ISO 9001-2015 Revision

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ISO 9001:2015 Revision

CONFERENCE PAPER · SEPTEMBER 2014

DOI: 10.13140/2.1.2046.5929

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Luis Fonseca

Polytechnic Institute of Porto

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Luis Miguel Fonseca ( [email protected] )

Adjunct Professor

ISEP - School of Engineering Polytechnic of Porto

Abstract

Purpose: This paper aims to discuss the rationale behind the ISO 9001:2015 revision and the status of

this (still ongoing) process. Key Stakeholders have (and are still working) towards a Quality Management

Systems with less emphasis on documentation and new/reinforced approaches like consideration of

organizational context and (relevant) Stakeholders, risk based thinking and knowledge management. The

main question is how far ISO/TC 176 can go without alienating the "traditional" user and at the same

time bonding Quality with Management.

Design/methodology/approach: the status of the revision process and a comparison of ISO

9001:2008 and the expected ISO 9001:2015 International Standard are presented, along with author

comments on the revision processes and its expected outcomes.

Findings: The revision should assure the standard reflects the changes of an increasingly complex,

demanding and dynamic environment and remains stable and adequate to provide assurance that

organizations by complying with them are able to provide conformity products and services that satisfy

their customers.

The core elements have been standardized by the “Annex SL” and it follows the Plan Do Check Act.

Some familiar elements have been omitted (e.g., Quality Manual title is no longer a specific requirement)

and some ideas should be reinforced or introduced.

Practical implications: There will be a 3 year transition process and major benefits like Quality

Management Systems with less emphasis on documentation and new/reinforced approaches as

consideration of organizational context and (relevant) Stakeholders, risk based thinking and knowledge

management.

Originality/value: Any opinions expressed by the author are personal viewpoints and information about

the revision of ISO 9001 is not yet final. The author thinks organizations will have to be clearer about what

they say they are going to offer and the main question is how far ISO/TC 176 can go without alienating

the "traditional" user.

Keywords: Quality Management Standards, Management Systems, ISO 9001 revision

Article Classification: General Review

1. Introduction

ISO 9001 standard has achieved great international visibility with more than 1 Million Organizations with

ISO 9001 certified Management Systems (MS) all over the world (ISO Survey 2012, accessible at

www.iso.org ).

The scientific studies (Boiral, 2012), have linked the success in the implementation of QMS ISO 9001 to

the Organisation's motivations (most significant results when the motivations are internal rather than

external) and to the way the standard is interpreted and implemented. Also the studies of Levine and

Toffel (2010, Harvard Business School) concluded, by analysing 1000 organizations of which 500 with

QMS implemented and certified and 500 without QMS implemented and certified, the first presented a set

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392 Proceedings of the 1 st International Conference on Quality Engineering and Management, 2014

of indicators significantly more favourable than the others: 9% higher sales volume and consequent

additional profits; more employment (10%) and better wages (7%) due to higher sales volumes and

profitability, and in combination with ISO 14001 less waste and incidents (these effects are more

pronounced in small organizations).

Figure 1 – ISO 9001 Certified Organizations Survey Trends

ISO has a Directive governing the publication of standards (to be reviewed every 5 years). Sometimes

the review confirms there is no change but are not the majority of the cases.

The ISO 9001:2008 revision process started by ISO/TC 176 aims to assure that the future ISO

9001:2015 standard reflects the changes of an increasingly complex, demanding and dynamic

environment and remains stable for the next 10 years. The requirements should be clearly

understandable and adequate to provide assurance that organizations by complying with them are able to

provide conformity products and services that satisfy their customers. ISO TC 176 has the following

structure: SC1 (Terms and Definitions), SC2 (Quality Systems, with WG 23 Implementation Guidance and

WG24 Revision of ISO 9001) and SC3 (Supporting Technologies). At the beginning of this process

(October 2011) ISO conducted a web survey with approximately 12000 answers (of which 1000 inPortuguese language), with the following main conclusions:

64% of the respondents wanted enhancement (7918 responses) to ISO 9001:2008

The Top 5 Concepts were: Resource Management, Voice of Customer, Measures, Knowledge

Management and Risk Management

In addition there were free text comments which concerned the following 5 main issues: Top

management involvement, Risk assessment, Business continuity / planning, Inclusion of finance,

Resources / competence / work environment.

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Proceedings of the 1 st International Conference on Quality Engineering and Management, 2014 393

Figure 2 – ISO 9001:2015 Forecast schedules

Where are we now?

June 2014: Publication of DIS for Ballot and Comment (changes might still happen to content

and publication date)

Nov 2014: meeting to review results of DIS Ballot

April 2015: Publication of FDIS

Sept 2015: Publication of ISO 9001:2015

In response to the proliferation of different MS Standards the core elements have been standardized

by the “Annex SL” (or “High Level Text” as it is sometimes referred to) and it follows, the Plan Do Check

Act (Clauses 6, 8, 9 and 10):

Clause 4 = The organization’s business environment and MS scope

Clause 5 = Leadership and organizational structure

Clause 6 = (PLAN) Planning

Clause 7 = Support processes and capability

Clause 8 = (DO) Operational processes

Clause 9 = (CHECK) Performance evaluation

Clause 10 = (ACT) Improvement

The DIS ballot is now scheduled to start on 2014-07-10 and to close on 2014-10-10. Although ISO

9001:2015 is not yet at DIS (Draft International Standard), there are some familiar elements have been

omitted (e.g., Quality Manual is no longer a specific requirement, the new requirement for “documented

information” gives greater freedom on how this is implemented) and some new ideas should be

reinforced:

1. More emphasis on process approach and less on documentation.

2. After considerable discussion Products and Services were chosen versus Goods and Services,

requiring further update of terminology.

3. Risk based thinking was introduced giving additional credibility to ISO 9001 within Business and

Top Management by adding some systematic evaluation of potential and actual issues with the

aim of making processes more robust and capable.

4. Organizational context should be considered and Interested Parties concept was also introduced

but with the precaution we are referring to relevant parties that must have some actual or

potential impact on the quality of products and services.

5. Concepts like Change Control and Strategic Direction will be reinforced on the future ISO

9001:2015 standard, trying to further approach and embed ISO 9001 and BusinessManagement.

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2. Detailed comparison of ISO 9001:2008 and ISO/DIS 9001:2015 versions

2.1. Quality Principles (SC1 (Terms and Definitions)

There has been a proposal to review the Quality Management Principles accordingly to the following

scheme:

Table 1 –Changes in Quality Management Principles proposed ISO/DIS 9001:2015 ((source:2014, ISO /TC 176/SC 2/WG 24/N 112)

1. Customer Focus 1. Customer Focus

2. Leadership 2. Leadership

3. Involvement of People 3. Engagement of People

4. Process Approach 4. Process Approach

5. System Approach to Management 5. Improvement

6. Continual Improvement 6. Evidence-based Decision Making

7. Factual Approach to Decision Making 7. Relationship Management

8. Mutually Beneficial Supplier

Relationships

Systems Approach: The Quality Management Principles (QMP) has been reduced

from 8 to 7; the one which was omitted is “Systems Approach”. This is largely because of the

failure of TC 176 to communicate clearly on the differences between Systems Approach and

Process Approach, so the QMP committee decided to amalgamate “systems” and “process”

under the new principle “Process Approach” which refers to “managing inter -related processes”.

A system is the management of inter-related processes so, although Systems Approach” is not a

principle, the new principle is more powerful as it redefines Process Approach as the processes

and their inter-relationships. Systems Approach is there in the new QMP and more clearly

expressed.

There are still some issues to solve (e.g. how to translate outputs, and outcomes in

Portuguese and Spanish, output a result of a process, but outcome?).

2.2. Omitted elements

Many people have commented that familiar elements have been omitted. Some of these are:

Quality Manual: No longer a title specific requirement but one can have one. The new requirement for

“documented information” gives greater freedom on how this is implemented.

Management Representative: it is no more a specific title but management are required to

appoint somebody with the Management Representative’s roles so the situation looks quite

similar.

Preventive Action: The change from “preventive action” to “risk and opportunity” (Cl. 6 Planning

for the quality management system) is an example of a change to the way management think

and of the issues of governance.

Systems Approach: The Quality Management Principles (QMP) have been reduced from 8 to 7;

the one which was omitted is “Systems Approach”. Systems and processes have been

incorporated under the new principle “Process Approach” which refers to “managing inter-related

processes”. A system is the management of inter -related processes so, although Systems

Approach” is not a principle, the new principle is more powerful as it redefines Process Approach

as the processes and their inter-relationships. Systems Approach is there in the new QMP and

more clearly expressed.

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Continual Improvement: Clause 10 is titled “Improvement” but clause 10.3 is titled “continual

improvement, as there are several types of improvement e.g., breakthrough and continuous

improvement.

2.3. New ideas introduced on the standard

New ideas have been included such as:

Risk based thinking: As already noted, this adds management credibility to the standard. But

“risk experts” should note that this is not ISO 31000 but more a way of thinking that replaces

preventive action and seeks to add some systematic evaluation of potential and actual issues

with the aim of making processes more robust and capable.

Interested Parties: this has been added to clause 4.2 but with the precaution that it is “relevant

interested parties”. To be relevant, the interested party must have some actual or potential

impact on the quality of the goods and services.

Change Control: This was included in the previous version of the standard but had now been

highlighted as, in practice, many systems fail because of incomplete (or lack of) changemanagement. It is now included in three places and this is another area of the standard that will

need refining in the Paris meeting.

Strategic Direction: This requirement has been added to Management Review to try to meld the

business and quality systems, but will auditors be ready for this?

Knowledge Management: Several examples of companies where their QMS scope no longer

matched the expertise available, e.g. situations were der to the economic crisis older staff in

organisations have taken early retirement and, in many cases, this has created a crisis of

knowledge management.

Leadership: “Top Management” is still there but Leadership doesn’t quite align with the

principles (where leadership is at all levels). Possibly the right wording would be “everything” and“everywhere”.

2.4. Comparing ISO 9001:2008 versus proposed ISO/DIS 9001:2015

The following tables aims to compare the present ISO 9001:2008 International Standard versus the

proposed ISO/DIS 9001:2015.

Table 2 – ISO 9001:2008 versus proposed ISO/DIS 9001:2015 (source: 2014, ISO /TC 176/SC

2/WG 24/N 112)

ISO 9001:2008 ISO/DIS 9001:2015

0. Introduction = 0. Introduction

1. Scope = 1. Scope

2. Normative References = 2. Normative References

3. Terms and Definitions = 3. Terms and Definitions

4. Quality Management Systems, 4. Context of the Organization

4.1 General Requirements 4.1. Understanding the organization and its

context

4.2 Documentation Requirements See section 7.5

4.2. Understanding the needs and expectations of

interested parties

4.3. Determining the scope of the quality

management system

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4.4 Quality Management System and its

processes

5. Management Responsibility 5. Leadership

5.1 Management commitment

5.2. Customer Focus 5.2. Quality Policy

5.3. Quality policy 5.3. Organizational roles, responsibilities and

authorities

5.4. Planning 6. Planning for the quality management system

6.1. Actions to address risks and opportunities

6.2. Quality Objectives and planning to achieve

them

6.3. Planning of changes

5,5 Responsibility, authority and

communication

See section 5.3 for staff responsibility and 7.4 for

communication

5.6 Management review See section 9.3 for management review

6. Resource Management 7. Support

6.1. Provision of Resources 7.1. Resources

6.2. Human resources 7.2. Competence

7.3 Awareness

7.4. Communication

6.3. Infrastructure See 7.1 for infrastructure

6.4 Work Environment See section 7.1 for workplace criteria

7.5 Documented Information

7. Product realization 8. Operation

7.1. Planning and Product realization 8.1. Operational planning and control

7.2. Customer related processes 8.2. Determination of requirements for products

and services

7.3. Design and development 8.3. Design and development of products and

services

7.4. Purchasing 8.4. Control of externally provided products and

services

7.5. Production and service provision 8.5. Production of products and services

7.6. Control of monitoring and measuring

equipment

8.6. Release of products and services

8.7. Control of nonconforming processes outputs,

products and services

8. Measurement, analysis and improvement 9. Performance evaluation

8.1. General 9.1. Monitoring, measurement, analysis and

evaluation

8.2. Monitoring and measurement 9.2. Internal audit

9.3. Management review

8.3. Control of nonconforming product See 8.8

8.4. Analysis of data See 9.1

8.5. Improvement 10. Improvement

10.1. General10.2 Nonconformity and corrective action

10.3.Continual Improvement

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Notes:

This matrix is the sole responsibility of the author. An “official” matrix comparing ISO 9001:2008

versus ISO/DIS 9001:2015 should be available only after the June meeting of ISO/TC

176/SC2/WG23.

SC2 will develop a guidance document ISO TS 9002:2015 supposed to be started on June 92014 and available when ISO 9001:2015 is published.

The new clauses in Section 4 require the organization to determine the issues and requirements

that can impact on the planning of the quality management system and can be used as an input

for its development.

Figure 3 – Risk Based approach

ISO/DIS 9011:2015 proposes a processes model showing the links with the clauses of the

international standard:

Figure 4 – ISO 9001:2015 proposed links (source: ISO)

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2.5. Somme issues still open

Generic implementation guidance (possibly to be numbered as ISO 9002).

Updated guidance for small businesses.

Service sector (revive and revise the old ISO 9004-2?).

Sector guidance (possible way to address concerns from Automotive Sector?)

Application for “one-off” projects (updated ISO 10006).

3. Conclusions

Based on what we know the author believes we should relax that ISO 9001:2015 should not be a major

source of concern, for the more than 1 Million certified organizations and the many Quality Professionals

and Scholars that work with it. It will have major benefits for Quality Management Systems with less

emphasis on documentation and new/reinforced approaches like consideration of organizational context

and (relevant) Stakeholders, risk based thinking and knowledge management. The author thinks one of

the major changes will be that organizations have to be clearer about what they say they are going to offer

and the main question is how far ISO/TC 176 can go without alienating the "traditional" user.

According to ISO the following will be the major changes in terminology:

Table 3 – Major differences in terminology between is 9001:2008 and the proposed ISO/DIS

9001:2015 (source: 2014, ISO /TC 176/SC 2/WG 24/N 112)

ISO 9001:2008 ISO/DIS 9001:2015

Products Products and Services

Exclusions Not used (See Annex A4. for clarification ofapplicability)

Documented records Documented information

Work environment Environment for the operation of process

Purchased product Externally provided products and services

Supplier External provider

There will be time for users to make any adjustments necessary to their quality management system –

a three-year transition period has already been agreed with ISO/CASCO and the IAF, after publication of

the new version, during which certifications to ISO 9001:2008 will continue to be recognised.

3.1. And what about the feedback from ISO 9001 community?

Some like very much the “Annex SL” approach, but other do not.

Some concerns that some requirements are being soft grading (e.g., Design & Development and

Calibration).

Concerns about “auditability” of some requirements (I agree this might be a major challenge for

Consultants and for Certification Bodies Auditors).

Some want more prescriptive requirements (e.g., Automotive Sector).

Introduction of the concept of “Relevant Interested parties” and “Risk Based Approach” is a new

reality.

Elimination of usual terminology and requirements like “Preventive action”; “Management

Representative”, “Quality Manual” still not liked by all.

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3.2. And last but not least, what should you do now?

Stay tuned to what’s happening with the revision to ISO 9001.

Get familiar with the concepts of “Risk-based thinking” and “Relevant interested parties”.

Look into www.iso.org . since periodic updates will be made available by ISO/TC176/SC2/WG23.

After publication of DIS (Draft International Standards schedule for mid-2014), start working on

understanding and incorporating the changes. DIS will be followed by FDIS (Final Draft Standard)

and finally IS (international Standard).

Is your organization pleased with your present Quality Management System? Is it really a lean

process based system? Does it integrates and supports your business well?

Depending on you the answer, some organizations should consider the 2015 ISO 9001 revision as a

great opportunity to reviews and reignite theirs systems. If the system is working well, maybe just adjust it

to the new ISO 9001.2015 changes.

And as many times happens when processes changes occurs some people will say this was a lost

opportunity to move to new heights of performance and provide a fresh new ISO 9001 that addresses newtechnology and advances in quality thinking, while others will say we have gone too far and could alienate

a significant part of the more than 1 Million certified organisations.

It is true that some representative e.g. from automotive industry think the revision is too, light. It

should incorporate tools like Quality Function Deployment, Failure Mode and Effects Analysis, Statistical

Process Control, Measurement System Analysis, Advanced Quality Planning Process and so on. As an

example of the opposition versus some of the proposed changes on ISO 9001.2015, let´s quote some of

IATF comments on document ISO /TC 176/SC 2/n 1206 dated 6 May 2014: for example, IATF “he

International Automotive Task Force (IATF), that is and an acts an "ad hoc" group of automotive

manufacturers and their respective trade associations, formed to provide improved quality products to

automotive customers worldwide and which members include IATF members include the following vehicle

manufacturers: BMW Group, Chrysler Group, Daimler AG, Fiat Group Automobile, Ford Motor Company,General Motors Company), PSA Peugeot Citroen, Renault SA, Volkswagen AG and the vehicle

manufacturers respective trade associations - AIAG (U.S.), ANFIA (Italy), FIEV (France), SMMT (U.K.) and

VDA (Germany) (source http://www.iatfglobaloversight.org/ accessed 2014.06.29). IATF disagrees with

the decision to raise the generic level of ISO 9001 where it results in the reduction of requirements.

Accordingly to IATF “ISO 9001 needs to be more prescriptive not more generic to bring value to the

organization. In the effort to achieve the goal of making the standard adaptable to every type and size of

industry, and to eliminate the needs for “exclusions” of specific requirements, the document has become

diluted and unusable compared to what was already working”. In the same line of thought IATF argues

that “when the he document will be released in 2015, it will be likely be viewed as not usable by users

including specifiers and regulators “.

Also some other users are concerned on how to address risks and opportunities with Top

Management, for example.

As said before, the author does believe that ISO 9001:2015 will have major benefits for Quality

Management Systems with less emphasis on documentation and new/reinforced approaches like

consideration of organizational context and (relevant) Stakeholders, risk based thinking and knowledge

management.

And let it be clearly: in the author personal opinion the main ISO 9001 revision goals have been

achieved; a more Performance related standard, more Friendly to sectors like Services and Small and

Medium Enterprises and not static but rather Risk Based. And has stated by Professor H. Lee from

Stanford (2004), some years ago, but still very much valid today, organizations (and I had the standards

assuring and supporting their performances) must be Agile (detect and respond), Adaptable (innovative

and resilient) and Aligned (constancy of purposes and values, transparent, authentic, responsible and

working forward long term mutual beneficial Stakeholders relationships).

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400 P di f th 1 I t ti l C f Q lit E i i d M t 2014

3. Acknowledgements

The author wants to Alex Ezrakhovich Joana dos Guimarães Sá (2014), Nigel H. Croft (2013) and Richard

Hadfield (Hadfield and Fonseca, 2014) from ISO TC 176 for the great learning and sharing during this ISO

9001 revision process. A special thanks also to the Portuguese members of TC 176 (Quality Managementand Assurance) where the author represents APQ – The Portuguese Association for Quality and to other

authors that have also being sharing their insights on this ISO revision process (e.g., Nascimento, 2013

and O’Byrne and Tighe, 2013).

4. References

ISO TC/176, accessed at www.iso.org/iso/iso_technical_committee?commid=53882

ISO Survey 2012, accessed at www.iso.org

Boiral, O., 2012, ISO 9000 and Organizational Effectiveness: A Systematic Review, QMJ, Vol 19, and

N º 370)

Croft, N.H., 2013, ISO 9001:2015, from CD to DIS, DNV Webinar

Hadfield R., Fonseca L., 2014, ISO9001:2015, APQ, ANO XLIII, Edição 01,pp32-36

IATF, 2014, accessed at ww.iatfglobaloversight.org.

ISO, 2014, ISO/TC 176/SC 2/N 1147, 2013, ISO/CD 9001.

ISO 2014, ISO/TC 176/SC 2/WG 24/N 112, 2014, ISO/DIS 9001. This document is presently under

ISO copyright and should not be forwarded to, or made available to, any 3rd Party -This document is a draft

circulated for comment and approval. It is therefore subject to change and may not be referred to as an

international standard until published as such.

Lee, H., L., 2004, Harvard Business Review, October 2004.

Levine D., Toffel, M.W., 2010, Quality Management and Job Quality: How the ISO 9001 Standard for

Quality Management Systems Affects Employers and Employees, Harvard Business School.

Nascimento J.C., 2013, Norma ISO 9001:2015, Panorama e tendência da revisão 2015, ABNT,

Exponorma.

O’Byrne, F., Tighe, J., 2013, NSAI Consultants Forum.

Sá, J.G., 2014, Workshop ISO 9001:2015 perspetivas futuras, Ponta Delgada.

Karapetrovic, S., 2002, Strategies for integration of management systems and standards, TQM

Magazine, 14(1) pp. 61-67).

Documents

ISO 9001-2015 Revision