognize systems, processes and documentations thatneed improvement.
In the form of an audit, we will examine your company. On the basis of questions
from various fields of action, a first impression is gained about the extent towhich your management system meets the essential requirements of ISO9001:2015. We will provide you with the results of the GAP analysis in a finaldiscussion.

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