Adventure ISO Revision - Quality Austria · Adventure ISO Revision ... fully design the transition to the new tasks put by ISO 9001:2015 and ISO 14001:2015. ... Annex SL (Supplement)

ISO Revision 1www.qualityaustria.com/revision_ewww.qualityaustria.com/revision_e Accredited by BMWFW

Adventure ISO RevisionWe guide you through the jungle of Standards

www.qualityaustria.com/revision_e ISO Revision2

Quality Austria sheds light on the jungle of Standards

The Revision of ISO 9001, ISO 14001 and ISO 45001 (formerly

OHSAS 18001 Occupational Health and Safety Assessment Se-

ries) offers new opportunities for the design of your management

system: a clearer alignment to corporate strategy, handling of risks

and opportunities, advancement of process focus and an intensi-

fied look at performance and effectiveness, just to name a few as-

pects. We would like to provide you with possibilites to success-

fully design the transition to the new tasks put by ISO 9001:2015

and ISO 14001:2015.

ISO 9001 sees a further development

This Revision was aimed at adapting the Standard to the changed

conditions of a business world that is becoming increasingly dynamic

and complex and at making the Standard more user friendly, at the

same time. Simultaneous use of several management standards (In-

tegrated Management System) is to be made easier. For this purpose,

the structure of the Standard has been changed. Now it is adjusted

to the harmonized model that will be used for all management system

standards in the future. With regard to contents, the Revision supports

organizations in aligning their management systems to the conditions

in which they are operating and thus making these systems as effective

Annex SL (Supplement)

Since 2012, the ISO/IEC Directives have had specifications about the

structure and key contents of management system standards. A new

Annex (Annex SL) has been adopted. This Annex instructs all technical

committees in the field of management systems in the way management

system standards need to be structured and in the core text they need

to include. Important topics of these Revisions are already determined

by the relevant requirements: The new priorities in connection with the

topics of risk based thinking, leadership, having a look at the context of

the organization, focussing on competence and the unified term of do-

cumented information are topics determined by this common structure

and relevant key contents. Besides ISO 9001, 14001 and 45001, this

Annex SL forms the basis for all future revisions of management system

standards. Thanks to this, common implementation of these Standards

within Integrated Management Systems is simplified for users.

Transition in the course of a Re-Certification Audit

The transition can be done in the course of a Re-Certification Audit. This

is the easiest option and is therefore recommended by us. As for the

audit times and audit procedure, nothing changes for you.

Benefits of an ISO certification

Increase of customer statisfaction, transparancy, legal security, market position, motivation of employees, com-petitiveness, profitability as well as trust with customers, partners and authorities

Decrease of error rates, costs and vulnerabilities

September 2015 September 2018

Surveillance Audit Re-Certification Audit

transition period

Surveillance Audit

Fig. 1

as possible. In this folder some important changes are compiled. This

shortlist of topics is aimed at facilitating the analysis of the Standard

for you. However, it can in no way replace a detailed analysis of the

Standard tailored to your organization. The transition period amounts

to three years from the publication of the Standards ISO 9001:2015

and ISO 14001:2015. Thus certificates acc. to ISO 9001:2008 or

ISO 14001:2004 will no longer be valid upon expiration of this transition

period (cf. Fig. 1).

However, the new requirements of ISO 9001:2015 or ISO 14001:2015

will be reviewed instead of those of the old versions of the Standards.

Transition in the course of a Surveillance Audit

This change can also be done in the course of a Surveillance Audit. At

transition, all requirements placed by the Standard will have to be re-

viewed. This is why a longer audit time will have to be planned than for

a regular Surveillance Audit, the extent amounting to that of a Re-Cer-

tification Audit. Then this audit will be regarded as a Re-Certification

Audit conducted in advance and the period of validity of the Certificate

will amount to three years again.

Re-Certification Audits based on ISO 9001:2008 or

ISO 14001:2004

If you still would like to have a Re-Certification Audit conducted on the

basis of ISO 9001:2008 or ISO 14001:2004 this is possible. However,

we would like to point out that we are, due to our accreditation rules,

obliged to restrict the validity of the certificate to the end of the transi-

tion period.

ISO Revision 3www.qualityaustria.com/revision_e

Step by step to certification acc. to ISO 9001:2015 and ISO 14001:2015

You have made it!Now you are ready for the Re-Certification Audit acc. to the new Standard!

Understand the Standards!

The Standards include new terms and concepts and are organized on the basis of a common struc-

ture. This does not only enable you to improve your systems but also to integrate them more easily. In

order to enhance understanding, the introductions and annexes of the Standards provide important ex-

planations. We invite you to attend our Revision trainings and to make use of qualityaustria publica-

tions about the key topics of the Revision in the qualityaustria TIMES (newsletter), in magazines (e.g.

the Q1 Magazine in German language), our YouTube Channel as well as on our social media platforms.

1

Identify the most important topics and use them for a further development of your system!

Choose the topics that can create most value for your organization. These topics usually concern the

subjects of risks and opportunities as well as context of the organization – e.g. business plan, plan-

ning and performance evaluation or the organization’s competence and/or knowledge. Address these

topics as early as possible as they are important levers for increasing your performance and customer

satisfaction!

2

Define the moment you change to the new Standard!

When will you have translated the new requirements into action? When is the most favourable mo-

ment for the transition? Discuss the possibilities with your auditor, our Customer Service Center or our

Technical Experts – we will support you in a very competent manner. In this respect, please keep the

three-year period upon publication of the new Standard in mind (cf. Fig. 1).

3

Conduct an internal audit in order to review the maturity and conformity of the system!

Have you made your changes and adapted the processes accordingly? Review in an internal audit

whether your system is effective, performance is achieved and the requirements of the revised

Standard are met.

5

Our recommendations for implementing the new requirements:

Plan a Delta Analysis!

You have already anchored the big changes in your processes. Make sure that you meet all single

requirements that have changed by conducting a Delta Analysis, i.e. a target-performance compari-

son. For this purpose, please use qualityaustria Delta Checklist or ask us to perform a Delta Status

Review.

4

7 Support Resources do not only include infrastructure and re-sources needed to operate the processes but also measuring devices and knowledge. “People” also are mentioned explicitly. Monitoring and measuring devices are now seen in a larger context, since measuring devices in the service sector (including surveys and empirical methods) also need to be deemed appropriate. Knowledge of the or-ganization has been added as a requirement. In this re-spect, identification, retention, distribution and acquisi-tion of knowledge are addressed to a particular extent. Support also covers documentation requirements (cf. 4.2 ISO 9001:2008). The term of “Documented infor-mation” supersedes the known terms of “Document”, “Record”, “Documented procedure”, etc. The focus is on expedience.

8 Operation The clause “Operation” now includes quality-speci-fic requirements referring to the specific processes for the realization of goods and services: operational planning and control, determination of requirements, development, control of external provision, production of goods and provision of services, release of goods and services and nonconforming goods and services. The specifications relating to planning have been put in more concrete terms, above all in terms of the cri-teria to be established for these processes as well as the controls adjusted to them. The field of design and development has changed in its structure and text. Detailed requirements relating to design and develop-ment review, verification and validation and the control of design and development changes are simplified. Purchasing and outsourced processes are summa-rized in the term “External provision”. Depending on what an organization delivers or what services or pro-cesses this organization provides, the kind and scope of the control of external provision can be designed in different ways.

9 Performance evaluation

The requirements relating to monitoring and measure-ment are more detailed: It will be required to determine what is produced at what time and which methods are used and when outputs are analyzed and assessed. As for the outputs, documented information needs to be retained as evidence. The Revision no longer in-cludes clauses specifically dealing with monitoring and measurement of products or processes.

10 Improvement Preventive action is no longer included in the norm either – the system itself, which is based on the risk based approach, is preventive. Improvement is not restricted to continual improvement anymore. Instead the organization needs to respond to changes. This can also include radical changes, innovation or re-or-ganization, if necessary.

Clause Remarks

0 Introduction The introduction explains some essential approaches of the Standard (process approach, context of the or-ganization, risk based thinking), includes new model charts and elaborates the connection with other ISO Standards in the field of quality or other management systems.

1 Scope The scope has remained unchanged. Now a separate clause (4.3) is dedicated to the “scope of the quality management system”.

2 Normative references

None

3 Terms and definitions

For terms and definitions the norm refers to ISO 9000:2015, which contains terms of the Annex SL as well as updated quality-specific expressions.

4 Context of the organization

Understanding the internal and external context of the organization is a major element for the design of adap-table and tailored management systems. Determining this context is a new requirement of ISO 9001. The identification of the requirements placed by the rele-vant interested parties is a newly anchored condition as well. The explicit possibility of exclusion of requi-rements in the clause dealing with product realization is no longer intended. „Application“ is now the core concept. The process approach, which entered ISO 9001 for the first time in 2000, has been consolidated while newly incorporating additional requirements (cf. Process Owner, input/output).

5 Leadership “Commitment” demonstrated by top management is of utmost importance for the success of a quality management system. This is reflected in the Revision. The requirements placed on top management relating to leadership, communication and ensuring that the quality management system is effective have been expanded accordingly. The responsibilities to be esta-blished, which are stated under the title “Management representative” in today’s version, have been extended (keywords customer focus, process outputs and ch-ange management).

6 Planning The most important new element in the field of plan-ning is the integration of the consideration of risks and opportunities. In this respect, Clause 6.1 includes the key issue of a risk based quality management system. Risks and opportunities need to be identified, and necessary measures also need to be established in detail. The requirements relating to quality objectives have been put in more concrete terms (cf. 5.4.1. ISO 9001:2008). For this purpose, it is required to draw up an action plan for the implementation and to plan and systematically carry out all changes.

Overview: The most important changes of ISO 9001:2015

The revised Standards ISO 9001:2015 and ISO 14001:2015 as well as ISO 45001, the successor of OHSAS 18001 (Occupational Health and Safety

Assessment Series), which is being drawn up, are all based on the binding requirements of the ISO Annex SL. This means that information relating

to quality management often form the basis for the requirements of ISO 14001:2015 and ISO 45001. As is shown in the table below, the creation of

an Integrated Management System on the basis of ISO Standards will be made much easier in future.

ISO Revisionwww.qualityaustria.com_e4

Clause Remarks

0 Introduction refer to ISO 9001:2015

1 Scope refer to ISO 9001:2015

2 Normative references

none

3 Terms and definitions

Integrated in the norm

4 Context of the organization

The requirement for an analysis of the context of the organization is aimed at better understanding one’s own organization conceptually and more comprehen-sively, e.g. in terms of the internal and external interes-ted parties, their needs and expectations as well as possible influencing factors. The context also means that the environmental condition needs to be taken into account. As this condition affects the organization while the organization affects the environmental condi-tion because of the organization’s activities, products and services.

5 Leadership Top management is required to demonstrate leaders-hip even more. This means that the environmental as-pects need to be integrated in the business processes, strategic planning and decision-making. Top manage-ment is given a more significant role, not only because top management is supposed to act as a role model (active leadership role) but also because the classical Environmental Representative no longer is required. In practice, however, this person will continue to be there to meet the comprehensive and variegated technical, legal, normative and ecological requirements of daily practice.

6 Planning Due to the Annex SL, the risk based approach can be found in ISO 14001:2015. This approach includes the determination of risks and opportunities from the per-spectives of analysis of the context, environmental as-pects and impacts, legal requirements and emergency preparedness and response. Opportunities and risks might be derived from this. Adequate actions will have to be planned, implemented and reviewed regarding their effectiveness. The organization will have to deter-mine the environmental aspects of the organization’s activities, products and services that the organization can control and influence.

Overview: The most important changes of ISO 14001:2015

Based on criteria to be established, the related en-vironmental impacts will have to be determined. The term of “Legal requirements” becomes “compliance obligations”. This implies compliance with legal re-quirements, additional burdens as well as voluntary self-commitment. Here basically only the wording has changed.

7 Support Awareness and competence are separate sub-clau-ses in Clause 7. This means that they are upgraded as compared to former times. Internal and external communication becomes more important. Internal communication is closely linked to the internal context. In analogy, external communication is closely linked to the external context. External communication is re-quired to enhance confidence by means of a dialogue about environmental performance with the external target groups. In Clause 7, the requirements placed on documented information are also established.

8 Operation Clause 8 is mainly dedicated to operational planning and control, above all control of the processes, inclu-ding the outsourced processes. The requirement for a life cycle perspective of products and services is a common theme throughout the Standard and is amply described in Clause 8.1. It is true that no detailed life cycle analysis in the sense of ISO 14044 is required. Nevertheless, the phases of life will have to be con-sidered, and the organizations are required to review to what extent they can control and influence them. In 8.2, “Emergency preparedness and response”, Clause 8 also defines the requirements relating to emergency preparedness and response.

9 Performance evaluation

Environmental performance needs to be improved. Basically the term is not new. Environmental perfor-mance is the measurable result of the management of environmental aspects within an organization. In the Revision, indicators play a role. Inputs in performan-ce evaluation also include review of compliance with compliance obligations, the internal audit as well as management review. Thus, the circle is closed for top management again.

10 Improvement Includes requirements regarding non-conformity, cor-rective actions as well as continious improvement.

Basically ISO 14001:2015 also follows the high level structure (HLS), as ISO 9001. In this table, we provide you with a compact overview of the

specific changes of the environmental management standard ISO 14001:2015.

ISO Revision www.qualityaustria.com/revision_e 5


Your tools for the ISO Adventure

Revision ISO 9001

Revision ISO 9001

Revision ISO 14001

Regarding details, dates and

places please visit our website

www.qualityaustria.com/revision_e







Revision ISO 45001

Seminar: The new ISO 14001:2015 Revision

In this one-day seminar we provide you with an overview of the substantial innovations and the new structure of the Standard. Further

we explain in which specific new requirements this has resulted and how they affect your organization. The seminar also offers time to

discuss the potentials of the implementation.

Seminar: The new ISO 45001 Revision

The OHSAS 18001 and some other occupational health and safety standards will be replaced by ISO 45001. The participants of this

one-day seminar will get a comprehensive overview of the essential changes and their practical application.

Seminar: The new ISO 9001 Revision

In this one-day seminar we provide you with an overview of the major changes, the new structure and the concrete new requirements

which affect your company. The presentation and discussion of implementation possibilities are also part of the seminar.

Seminar: QM-Workshop ISO 9001 Revision

The ISO 9001 Revision provides companies with the opportunity to adjust their quality management system in a better way according

to their needs. The new elements reflect the modern practice of the management and focus on results as well as quality performance.

In this one-day Revision-workshop specific implementation approaches are developed with the participants and discussed by means

of examples and questions.

Status Evaluation Implementation of the new requirements ISO 9001 (Compact Delta-Audits)

By means of a checklist, corresponding to the respectively latest development status of the Standard, the new requirements of the

Standard are addressed in detail and the degree of implementation is audited. This status evaluation can contain the entire new Stan-

dard or only selected elements. The audit time required is stipulated according to the extent and complexity of the organization. For

small and medium sized organizations the duration is usually estimated one day.

ISO Revision www.qualityaustria.com/revision_e

Book recommendation

In the new book written by Dr. Anni Koubek, “Praxisbuch ISO

9001:2015. Die neuen Anforderungen verstehen und umsetzen”

(“Practical book ISO 9001:2015. Understanding and implemen-

ting the new requirements”), you can read first-hand practical sug-

gestions. This book was published in cooperation with Quality Aus-

tria, DGQ and SQS in the Hanser Publishing House.

Anni Koubek (Hrsg.)

PraxisbuchISO 9001:2015Die neuen Anforderungen

verstehen und umsetzen

€ 49,99 ISBN: 978-3-446-44523-9E-Book: € 39,99 ISBN: 978-3-446-44612-0

ISO 9001 Revision explained in simple terms

In the news area of our website, you will find information about the

Revision in several technical contributions. Here you can, among

other things, find the series of articles “ISO 9001 Revision explained

in simple terms”, which deals with a key concept of the Revision in

each contribution. Enjoy your reading!

Stay up to date with the quality austria TIMES

In our newsletter, the qualityaustria TIMES, you regularly receive

the latest information on the Revision as well as on many other

cutting-edge topics. Register for the newsletter now!

www.qualityaustria.com/newsletter

In the qualityaustria YouTube Channel we provide you

with informative videoclips on a regular basis. Sub scribe

now for free! www.youtube.com/qualityaustriachan

Stay on the right track

Contact

We hope that we can support you in planning your

management system and guaranteeing its further

development with this information folder. As for

further information, our employees in the Customer

Service Center, your auditor or our technical ex-

perts will be pleased to be at your disposal.

For further information regarding our products and

the Revision please visit our website:

www. qualityaustria.com/revision_e.

Dr. Anni KoubekExecutive Vice PresidentInnovation, Business Development [email protected]

Axel Dick, MScExecutive Vice President Business Development Environment and Energy [email protected]

Eckehard Bauer, MScExecutive Vice PresidentKey Account and Business Development Risk and Safety, Security, Business Continuity, [email protected]

Public qualityaustria trainings can be booked one-to-one as custo-

mized In-house trainings. Additionally we can conduct individual

customized workshops for you. For larger groups of employees in par-

ticular, in-house trainings can be more cost efficient and effective. Find

more information on our website www.qualityaustria.com/inhouse

7

More offers regarding the revisioned norms as well as information regarding

J webinars J English-language E-Learning J status reports J Focus Audits

can be found at www.qualityaustria.com/revision_e.


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changes to its products. The data in the con-

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kindly ask for your understanding.

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Responsible for the content:

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Begutachtungs GmbH.

Subject to changes and misprints.

Edition: February 2017

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for the Integrated Management System

Be smart – change now to the revised norms!

Don‘t forget the

transition period!

Documents

Adventure ISO Revision - Quality Austria · Adventure ISO Revision ... fully design the transition to the new tasks put by ISO 9001:2015 and ISO 14001:2015. ... Annex SL (Supplement)