Public Report on the results of the ISO 9001 User Survey 2020

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Public Report on the results of the ISO 9001 User Survey 2020

Prepared by ISO/TC 176/SC 2/TG 5 “Preparing for a potential revision of ISO 9001”

May 2021 Introduction

On 29 July 2020, a web-based, world-wide user survey was launched to support understanding of current and future user needs for the international standard ISO 9001 Quality Management Systems – Requirements. This report contains a summary of the substantive data, graphical analysis and findings of the survey.

Analysis of 8397 survey responses indicates that:

There was a slight majority of respondents choosing option “A” for confirming ISO 9001:2015 versus those selecting option “B” for revising the standard.

A relatively high number of organizations expressed having no difficulties in conforming with the requirements of ISO 9001, particularly small and medium enterprises (SMEs).

There was good support for potential new topics to be addressed in future ISO 9001 revisions.

There was a slight advantage for smaller organizations in using ISO 9001, and for those who have been using the standard for less than 20 years.

ISO/TC176/SC2 created a team called Task Group 5 (TG 5) in November 2019 to prepare for the possibility of a potential revision of ISO 9001, and TG 5 conducted the survey. It was available in 14 languages and closed on 31 December 2020.

8397 responses were received from people and organizations representing a wide variety of sectors, across 149 countries.

It has been determined that the sample is valid, with a confidence interval of 95% and an accepted error rate of 5%.

The survey data shows no major variation in responses received due to:

o the size or geography of the organizations. o the different level (operational, intermediate managerial or executive) or function of the

respondent in the organization. o whether or not the organization was certified to ISO 9001. o the sector in which the organization operates.

A comprehensive internal report was provided to the ISO/TC 176/SC 2/AG 1 Strategic Planning and Operations Task Group (SPOTG) for consideration alongside the systematic review conducted by TC 176/SC 2 members, in developing its recommendation on the action to be taken on ISO 9001:2015 (which was to confirm the standard).


RESULTS AND CHARTS “Which of the following options would you prefer for the future of ISO 9001?” Respondents could select more than one option.

5332 responses There were additional comments on this question that have been combined into main topics. Topics for revising ISO 9001

Topics for Option B - Revise ISO 9001 # of Responses %

1. Minor revision to reflect changing needs (includes risk management, technologies, sustainability, ROI, clause updates, etc.)

157 33%

2. Improved integration with other management system standards 53 11%

3. Simplify and clarify, more examples and guidance 49 10% 4. Improved sector relevance 33 7% 5. Develop scalable QMS for SME and size of the organization 22 5% 6. Service/Products 16 3% 7. Non-specific comments 7 1%

Total 337 70%

Themes for “Other” comments

Themes for Other comments # of Responses %

1. Non-specific comments 65 14% 2. Revert to ISO 9001:2008 16 3% 3. Certification & Audit issues 11 2%

Total 92 19% Total comments received included Option A 7%, Option C 4%, and option D less than 1%

22211950 1824

129

550

0

500

1000

1500

2000

2500

Option A - Leave ISO 9001

unchanged – re-confirm “as-is”

until next review

Option B - ReviseISO 9001

Option C - Considerdeveloping a range

of standards toreflect

organizationsdifferent maturity

levels

Option D -Withdraw and donot replace ISO

9001

Other options –please provide details in the

Comments box below


“At what level are you in your organization?”

7954 responses.

“Do you…?”

7974 responses.

36.5%

43.1%

20.4%

Executive level (e.g. person responsible for the organization's strategy)Intermediate management levelOperational level

76.0%

62.8% 62.1%

0%

10%

20%

30%

40%

50%

60%

70%

80%

Have responsibility orsupervision of the quality

management system?

Use the quality managementsystem as part of your daily

activities?

Do you have another role, suchas internal or external auditor,

training provider, etc.?


“What is the size of your organization in number of employees and other persons under the control of your organization?”

7984 responses.

“How long have you been using ISO 9001?”

7975 responses.

38%

36%

27%

Small (1-49)

Medium (50-500)

Large (over 500)

20%

25%

26%

29%0 - 5 years

6 - 12 years

13 - 20 years

more than 20 years


“Has your organization used a quality management system based on ISO 9001? “

7678 responses. Note: Participants who responded “no” to this question were taken directly to the end of the survey and so did not provide responses to subsequent questions.

0.13%

0.27%

0.56%

1.06%

1.07%

1.85%

2.97%

3.57%

7.99%

8.11%

72.41%

0% 10% 20% 30% 40% 50% 60% 70% 80%

No, because its text is written in language that is toodifficult to understand

No, because it is too difficult to implement

No, because it is too expensive or viewed as non-value-added

No, because we are not aware of it

Yes, used it in the past but it no longer meets ourneeds

No, because it is not required by our customers

Yes, approved by a (2nd party) customer, regulatorybody or other body having a relationship to your

organization

Yes, making a (1st party) self-declaration ofconformity to the standard

Yes, but not seeking certification or needing todeclare conformity

Other (please provide details in the Comments boxbelow)

Yes, certified by an independent (3rd party) registraror certification body


“Does your QMS...? (1 indicates "not at all" while 5 indicates "completely")”

6732 responses.

3.6

3.7

3.7

3.9

3.9

3.9

3.9

3.9

4

4.1

1 2 3 4 5

Improve the management of the supply chain?

Improve your organizational culture andinteractions?

Provide you with a competitive advantage?

Increase customer confidence in the productsand/or services provided by your organization?

Support the achievement of strategic objectives?

Help you manage risks and opportunities related toyour product and/or service?

Assist in meeting the market needs for yourorganization?

Assist in meeting your business sustainability?

Facilitate improvement in the level of customersatisfaction?

Improve the management and control of your organization’s processes?


“Are you familiar with and how beneficial is the vocabulary in ISO 9000 to gain a better understanding of ISO 9001 requirements?”

6468 responses. “To what extent do you use ISO/TS 9002 to gain a better understanding of ISO 9001 requirements?”

6435 responses. “How beneficial are the supporting documents and presentation materials on the ISO/TC 176/SC 2 website that are available for your use?”

6355 responses.

39.6% 35.8%

17.1%

4.7% 2.8%

0%

5%

10%

15%

20%

25%

30%

35%

40%

5 Completely 4 Considerably 3 Moderately 2 Slightly 1 Not at all

35.3%

23.1%

16.8% 16.1%

8.8%

0%

5%

10%

15%

20%

25%

30%

35%

40%

1 Not at all 3 Moderately 4 Considerably 2 Slightly 5 Completely

32.3%

21.6% 19.6%15.9%

10.6%

0%

5%

10%

15%

20%

25%

30%

35%

40%

3 Moderately 4 Considerably 1 Not at all 2 Slightly 5 Completely


“Has applying ISO 9001 requirements to your organization resulted in …? (Scoring: 1 indicates "no advantage" while 5 indicates "an advantage")”

5985 responses. “With the Implementation of ISO 9001:2015, how adequately has it facilitated you to address the following in your organization: (Scoring: 1 indicates "not at all" while 5 indicates "completely")”

5922 responses.

3.23.53.5

3.73.73.7

3.83.83.83.83.83.8

3.93.93.9

4.1

1 2 3 4 5

Improved financial performance

Improved external provider communication

Increased external provider performance

Effective use of data as business management tool

Improved interaction with other interested parties

Improvements to the culture of the organization

Improved management of business processes

Increased leadership commitment

Increased knowledge management

Improved customer communication

Improved awareness and engagement of staff

Effective risk and opportunity management

Increased continual improvement

Enhanced customer satisfaction

More effective management reviews

Improved documented information

3.6

3.6

3.6

3.7

3.7

3.7

3.8

3.8

3.9

3.9

4

4.1

1 2 3 4 5

Knowledge management

Resource management

Supplier management control

Organization context and sustainability

Prevention of failures

Data analysis

Risk-based thinking

Leadership

Customer focus

Measurement and monitoring

Process approach

Documented information


“Identify any difficulty you have in applying clauses 0 – 10 and the Annexes.”

5307 responses.

0% 10% 20% 30% 40% 50% 60% 70% 80% 90%

Annex B - Other International Standards on QualityManagement and Quality Management Systems

Development by ISO/TC176

Annex A - Clarification of new structure,terminology and concepts

10 - Improvement

9 - Performance evaluation

8 - Operation

7 - Support

6 - Planning

5 - Leadership

4 – Context of the organization

3 – Terms and definitions

2 - Normative references

1 - Scope

0 - Introduction

No difficulties Lack of ability to apply to the organization

Benefit does not outweigh the cost Redundant (not necessary)

Omission (something additional is required) Ambiguity (2 or more possible meanings)


“How important is it to enhance the current content in ISO 9001 with the following concepts in the next revision? (Scoring: 1 indicates "not at all" while 5 indicates "very important")”

5274 responses.

3

3

3.3

3.4

3.5

3.6

3.6

3.7

3.7

3.7

3.7

3.7

3.8

3.8

3.9

3.9

1 2 3 4 5

Climate change

Demographic change

Circular economy

Aspects of information

Mutually beneficial relationship management

Emerging technologies

Agility

People aspect

Organizational culture

Innovation

Customer experience

Ethics and integrity

Knowledge management

Integration of different disciplines of management(e.g. health and safety, environment, IT security)

Business continuity planning

Change management


There were additional comments on this question that have been combined into main themes.

Specific to the concepts

Themes # of Responses %

1. Emerging technologies, aspects of information 54 9% 2. People and culture 41 7% 3. Ethics and integrity, circular economy, climate 35 6% 4. Relationship management 18 3% 5. Integration of different disciplines of management 15 3% 6. Non-specific comments 13 2% 7. Change management 7 1% 8. Business continuity 5 1%

Total 188 32%

“Other” comments


9. Non-specific comments 166 28% 10. Financial aspects / Value / Efficiencies 60 10% 11. Business management. leadership & objectives 50 8% 12. Other content suggestions 48 8% 13. Risk 42 7% 14. Relevance re size, maturity, activities 28 5% 15. Compliance 13 2%

Total 407 68%


The final question in the survey allowed for any further comments from respondents.

One thousand, one hundred and thirty-three (1133) relevant comments were analyzed from a total of one thousand, four hundred and forty-seven (1447). The table below shows the high-level analysis separated into some broad topics.

Composition of comments from the final question

Topics # of Responses %

Other themes (see below) 364 32% Non-specific comments 239 21% "Future" concepts 214 19% Decision on ISO 9001:2015 206 18% Improvements for specific clauses 110 10%

Total 1133 100%

There were further comments on the future of ISO 9001:2015. “Other” themes


1. Compliance / Certification issues 103 9% 2. Guidance / Implementation improvements 67 6% 3. Improved relevance in relation to e.g., size, maturity,

activities 64 6%

4. Business management, leadership & objectives 41 4% 5. Risk 28 2% 6. Financial aspects / Value / Efficiencies 15 1% 7. Additional process focus 14 1% 8. Clarity regarding design and development 12 1% 9. Service focus 10 1% 10. Technologies, data & cyber security 5 0% 11. Reinstate ISO 9001:2008 5 0%

Total 364 32%


Annex A – Listing of ISO/TC 176/SC 2/TG 5 members who contributed to the User Survey.

In addition to the names listed below recognition needs to be given to Ms. Petya Lilova from ISO’ Secretary General’s Office for her dedication and support in establishing and managing the online survey

Last name, First name Role/Representing Chattergoon, Devindra Convenor (Trinidad and Tobago) Uhrig, Lisa Secretary (United States) Dzedik, Valentin Deputy Convenor (Russian Federation) Cressionnie, Buddy Deputy Convenor (United States) Simpson, Paul ISO/TC 176/SC2 Chair Corrie, Charles ISO/TC 176/SC 2 Committee Manager Bell, Rosemarie Australia McLean, Michael Australia L'Esperance, Pierre Canada Marshall, Robert T. Canada Amestica, Carlos Chile Fuenzalida, Patricio Chile López, Marly Chile Kang, Jian China Barrantes, Laura Costa Rica Civet, Rodolphe France Bünting, Frank Germany Stühler, Leo Germany Votsmeier, Thomas Germany Proll, Kristofer Germany Rouzbeh, Mir Mohammad Iran, Islamic Republic of Sarkissian, Hovsep Hovsep Iran, Islamic Republic of Teimoori, Hossein Iran, Islamic Republic of Cox, Kieran Ireland Seaver, Matt Ireland Sheps, Isaac Israel Suda, Shinsuke Japan Takekita, Shinko Japan Jeffries, Sheronda Liaison IAF Poldermans, Bastiaan Liaison IIOC


Last name, First name Role/Representing Trott, Chris Liaison IIOC Anastaopoulos, George Liaison IPC Roshka, Natalia Liaison IPC Deguchi, Naoki Liaison ISO/TC269 Dos Guimarães Sá, Joana Liaison IQNet Vivas Torrez, Wilbert Arturo Mexico Schumacher, Warner Netherlands Elliot, Lily Peru Gatera, Emmanuel Rwanda Manirareba, Ildephonse Rwanda Mugabekazi, Sylvie Rwanda Shema Mugambira, Emmy Rwanda Ericsson, Gustaf Sweden Hedin, Eva-Stina Sweden Skalin, Hans Sweden Campbell, Orett Trinidad and Tobago Braham, Mark United Kingdom Somerville, Sam United Kingdom Freeman, Robert United States


Annex B – Breakdown of respondents’ country or region

Countries Number of answers

Brazil 10.9% 860

France 9.1% 716

United States 8.7% 684

Germany 8.0% 632

Portugal 5.8% 459

Mexico 4.5% 350

Peru 3.7% 294

United Kingdom 3.2% 253

Japan 3.2% 251

India 3.0% 239

Russia 2.8% 221

China 2.7% 209

Belgium 1.8% 140

Iran, Islamic Republic of 1.8% 138

Italy 1.8% 138

Australia 1.4% 110

Colombia 1.3% 99

Malaysia 1.1% 90

Spain 1.1% 84

Netherlands 1.0% 81

Saudi Arabia 1.0% 81

South Africa 0.9% 72

Canada 0.8% 65

Sweden 0.8% 60

Indonesia 0.7% 56

Venezuela 0.7% 55

Costa Rica 0.7% 53

Egypt 0.6% 50



Algeria 0.6% 49

United Arab Emirates 0.6% 49

Finland 0.6% 46

Turkey 0.6% 45

Switzerland 0.6% 44

Argentina 0.6% 43

Austria 0.5% 41

Dominican Republic 0.5% 41

Chile 0.5% 35

Ecuador 0.4% 33

Trinidad and Tobago 0.4% 33

Morocco 0.4% 28

Norway 0.4% 28

Nigeria 0.4% 27

New Zealand 0.3% 23

Senegal 0.3% 23

Bolivia 0.3% 22

Uzbekistan 0.3% 22

Philippines 0.3% 20

Kenya 0.3% 19

Greece 0.2% 17

Iraq 0.2% 17

Panama 0.2% 17

Poland 0.2% 17

Romania 0.2% 16

Ukraine 0.2% 16

Croatia 0.2% 15

Cuba 0.2% 15

Ethiopia 0.2% 15

Rwanda 0.2% 15

Czechia 0.2% 14

Denmark 0.2% 14



Ireland 0.2% 14

Israel 0.2% 14

Malta 0.2% 14

Nicaragua 0.2% 14

Pakistan 0.2% 13

Serbia 0.2% 13

Singapore 0.2% 13

Tunisia 0.2% 13

Bangladesh 0.2% 12

Jamaica 0.2% 12

Angola 0.1% 11

Azerbaijan 0.1% 11

Bahrain 0.1% 11

Bulgaria 0.1% 11

Slovenia 0.1% 11

Suriname 0.1% 11

Oman 0.1% 10

Qatar 0.1% 10

Guyana 0.1% 9

Libya 0.1% 9

El Salvador 0.1% 8

Hungary 0.1% 8

Sri Lanka 0.1% 8

Thailand 0.1% 8

Albania 0.1% 7

Korea, The Republic of (South) 0.1% 7

Sudan 0.1% 7

Uganda 0.1% 7

Cameroon 0.1% 6

Guatemala 0.1% 6

Kazakhstan 0.1% 6

Latvia 0.1% 6



Palestine, State of 0.1% 6

Syria 0.1% 6

Uruguay 0.1% 6

Yemen 0.1% 6

Belarus 0.1% 5

Cyprus 0.1% 5

North Macedonia 0.1% 5

Botswana 0.1% 4

Côte d'Ivoire 0.1% 4

Hong Kong, China 0.1% 4

Mongolia 0.1% 4

Myanmar 0.1% 4

Saint Lucia 0.1% 4

Slovakia 0.1% 4

Zimbabwe 0.1% 4

Afghanistan 0.1% 3

Belize 0.0% 3

Georgia 0.0% 3

Ghana 0.0% 3

Honduras 0.0% 3

Jordan 0.0% 3

Lebanon 0.0% 3

Luxembourg 0.0% 3

Madagascar 0.0% 3

Mauritius 0.0% 3

Armenia 0.0% 2

Bosnia and Herzegovina 0.0% 2

Cabo Verde 0.0% 2

Congo, Democratic Republic of the 0.0% 2

Fiji 0.0% 2

Kuwait 0.0% 2

Maldives 0.0% 2



Mali 0.0% 2

Mozambique 0.0% 2

Sao Tome and Principe 0.0% 2

Tanzania, United Republic of 0.0% 2

Timor-Leste 0.0% 2

Vietnam 0.0% 2

Zambia 0.0% 2

Andorra 0.0% 1

Barbados 0.0% 1

Bhutan 0.0% 1

Burkina Faso 0.0% 1

Equatorial Guinea 0.0% 1

Iceland 0.0% 1

Korea, Democratic People's Republic of (North)

0.0% 1

Kyrgyzstan 0.0% 1

Moldova, Republic of 0.0% 1

Nepal 0.0% 1

Paraguay 0.0% 1

San Marino 0.0% 1

Somalia 0.0% 1

South Sudan 0.0% 1

Tajikistan 0.0% 1

Togo 0.0% 1

Turkmenistan 0.0% 1

Vanuatu 0.0% 1


Annex C – Respondents’ sector

Industrial Sector (based on the IAF’s ID1:2014 codes)

Percentage

Agriculture, forestry, and fishing 1.0%

Mining and quarrying 0.7%

Food products, beverages, and tobacco 2.9%

Textiles and textile products 1.1%

Leather and leather products 0.1%

Wood and wood products 0.4%

Pulp, paper, and paper products 0.7%

Publishing companies 0.2%

Printing companies 0.5%

Manufacture of coke and refined petroleum products 0.5%

Nuclear fuel 0.1%

Chemicals, chemical products, and fibers 4.3%

Pharmaceuticals 1.3%

Rubber and plastic products 2.5%

Non-metallic mineral products 0.4%

Concrete, cement, lime, plaster etc. 0.5%

Basic metals and fabricated metal products 4.5%

Machinery and equipment 4.4%

Electrical and optical equipment 3.5%

Shipbuilding 0.3%

Aerospace 3.6%

Other transport equipment 1.4%

Manufacturing not elsewhere classified 6.2%

Recycling 0.3%

Electricity supply 0.8%

Gas supply 0.3%

Water supply 0.4%


Industrial Sector (based on the IAF’s ID1:2014 codes)

Percentage

Construction 3.4%

Wholesale and retail trade; repair of motor vehicles, motorcycles, and personal and household goods 0.8%

Hotels and restaurants 0.2%

Transport, storage, and communication 2.1%

Financial intermediation; real estate; renting 0.5%

Information technology 3.4%

Engineering services 6.2%

Other services 16.2%

Public administration 2.6%

Education 4.4%

Health and social work 2.7%

Other social services 0.9%

Other 13.7%

Documents

Public Report on the results of the ISO 9001 User Survey 2020