Summary of changes between ISO 9001:2008 & ISO 9001:2015

Proposed 3 year transition period for organisations to adopt the new standard – expected to be published late 2015.

The shape, structure and ‘feel’ of the document has changed – it is being issued under the common document format, with common text and terminology used across various management system standards.

1. Product has now become goods and services.

2. Removal of exclusions

3. Intended to be more easily applied to service industries

2.1 New clauses

4.1 Understanding the organisation and its context

4.2 Understanding the needs and expectations of interested parties

4.4.2 Process approach – is now a clause, not just a principle

2.2 Other changes

1. Continual improvement has become just improvement.

2. Preventive action clause removed – risk and preventive action integrated into rest of standard under the title of ‘risks and opportunities’.

3. Documents and records are now referred to as documented information.

4. Purchasing and outsourcing – control of external provision of goods and services – risk based approach to the amount of control applied.

1 Scope

Unchanged apart from Note 1 b) – ‘realisation processes’ becomes ‘operational processes’

1.2 Removed 1.1

2 Normative References

ISO 9000:2005 becomes ISO 9000:2015

3 Terms and Definitions

Reference to ‘product = service’ removed

A list of common definitions included

4 Context of the organisation

4.1 Understanding the organisation and its context – new clause

This is a new requirement in which the organisation is required to demonstrate that it understands what influences there are on it with regard to both internal and external issues and may affect its strategic direction e.g. where it sits in the marketplace and what effect changes may have on its future.

4.2 Determining the scope of the quality management system

This is now a stated requirement of the standard and requires the organisation to

determine the boundaries and applicability of the QMS. It also makes reference to 4.1 – (the context of the organisation).

There is also a requirement to state the scope in terms of the ‘goods and services’ delivered and the sites of the organisation to be included.

There is a requirement to document and justify any exclusions from the standard – limited to clauses 7.1.4 to 8. Exclusions cannot be justified by a decision to arrange for an external provider to perform a function or process.

4.4 Quality management system

4.4.1 General – Still a requirement establish, implement, etc a QMS

4.4.2 Process approach – now a stated requirement but the content is largely the same as

previous clause 4.1 apart from a requirement to determine the risks to conformity if

processes are ineffective.

5 Leadership

5.1 Leadership and commitment

This is a new clause title but it contains much of what is currently in section 5.

5.1.1 This relates to commitment to the QMS (currently 5.1) – There is a requirement for top management to demonstrate leadership and commitment with respect to the QMS e.g. ensuring the policy and objectives are compatible with the strategic direction, the policy is understood and followed, the QMS is integrated into the organisation’s business processes, etc.

5.1.2 This relates to commitment to customers (currently 5.2) – there are additional

requirements based on the need to identify and address any risks to conformity of goods

and services to customers.

5.2 Quality policy

Largely unchanged from current version (currently 5.3) but does have some additional

requirements about its availability to interested parties and being available as documented


5.3 Organisational roles, responsibilities and authorities

Small changes to existing requirements (currently 5.5), no longer requires a specific position

of a management representative.

6 Planning

Whilst this is a familiar title, it is mostly a new section which relates to the establishment of

the QMS.

6.1 Actions to address risks and opportunities.

The general requirement here is that the QMS must be able to achieve its intended

outcomes and consistently satisfy customers by integrating the QMS into the business and

by identifying and managing risks and opportunities.

6.2 Quality objectives and planning to achieve them

This is the existing requirement for quality objectives (currently 5.4.1) but has additional

requirements for them to be measurable and be relevant to conformity of goods and

services and customer satisfaction. There is additional information regarding the planning of objectives.

6.3 Planning of changes

This is mostly what was in 5.4.2 and relates to the need to manage changes to the QMS and

to ensure that risks and opportunities are considered when changes are made.

7 Support

This is a new title but it contains mostly what is currently in section 6 (resource

management) plus some additional requirements.

7.1 Resources

7.1.1 General

A basic requirement to determine and provide sufficient resources to establish and

maintain a QMS. It also calls for consideration of which resources will be provided internally

as opposed to those which will be sourced externally.

7.1.2 Infrastructure

Virtually unchanged from present 6.3 but brings in customer satisfaction. The examples are

now in a note rather than in the main text.

7.1.3 Process environment

This is also largely unchanged from the current 6.4 but again brings in customer satisfaction.

7.1.4 Monitoring and measuring devices

Whilst the clause title is the same as the current 7.6, the requirements of this clause have

been considerably reduced. Specific industry requirements will most likely dictate the amount of control applied.

7.1.5 Knowledge

This is a new requirement.

7.2 Competence

This is currently addressed under clause 6.2 and is mostly unchanged – it has been spread

out across a number of clause headings.

7.3 Awareness

This was previously addressed under clause 6.2.2

7.4 Communication

This was previously included in clause 5.5.3 and related to internal communication. It now

includes external communication too and has been expanded.

7.5 Documented information

7.5.1 General

Whereas the current version of ISO 9001 has 2 clauses relating to the control of documents

and records, the proposed changes include changing the title to documented information –

which includes both documents and records.

7.5.2 Creating and updating

This is a new clause, though the intent to do these actions has always been there.

7.5.3 Control of documented information

These requirements are virtually the same as are currently in clauses 4.2.3 & 4.2.4 of ISO


8 Operation

8.1 Operational planning and control

This is the equivalent of the current clause 7.1 and is largely unchanged though there are a

few small additions and clarifications.

8.2 Determination of market needs and interactions with customers

This is the equivalent of the current clause 7.2

8.2.1 General

A broad statement regarding the need to implement a process for these activities.

8.2.2 Determination of requirements related to the goods and services

This is almost identical to the current clause 7.2.1

8.2.3 Review of requirements related to the goods and services

Once again, this is almost identical to the existing requirements in clause 7.2.2

8.2.4 This is almost identical to clause 7.2.3 but has a few small additions.

8.3 Operational planning process

This is very similar to the existing clause 7.1 but also contains additional elements to be

considered as part of the planning process.

8.4 Control of external provision of goods and services

This requirement includes what is currently included in the purchasing clause (7.4) and it

also any outsourced processes (addressed in clause 4.1).

8.4.1 A simple statement that externally provided goods and services must conform to specified requirements.

8.4.2 Type and extent of control of external provision

There is a general statement regarding the type and amount of controls to be applied

should be dependent on the risks involved and their potential impacts. Similarly, as required

currently by clause 7.4.1, the organisation must establish and apply methods for evaluating,

selecting and re-evaluating external providers. Records of these activities are to be


8.4.3 Documented information for external providers

This clause is based on what is currently in clause 7.4.2 but there also a few additions. This

clause now refers to handling customer property (currently clause 7.5.4) and also the need

to monitor the performance of external providers and to keep documented information.

8.5 Development of goods and services

The whole of this section (8.5.1 to 8.5.3) is new in comparison with the current version of

ISO 9001. It largely takes over from the current design and development clause (7.3) but is

considerably different in its content.

8.6 Production of goods and provision of services

8.6.1 Control of production of goods and provision of services

This clause is the equivalent of clauses 7.5.1 and 7.5.2 of the current version of ISO 9001. It

is not identical but contains very similar information plus a few additions.

8.6.2 Identification and traceability

This is almost identical to the current requirement (currently clause 7.5.3).

8.6.3 Property belonging to customers or external providers

This is again almost identical to the existing clause on the subject (customer property,

currently clause 7.5.4).

8.6.4 Preservation of goods and services

Very similar to the existing clause (7.5.5) but with a little more emphasis on process outputs

in relation to provision of services rather than products.

8.6.5 Post-delivery activities

This is mostly a new requirement, though there was previously mention in clause 7.2.

– This clause provides more detail of the requirement.

8.6.6 Control of changes

This is a new clause title but there are links into the existing clauses 4.2.3 (controlling

changes to documents) and clause 5.4.2 (controlling changes to the QMS. This clause has

brought these 2 elements together under 1 heading.

8.7 Release of goods and services

Whilst this is a new title, the requirements are very similar to the existing clause 82.4

(monitoring and measurement of product).

8.8 Nonconforming goods and services

Almost the same as the existing clause 8.3 (control of nonconforming product) but slightly

re-worded. An extra statement has been added to remind us that customer satisfaction

must be achieved. Some of the detail has been taken out of the clause and put into a note.

There is also a requirement to maintain documented information regarding the nature of

nonconformities discovered and the actions taken.

9 Performance evaluation

9.1.1 Monitoring, measurement, analysis and evaluation

The content of this clause is largely what is currently in clause 8.2 monitoring and

measurement but it has been further developed.

It requires the organisation to take into account the risks and opportunities to determine

what they will monitor and measure in order to:

1. Demonstrate conformity of goods and services

2. Evaluate the performance of processes

3. Ensure the conformity and effectiveness of the QMS

4. Evaluate customer satisfaction

5. Evaluate the performance of external providers

In doing the above, the organisation must determine the methods to be used, when the

activities will be performed, when the results will be analysed and determine the performance indicators.

Overall, this clause has pulled together the monitoring and measuring activities, added to them and requires the organisation to consider what they expect to achieve and how closely they have met those expectations. More specific details are included below.


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