Annex
A
(informative]
Clarification of new structure,
terminology and concepts
A.1 Structure and terminology
The
clause structure (i.e. clause sequence) and some of the terminology of this
edition ofth is International Standard, in comparison with the previous edition
(ISO 9001:2008), have been changed to improve alignment with other management
systems standards.
There
is no requirement in this International Standard for its structure and
terminology to be applied to the documented information of an organization's
quality management system.
The
structure of clauses is intended to provide a coherent presentation of
requirements, rather than a model for documenting an organization's policies,
objectives and processes. The structure and content of documented information
related to a quality management system can often be more relevant to its users
if it relates to both the processes operated by the organization and information
maintained for other purposes.
There
is no requirement for the terms used by an organization to be replaced by the
terms used in this International Standard to specify quality management system
requirements. Organizations can choose to use terms which suit their operations
(e.g. using "records", "documentation" or
"protocols" rather than "documented information"; or
"supplier", "partner" or "vendor" rather than
"external provider"). Table; A.1 .shows the major differences in
terminology between this edition of this International Standard and the
previous edition.
ISO
9001:2008
|
ISO
9001:2015
|
Products
|
Products
and services
|
Exclusions
|
Not used
(See Clause
A.5 for clarification of applicability)
|
Management
representative
|
Not used
(Similar
responsibilities and authorities are assigned but no requirement for a single
management representative)
|
Documentation,
quality manual, documented procedures, records
|
Documented
information
|
Work
environment
|
Environment
for the operation of processes
|
Monitoring
and measuring equipment
|
Monitoring
and measuring resources
|
Purchased
product
|
Externally
provided products and services
|
Supplier
|
External
provider
|
A.2 Products and services
ISO
9001:2008 used the term "product" to include all output categories.
This edition of this International Standard uses "products and
services". The term "products and services" includes all output
categories (hardware, services, software and processed materials).
The
specific inclusion of "services" is intended to highlight the
differences between products and services in the application of some
requirements. The characteristic of services is that at least part of the
output is realized at the interface with the customer. This means, for example,
that conformity to requirements cannot necessarily be confirmed before service
delivery.
In
most cases, products and services are used together. Most outputs that
organizations provide to customers, or are supplied to them by external
providers, include both products and services. For example, a tangible or
intangible product can have some associated service or a service can have some
associated tangible or intangible product.
A.3 Understanding the needs and
expectations of interested parties
Subclause
4.2 specifies requirements for the organization to determine the interested
parties that are relevant to the quality management system and the requirements
of those interested parties. However, 4J! does not imply extension of quality
management system requirements beyond the scope of this International Standard.
As stated in the scope, this International Standard is applicable where an
organization needs to demonstrate its ability to consistently provide products
and services that meet customer and applicable statutory and regulatory
requirements, and aims to enhance customer satisfaction.
There
is no requirement in this International Standard for the organization to
consider interested parties where it has decided that those parties are not
relevant to its quality management system. It is for the organization to decide
if a particular requirement of a relevant interested party is relevant to its
quality management system.
A.4 Risk-based thinking
The
concept of risk-based thinking has been implicit in previous editions of this
International Standard, e.g. through requirements for planning, review and
improvement. This International Standard specifies requirements for the
organization to understand its context (see 4JJ and determine risks as a basis
for planning (see 1L1]. This represents the application of risk-based thinking
to planning and implementing quality management system processes (see ^A) and
will assist in determining the extent of documented information.
One
of the key purposes of a quality management system is to act as a preventive
tool. Consequently, this International Standard does not have a separate clause
or subclause on preventive action. The concept of preventive action is
expressed through the use of risk-based thinking in formulating quality
management system requirements.
The
risk-based thinking applied in this International Standard has enabled some
reduction in prescriptive requirements and their replacement by
performance-based requirements. There is greater flexibility than in ISO
9001:2008 in the requirements for processes, documented information and
organizational responsibilities.
Although
&J. specifies that the organization shall plan actions to address risks,
there is no requirement for formal methods for risk management or a documented
risk management process. Organizations can decide whether or not to develop a
more extensive risk management methodology than is required by this
International Standard, e.g. through the application of other guidance or
standards.
Not
all the processes of a quality management system represent the same level of
risk in terms of the organization's ability to meet its objectives, and the
effects of uncertainty are not the same for all organizations. Under the
requirements of £LL the organization is responsible for its application of
risk-based thinking and the actions it takes to address risk, including whether
or not to retain documented information as evidence of its determination of
risks.
A. 5 Applicability
This
International Standard does not refer to "exclusions" in relation to
the applicability of its requirements to the organization's quality management
system. However, an organization can review the applicability of requirements
due to the size or complexity of the organization, the management model it
adopts, the range of the organization's activities and the nature of the risks
and opportunities it encounters.
The
requirements for applicability are addressed in 4.3, which defines conditions
under which an organization can decide that a requirement cannot be applied to
any of the processes within the scope of its quality management system. The
organization can only decide that a requirement is not applicable if its
decision will not result in failure to achieve conformity of products and
services.
A.6 Documented information
As
part of the alignment with other management system standards, a common clause
on "documented information" has been adopted without significant
change or addition [see ZJij. Where appropriate, text elsewhere in this
International Standard has been aligned with its requirements. Consequently,
"documented information" is used for all document requirements.
Where
ISO 9001:2008 used specific terminology such as "document" or
"documented procedures", "quality manual" or "quality
plan", this edition of this International Standard defines requirements to
"maintain documented information".
Where
ISO 9001:2008 used the term "records" to denote documents needed to
provide evidence of conformity with requirements, this is now expressed as a
requirement to "retain documented information". The organization is
responsible for determining what documented information needs to be retained,
the period of time for which it is to be retained and the media to be used for
its retention.
A
requirement to "maintain" documented information does not exclude the
possibility that the organization might also need to "retain" that
same documented information for a particular purpose, e.g. to retain previous
versions of it.
Where
this International Standard refers to "information" rather than
"documented information" (e.g. in 4J.: "The organization shall
monitor and review the information about these external and internal
issues"), there is no requirement that this information is to be
documented. In such situations, the organization can decide whether or not it
is necessary or appropriate to maintain documented information.
A.7 Organizational knowledge
In
7.1.6. this International Standard addresses the need to determine and manage
the knowledge maintained by the organization, to ensure that it can achieve
conformity of products and services.
Requirements
regarding organizational knowledge were introduced for the purpose of:
a)
safeguarding the organization from loss of knowledge, e.g.
-
through staff turnover;
-
failure to capture and share information;
b)
encouraging the organization to acquire knowledge, e.g.
-
learning from experience;
-
mentoring;
-
benchmarking.
A.8 Control of externally provided
processes, products and services
All
forms of externally provided processes, products and services are addressed in
&4, e.g. whether through:
a)
purchasing from a supplier;
b)
an arrangement with an associate company;
c)
outsourcing processes to an external provider.
Outsourcing
always has the essential characteristic of a service, since it will have at
least one activity necessarily performed at the interface between the provider
and the organization.
The
controls required for external provision can vary widely depending on the
nature of the processes, products and services. The organization can apply
risk-based thinking to determine the type and extent of controls appropriate to
particular external providers and externally provided processes, products and
services.
Annex
B
(informative]
Other International Standards on
quality management and quality management systems developed by ISO/TC 176
The
International Standards described in this annex have been developed by 1SO/TC
176 to provide supporting information for organizations that apply this
International Standard, and to provide guidance for organizations that choose
to progress beyond its requirements. Guidance or requirements contained in the
documents listed in this annex do not add to, or modify, the requirements of this
International Standard.
Table
B.I shows the relationship between these standards and the relevant clauses of
this International Standard.
This
annex does not include reference to the sector-specific quality management
system standards developed by ISO/TC 176.
This
International Standard is one of the three core standards developed by ISO/TC
176.
-
ISO 9000 Quality management systems — Fundamentals and vocabulary
provides an essential
background for the proper understanding and implementation of this International Standard.
The quality management principles are described in detail in ISO 9000 and have been taken into
consideration during the development of this International Standard. These principles are not
requirements in themselves, but they form the foundation of the requirements specified by this
International Standard. ISO 9000 also defines the terms, definitions and concepts used in this
International Standard.
background for the proper understanding and implementation of this International Standard.
The quality management principles are described in detail in ISO 9000 and have been taken into
consideration during the development of this International Standard. These principles are not
requirements in themselves, but they form the foundation of the requirements specified by this
International Standard. ISO 9000 also defines the terms, definitions and concepts used in this
International Standard.
-
ISO 9001 (this International Standard] specifies requirements
aimed primarily at giving confidence in the products and services provided by
an organization and thereby enhancing customer satisfaction. Its proper
implementation can also be expected to bring other organizational benefits,
such as improved internal communication, better understanding and control of
the organization's processes.
-
ISO 9004 Managing for the sustained success of an organization — A
quality management approach provides guidance for organizations that choose to
progress beyond the requirements of this
International Standard, to address a broader range of topics that can lead to improvement of the
organization's overall performance. ISO 9004 includes guidance on a self-assessment methodology
for an organization to be able to evaluate the level of maturity of its quality management system.
International Standard, to address a broader range of topics that can lead to improvement of the
organization's overall performance. ISO 9004 includes guidance on a self-assessment methodology
for an organization to be able to evaluate the level of maturity of its quality management system.
The
International Standards outlined below can provide assistance to organizations
when they are establishing or seeking to improve their quality management
systems, their processes or their activities.
-
ISO 10001 Quality management — Customer satisfaction — Guidelines
for codes of conduct for organizations provides guidance to an organization in
determining that its customer satisfaction
provisions meet customer needs and expectations. Its use can enhance customer confidence in an
organization and improve customer understanding of what to expect from an organization, thereby
reducing the likelihood of misunderstandings and complaints.
provisions meet customer needs and expectations. Its use can enhance customer confidence in an
organization and improve customer understanding of what to expect from an organization, thereby
reducing the likelihood of misunderstandings and complaints.
-
ISO 10002 Quality management — Customer satisfaction — Guidelines
for complaints handling in organizations provides guidance on the process of
handling complaints by recognizing and addressing the needs and expectations of
complainants and resolving any complaints received. ISO 10002 provides an open,
effective and easy-to-use complaints process, including training of people. It
also provides guidance for small businesses.
-
ISO 10003 Quality management — Customer satisfaction — Guidelines for
dispute resolution external to organizations provides guidance for effective
and efficient external dispute resolution for product-related complaints.
Dispute resolution gives an avenue of redress when organizations do not remedy
a complaint internally. Most complaints can be resolved successfully within the
organization, without adversarial procedures.
-
ISO 10004 Quality management — Customer satisfaction — Guidelines
for monitoring and measuring provides guidelines for actions to enhance
customer satisfaction and to determine opportunities for improvement of
products, processes and attributes that are valued by customers. Such actions
can strengthen customer loyalty and help retain customers.
-
ISO 10005 Quality management systems — Guidelines for quality
plans provides guidance on establishing and using quality plans as a means of
relating requirements of the process, product, project or contract, to work
methods and practices that support product realization. Benefits of
establishing a quality plan are increased confidence that requirements will be
met, that processes are in control and the motivation that this can give to those
involved.
-
ISO 10006 Quality management systems — Guidelines for quality
management in projects is applicable to projects from the small to large, from
simple to complex, from an individual project to being part of a portfolio of
projects. ISO 10006 is to be used by personnel managing projects and who need
to ensure that their organization is applying the practices contained in the
ISO quality management system standards.
-
ISO 10007 Quality management systems — Guidelines for
configuration management is to assist organizations applying configuration
management for the technical and administrative direction over the life cycle
of a product. Configuration management can be used to meet the product
identification and traceability requirements specified in this International
Standard.
-
ISO 10008 Quality management — Customer satisfaction — Guidelines
for business-to-consumer electronic commerce transactions gives guidance on how
organizations can implement an effective and efficient business-to-consumer
electronic commerce transaction (B2C ECT) system, and thereby provide a basis
for consumers to have increased confidence in B2C ECTs, enhance the ability of
organizations to satisfy consumers and help reduce complaints and disputes.
-
ISO 10012 Measurement management systems — Requirements for
measurement processes and measuring equipment provides guidance for the
management of measurement processes and metrological confirmation of measuring
equipment used to support and demonstrate compliance with metrological requirements.
ISO 10012 provides quality management criteria fora measurement management
system to ensure metrological requirements are met.
-
ISO/TR 10013 Guidelines for quality management system
documentation provides guidelines for the development and maintenance of the
documentation necessary for a quality management system. ISO/TR 10013 can be
used to document management systems other than those of the ISO quality
management system standards, e.g. environmental management systems and safety
management systems.
-
ISO 10014 Quality management — Guidelines for realizing financial
and economic benefits is addressed to top management. It provides guidelines
for realizing financial and economic benefits through the application of
quality management principles, it facilitates application of management
principles and selection of methods and tools that enable the sustainable
success of an organization.
-
ISO 10015 Quality management — Guidelines for training provides
guidelines to assist organi7ations in addressing issues related to training.
ISO 10015 can be applied whenever guidance is required to interpret references
to "education" and "training" within the ISO quality
management system standards. Any reference to "training" includes all
types of education and training.
-
ISO/TR 10017 Guidance on statistical techniques for ISO 9001:2000
explains statistical techniques which follow from the variability that can be
observed in the behaviour and results of processes, even under conditions of
apparent stability. Statistical techniques allow better use of available data
to assist in decision making, and thereby help to continually improve the
quality of products and processes to achieve customer satisfaction.
-
ISO 10018 Quality management — Guidelines on people involvement
and competence provides guidelines which influence people involvement and
competence. A quality management system depends on the involvement of competent
people and the way that they are introduced and integrated into the
organization. It is critical to determine, develop and evaluate the knowledge,
skills, behaviour and work environment required.
-
ISO 10019 Guidelinesfor theselection ofquality management system
consultants and useoftheirservices
provides guidance for the selection of quality management system consultants and the use of their
services. It gives guidance on the process for evaluating the competence of a quality management
system consultant and provides confidence that the organization's needs and expectations for the
consultant's services will be met.
provides guidance for the selection of quality management system consultants and the use of their
services. It gives guidance on the process for evaluating the competence of a quality management
system consultant and provides confidence that the organization's needs and expectations for the
consultant's services will be met.
-
ISO 19011 Guidelines for auditing management systems provides guidance
on the management of an audit programme, on the planning and conducting of an
audit of a management system, as well as on the competence and evaluation of an
auditor and an audit team. ISO 19011 is intended to apply to auditors,
organizations implementing management systems, and organizations needing to
conduct audits of management systems
Table
B.1 — Relationship between other International Standards on quality management
and quality management systems and the clauses of this International Standard
Other
International Standard
|
Clause
in this International Standard
|
||||||
4
|
5
|
6
|
7
|
8
|
9
|
10
|
|
ISO 9000
|
All
|
All
|
All
|
All
|
All
|
All
|
All
|
ISO 9004
|
All
|
All
|
All
|
All
|
All
|
All
|
All
|
ISO 10001
|
8.2.2,
8.5.1
|
9.1.2
|
|||||
ISO 10002
|
8.2.1,
|
9.1,2
|
10.2.1
|
||||
ISO 10003
|
9.1.2
|
||||||
ISO 10004
|
9.1.2.9.1.3
|
||||||
ISO 10005
|
S3
|
All
|
All
|
21
|
10.2
|
||
ISO 10006
|
All
|
All
|
All
|
All
|
All
|
All
|
All
|
ISO 10007
|
8.5.2
|
||||||
ISO 10008
|
All
|
All
|
All
|
All
|
All
|
All
|
All
|
ISO 10012
|
7.1.5
|
||||||
1SO/TR
10013
|
zs
|
||||||
ISO 10014
|
All
|
All
|
All
|
All
|
All
|
All
|
All
|
ISO 10015
|
12.
|
||||||
ISO/TR
10017
|
6J.
|
7.1.5
|
£1
|
||||
ISO 10018
|
All
|
All
|
All
|
All
|
All
|
All
|
All
|
ISO 10019
|
8,4
|
||||||
ISO 19011
|
9.2
|
||||||
NOTE "All" indicates that all the subclauses in the
specific clause of this International Standard ate related to the other
International Standard.
|
|||||||
Bibliography
1)
ISO 9004, Managing for the sustained success ofan organization —A
quality management approach
2)
ISO 10001, Quality management — Customer satisfaction — Guidelines
for codes of conduct for organizations
3)
ISO 10002, Quality management — Customer satisfaction — Guidelines
for complaints handling in organizations
4)
ISO 10003, Quality management — Customer satisfaction — Guidelines
for dispute resolution external to organizations
5)
ISO 10004, Quality management—Customer satisfaction — Guidelines
for monitoring and measuring
6)
ISO 10005, Quality management systems — Guidelines for quality
plans
7)
ISO 10006, Quality management systems — Guidelines for quality
management in projects
8)
ISO 10007, Quality management systems — Guidelines for
configuration management
9)
ISO 10008, Quality management — Customer satisfaction — Guidelines
for business-to-consumer electronic commerce transactions
10)
ISO 10012, Measurement management systems — Requirements for
measurement processes and measuring equipment
11)
ISO/TR10013, Guidelines for quality management system
documentation
12)
ISO 10014, Quality management — Guidelines for realizing financial
and economic benefits
13)
ISO 10015, Quality management—Guidelines for training
14)
ISO/TR 10017, Guidance on statistical techniques for ISO 9001:2000
15)
ISO 10018, Quality management— Guidelines on people involvement
and competence
16)
ISO 10019, Guidelines for the selection of quality management system
consultants and use of their services
17)
ISO 14001, Environmental management systems — Requirements with
guidance for use
18)
ISO 19011, Guidelines for auditing management systems
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ISO 31000, Risk management — Principles and guidelines
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ISO 37500, Guidance on outsourcing
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ISO/IEC 90003, Software engineering — Guidelines for the
application of ISO 9001:2008 to computer software
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IEC 60300-1, Dependability management — Part 1: Guidance for
management and application
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IEC 61160, Design review
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Quality management principles, ISO
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ISO 9001 for Small Businesses — What to do, ISO3)
i operate a small computer shop at home and most customers enjoy playing online games;; AMREP Taiwan
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