New ISO Standards
Transition Workshop (Auditors)
Transition Workshop (Auditors)
ISO
9001:2015
What has Changed?
new concepts are considered - more risk
based thinking
the customer remains the primary focus
a new common ISO format has been
developed for use across all Management System Standards
a significant re-ordering of the key
clauses.
Key Changes
increased emphasis on Achieving
Value for the
organisation and its customers
increased emphasis on understanding and control
of Risk to the
organisation
reduced emphasis on Documentation
no stated requirement for Documented
Procedures
no reference to a Quality
Manual.
And………
no requirement for a Management
Representative
no formal requirement for Preventive Action
outsourcing is now External
Provision
enhanced Leadership Requirements
Organisational Context – responsiveness to changing Business Environment
No exclusions, only Not
Applicable clauses!
High Level Structure
the new standard adopts the high-level structure and terminology of Annex SL (used for
the development of all new ISO standards)
High Level Structure - identical core
text and common terms and core definitions for use in all Management System
Standards:
purpose - enhance the consistency and alignment of
different management system standards
organisations that
integrate multiple standards (eg QMS, EMS, OHS) will see the most benefit
uses simplified
language and writing styles to aid understanding and consistent interpretations
of requirements.
Common structure for
MSS
Introduction
1.Scope
2.Normative references
3.Terms and definitions
4.Context of the
organization
5.Leadership
6.Planning
7.Support
8.Operation
9.Performance evaluation
10.Improvement.
•
Clause structure
(4-6)
4. Context of the
organization
Understanding
the organization and its context
Understanding
the needs and expectations of interested parties
Determining
the scope of the XXX management system
XXX
management system
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
Top management
requirements
5.1 Leadership and
commitment
Top management shall demonstrate
leadership and commitment by:
Ensuring (ie someone
else can
do it)
•the Quality Policy and quality
objectives are established for the QMS and are compatible with the context and
strategic direction of the organisation
•the integration of QMS requirements
into the organisation’s business processes
•the resources needed for the QMS are
available
•the QMS achieves its intended results
•
Doing (ie they must do
it themselves)
•take accountability for the
effectiveness of the QMS
•promote the use of the process approach
and risk-based thinking
•communicate the importance of effective
quality management and of conforming to QMS requirements
•engage, direct and support persons to
contribute to the effectiveness of the QMS
•promote improvement
•support other relevant management roles
to demonstrate their leadership as it applies to their areas of responsibility.
Risk-based approach
organisations are required to
understand its context (Clause 4.1) and determine the risks and opportunities
that need to be addressed (Clause 6.1)
one of the key purposes of a QMS is to
act as a preventive tool
there is no separate clause or
sub-clause titled “preventive action”
the concept of preventive action is
expressed through a risk-based approach to formulating QMS requirements.
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.
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.
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.
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.
ISO 9001:2015
Quality Management
Systems – requirements.
Introduction
0.1 General
0.2 Quality management principles
0.3 Process approach
0.4 Relationship with other MSS
•introduces the
rationale for the Standard
•more formally
structured.
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.
0.2 Quality
management principles
ISO 9001:2008 was based on eight
quality management principles whereas the revised version refers to just seven
the principle of “a systems approach to
management” has been dropped
the last principle is now called
“Relationship management” instead of “Mutually beneficial supplier
relationships”.
New Principles
0.3 Process Approach
understand and manage interrelated
processes as a system
enables consistent and predictable
results
PDCA cycle is fundamental
introduces risk based thinking (always
been an implied requirement).
0.4 Relationship with
other MSS
now a framework to improve alignment
among all International Standards for management systems
better facilitates immigration.
Section 1 - Scope
•consistently
provide products and services to meet requirements and enhance customer
satisfaction – no change
•all requirements
are intended to be applicable to all organisations, regardless of type, size
and product provided –
no change
•removal of
exclusions.
•
•
•
Section 2 – Normative
references
•ISO 9000:2015,
Quality management systems – Fundamentals and vocabulary
▫also describes quality
management principles in detail.
Section 3 – Terms and
Definitions
no terms and definitions
reference to ISO 9000 – no change
maintains clause numbering for
consistency.
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.
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.
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.
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.
Section 4 – Context
of the Organisation
Section 4 – Context
of the Organisation
4.1 Understanding the
organisation and its context
4.2 Understanding the
needs and expectations of interested parties
4.3 Determining the
scope of the quality management system
4.4 Quality
management system and its processes
•this
is a new clause and provides a key insight into the organisation
What
constitutes the organisation’s quality management system.
Section 4 – Context
of the organisation
4.1 Understanding the
organisation and its context
4.2 Understanding the needs and
expectations of interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system and its
processes
•determine external and internal issues
relevant to the QMS
•must monitor these issues.
Section 4 – Context
of the organisation
4.1 Understanding the organisation and
its context
4.2 Understanding the
needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system and its
processes
•determine interested parties relevant to
the QMS
•determine their needs and expectations
•must monitor information about
interested parties’ requirements.
•
Section 4 – Context
of the organisation
4.1 Understanding the organisation and its context
4.2 Understanding the needs and
expectations of interested parties
4.3 Determining the scope of the quality management
system
4.4 Quality management system and its
processes
•establish scope by
determining boundaries and applicability of the QMS to consider
external/internal issues, requirements of interested parties and the
organisation’s products and services
•scope
must be documented and available, justify any clauses of ISO 9001 that is not
applicable
•any
N/A clauses must not effect conformity of
products/services and customer satisfaction.
•
Section 4 – Context
of the organisation
4.1 Understanding the organisation and its context
4.2 Understanding the needs and
expectations of interested parties
4.3 Determining
the scope of the quality management
system
4.4 Quality management
system and its processes
•must establish,
implement, maintain and continually improve the QMS
•interaction of
processes required (but not documented!)
•assign
responsibilities and authorities for processes
•retain documented
information to ensure in the processes
Documented procedures are not necessarily required….
except where they are needed!
except where they are needed!
•
Section 5 -
Leadership
Section 5 –
Leadership
5.1 Leadership and
commitment
5.2 Policy
5.3 Organisational
roles, responsibilities and authorities
•top
management to now have a greater involvement in the QMS
What
is required by top management.
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
•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;
•
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
•
•communicate importance
of effective QMS and conformance
•ensure QMS achieves
intended results
•promote improvement
•support other
management to demonstrate leadership.
•
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
•top management must
ensure:
•customer
and regulatory requirements are met
•risks and
opportunities are determined and addressed
•focused on enhancing
customer satisfaction.
•
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
•must be available
internally and to interested parties.
Section 5 –
Leadership
5.1 Leadership
and commitment
5.2 Policy
5.3 Organisational
roles, responsibilities and authorities
•
•ensures
responsibilities and authorities for relevant roles are assigned, communicated
and understood
•no formal requirement
for specific management representative
•specific mention of
changes to QMS.
•
Section 6 – Planning
Section 6 – Planning
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
•introduces
risk based approach to planning
•addresses risks, opportunities and
quality objectives
How
quality planning is achieved.
Section 6 – Planning
6.1 Actions to address risks and
opportunities
6.2 Quality objectives and planning to
achieve them
6.3 Planning of changes
•when planning, must
consider external/internal issues and interested parties
•determine risks to
ensure QMS achieves results, enhance desirable effect and achieve improvement
•must evaluate
effectiveness of actions
•must be risk based.
Section 6 – Planning
6.1 Actions
to address risks and opportunities
6.2 Quality objectives
and planning to achieve them
6.3 Planning of changes
•quality
objectives need to be established at relevant functions, levels and processes
•these
objectives should be:
─consistent with the Quality
Policy, measurable and take into account applicable requirements
─relevant to conformity of
products and services, and the enhancement of customer satisfaction
─monitored, communicated and
updated as appropriate
•must
determine what, how, who, when, etc
•quality
objectives must be
documented.
Section 6 – Planning
6.1 Actions
to address risks and opportunities
6.2 Quality objectives and planning to
achieve them
6.3 Planning of changes
•
•where
change is needed, it needs to be carried out in a planned and systemic manner
•must
ensure integrity of QMS.
Section 7 - Support
Section 7 - Support
7.1
Resources
7.2
Competence
7.3
Awareness
7.4
Communication
7.5
Documented information
•
•newly constructed clause
•much of what was in 2008 Version
Clauses 4,5 & 6
•
The
support required to meet the organisation’s goals.
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
•
•must provide resources
for the implementation and maintenance of the QMS
•must consider
constraints of existing resources and what may be provided from external
providers.
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
•must determine and
provide people necessary for effective information of QMS and
operations/control of processes.
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
•same as for previous
Clause 6.3.
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
•
•same
as for previous Clause
6.4
•note
definition of work environment.
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
•previous Clause 7.6
split into two clauses
•determine
resources needed to ensure valid and reliable monitoring and measuring results
•resources
must be suitable for the activity and maintained as fit for purpose
•evidence of fit for
purpose must be retained
•other
requirements for measuring equipment unchanged.
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 required to
determine, maintain and make available the knowledge necessary for the
operation of its processes and to achieve conformity of products and services
•particular care
required for changing need and trends.
•
7.1.6 Organisational
Knowledge
Note:
•organisational
knowledge can include information such as intellectual property and lessons
learned
•may consider:
─internal sources (eg learning from failures
and successful projects, capturing undocumented knowledge and expert
experience)
─external sources (eg standards, training,
conferences, knowledge from customers or providers).
-
Section 7 - Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
•very similar to
previous Clause 6.2.2
•removal of providing
‘training’ to ‘competence’
•documented information
(record) must be obtained of competence.
•
•
Section 7 - Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
•
•specific clause for
awareness
•must be aware of
Quality Policy, quality
objectives, contribution to effective QMS and implication of not conforming
with QMS.
Section 7 - Support
7.1 Resources
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
•
•much expanded clause
for communication
•must now determine
what will be communicated internally and externally about the QMS, when, to
whom, how and by whom.
Section 7 - Support
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented information
•QMS
needs documented information required by the Standard and as determined by the
organisation
Note: the extent of
documented information can differ from one organisation to another due to its
size, activities, processes, products and services, complexity of processes and
their interactions, and the competence of people.
Section 7 - Support
7.5 Documented information
7.5.1 General
7.5.2 Creating and
updating
7.5.3 Control of documented information
•documented information requires:
▫identification and
description
▫format and media
▫review and approval.
Section 7 - Support
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of
documented information
•
•combines previous Clauses 4.2.3
(documentation) and 4.2.4 (records).
•
Section 8 - Operation
Section 8 - Operation
8.1 Operational
planning and control
8.2 Requirements for
products and services
8.3 Design and
development of products and services
8.4 Control of
externally provided processes, products and services
8.5 Production and
service provision
8.6 Release of
products and services
8.7 Control of
nonconforming outputs
•covers many of the Product Realisation
requirements contained in Clause 7 of the 2008 version
•
The
heart of the management system
(the business).
(the business).
Section 8 - Operation
8.1 Operational planning and control
•similar to previous Clause 7.1
•must plan, implement and control
processes needed to meet requirements for the provision of products and
services
•must control planned changes and review
unintended changes
•any outsourced
processes must be controlled.
Section 8 - Operation
8.2 Requirements for products and services
8.2.1
Customer communication
8.2.2 Determining the
requirements for products and services
8.2.3 Review of
requirements for products and services
8.2.4 Changes to
requirements for products and services
•same as previous
Clause 7.2.3
•includes communicating with customers
about handling and controlling their property, establishing contingency
requirements, when relevant.
Section 8 - Operation
8.2 Determination of requirements for
products and services
8.2.1 Customer
communication
8.2.2
Determining
the requirements for products and services
8.2.3 Review of
requirements for products and services
8.2.4 Changes to
requirements for products and services
•same as previous Clause 7.2.1
•plus the organisation must meet the
claims of products or services it offers.
Section 8 - Operation
8.2 Determination of requirements for
products and services
8.2.1 Customer
communication
8.2.2 Determining
the requirements for
products and services
8.2.3
Review of requirements for products and services
8.2.4 Changes to
requirements for products and services
•combines previous Clauses 7.2.1 and 7.2.2
•documented
information required on results of the review and any new requirements.
•
Section 8 - Operation
8.3 Design and
development of products and services
•
•where the detailed
requirements of the organisation’s products and services are not already
established or not defined by the customer or by other interested parties, such
that they are adequate for subsequent production or service provision, the
organisation shall establish, implement and maintain a design and development
process;
Section 8 - Operation
8.3 Design and development of products and services…cont
•
•changes are mainly
terminology and simplified wording
•there is, however, a significantly
increased focus on the role the customer has in all stages of the design
process
•the need for
documented information to confirm appropriateness of all stages is also clearly
stated
•any changes made to design inputs and
design outputs during the design and development must be clearly identified.
•
•
Section 8 - Operation
8.4 Control of externally provided processes, products and services
8.4.1 General
8.4.2 Type and extent
of control
8.4.3 Information for external providers
•
•changes are mainly
terminology and revised wording (ie suppliers become ‘external
providers!’)
•much as before, each stage of the
purchasing process, including evaluation, selection, performance monitoring and
re-evaluation remains a key requirement
•there is a significant increase in the
steps needed to control external provision.
•
Section 8 - Operation
•
8.5 Production and service provision
8.5.1 Control of production and service
provision
8.5.2 Identification and traceability
8.5.3 Property belonging to
customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes
•changes are mainly
terminology and revised wording
•the most significant change is the move
of monitoring and measuring equipment to Section 7
•reference to
‘changes and post delivery activities’ have been strengthened.
Section 8 - Operation
8.5 Production and service provision
8.5.1 Control of
production and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to
customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes
•previous
Clauses 7.5.1 and 7.5.2 combined.
Section 8 - Operation
8.5 Production and service provision
8.5.1 Control of production and service
provision
8.5.2 Identification
and traceability
8.5.3 Property belonging to
customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes
•no
change.
Section 8 - Operation
8.5 Production and service provision
8.5.1 Control of production and service
provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes
•no
change.
Section 8 - Operation
8.5 Production and service provision
8.5.1 Control of production and service
provision
8.5.2 Identification and traceability
8.5.3 Property belonging to
customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes
•no
change.
Section 8 - Operation
8.5 Production and service provision
8.5.1 Control of production and service
provision
8.5.2 Identification and traceability
8.5.3 Property belonging to
customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery
activities
8.5.6 Control of changes
•new clause for post-delivery activities
•a number of considerations are required.
Section 8 - Operation
8.5 Production and service provision
8.5.1 Control of production and service
provision
8.5.2 Identification and traceability
8.5.3 Property belonging to
customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of
changes
•specific clause for control of changes
to ensure continuing conformity
•documented information must be retained
describing the review of changes and any action arising.
Section 8 - Operation
•
8.6 Release of
products and services
•must verify that
product and service requirements have been meet and evidence of conformity
retained
•release to customer does not proceed
until the planned verification of conformity has been satisfactorily completed,
unless otherwise approved by a relevant authority and by the customer
•documented information to provide
traceability to the person(s) authorising release for delivery to the customer.
Section 8 - Operation
8.7 Control of
nonconforming outputs
•
•similar to previous Clause 8.3
•documented information required
describing nonconformity, actions taken, any concessions and authority for
taking action.
Section 9 –
Performance Evaluation
Section 9 –
Performance Evaluation
9.1 Monitoring,
measurement, analysis and evaluation
9.2 Internal audit
9.3 Management review
•
Determining what is to be monitored,
measured, analysed and evaluated will enable the organisation to determine ‘if
the management system suitable, adequate and effective ?’
How
performance of the QMS is evaluated.
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
•must determine what
needs to be monitored and measured, the methods for monitoring, measurement,
analysis and evaluation, as applicable, to ensure valid results
•additionally, when the monitoring and
measuring is to be performed and when the results from monitoring and
measurement is to be analysed and evaluated
•retain appropriate
documented information as evidence of the results.
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
•same as previous Clause 8.2.1.
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
•information
resulting from monitoring and measuring appropriate data should be analysed and
evaluated
•the results of analysis is to be used to
evaluate seven specific criteria described.
•
Section 9 –
Performance Evaluation
9.1 Monitoring,
measurement, analysis and evaluation
9.2
Internal audit
9.3 Management review
•
•same as previous
Clause 8.2.2
•split into two sub-clauses
•still at planned
intervals
•evidence of
internal audits and results must be documented.
Section 9 –
Performance Evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.2 Internal audit
9.3
Management review
•
•similar to previous Clause 5.6
•still at planned intervals
•clearer agenda items (inputs)
•evidence of management review results
must be documented.
•
Section 10 -
Improvement
Section 10 -
Improvement
10.1 General
10.2 Nonconformity
and corrective action
10.3 Continual
improvement
•QMS must
continually improve
•nonconformities must be identified and
reacted to
•corrective action
must be considered
Continual
improvement remains a core focus of the QMS.
•
•
Section 10 –
Improvement
10.1 General
10.2 Nonconformity and corrective
action
10.3 Continual improvement
•opportunities for
improvement must be determined
•action must be taken to meet customer
requirements and enhance customer satisfaction:
▫improve products and
service
▫correcting, preventing
or reducing undesired effects
▫improve performance
and effectiveness of the QMS.
Section 10 -
Improvement
10.1 General
10.2 Nonconformity and
corrective action
10.3 Continual improvement
•nonconformities (including complaints)
must be reacted to and applicable action taken
•root cause analysis must be considered
based on its significance
•effectiveness of
corrective action must be reviewed
•change QMS if required
•evidence of action taken from
nonconformities must be documented
•evidence of results of corrective action
must be documented.
Section 10 –
Improvement
10.1 General
10.2 Nonconformity and corrective
action
10.3 Continual
improvement
•organisations must
continually improve the suitability, adequacy and effectiveness of the QMS
•must consider
results of analysis and evaluation, and outputs from management review.
Annex A –
Clarification
information on new structure,
terminology and concepts.
Annex B – Other
(informative)
other international standards on
quality management and quality management systems developed by ISO/TC 176.
Summary of Changes
better format and ease for integration
increased emphasis of achieving value
enhanced leadership requirements
risk based thinking
documentation requirements
interested parties.
Any Questions?
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