Professional Documents
Culture Documents
5. Leadership
Leadership and commitment
Policy
Organizational roles, responsibilities and authorities
6. Planning
Actions to address risks and opportunities
Objectives and plans to achieve them.
Clause structure (7-10)
7. Support
Resources
Competence
Awareness
Communication
Documented information
8. Operation
Operational planning and control
9. Performance evaluation
Monitoring, measurement, analysis and evaluation
Internal audit
Management review
10. Improvement
Nonconformity and corrective action
Continual improvement.
Control
Outsourcing and purchasing External provision
Documents and records Documented information
Management representative Assigned responsibility and authority
Quality Manual
a) how scope is determined
c) Details and justification for any exclusions details and justification for any n/a reqt
d) Documented procedures
e) Description of the interaction between QMS processes required inputs and expected outputs.
Top management requirements
5.1 Leadership and commitment
Top management shall demonstrate leadership and commitment by:
2015 – Annex A
Applicability
• no specific reference to “exclusions” when determining
applicability of requirements to the organisation’s QMS
• an organisation will need to review the applicability of
requirements due to the size of the organisation, the
management model it adopts, the range of activities and
the nature of the risks and opportunities it encounters.
2015 – Annex A
Document information
• a common clause of “Documented Information” has
been adopted
• the terms “documented procedure” and “record” have
both been replaced throughout the requirements by
“documented information”
• documented procedures (eg to define, control or support
a process) are now expressed as a requirement to
maintain documented information
• records are now expressed as a requirement to retain
documented information.
2015 – Annex A
Organisational knowledge
• organisational knowledge (Clause 7.1.6) addresses the
need to determine and maintain the knowledge obtained
by the organisation and its personnel, to ensure that it can
achieve conformity of products and services
• the process for considering and controlling knowledge
needs to take account the organisation’s context, its size
and complexity, the risks and opportunities it needs to
address and the need for accessibility of knowledge
• the balance between knowledge held by competent
people and knowledge made available by other means is
at the discretion of the organisation.
2015 – Annex A
Control of externally provided
processes, products and services
• control of externally provided products and services (Clause
8.4) addresses all forms of external provision, whether by:
▫ purchasing from a supplier
▫ an arrangement with an associate company
▫ the outsourcing of processes and functions of the
organisation, or by any other means
• now required to take a risk-based approach to determine the
type and extent of controls appropriate to external providers
and externally provided products and services.
2015 – Annex A
ISO 9001:2015
Quality Management Systems – requirements.
Introduction
0.1 General • introduces the rationale
0.2 Quality management for the Standard
principles • more formally structured.
2008 – Introduction
0.1 General
• identifies potential benefits
• it is not the intent of the standard to imply:
─ uniformity in the structure of different quality
management systems
─ uniformity of documentation to align to the clauses
of the Standard
─ impose specific terminology to be used.
2008 – Clause 2
Section 3 – Terms and Definitions
2008 – Clause 3
Some Terms (docs)
• document – information and the medium on which it is
contained
• documented information - information required to be
controlled and maintained by an organisation and the
medium on which it is contained
• procedure – specified way to carry out an activity or a
process (can be documented or not)
• record – document stating results achieved or providing
evidence of activities performed.
2008 – Clause 3
More Terms (improvement)
• improvement – activity to enhance performance
• objective – result to be achieved
• nonconformity – non-fulfilment of a requirement
• correction – action to eliminate a detected nonconformity
• corrective action – action to eliminate the cause of a
nonconformity and prevent recurrence
• preventive action – action to eliminate the cause of a potential
nonconformity or other undesirable situation
• verification – confirmation that specified requirements have
been fulfilled
• validation – confirmation that requirements for a specified
intended use or application have been fulfilled.
2008 – Clause 3
More Terms (product)
• product – output of an organisation that can be produced without
any transaction taking place between the organisation and the
customer
• service – output of an organisation with at least one activity
necessarily performed between the organisation and the
customer
• performance - measurable results
• risk - effect (positive or negative) of uncertainty
• outsource - to make an arrangement where an external
organisation performs part of an organisation’s function or
process - Note: An external organisation is outside the scope of
the management system although the outsourced function or
process is within the scope.
2008 – Clause 3
More Terms (people)
• top management – person or group of people who directs and
controls an organisation at the highest level
• QMS consultant – advisor on QMS realisation – can assist in
realising parts of a QMS
• interested party – person or organisation that can have an affect,
be affected by, or perceive itself to be affected by a decision or
activity
• competence – ability to apply knowledge and skills to achieve
intended results
• infrastructure – facilities, equipment & services
• work environment - conditions under which work is performed.
2008 – Clause 3
Section 4 – Context of the Organisation
2008 – Clause 5
Section 5 – Leadership
5.1 Leadership and • top management to now
commitment have a greater involvement
in the QMS
5.2 Policy
5.3 Organisational roles, What is required by top
responsibilities and management.
authorities
• new clause
• must take accountability for the QMS’ effectiveness
• ensure Quality Policy and quality objectives are established
• ensure QMS is integrated into business processes
• ensure resources are available;
2008 – Clause 5
Section 5 - Leadership
5.1 Leadership and commitment
5.1.1 General…cont
5.5.1 Customer focus
5.2 Policy
5.3 Organisational roles, responsibilities and authorises
2008 – Clause 5
Section 5 - Leadership
5.1 Leadership and commitment
5.1.1 General
5.5.1 Customer focus
5.2 Policy
5.3 Organisational roles, responsibilities and authorises
2008 – Clause 5
Section 5 – Leadership
5.1 Leadership and commitment
5.2 Policy
5.3 Organisational roles, responsibilities and authorities
• now split into two sub-clauses to save the confusion in the previous
version of what must be in the policy and what must be done with
the policy
• must be documented
2008 – Clause 6
Section 7 - Support
7.1 Resources • newly constructed clause
7.2 Competence • much of what was in 2008
Version Clauses 4,5 & 6
7.3 Awareness
2008 – Clause 6
Section 7 - Support
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation of processes
7.1.5 Monitoring and measuring resources
7.1.6 Organisational knowledge
• new clause
• may consider:
2008 – Clause 7
Section 8 - Operation
8.1 Operational planning and control • covers many of the
8.2 Requirements for products and Product Realisation
services requirements
contained in Clause 7
8.3 Design and development of
of the 2008 version
products and services
8.4 Control of externally provided
The heart of the
processes, products and services
management system
8.5 Production and service provision (the business).
8.6 Release of products and services
8.7 Control of nonconforming outputs
2008 – Clause 7
Section 8 - Operation
8.1 Operational planning and control
• any changes made to design inputs and design outputs during the
design and development must be clearly identified.
• no change.
• no change.
• no change.
• must verify that product and service requirements have been meet
and evidence of conformity retained
2008 – Clause 8
Section 9 – Performance Evaluation
9.1 Monitoring, Determining what is to be
measurement, analysis monitored, measured, analysed
and evaluation and evaluated will enable the
organisation to determine ‘if the
9.2 Internal audit management system suitable,
9.3 Management review adequate and effective ?’
2008 – Clause 8
Section 9 – Performance Evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation