for ISO 9001:2015
GIC Indonesia Training Division
Agenda
DAY ONE Introduction
Rationale for changes
Salient Points on ISO 9001:2015 Comparison with ISO 9001:2008
Clause 4 -‐ Context of the Organization Clause 5 -‐ Leadership
Copyright GIC 2014
DAY TWO
Clause 6 -‐ Planning for the Quality Management System
Clause 7 -‐ Support Clause 8 -‐ Operation
Clause 9 -‐ Performance Evaluation Clause 10 -‐ Improvement
Objective
This training has been developed
to provide basic
information and updates on the revision
to ISO
9001 to interested parties and will be updated
periodically until the final version is published.
Disclaimer
The is
possibility
that you have already implemented
beyond the ISO 9001:2008
requirements and
accidentally cover the ISO 9001:2015 DIS requirements
But you have to pay attention to the
NEW approach
that may not be implemented yet by your organisation
Disclaimer
Any claims or statements made by the presenter based on
this presentation represent their own opinions and/or
interpretation, and are not formally endorsed by GIC.
!
This presentation includes information related to the
status of the revision process as of April 2015
!
Further changes are likely as the revision process
progresses, so you should NOT make changes to your
management system at this stage until the new revision
has been published officially.
Introduction – Review of ISO Standards
•
Every five years
, ISO Standards are reviewed to ensure they
are up-‐to-‐date.
•
ISO Technical Committee 176
is responsible for the
development of the ISO 9001 and ISO 9004 International
Standards as other International Standards and documents in
the ISO 9000 Family.
• A
formal global review
of ISO 9001 was completed in 2012
among ISO member bodies. This resulted in a decision to
revise the standard
Introduction – Review of ISO Standards
• As with all ISO standards, this will be a
consensus process
• All ISO’s National Member Bodies (NMBs) and official liaison members nominate experts to participate in the drafting
process
• Work on the revision has already begun and the
Draft
International Standard (DIS)
has been released and voting
shall start on 2014-‐07-‐10 and voting ends on 2014-‐10-‐10.
Introduction -‐ Key Messages
• According to ISO Survey 2012 —
more than
1.1 million certificates
around the globe
•
73% of all MSS
(Management
System Standards) certificates are
ISO 9001 certificates
•
ISO 14001 will be published
around the same time
• ISO 9001:2015 — the changes
proposed are
significant
Introduction – The ISO 9001 evolution
1987
•
The first ISO 9000 series was published.
•
It was based on BS5750.
•
Focused on Quality Control
1994
•
There were
3 certification standards
that
were released (i.e. ISO 9001, ISO 9002, ISO
9003)
•
Elemental approach
(consisting 20
Elements) focused on producing products
at a consistent level of quality.
Introduction – The ISO 9001 evolution
2000
There is a significant changes or leap from 1994 version to 2000
such as:
•
From elemental to a
Process Model
on Quality Management
System using the PDCA (Deming Cycle)
•
From the 1994 with 3 Certification Standards to 2000 version
of only
1 Certification Standard
(but with exclusion to clauses
applicable only on clause 7).
2008
•
No significant changes. The changes are mostly clarifications.
Introduction – The ISO 9001 evolution
2015
!
2015
▪
New concepts are being considered
▪
The customer remains the primary focus
▪
A new common ISO format has been developed for use across
all Management System Standards
Introduction – The ISO 9001 evolution
Why is the Standard changing?
•
`
▪
Evolution of “business environment”
▪
Evolution of management systems
▪
Evolution of quality
Rationale for Changes
ISO 9001:2008 Structure ISO 14001:2004 Structure
4.1 General Requirements 4.2 Documentation Requirements 5 Management responsibility 6 Resource Management 7 Product Realization 4.1 General requirements 4.2 Environmental policy 4.3 Planning
4.4 Implementation and operation 4.5 Checking
•
In the last 25 years,
many other Management Systems
Standards have come into
use world wide.
•
These
various standards have different format or structure
.
Here is an example of comparison between ISO 9001 and ISO
14001:
Rationale for Changes
•
Organizations that use multiple Management System
Standards are increasingly
demanding a common
format
and language that is aligned between those
standards.
•
Hence, if there is a common format,
integration will be
easier
.
High Level Structure -‐ Common Text
Annex SL
•
Mandated by ISO’s Technical Management Board (TMB)
•
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
•
Organizations who implement a single system addressing
multiple standards (e.g. QMS, EMS, ISMS etc) will see the
most potential benefit
High Level Structure (HLS)
1. Scope
2. Normative references 3. Terms and definitions
4. Context of the organization
• Understanding the organization and its context
• Needs and requirements
• Scope • Management System 5. Leadership • General • Management commitment • Policy
• Roles, responsibility and authority
6. Planning
• Actions to address risks & opportunities
• Objectives and plans to achieve them 7. Support
•
Resources•
Competence•
Awareness•
Communication•
Documented information 8. Operation•
Operational planning and control9. Performance evaluation
•
Monitoring, measurement, analysis & evaluation•
Internal audit•
Management review10. Improvement
•
Non conformity and corrective action•
Continual ImprovementRationale for Changes
▪
Decrease
the emphasis on Documentation
▪
Increase
the emphasis on Achieving Value for the
Organization and its customers
▪
Increase
emphasis on Risk Management to achieve
objectives
Salient Points
1. Structure and Terminology
2. Product and Services
3. Context of the Organization
4. Documented Information
5. Risk-‐based Approach
6. Scope and Applicability
7. Organizational Knowledge
8. Control of externally provided products and services
Salient Points
1. Structure and Terminology
!
ISO 9001:2008 ISO 9001:2015
Products Products and services
Exclusions Not used (See Annex A.4 for clarification of applicability)
Documentation, records Documented information
Work environment Environment for the operation of processes
Purchased product Externally provided products and services
Supplier External provider
Salient Points
2. Products and Services
!
2008
: The term “product” to include all output
categories.
2015
: The term “products and services” includes all
output categories (hardware, services, software and
processed materials.
In most cases, the terms “products” and “services” are
used together.
Most output
that organizations provide
to customers,
or are supplied
to them by external
providers, include both products and services.
Salient Points
•
3. Context of the organisation
!
There are two new clauses relating to the context of the
organization:
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectation of interested
parties.
The titles of clauses 4.1 and 4.2 provide for
alignment with
other management system standards
. They do not imply
extension of quality management system requirements
beyond the Scope of this International Standard.
Salient Points
4. Documented Information
!
The terms “
documented procedure
” and “
record
” have
both been replaced throughout the requirements text by
“
documented information
”.
Where ISO 9001:2008 would have referred to documented
procedures (e.g. to define, control or support a process) this is now expressed as a requirement to maintain documented information.
!
Where ISO 9001:2008 would have referred to records this is now expressed as a requirement to retain documented information.
Salient Points
5. Risk-based Approach
It requires the organization to
understand its context
(clause 4.1) and
determine the risks and opportunities
that need to be addressed
(clause 6.1).
With the inclusion of this approach, it has facilitated
some reduction in prescriptive requirements and their
replacement by performance-based requirements.
Although risks and opportunities have to be determined and
addressed, the standard
does not require for formal risk
management or a documented risk management process
.
Salient Points
6. Applicability
This Standard
no longer makes specific reference to
‘exclusions’
when determining the applicability of its
requirements to the organization’s quality management
system.
When a requirement can be applied within the scope of its QMS, the organization cannot decide that it is not applicable.
Where a requirement cannot be applied (for example where the relevant process is not carried out) the organization can determine that the
requirement is not applicable.
However, this is non-applicability cannot be allowed to result in failure to achieve conformity of products and services or meet the
organization’s aim to enhance customer satisfaction.
Salient Points
7. Organizational knowledge
Clause 7.1.6 Organizational knowledge addresses the
need to
determine and maintain the knowledge obtained
by the organization
, including by its personnel, to
ensure that it can achieve conformity of products and
services.
The process for considering and controlling past, existing and additional knowledge needs to take account of the organization’s
context, including 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 organization, provided that conformity of products and services can be achieved.
Salient Points
8. Control of externally provided products and
services
This addresses
all forms of external provision
, whether
it is by purchasing from a
supplier
, through an
arrangement with an
associate company
, through the
outsourcing
of processes and functions of the
organizations or by any other means.
The organization is required to take a risk-based approach to
determine the type and extent of controls appropriate to particular external providers and externally provided products and services.
Clause 4 -‐ Context of the organisation
4.1 Understanding the organization 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
!
4.1 Understanding the organization and its context
!
The organization shall 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) of its quality management system.
!
The organization shall monitor and review the information about these external
and internal issues.
!
NOTE 1 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional or local.
NOTE 2 Understanding the internal context can be facilitated by considering issues related to values, culture knowledge and performance of the organization.
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External context includes*
• cultural, social, political, legal, regulatory, financial, technological, economic, natural and competitive environment, whether international, national,
regional or local;
• relationships with, and perceptions/values of external stakeholders
!
Internal context includes* • corporate culture;
• governance, organizational structure, roles and accountabilities; • policies, objectives, and strategies
• resources (capital, time, people, processes, systems technologies);
• information systems, information flows and decision-‐making processes (both formal and informal)
!
* (taken from ISO 31000) Copyright GIC 2014
Context of Organization
The context of the organisation equates to the business environment the organisation
is operating in.
!
It is about the organisation understanding
its place in the universe.
!
Purpose: Clothing manufacturer
!
Intended outcome: Production of men’s suits
!
Internal issues •Automation •Workforce •Design secrets •Capacity •Company culture •Innovation!
External issues •Customers •Fashion •New markets •Deadlines •Competition •Regulators •Utilities!
(Relevant) interested parties
•Consumers •Employees
•Owners/shareholders •Society
•Suppliers and partners
4. Context of Organization
4.2 Understanding the needs and expectations of interested
parties
!
Due to their impact or potential impact on the organisation’s ability to
consistently provide products and services that meet customer and applicable
statutory and regulatory requirements, the organization shall determine:
a) the interested parties that are relevant to the quality management system; b) the requirements of these interested parties that are relevant to the
quality management system.
!
The organization shall monitor and review the information about these interested parties and their relevant requirements.
What is Interested Party
4. Context of Organization
4.3 Determining the scope of the quality management
system
!
The organizaeon shall determine the boundaries and applicability of the quality
management system to establish its scope.
!
When determining this scope, the organizaeon shall consider: a) the external and internal issues referred to in 4.1;
b) the requirements of relevant interested parees referred to in 4.2; c) the products and services of the organizaeon.
!
Where a requirement of this Internalonal Standard within the determined scope can be applied, then it shall be applied by the organizalon.
!
4. Context of Organization
4.3 Determining the scope of the quality management
system
!
If any requirement(s) of this Internaeonal Standard cannot be applied, this shall not affect the organizaeon’s ability or responsibility to ensure conformity of
products and services.
!
The scope shall be available and be maintained as documented informalon
staeng the:
• products and services covered by the quality management system; • juseficaeon for any instance where a requirement of this Internaeonal
Standard cannot be applied.
4. Context of Organization
4.4 Quality management system and its processes
!
The organizaeon shall establish, implement, maintain and conenually improve a quality management system, including the processes needed and their
interaceons, in accordance with the requirements of this Internaeonal Standard.
!
The organizaeon shall determine the processes needed for the quality
management system and their applicaeon throughout the organizaeon and shall determine:
a) the inputs required and the outputs expected from these processes;
b) the sequence and interaclon of these processes;
c) the criteria, methods, including measurements and related performance
indicators needed to ensure the effeceve operaeon, and control of these processes;
d) the resources needed and ensure their availability;
4. Context of Organization
4.4 Quality management system and its processes
!
e) the assignment of the responsibililes and authoriles for these processes;
f) the risks and opportuniles in accordance with the requirements of 6.1, and
plan and implement the appropriate aceons to address them;
g) the methods for monitoring, measuring, as appropriate, and evalualon of
processes and, if needed, the changes to processes to ensure that they achieve intended results;
h) opportuniles for improvement of the processes and the quality management system.
!
The organizaeon shall maintain documented informalon to the extent
necessary to support the operaeon of processes and retain documented
informalon to the extent necessary to have confidence that the processes are being carried out as planned.
Clause 5 -‐ Leadership
5.1 Leadership and commitment
5.1.1 Leadership and commitment to the quality management system 5.1.2 Customer focus
5.2 Quality policy
5.3 Organisation roles, responsibilities and authorities
!
Management Vs Leadership
What is TOP MANAGEMENT
DEFINITIONS (ANNEX SL)
a person or group of people who directs and controls an
organisation at the highest level
!
Note 1 Top management has the power to delegate authority and provide
resources within the organization.
Note 2 If the scope of the management system (3.04) covers only part of an
organization then top management refers to those who direct and control that
part of the organization.
5.1 Leadership and Commitment
5.1.1 Leadership and commitment for the quality management
system
Top management shall demonstrate leadership and commitment with respect to the quality management system by:
a) taking accountability of the effectiveness of the quality management system;
b) ensuring that the quality policy and quality objectives are established for
the quality management system and are compatible with the strategic direction and the context of the organization ;
c) ensuring that the quality policy is communicated, understood and applied
within the organization;
d) ensuring the integration of the quality management system requirements
into the organisation’s business processes;
e) promoting awareness of the process approach;
5.1 Leadership and Commitment
f) ensuring that the resources needed for the quality management system are
available;
g) communicating the importance of effective quality management and of conforming to the quality management system requirements;
h) ensuring that the quality management system achieves its intended
results;
i) engaging, directing and supporting persons to contribute to the effectiveness of the quality management system;
j) promoting continual improvement;
k) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.
!
NOTE Reference to “business” in this International Standard can be interpreted broadly to mean those activities that are core to the purposes of the
organization’s existence; whether the organization is public, private, for profit
5.1 Leadership and Commitment
5.1.2 Customer Focus
!
Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that:
a) customer requirements and applicable statutory and regulatory requirements are determined and met;
b) the risks and opportuniles that can affect conformity of products and
services and the ability to enhance customer saesfaceon are determined and addressed;
c) the focus on consistently providing products and services that meet customer and applicable statutory and regulatory requirements is maintained;
d) the focus on enhancing customer saesfaceon is maintained.
5. Leadership
5.2 Quality policy
!
5.2.1 Top management shall establish, review and maintain a quality policy that:
a) is appropriate to the purpose and context of the organizalon;
b) provides a framework for sejng and reviewing quality objeceves; c) includes a commitment to saesfy applicable requirements;
d) includes a commitment to conenual improvement of the quality management system.
!
5.2.2 The quality policy shall:
a) be available as documented informaeon;
b) be communicated, understood and applied within the organizaeon;
c) be available to relevant interested parles, as appropriate.
5. Leadership
5.2 Organizational roles, responsibilities and authorities
!
Top management shall ensure that the responsibiliees and authoriees for relevant roles are assigned, communicated and understood within the organizaeon.
!
Top management shall assign the responsibility and authority for:
a) ensuring that the quality management system conforms to the requirements of this Internaeonal Standard;
b) ensuring that the processes are delivering their intended outputs;
c) reporlng on the performance of the quality management system, on
opportuniles for improvement and on the need for change or innovalon, and especially for reporlng to top management;
d) ensuring the promoeon of customer focus throughout the organizaeon; e) ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and
Clause 6 -‐ Planning for the QMS
!
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
!
!
What is RISK
DEFINITIONS (ANNEX SL)
effect of uncertainty
!
Note 1 An effect is a deviation from the expected — positive or negative.
Note 2 Uncertainty is the state, even partial, of deficiency of information related
to, understanding or knowledge of, an event, its consequence, or likelihood.
Note 3 Risk is often characterised by reference to potential events (ISO Guide
73, 3.5.1.3) and consequences (ISO Guide 73, 3.6.1.3), or a combination of these.
Note 4 Risk is often expressed in terms of a combination of the consequences of
an event (including changes in circumstances) and the associated likelihood (ISO
Guide 73, 3.6.1.1) of occurrence.
6.1 Action to address risks and opportunities
!
6.1 Actions to address risks and opportunities
6.1.1 When planning for the quality management system, the organization shall consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be
addressed to:
a) give assurance that the quality management system can achieve its intended result(s);
b) prevent, or reduce, undesired effects; c) achieve continual improvement.
6.1 Action to address risks and opportunities
6.1.2 The organization shall plan:
a) actions to address these risks and opportunities; b) how to:
1) integrate and implement the actions into its quality management system processes (see 4.4);
2) evaluate the effectiveness of these actions.
Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.
!
NOTE Options to address risks and opportunities can include: avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source,
changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.
Risk Analysis
6.2 Quality objectives and planning
to achieve them
6.2.1 The organizaeon shall establish quality objeceves at relevant funceons,
levels and processes.
!
The quality objeceves shall:
a) be consistent with the quality policy,
b) be measurable;
c) take into account applicable requirements;
d) be relevant to conformity of products and services and the enhancement of customer saesfaceon;
e) be monitored;
f) be communicated;
g) be updated as appropriate.
!
The organizaeon shall retain documented informalon on the quality objeceves.
6.2 Quality objectives and planning
to achieve them
6.2.2 When planning how to achieve its quality objeceves, the organizaeon shall determine:
a) what will be done;
b) what resources will be required;
c) who will be responsible;
d) when it will be completed;
e) how the results will be evaluated.
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Nothing’s new but easier to be understood
6.3 Planning of changes
Where the organizaeon determines the need for change to the quality
management system (see 4.4) the change shall be carried out in a planned and systemaec manner.
!
The organizaeon shall consider:
a) the purpose of the change and any of its potenlal consequences;
b) the integrity of the quality management system; c) the availability of resources;
d) the allocaeon or reallocaeon of responsibiliees and authoriees.
Clause 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 Organizational knowledge
7.2
Competence
7.3
Awareness
7.4
Communication
7.5. Documented Information
7.5.1 General7.5.2 Creating and Updating
!
!
7.1 Resources
!
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7.1.1 General
The organizaeon shall determine and provide the resources needed for the
establishment, implementaeon, maintenance and conenual improvement of the quality management system.
!
The organizaeon shall consider:
a) the capabiliees of, and constraints on, exiseng internal resources; b) what needs to be obtained from external providers.
!
7.1.2 People
To ensure that the organizaeon can consistently meet customer and applicable statutory and regulatory requirements, the organizaeon shall provide the
persons necessary for the effeceve operaeon of the quality management system, including the processes needed.
7.1 Resources
!
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7.1.3 Infrastructure
The organizaeon shall determine, provide and maintain the infrastructure for the operaeon of its processes to achieve conformity of products and services.
NOTE Infrastructure can include:
a) buildings and associated ueliees;
b) equipment including hardware and solware; c) transportaeon;
d) informaeon and communicaeon technology.
!
7.1.4
Environment for the operalon of processes
The organizaeon shall determine, provide and maintain the environment necessary for the operaeon of its processes and to achieve conformity of products and services.
NOTE Environment for the operaeon of processes can include physical, social,
psychological, environmental and other factors (such as temperature, humidity, ergonomics and cleanliness).
Previously
7.1 Resources
!
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7.1.5 Monitoring and measuring resources
!
Where monitoring or measuring is used for evidence of conformity of products and services to specified requirements the organizaeon shall
determine the resources needed to ensure valid and reliable monitoring and
measuring results.
!
The organizaeon shall ensure that the resources provided:
a) are suitable for the specific type of monitoring and measurement aceviees being undertaken;
b) are maintained to ensure their conlnued fitness for their purpose.
!
The organizaeon shall retain appropriate documented informalon as evidence
7.1 Resources
!
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Where measurement traceability is: a statutory or regulatory requirement; a customer or relevant interested party expectaeon; or considered by the
organizaeon to be an esseneal part of providing confidence in the validity of measurement results; measuring instruments shall be:
• verified or calibrated at specified intervals or prior to use against measurement standards traceable to internaeonal or naeonal measurement standards. Where no such standards exist, the basis used for calibraeon or verificaeon shall be
retained as documented informaeon;
• idenlfied in order to determine their calibralon status;
• safeguarded from adjustments, damage or deterioralon that would invalidate the calibraeon status and subsequent measurement results.
!
The organizaeon shall determine if the validity of previous measurement results
has been adversely affected when an instrument is found to be defeclve during
its planned verificaeon or calibraeon, or during its use, and take appropriate correceve aceon as necessary.
7.1 Resources
!
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7.1.6 Organizalonal knowledge
!
The organizaeon shall determine the knowledge necessary for the operalon of
its processes and to achieve conformity of products and services.
!
This knowledge shall be maintained, and made available to the extent
necessary.
!
When addressing changing needs and trends, the organizaeon shall consider its current knowledge and determine how to acquire or access the necessary
addieonal knowledge.
!
NOTE 1 Organizaeonal knowledge can include informaeon such as intellectual
property and lessons learned.
!
NOTE 2 To obtain the knowledge required, the organizaeon can consider:
a) internal sources (e.g. learning from failures and successful projects, capturing undocumented knowledge and experience of topical experts within the
organizaeon);
b) external sources (e.g. standards, academia, conferences, gathering knowledge with customers or providers).
7.2 Competence
!
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The organizaeon shall:
a) determine the necessary competence of person(s) doing work under its
control that affects its quality performance;
b) ensure that these persons are competent on the basis of appropriate educaeon, training, or experience;
c) where applicable, take aceons to acquire the necessary competence, and evaluate the effeceveness of the aceons taken;
d) retain appropriate documented informaeon as evidence of competence.
!
NOTE Applicable aceons can include, for example, the provision of training to,
the mentoring of, or the re-‐assignment of currently employed persons; or the
7.3 Awareness
!
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Persons doing work under the organization’s control shall be aware of: a) the quality policy;
b) relevant quality objectives;
c) their contribution to the effectiveness of the quality management system, including the benefits of improved quality performance;
d) the implications of not conforming with the quality management system requirements.
7.4 Communication
!
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The organizaeon shall determine the internal and external communicaeons
relevant to the quality management system including: a) on what it will communicate;
b) when to communicate;
c) with whom to communicate; d) how to communicate.
7.5 Documented Information
!
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7.5.1 General
!
The organizaeon’s quality management system shall include
a) documented informaeon required by this Internaeonal Standard;
b) documented informaeon determined by the organizaeon as being necessary for the effeceveness of the quality management system.
!
NOTE The extent of documented informaeon for a quality management system
can differ from one organizalon to another due to:
a) the size of organizaeon and its type of aceviees, processes, products and
services;
b) the complexity of processes and their interaceons;
7.5 Documented Information
!
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7.5.2 Creating and updating
!
When creaeng and updaeng documented informaeon the organizaeon shall ensure appropriate:
a) idenlficalon and descriplon (e.g. a etle, date, author, or reference number);
b) format (e.g. language, solware version, graphics) and media (e.g. paper, electronic);
c) review and approval for suitability and adequacy.
7.5 Documented Information
!
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7.5.3 Control of documented information
!
7.5.3.1 Documented informaeon required by the quality management system and by this Internaeonal Standard shall be controlled to ensure:
a) it is available and suitable for use, where and when it is needed;
b) it is adequately protected (e.g. from loss of confideneality, improper use, or
loss of integrity).
Nothing’s new but easier to be understood
7.5 Documented Information
!
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7.5.3 Control of documented information
!
7.5.3.2 For the control of documented informaeon, the organizaeon shall address the following aceviees, as applicable:
a) distribulon, access, retrieval and use;
b) storage and preservalon, including preservaeon of legibility; c) control of changes (e.g. version control);
d) retenlon and disposilon.
!
Documented informaeon of external origin determined by the organizaeon to
be necessary for the planning and operaeon of the quality management system shall be idenefied as appropriate, and controlled.
!
NOTE Access can imply a decision regarding the permission to view the
documented informaeon only, or the permission and authority to view and change the documented informaeon.
Nothing’s new but easier to be understood
Clause 8 -‐ Operation
8.1
Operational planning and control
8.2
Determination of requirements for products and services
8.2.1 Customer communication
8.2.2 Determination of requirements for products and services 8.2.3 Review of requirements related to products and services
8.3
Design and development of products and services
8.3.1 General
8.3.2 Design and development planning 8.3.3 Design and development inputs 8.3.4 Design and development controls 8.3.5 Design and development outputs 8.3.6 Design and development changes
!
!
Clause 8 -‐ Operation
8.4
Control of externally provided products and services
8.4.1 General
8.4.2 Type and extent of control of external provision 8.4.3 Information for external providers
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
8.6
Release of products and services
8.7
Control of nonconforming process outputs, products and
services
8.1 Operational Planning and Control
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Copyright GIC 2014
The organizaeon shall plan, implement and control the processes, as outlined in
4.4, needed to meet requirements for the provision of products and services and to implement the aceons determined in 6.1, by:
a) determining requirements for the product and services;
b) establishing criteria for the processes and for the acceptance of products and
services;
c) determining the resources needed to achieve conformity to product and service requirements;
d) implemeneng control of the processes in accordance with the criteria ;
e) retaining documented informaeon to the extent necessary to have confidence that the processes have been carried out as planned and to demonstrate
conformity of products and services to requirements.
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The output of this planning shall be suitable for the organizaeon's operaeons.
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The organizaeon shall control planned changes and review the consequences of
unintended changes, taking aclon to milgate any adverse effects, as necessary.
The organizaeon shall ensure that outsourced processes are controlled in
8.2 Determination of Requirements for Products
and Services
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Copyright GIC 20148.2.1 Customer communicalon
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The organizaeon shall establish the processes for communicaeng with customers in relaeon to:
a) informalon relaeng to products and services;
b) enquiries, contracts or order handling, including changes;
c) obtaining customer views and perceplons, including customer complaints;
d) the handling or treatment of customer property, if applicable;
8.2 Determination of Requirements for Products
and Services
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Copyright GIC 2014
8.2.2 Determinalon of requirements related to products and
services
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The organizaeon shall establish, implement and maintain a process to determine the requirements for the products and services to be offered to poteneal
customers.
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The organizaeon shall ensure that:
a) product and service requirements (including those considered necessary by the organisaeon), and applicable statutory and regulatory requirements, are
defined;
b) it has the ability to meet the defined requirements and substanlate the claims
8.2 Determination of Requirements for Products
and Services
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Copyright GIC 2014
8.2.3 Review of requirements related to products and services
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The organizaeon shall review, as applicable:
a) requirements specified by the customer, including the requirements for delivery and post-‐delivery aceviees;
b) requirements not stated by the customer, but necessary for the customers' specified or intended use, when known;
c) addieonal statutory and regulatory requirements applicable to the products and services;
d) contract or order requirements differing from those previously expressed.
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NOTE Requirements can also include those arising from relevant interested parles.
8.2 Determination of Requirements for Products
and Services
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Copyright GIC 2014
8.2.3 Review of requirements related to products and services
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This review shall be conducted prior to the organizaeon’s commitment to supply products and services to the customer and shall ensure contract or order
requirements differing from those previously defined are resolved.
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Where the customer does not provide a documented statement of their
requirements, the customer requirements shall be confirmed by the organizalon before acceptance.
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Documented informalon describing the results of the review, including any new
or changed requirements for the products and services, shall be retained.
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Where requirements for products and services are changed, the organizaeon shall ensure that relevant documented informaeon is amended and that relevant
8.3 Design and Development of Products and
Services
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Copyright GIC 20148.3.1 General
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Where the detailed requirements of the organizalon’s products and services are not already established or not defined by the customer or by other interested parles, such that they are adequate for subsequent produclon or service
provision, the organizalon shall establish, implement and maintain a design and development process.
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NOTE 1 The organizaeon can also apply the requirements given in 8.5 to the development of processes for produceon and services provision
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NOTE 2 For services, design and development planning can address the whole
service delivery process. The organizaeon can therefore choose to consider the requirements of clauses 8.3 and 8.5 together.
