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.
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.
5.1 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.
Whilst this is a familiar title, it is mostly a new section which relates to the establishment of
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.
This is a new title but it contains mostly what is currently in section 6 (resource
management) plus some additional requirements.
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.
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.
This is a new requirement.
This is currently addressed under clause 6.2 and is mostly unchanged – it has been spread
out across a number of clause headings.
This was previously addressed under clause 6.2.2
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
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
8.1 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
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.