n of ISO 9001 Quality Management Systems Requirements...
Revision of ISO 9001 Quality Management Systems – Requirements Frequently Asked Questions When will the new ISO 9001 be published
? The international standard ISO 9001:2008 Quality management systems – Requirements is currently being revised.
The draft international standard (ISO/DIS 9001:2014) has now been released for comment.
The revised ISO 9001 is planned to be released in late 2015.
? This is the first major revision of ISO 9001 since 2000.
ISO has developed a common framework for ISO management system standards in order to enhance alignment between them the ISO committee conducted a user survey and analysed the input on potential new or changed requirements there is a need to reflect current business practices and technology ISO 9001 provides a generic set of quality management system (QMS) requirements but improvement is needed to make it more readily applicable,
particularly to the service sector.
? ISO/DIS 9001:2014 Quality management system – Requirements is the ISO draft international standard (ISO/DIS) that is released for public comment.
including Standards New Zealand,
submit comments and vote in the ballot whether to accept the ISO/DIS for revision to a final draft international standard (ISO/FDIS).
The ballot period will conclude on 7 October 2014.
The ISO/FDIS will be distributed for ballot and further comments in early 2015 but only editorial and clarification changes are likely to be accepted at this stage.
Where can I obtain a copy of ISO/DIS 9001:2014
? The ISO/DIS is currently available for purchase directly from Standards New Zealand.
Note that ISO/DIS 9001:2014 is copyright-protected by ISO.
? Comments on the ISO/DIS or issues raised in this article can be submitted either: a) In the comments and queries form (go back to the main web page for a link) or b) Using the ISO comments template (go back to the main web page for a link).
We recommend that people making detailed comments use this template since it allows for reference to line numbers and clause numbers as well as submitting reasons for suggested changes and suggested alternative text.
Public comments need to be submitted to Standards New Zealand prior to 8 September 2014 to allow time to prepare the New Zealand submission.
Can I ask questions about the ISO/DIS
? To ask questions about the ISO/DIS,
please use the comments and queries form.
Standards New Zealand will post timely replies to queries.
How will New Zealand comments on the ISO/DIS be prepared
? The Standards New Zealand international review group (IRG) responsible for quality management standards will prepare New Zealand’s submission on the ISO/DIS,
taking account of submitted comments.
the committee is responsible for reaching an agreed position.
is a member of the ISO Working Group responsible for drafting the ISO 9001 revision.
She will advise on matters such as where suggested changes fall outside the design specification for the revision and the use of consistent terminology in submitted alternative text.
alternative text needs to be submitted.
What are the main changes to the standard
? The main changes to ISO 9001 are listed below (see also Can you explain the main contents of the ISO/DIS
There are changes to the structure and terminology used in the standard (see below Why has the structure been changed
?) The term ‘products and services’ is used throughout to cover all categories of outputs to customers A full list of definitions is currently included in ISO 9001 since ISO 9000 is not yet revised There are some new requirements,
most making implicit requirements more explicit Many requirements have been reworded for clarification or to apply consistent language There is no provision for excluding requirements of the standard for certification – where a requirement can be applied within the determined scope,
it must be applied There is a new requirement to determine issues related to the context of the organisation There is a new requirement to determine risks and opportunities as a basis for planning but no requirement for formal risk management
Requirements for leadership are strengthened There is no requirement for a ‘management representative’ but responsibilities and authorities for management the quality management system need to be allocated There are additional requirements for control of changes to the quality management system The term ‘documented information’ replaces ‘documents and records’ There is no requirement for a ‘quality manual’ There is a new requirement for controlling organisational knowledge The requirements for monitoring and measuring ‘resources’ (rather than ‘equipment’) is more flexible for application to different monitoring and measurement situations The terms ‘external provider’ and ‘external provision’ are used to define requirements for purchasing,
and outsourcing There is no specific requirement for preventive action.
? ISO has developed a framework to enhance alignment between its management system standards,
including: major clause headings high level text common terminology definitions.
identical core text and common terms and core definitions for use in Management Systems Standards in the ISO/IEC Directives,
Consolidated ISO Supplement,
Working groups drafting new or revised management system standards use the framework and add discipline-specific clauses and text.
Using this framework for the ISO 9001 revision has changed the order of some clauses and introduced some new requirements compared to ISO 9001:2008.
Framework headings and text are identified in the ISO/DIS by a blue font (see below What is the blue text and can it be changed
What is the blue text and can it be changed
? A blue font is used in the ISO/DIS to identify headings,
and text provided in the ISO framework.
The blue font is used only to facilitate review – it will not be used in the published version ISO 9001:2015.
Changes to the ISO framework (blue text) will only be considered where necessary to reflect specific quality management requirements or other compelling reasons such as translatability.
One example is that the term ‘outcomes’ of a system has been changed to ‘results’ because in some languages ‘output’ and ‘outcome’ would normally be translated by the same word.
Changes such as this are likely to be adopted in the next revision of the ISO framework.
Changes to the blue text of a ‘wordsmithing’ nature will not be incorporated in this revision of ISO 9001.
? Changes in structure and terminology in the revised ISO 9001 do not need to be reflected in an organisation’s quality management system (QMS) documentation.
the structure of clauses in ISO 9001 is not intended as a model for documenting an organisation’s policies,
As to terminology,
organisations can use the terms that best suit their operations.
an organisation might want to continue to distinguish ‘documented procedures’ and ‘records’.
What documentation is required under the ISO/DIS
? The risk-based approach used in drafting the ISO/DIS means that there should be more flexibility for organisations to decide what documentation they need.
The term has probably also contributed to the tendency of some organisations to follow the clauses of ISO 9001,
rather than the logic of their management system,
continue to use the term ’quality manual’ if they choose.
The ISO/DIS uses the term ‘documented information’ to cover both ‘documented procedures’ and ‘records’ in ISO 9001:2008.
Where such information is needed to implement the quality management system,
the requirement is to ‘maintain’ documented information.
the requirement is to ‘retain’ documented information.
The distinction between ‘maintain’ and ‘retain’ is simply a matter of the requirements making sense in context.
? 0 Introduction The Introduction includes the process approach,
Comment: Managing processes within a coherent system has been the basis for quality management system requirements since ISO 9001:2000.
Guidance on the process approach and the PDCA cycle has been enhanced.
The Introduction clarifies that there is no requirement for a formal risk management process.
Comment on ‘exclusions’: Clause 4.3 deals with determining the scope of the organisation’s quality management system (QMS).
This says that where a requirement within the determined scope can be applied,
this must not affect the organisation’s ability or responsibility to ensure conformity of products and services.
In the ISO/DIS there are many pages of definitions and comments can be made on individual definitions.
and how many should be included,
will be reviewed once the alignment with the revision of ISO 9000 is clarified.
understanding the needs and expectations of interested parties,
determining the scope of the quality management system,
and the quality management system and its processes.
NEW on ‘context’: The organisation has to ‘determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s)’ as a basis for planning the quality management system.
The organisation has to ‘monitor and review’ this information – in small organisations this is likely to be combined with management review activities.
NEW on ‘interested parties’: The organisation has to determine ‘the interested parties that are relevant to the quality management system’ and ‘the requirements of these interested parties that are relevant to the quality management system’.
Note that this requirement is limited to ‘relevant’ interested parties and the ‘requirements’ (not needs and expectations) of those parties.
The subclause title ‘understanding the needs and expectations of interested parties’ is retained to align with other management system standards.
Comment: There is more emphasis than previously on leadership and commitment.
NEW on addressing risks and opportunities: The organisation is required to determine the risks and opportunities that need to be addressed,
based on the issues and requirements referred to in clause 4.
While this is a new requirement,
a risk-based approach has been implicit in previous versions of ISO 9001.
Addressing risks and opportunities should enable organisations to ‘tune’ the requirements of ISO 9001 to their particular circumstances.
Comment on ‘planning of changes’: ISO 9001:2008 clause 5.4.2 (b) required that the integrity of QMS be maintained when changes are made.
explicit in a new clause 6.3 defining what the organisation needs to consider including,
the availability of resources.
There is also a requirement in clause 8.5.6 on control of changes in production and provision processes.
The requirement for control of design and development changes is retained.
and whether there is unnecessary duplication,
the environment for operation of processes,
monitoring and measurement resources,
and organisational knowledge),
Comment on ‘documented information’: Much of this clause will look familiar to current users apart from a change of terminology to ‘documented information’ covering ‘documented procedures’ and ‘records’ in past ISO 9001 editions.
NEW requirement on ‘organisational knowledge’: There is a requirement to ‘determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services’ and to maintain and make available that knowledge to the extent necessary.
determination of requirements for products and services,
control of externally provided products and services,
production and service provision,
release of products and services,
and control of nonconforming process outputs,
Comment on clause 8.3 ‘design and development’: The requirements for design and development are not greatly changed.
Consideration was given to simplifying the requirements to make them more readily applicable to the service sector.
However the ISO/DIS reflects a majority view that making the requirements too generic would lose value to many current users.
Comment on clause 8.4 ‘externally provided products and services’: this clause applies to all forms of external provision – purchasing,
and so on – in order to be applicable in a more complex business environment.
NEW on clause 8.5.6 ‘control of changes’: there is a requirement for control of changes during production and service provision.
nonconformity and corrective action,
This is because one of the key purposes of a quality management system is to act as a preventive tool.
and concepts (a useful guide to current users of ISO 9001)
Annex B: Quality management principles (the revised edition of the principles) Annex C: The ISO 10000 portfolio of quality management standards.
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