New ISO Standards
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
Outsourcing and purchasing
External provision
Documents and records
Documented information
Management representative
Assigned responsibility and authority
Quality Manual
a)
how scope is determined
b) QMS scope
types of products and services
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:
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.
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
0.2 Quality management
principles
0.3 Process approach
0.4 Relationship with other
MSS
2008 – Introduction
• 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.
2008 – Clause 0.1
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”.
2008 – Clause 0.2
New Principles
1. Customer Focus
1. Customer Focus
2. Leadership
2. Leadership
3. Involvement of People
3. Engagement of People
4. Process Approach
4. Process Approach
5. System Approach to
Management
5. Improvement
6. Continual Improvement
7. Factual Approach to
Decision Making
6. Evidence-based Decision
Making
8. Mutually Beneficial
Supplier Relationships
7. Relationship
Management.
2008 – Clause 0.2
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).
2008 – Clause 0.3
0.4 Relationship with other MSS
• now a framework to improve alignment among all
International Standards for management systems
• better facilitates immigration.
2008 – Clause 0.4
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.
2008 – Clauses 1.1 & 1.2
Section 2 – Normative references
• ISO 9000:2015, Quality management systems –
Fundamentals and vocabulary
▫ also describes quality management principles in detail.
2008 – Clause 2
Section 3 – Terms and Definitions
• no terms and definitions
• reference to ISO 9000 – no change
• maintains clause numbering for consistency.
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 – No direct equivalent
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
2008 – No direct equivalent
• 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.
2008 – No direct equivalent
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.
2008 – No direct equivalent
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.
2008 – Clauses 1.2 & 4.2.2
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!
2008 – Clause 4.1
Section 5 - Leadership
2008 – Clause 5
Section 5 – Leadership
5.1 Leadership and
commitment
5.2 Policy
5.3 Organisational roles,
responsibilities and
authorities
2008 – No direct equivalent
• 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;
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
• communicate importance of effective QMS and conformance
• ensure QMS achieves intended results
• promote improvement
• support other management to demonstrate leadership.
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
• top management must ensure:
• customer and regulatory requirements are met
• risks and opportunities are determined and addressed
• focused on enhancing customer satisfaction.
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
• must be available internally and to interested parties.
2008 – Clause 5.3
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.
2008 – Clause 5.5
Section 6 – Planning
2008 – Clause 5.4.2
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
2008 – Clause 5.4.2
• 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.
2008 – Clauses 5.4.2 & 8.5.3 3
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.
2008 – Clause 5.4.1
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.
2008 – Clause 5.4.2
Section 7 - Support
2008 – Clause 6
Section 7 - Support
7.1 Resources
7.2 Competence
• newly constructed clause
• much of what was in 2008
Version Clauses 4,5 & 6
7.3 Awareness
7.4 Communication
7.5 Documented information
2008 – Clause 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.
2008 – Clause 6.1
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.
2008 – Clause 6.1
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.
2008 – 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.
2008 –Clause 6.4
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.
2008 –Clause 7.6
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 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.
2008 – No equivalent clause
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).
2008 – No equivalent clause
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.
2008 – Clause 6.2.2
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.
2008 – Clause 6.2.2
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.
2008 – Clause 5.5.3
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.
2008 – Clause 4.2.1
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.
2008 – Clause 4.2.3
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).
2008 – Clauses 4.2.3 & 4.2.4
Section 8 - Operation
2008 – Clause 7
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
2008 – Clause 7
• covers many of the
Product Realisation
requirements
contained in Clause 7
of the 2008 version
The heart of the
management system
(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.
2008 – Clause 7.1
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.
2008 – Clause 7.2.3
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.
2008 – Clause 7.2.1
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.
2008 – Clause 7.2.2
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;
2008 – Clauses 7.3
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.
2008 – Clause 7.3
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.
2008 – Clauses 7.4
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.
2008 – Clauses 7.5
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.
2008 – Clauses 7.5.1 & 7.5.2
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.
2008 – Clause 7.5.3
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.
2008 – Clauses 7.5.4
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.
2008 – Clauses 7.5.5
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.
2008 – Clauses 7.5.1
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.
2008 – Clauses 7.3.7
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.
2008 – Clause 8.2.4
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.
2008 – Clause 8.3
Section 9 – Performance Evaluation
2008 – Clause 8
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.
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
• 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.
2008 – Clause 8.2.3
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.
2008 – 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.
2008 – Clause 8.4
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.
2008 – Clause 8.2.2
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.
2008 – Clause 5.6
Section 10 - Improvement
2008 – Clause 8.5
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.
2008 – Clause 8.5
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.
2008 – Clause 8.5.1
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.
2008 – Clauses 8.3 & 8.5.2
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.
2008 – Clause 8.5.1
Annex A – Clarification
• information on new structure, terminology and concepts.
2008 – No equivalent clause
Annex B – Other (informative)
• other international standards on quality management
and quality management systems developed by
ISO/TC 176.
2008 – No equivalent clause
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?