Introduction

With the release of the DRAFT International Standard “ISO/DIS 9001” I thought that it would be useful to summarize the changes from the ISO 9001:2015 standard.

There have been many misleading comments made on social medial concerning the anticipated changes, so I thought it was time to set matters straight!

In this article I shall only be addressing the changes to the ‘requirements clauses’ (4 thro’ 10) without any of my personal views!

Here are the changes .. .. ..

4 Context of the organization

4.1 Understanding the organization and its context

The 2024 amendments concerning ‘climate change’ are now embedded as a requirement – “determine whether climate change is a relevant issue”.

NOTE 3 Adds to the consideration of the internal context “the organization’s strategic direction and resources”.

4.2 Understanding the needs and expectations of interested parties

Simplified wording “The organization shall determine” and adds a NOTE from the 2024 amendments pointing out that “relevant interested parties can have requirements related to climate change”

4.3 Determining the scope of the quality management system

Simplified wording but no changes to the basic requirements. Deletes “b) the requirements of relevant interested parties” that is replace with b) the requirements referred to in 4.2”.

4.4 Quality management system

4.4.1

No changes in requirements.

4.4.2

Simplifies wording that stresses the requirement to have “documented information available to the extent necessary”

5 Leadership

5.1 Leadership and commitment

5.1.1 General

Significantly adds “i) promoting quality culture and ethical behaviour” and adds “continual” to g).

A new NOTE 2 is added to align with i) “quality culture and ethical behaviour are reflected in the organization’s shared values, attitudes, and established practices.

5.1.2 Customer focus

No changes in requirements.

5.2 Quality policy

Adds the word “Quality” to the subclause heading and adds “e) to take into account the context of the organization and supports its strategic direction”.

5.2.2

Adds new bullet d) to reinforce that the quality policy must be “understood and applied within the organization”.

5.3 Roles, responsibilities and authorities Inserts new bullet e) to require the reporting on “opportunities for improvement to top management”

6 Planning

6.1 Actions to address risks and opportunities

6.1.1 Determining risks and opportunities

Subclause heading added and “continual” added to c).

6.1.2 Actions to address risks

Subclause heading added and significant re-wording of the clause – but no real changes in requirements.

The word “opportunities” is deleted to now read “Actions taken to address risks shall be proportionate …”

NOTE 1 & NOTE 2 re-written to only focus on “risks” only

6.1.3 Actions to address opportunities

Completely new subclause focusing only on “opportunities” largely taken from 6.1.2 with “risks” replace by “opportunities”.

New NOTE added to provide examples of “actions to address opportunities”.

6.2 Quality objectives and planning to achieve them

The requirement to “maintain documented information” replaced by g) that says that “the quality objectives must be available as documented information”

6.2.2

No changes in requirements.

6.3 Planning of changes

Significant re-wording but no real changes in requirements. Three additional ‘bullets’ added to address the original requirements.

7 Support

7.1 Resources

7.1.1 General

No changes in requirements.

7.1.2 People

No changes in requirements.

7.1.3 Infrastructure

No changes in requirements, but the NOTE header edited to say “all types of work (e.g. on site, remote or a combination thereof) …”

7.1.4 Environment for the operation of processes

No changes in requirements, but the NOTE header edited to include the words “combination of factors, which can differ depending on the products and services provided” – bullet points unaltered.

The requirement relating to ‘factors’ is re-written and now reads: “Some factors are dependent on the organizational quality culture, including ethical behaviour”.

7.1.5 Monitoring and measuring resources

7.1.5.1 General

No changes in requirements with minor re-wording.

7.1.5.2 Traceability of measurement results

No changes in requirements with minor re-wording.

b) now explicitly refers to “calibration or verification status”.

c) now states “invalidate measurement results”.

7.1.6 Organizational knowledge

No significant changes in requirements with addition of: “the intended results of its quality management system“

NOTE 2 & NOTE 2 deleted and replaced with new NOTE providing “examples of sources of organizational knowledge …”

7.2 Competence

No changes in requirements with “the performance and effectiveness of the quality management system” replace by “affects its quality management system performance”.

7.3 Awareness

New requirement added as a bullet e) to specifically address awareness of “organizational quality culture and ethical behaviour”

7.4 Communication

No changes in requirements.

7.5 Documented information

7.5.1 General

No changes in requirements.

7.5.2 Creating and updating documented information

The words “documented information” added to subclause title.

The phrase: “this International Standard” replaced with: ”this document”.

7.5.3 Control of documented information

7.5.3.1

The phrase: “this International Standard” replaced with: ”this document”.

7.5.3.2

No changes in requirements.

8 Operation

8.1 Operational planning and control

No changes in requirements with minor re-wording.

8.2 Requirements for products and services

8.2.1 Customer communication

Additional requirement added to e) “… including where relevant to any disruptions in the products or services provided”.

New NOTE added to explain ‘customer communication’ methods.

8.2.2 Determining the requirements for products and services

No changes in requirements.

8.2.3 Review of the requirements for products and services

8.2.3.1

No changes in requirements.

8.2.3.2

No changes in requirements with minor re-wording.

8.2.4 Changes to requirements for products and services

No changes in requirements with minor re-wording.

8.3 Design and development of products and services

No changes in requirements – but please note that his clause refers to products and services only!

8.3.1 General

No changes in requirements.

8.3.2 Design and development planning

8.3.3 Design and development inputs.

8.3.3 Design and development inputs

No changes in requirements – but new NOTE added to explain that “inputs are not always fully defined or known initially – instead, they can evolve”.

8.3.4 Design and development controls

No changes in requirements.

8.3.5 Design and development outputs

No changes in requirements.

8.3.6 Design and development changes

No changes in requirements.

8.4 Control of externally provided processes, products and services

8.4.1 General

No changes in requirements.

8.4.2 Type and extent of control

No changes in requirements.

8.4.3 Information for external providers

Addition to d) … and, where applicable, it’s customers and other relevant interested parties”

8.5 Production and service provision

8.5.1 Control of production and service provision

Additional bullet a) 2) “the activities to be performed”.

New NOTE added to explain that: “… organizations can choose to engage in product and service verification or process validation activities, or both, as appropriate”

8.5.2 Identification and traceability

No changes in requirements.

8.5.3 Property belonging to customers or external providers

No changes in requirements.

8.5.4 Preservation

No changes in requirements.

8.5.5 Post-delivery activities

No changes in requirements.

8.5.6 Control of changes

No changes in requirements.

8.6 Release of products and services

No changes in requirements.

8.7 Control of nonconforming outputs

8.7.1

No changes in requirements.

8.7.2

No changes in requirements.

9 Performance evaluation

9.1 Monitoring, measurement, analysis and evaluation

9.1.1 General

No changes in requirements.

9.1.2 Customer satisfaction

No changes in requirements but NOTE reworded to provide further sources of information relating to customer satisfaction (e.g. social media).

9.1.3 Analysis and evaluation

No changes in requirements.

9.2 Internal audit

9.2.1 General

No changes in requirements but the phrase: “this International Standard” replaced with: ”this document”.

9.2.2 Internal audit programme

The words “Internal audit programme” added as the subclause title.

The NOTE extended to explicitly say that ISO 19011 is for: “guidance on auditing management systems”.

9.3 Management review

9.3.1 General

No changes in requirements.

9.3.2 Management review inputs

New bullet c) added to include “changes in changes in needs and expectations of interested parties that are relevant to the quality management system”.

9.3.3 Management review results

No changes in requirements.

10 Improvement

10.1 Continual improvement

Note the subclause re-numbering from 10.3 to 10.1.

No changes in requirements but new NOTE added to explain that: “Improvement can be achieved through incremental and breakthrough change, innovation or reorganization initiatives”.

10.2 Nonconformity and corrective action

10.2.1

No changes in requirements but new NOTE added to explain that: “ Customer complaints can be a source of nonconformities”.

10.2.2

No changes in requirements.

Note that the specific requirement “10.3 Continual improvement” has been deleted – the requirements are covered in various other clauses of the document.