INTERNATIONAL
STANDARD
ISO
10005
Third edition
2018-06
Quality management — Guidelines for
quality plans
Management de la qualité — Lignes directrices pour les plans qualité
Reference number
ISO 10005:2018(E)
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ISO 10005:2018(E)
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ISO 10005:2018(E)
Contents
Page
Foreword .......................................................................................................................................................................................................................................... v
Introduction .............................................................................................................................................................................................................................. vii
1
Scope ................................................................................................................................................................................................................................. 1
2
Normative references ...................................................................................................................................................................................... 1
3
Terms and definitions ..................................................................................................................................................................................... 1
4
Using a quality plan ........................................................................................................................................................................................... 2
4.1
4.2
4.3
Introduction .............................................................................................................................................................................................. 2
Requesting external provider quality plans .................................................................................................................. 2
Managing external provider quality plans ...................................................................................................................... 3
5.1
5.2
5.3
5.4
Context o f the quality plan ............................................................................................................................................................ 4
Inputs to the quality plan ............................................................................................................................................................... 4
Defining the scope o f the quality plan ................................................................................................................................ 5
Preparation o f the quality plan ................................................................................................................................................. 5
5.4.1 Initiation.................................................................................................................................................................................. 5
5.4.2 Defining the quality plan........................................................................................................................................... 5
5.4.3 Consistency and compatibility............................................................................................................................. 5
5.4.4 Presentation and structure ..................................................................................................................................... 6
5
Development of a quality plan ............................................................................................................................................................... 4
6
Content of the quality plan ......................................................................................................................................................................... 6
6.1
6.2
6.3
6.4
6.5
6.6
6.7
6.8
6.9
6.10
6.11
6.12
6.13
6.14
7
General ........................................................................................................................................................................................................... 6
Scope o f the quality plan ................................................................................................................................................................ 6
Quality plan inputs .............................................................................................................................................................................. 6
Quality objectives .................................................................................................................................................................................. 7
Quality plan responsibilities ....................................................................................................................................................... 7
Control o f documented information ..................................................................................................................................... 7
Resources ..................................................................................................................................................................................................... 8
6.7.1 Provision o f resources ................................................................................................................................................. 8
6.7.2 Materials, products and services ....................................................................................................................... 8
6.7.3 People ........................................................................................................................................................................................ 8
6.7.4 Infrastructure and environment for the operation o f processes ........................................... 8
6.7.5 Monitoring and measuring resources ........................................................................................................... 8
Customers and other interested parties communication .................................................................................. 9
Design and development ................................................................................................................................................................ 9
6.9.1 Design and development process ...................................................................................................................... 9
6.9.2 Control o f design and development changes ........................................................................................... 9
Externally provided processes, products and services ..................................................................................... 10
Production and service provision ........................................................................................................................................ 10
Identification and traceability ................................................................................................................................................ 11
Property belonging to customers or external providers ................................................................................. 11
Preservation o f outputs ................................................................................................................................................................ 11
6.15 Control of nonconforming outputs ..................................................................................................................................... 12
6.16 Monitoring and measurement ................................................................................................................................................ 12
6.17 Audits ........................................................................................................................................................................................................... 12
Operation and control of the quality plan ............................................................................................................................... 13
7.1
Review and acceptance o f the quality plan ................................................................................................................. 13
7.2
Implementation and monitoring o f the quality plan........................................................................................... 13
7.3
Revision o f the quality plan....................................................................................................................................................... 14
7.4 Feedback and improvement ..................................................................................................................................................... 14
Annex A (in formative) Examples of formats for quality plans ............................................................................................... 15
Annex B (in formative) Schematic representation of a process approach applied to quality plans . 22
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ISO 10005:2018(E)
Annex C (informative) Correlation matrix between the clauses in this document and those
in ISO 9001:2015 ............................................................................................................................................................................................... 23
Annex D (informative) Correlation matrix between the clauses of this document and the
quality management principles from ISO 9000:2015 ................................................................................................ 24
Bibliography ............................................................................................................................................................................................................................. 27
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ISO 10005:2018(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation o f national standards
bodies (ISO member bodies). The work o f preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters o f
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the di fferent approval criteria needed for the
di fferent types o f ISO documents should be noted. This document was dra fted in accordance with the
editorial rules o f the ISO/IEC Directives, Part 2 (see www.iso .org/directives).
Attention is drawn to the possibility that some o f the elements o f this document may be the subject o f
patent rights. ISO shall not be held responsible for identi fying any or all such patent rights. Details o f
any patent rights identified during the development o f the document will be in the Introduction and/or
on the ISO list o f patent declarations received (see www.iso .org/patents).
Any trade name used in this document is in formation given for the convenience o f users and does not
constitute an endorsement.
For an explanation on the voluntary nature o f standards, the meaning o f ISO specific terms and
expressions related to con formity assessment, as well as in formation about ISO’s adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www.iso .org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 176,
assurance, Subcommittee SC 2, Quality systems
.
Quality management and quality
This third edition cancels and replaces the second edition (ISO 10005:2005), which has been technically
revised.
The main changes compared with the previous edition are as follows.
a) It applies the terminology from ISO 9000:2015, which includes changes to key definitions, such as:
1)
2)
or the definition o f "quality plan" (see 3.2), which has been modified to replace the phrase
“procedures and associated resources to be applied when and by whom” by “actions,
responsibilities and associated resources”;
f
or the definition o f “specific case” (see 3.3), which has been modified to make re ference to
“service”, as ISO 9001:2015 now re fers to “products and services” and no longer just to
“products”;
f
3) the replacement o f the terms "documentation" and "record" by the term “documented
in formation”, which is generally used in ISO management system standards to include both
“procedures” and “records” which are not necessarily distinct from each other in a digital
environment (documented in formation needed to support process operation is “maintained”,
which means that it is established and updated as required; documented in formation that
provides evidence o f con formity with requirements is “retained” which means that it is
protected from unintended alterations).
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ISO 10005:2018(E)
Table 1 — Major changes to terms in this document since its previous edition
Products
Documentation
Quality manual
ISO 10005:2005
Documented procedures
Records
Purchased product
Supplier
Monitoring and measuring equipment
This document
Products and services
Documented in formation
Externally provided processes, products and services
External provider
Monitoring and measuring resources
b) It is aligned to ISO 9001:2015, leading to:
1) a significant revision in the clause/subclause sequence, titles and the addition o f new material,
e.g. the inclusion of “5.2 Context of a quality plan”, or the extension of 7.2 to also reference the
monitoring o f a quality plan;
2) the incorporation o f “risk-based thinking”.
c) A new clause (Clause 4) on using a quality plan.
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Introduction
0.1 General
This document was prepared to address the need for guidance on quality plans, either in the context o f
an established quality management system or as an independent management activity. In either case,
quality plans provide a means o f relating specific requirements o f the process, product, service, project
or contract to work methods and practices. Quality plans are most e ffective when they are compatible
with other associated plans. The guidance in this document can also be used where quality plans are
integrated with other management plans or quality management systems.
Benefits o f establishing a quality plan include increased confidence that requirements will be met,
greater assurance that processes are in control and the motivation it can give to those involved. It might
also give insight into opportunities for innovation and improvement.
The guidance on quality plans in this document is based on the quality management principles described
in ISO 9000 and the concepts used in ISO 9001 for the establishment o f quality management systems.
Clause 6, which describes the typical contents o f a quality plan, includes guidance to applying relevant
ISO 9001 requirements. The guidance is limited to quality plans and does not replace guidance given in
ISO 9000 on quality management concepts or ISO/TS 9002 on the application o f ISO 9001 requirements
within an organization.
This document does not replace the guidance given in industry-specific documented in formation. Where
quality plans are required for project applications, the guidance provided in this document is intended
to be complementary to the guidance provided in ISO 10006. Some terms used in this document have
been changed with respect to its previous edition to improve alignment with ISO 9001:2015 and other
management system standards. There is no need for the terms used by an organization, whether in
speci fying quality plan requirements or developing a quality plan, to be replaced by the terms used in
this document.
In this document, the following verbal forms are used:
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
In formation marked as “NOTE” is for guidance in understanding or clari fying the associated text.
NOTE
See https: //committee .iso .org/home/tc176sc2 for guidance on the topics in this Introduction.
0.2 Using this document
This Introduction explains some underlying concepts and changes to terms used in the previous edition
of this document.
Clauses 1 to 3 provide basic in formation (Scope, Normative re ferences, and Terms and definitions).
Clause 4 summarizes how quality plans can be used.
Clause 5 describes the process o f developing a quality plan.
Clause 6 describes the typical contents o f a quality plan.
Clause 7 describes the operation and control o f a quality plan.
Annex A provides examples o f simple quality plans.
Annex B provides a schematic representation o f a process approach applied to a quality plan
Annex C provides a correlation matrix between the clauses o f this document and those o f ISO 9001:2015.
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ISO 10005:2018(E)
Annex D provides a correlation matrix between the clauses o f this document and the quality
management principles from ISO 9000:2015.
The Bibliography includes a list o f standards and other relevant in formation.
0.3 Process approach
The process approach means the systematic management o f processes and their interactions to achieve
intended results. Applying the process approach to quality plans assists organizations to manage the
inputs, activities and outputs o f each process within a coherent system o f interrelated processes.
Processes re ferenced in a quality plan can interact with:
— each other (interactions among quality plan processes);
— other processes operated within the organization’s management system;
— processes operated within other organizations (such as customers and external providers).
When considering how to manage its processes and their interactions, the organization can address
these through a quality plan whether or not it has a quality management system.
Annex B provides a schematic representation o f a process approach applied to quality plans.
0.4 Risk-based thinking
Risk-based thinking means applying a systematic approach to considering risk (the e ffect o f uncertainty)
so that risks can be understood and managed appropriately.
The application o f risk-based thinking to the development and use o f a quality plan enables an
organization to determine the importance o f particular issues and take appropriate actions to manage
both risks and opportunities.
A customer requesting that a provider prepares a quality plan can apply risk-based thinking to
determine the minimum requirements for the type and extent o f the monitoring activities.
When developing a quality plan, the organization can apply risk-based thinking in deciding the
processes, resources and control methods to be used. Particularly where an organization uses a
standard model or template for di fferent quality plans, risk-based thinking can assist those involved to
make each quality plan fit for its intended purpose.
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INTERNATIONAL STANDARD
ISO 10005:2018(E)
Quality management — Guidelines for quality plans
1 Scope
T his do cument gives guidelines
for es tablishing, reviewing, accepting, applying and revis ing quality plans .
T h i s do c u ment i s appl ic able to qua l ity pla n s
for
any i ntende d output, whe ther a pro ce s s , pro duc t,
s er vice, proj e c t or contrac t, a nd any typ e or s i ze o f organ i z ation .
I t i s appl ic able whe ther or no t the organ i z ation h as a management s ys tem i n con form ity with I S O 9 0 01 .
T h i s do c ument provide s gu idance and do e s no t s p e c i fy re qu i rements .
fo c u s e d
It is
pri mari ly on
the
provi s ion
o f outputs
and
is
no t a
guide
to
the
plan n i ng o f qua l ity
management s ys tem development.
To avo id u ndue rep e tition o f “pro ce s s , pro duc t, s er vice , proj e c t o r co ntrac t”, th i s do c u ment u s e s the
NO TE
ter m “s p e c i fic c a s e”.
2 Normative references
T he
fol lowi ng
do c u ments are re ferre d to i n the tex t i n s uch a way th at s ome or a l l o f thei r content
con s titute s re qu i rements o f th i s do c u ment. For date d re ference s , on ly the e d ition cite d appl ie s . For
u ndate d re ference s , the late s t e d ition o f the re ference d do c ument (i nclud i ng a ny amend ments) appl ie s .
I S O 9 0 0 0 : 2 01 5 ,
Quality management systems — Fundamentals and vocabulary
3 Terms and definitions
Fo r
the
purposes
fo l lo w i n g
o f th i s
do c u ment,
the
ter m s
a nd
de fi n i tio n s
g i ve n
in
ISO
9 0 0 0 : 2 01 5
a nd
the
ap p l y.
I S O and I E C mai nta i n term i nolo gic a l datab a s e s
for
u s e i n s tand ard i z ation at the
fol lowi ng
add re s s e s:
https://www.iso .org/obp
http://www
.org/
—
I S O O n l i ne brows i ng pl at form: avai l able at
—
I E C E le c trop e d ia: avai lable at
. ele c trop e d i a
3.1
documented information
i n formation re qu i re d to b e control le d a nd mai nta i ne d by a n organ i z ation and the me d iu m on wh ich it
i s conta i ne d
N o te 1 to entr y: D o c u mente d i n for m ation c a n b e i n a ny
fo rm at a nd
me d ia a nd
from
a ny s ou rce .
N o te 2 to entr y: D o c u mente d i n for m ation c a n re fer to:
—
the m a n agement s ys tem , i nclud i ng rel ate d
—
i n fo rm ation c re ate d i n o rder
—
e vidence o f re s u lts ach ie ve d .
for
quality plans
(
3 . 2 ) a nd p ro ce s s e s;
the orga n i z ation to o p erate (do c u mentatio n) ;
[S OU RC E : I S O 9 0 0 0 : 2 01 5 , 3 . 8 . 6 , mo d i fie d — I n No te 2 to entr y, the fi rs t l i s t item ha s b e en mo d i fie d, a nd
No te 3 to entr y ha s b e en dele te d .]
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ISO 10005:2018(E)
3.2
quality plan
specification o f the actions, responsibilities and associated resources to be applied to a specific object
[SOURCE: ISO 9000:2015, 3.8.9, modified — The phrase “procedures and associated resources to be
applied when and by whom” has been replaced by “actions, responsibilities and associated resources”,
and the notes to entry have been deleted.]
3.3
<quality plans> subject o f a quality plan (3.2 )
s
p
e
c
i
f
i
c
c
a
s
e
Note 1 to entry: The specific case can be a process, product, service, project, contract or other intended output
for the quality plan.
4 Using a quality plan
4.1 Introduction
A quality plan describes how an organization will provide an intended output, whether that output is a
process, product, service, project or contract (termed the “specific case” in this document).
Quality plans are developed where they are considered necessary to meet needs and expectations
related to a specific case.
Where the organization has an established management system, quality plans might be necessary i f
requested by a customer or considered use ful for other reasons. On the other hand, where no established
management system exists, quality plans can provide a framework for meeting the requirements o f
the specific case. They can also assist the organization to develop its own management system and its
processes.
The organization should decide where there is need for quality plans. There are a number o f situations
where quality plans can be use ful or necessary, for example:
a) to show how the organization’s quality management system applies to a specific case;
b) to meet customer, other interested parties or the organization’s own requirements;
c) to develop and validate new products, services or processes;
d) to demonstrate, internally and/or externally, how requirements will be met;
e) to organize and manage activities to meet requirements and quality objectives;
f
) to optimize the use o f resources in meeting quality objectives;
g) to minimize the risk o f not meeting requirements;
h) to control the establishment o f a new or modified organization, site or partnering arrangement;
i)
as a basis for monitoring and assessing compliance with the requirements for quality;
j)
in the absence o f an established management system.
4.2 Requesting external provider quality plans
An organization may choose to request that an external provider or a prospective external provider
submit a quality plan related to a specific case (this can relate to external providers who are part o f the
same organization, e.g. a separate division). Both the organization requesting a quality plan and the
prospective external provider should consider the reasons for using a quality plan and the benefits that
might be achieved through its use.
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ISO 10005:2018(E)
The organization requesting an external provider quality plan should apply risk-based thinking to the
nature o f the specific case, the evaluation and selection o f external provider(s) and opportunities for
benefits. There can be benefits to both the organization and potential external providers in using riskbased thinking.
Consideration o f risks related to the specific case can increase the options for requesting quality plans
rom external providers, for example:
f
a) speci fying intended results rather than the methods and resources to be applied to the specific case
(such as in per formance-based contracts) can allow external providers to introduce innovation in
methods, practices and resources;
b) speci fying minimum requirements for controls and documented in formation allows an external
provider to apply their own processes and experience;
c) defining quality plan requirements for the specific case rather than requiring con formity with a
management system standard, such as ISO 9001, can enable participation by a broader range o f
potential external providers with di fferent levels o f maturity o f their management systems.
Examples o f specifications o f requirements for external provider quality plans relevant to particular
sectors can o ften be found in industry codes o f practice, requests for o ffers o f products and services
or other publicly available sources. However, care should be taken to ensure that such examples are
appropriately adapted to the specific case.
Requirements for external provider quality plans can be included in specifications for other management
plans such as service management plans, project management plans, construction management plans
or production and installation plans.
4.3 Managing external provider quality plans
A quality plan can ensure that an organization has a common understanding with an external provider
about how its requirements will be met. The organization should decide what level o f monitoring is
required to assess external provider per formance, such as ongoing monitoring, acceptance checks,
assessment and auditing.
The monitoring approach can be decided based on various factors, such as:
a) the nature and scope o f the specific case;
b) risks associated with the specific case;
c) the capability o f the external provider;
d) knowledge and expertise held by the organization requesting the quality plan.
Establishing a common understanding o f the quality plan between the organization and the external
provider is particularly important where the specific case involves high levels o f risk and complexity.
A common understanding means that the organization has a basis for confidence in satis factory
per formance by the external provider and the external provider has a basis for communicating with
the organization about potential problems.
Achieving such a relationship can facilitate:
— clarity o f roles, including those o f independent assessors used by the organization;
— maintaining the confidentiality o f shared in formation and intellectual property;
— deciding on e ffective methods and responsibilities for communication;
— responding to supply chain and contract issues.
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ISO 10005:2018(E)
5 Development of a quality plan
5.1 Context of the quality plan
Unders tand i ng the contex t o f the qua l ity plan a nd its i ntende d re s u lts provide s a b a s i s
for
de term i n i ng
ri s ks and opp or tu n itie s to b e add re s s e d .
T he conte xt o f the qua l ity plan c an i nclude:
a)
e xi s ti ng management pl an s or pro ce s s e s wh ich wi l l s upp or t the qua l ity pla n, whe ther or no t the s e
pro ce s s e s are p a r t o f an e s tabl i s he d ma nagement s ys tem;
b)
i nterna l i s s ue s that c a n a ffe c t the abi l ity o f the orga n i z ation to ach ieve the i ntende d re s u lts , s uch
a s con s trai nts on re s ou rce s , how the qua l ity plan wi l l b e com mu n ic ate d to its u s ers a nd whe ther
work wi l l b e ca rrie d out at d i fferent s ite s;
c)
e xterna l
i s s ue s
relate d
to
the
s p e c i fic
c as e,
s uch
as
s tatutor y
and
re gu lator y
re qu i rements ,
comp e titive a nd ma rke t i s s ue s;
d)
the as p e c ts o f b o th the i nterna l and e xterna l i s s ue s o f the organ i z ation that relate to the s p e c i fic
c a s e,
e)
for
exa mple qua l ity a nd marke t obj e c tive s;
the ne e d s and exp e c tation s o f relevant i ntere s te d p a r tie s , i nclud i ng c u s tomers , employe e s , e xterna l
providers , e tc .
NO TE 1
Unders ta nd i n g
the
e x ter n a l
co nte x t
can
be
fac i l itate d
by
con s ideri n g
te ch nolo gic a l , co mp e titive , m a rke t, c u ltu ra l , s o c i a l , envi ro n menta l a nd e cono m ic
i s s ue s
fac to rs ,
arising
fro m
le ga l ,
whe ther i nter n ation a l ,
n ation a l , re gio n a l o r lo c a l .
NO TE 2
Unders ta nd i n g the i nter n a l conte x t c a n b e
fac i l itate d
b y con s ideri n g i s s ue s rel ate d to va lue s , c u ltu re ,
knowle dge a nd p er fo r ma nce o f the o rga n i z atio n .
Ri s ks s hou ld b e de term i ne d and add re s s e d, i n order to provide con fidence th at i ntende d re s u lts wi l l b e
ach ieve d and u nde s i re d e ffe c ts wi l l b e prevente d or re duce d .
O pp or tu n itie s
for
i mprovement s hou ld b e con s idere d,
i nc re a s e e ffe c tivene s s and e fficienc y. O pp or tu n itie s
for
for
e xample to me e t c u s tomer exp e c tation s or
i n novation ca n a l s o b e i mp or ta nt,
where d ra ft qua l ity plan s a re s ubm itte d as p ar t o f a tenderi ng pro ce s s
services.
O nce the contex t
for
for
for
example
provi s ion o f pro duc ts and
the qua l ity pla n and its i ntende d re s u lts are u nders to o d, the s cop e and obj e c tive s
o f the qua l ity pla n c an b e defi ne d . T he
decided.
format
and level o f de ta i l ne e de d
for
the qua l ity plan c a n a l s o b e
5.2 Inputs to the quality plan
T he organ i z ation s hou ld de term i ne the i nputs to the qua l ity pl an,
for
exa mple:
a)
c u s tomer re qui rements , s tatutor y, regu lator y a nd i ndu s tr y s p e c i fic ation s;
b)
i n formation on the ne e d s o f u s ers o f the qua l ity pla n;
c)
o ther relevant qua l ity pl an s;
d)
re qui rements o f the s p e ci fic c as e;
e)
a s s e s s ments o f ri sks and opp or tun itie s relate d to the s p e c i fic c a s e;
f)
re qui rements
g)
management s ys tem re qu i rements o f the orga n i z ation;
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ISO 10005:2018(E)
h) documented in formation relevant to the quality plan;
i)
communication requirements for the quality plan.
5.3
Defining the scope o f the quality plan
The organization should determine what is to be covered by the quality plan. The scope o f the quality
plan will depend on several factors, including:
a) the requirements o f customers and other relevant interested parties;
b) the types o f products and services to be provided;
c) the organization’s processes and their quality characteristics;
d) the resources needed to achieve the intended results;
e) the extent to which the quality plan is supported by an established quality management system.
There can be benefits from reviewing the scope o f the quality plan with the customer or other relevant
interested parties.
5.4 Preparation of the quality plan
5.4.1
Initiation
In preparing the quality plan, the organization should determine the respective roles, responsibilities
and authorities within the organization and, where applicable, the relevant responsibilities and
authorities o f external parties.
The quality plan should be prepared with the participation o f people who are involved in the specific
case, both within the organization and, where appropriate, relevant interested parties. Where a
particular resource has limited availability, the quality plan might need to speci fy how the demand for
resources will be satisfied.
5.4.2
Defining the quality plan
The quality plan should indicate how the required activities will be carried out, either directly or
by re ference to appropriate documented in formation (e.g. project plan, work instruction, checklist,
so ftware application).
Where an organization has an established management system, it may select, adapt, or supplement
existing documented in formation for use in, or re ference by, the quality plan.
Where a requirement results in a deviation from the organization’s management system the resulting
risks and opportunities associated with the deviation should be considered; such deviations should be
justified, agreed and approved.
A quality plan may be included as part o f other documented in formation, for example, project quality
plans are o ften included in project management plans (see ISO 10006).
5.4.3
Consistency and compatibility
The content and format o f the quality plan should be consistent with the scope, the inputs, the needs o f
the users o f the quality plan and its intended outputs.
The level o f detail in the quality plan should be consistent with any agreed requirements, the
organization’s methods o f operation and the complexity o f the activities to be per formed. The need for
compatibility with other management plans applicable to the specific case should also be considered.
© ISO 2018 – All rights reserved
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5
ISO 10005:2018(E)
An organization may decide to prepare a quality plan that con forms to applicable requirements o f
ISO 9001. A correlation matrix to ISO 9001:2015 is provided in Annex C for guidance.
5.4.4 Presentation and structure
A quality plan may be formally defined and presented using di fferent methods, for example:
a) graphical representations (e.g. process map, work flow charts);
b) written work instructions (e.g. textual description, table, document matrix, checklists, manual);
c) visual media, electronic methods;
d) so ftware applications;
e) combination o f methods.
These methods should be appropriate to the application and users o f the quality plan.
The quality plan may contain a number o f distinct plans, for example for particular aspects, processes
or functions. Control o f the inter faces between the di fferent plans needs to be clearly defined.
NOTE
Examples o f quality plans are provided in Annex A .
6 Content of the quality plan
6.1 General
The guidance in 6.2 to 6.17 indicates what should be considered for inclusion in a quality plan.
Documented in formation necessary for the intended users o f the quality plan may be contained within
the quality plan or, where available from other sources (e.g. an intranet or extranet), may be re ferenced
or linked electronically.
Some topics not mentioned in 6.2 to 6.17 could be added depending on the nature and the scope of the
specific case. Where a customer requires specific topics or a specific structure, the quality plan should
be prepared in accordance with those requirements.
The quality plan for a specific case should cover the topics examined in 6.2 to 6.17 as appropriate. Some
topics in this guidance might not be applicable, for example where design and development are not
involved.
6.2 Scope of the quality plan
The scope should be clearly stated in the quality plan (see 5.3 ). This should include:
a) a simple statement o f the purpose and expected output o f the specific case;
b) the aspects o f the specific case to which it will be applied, including particular restrictions to its
applicability;
c) the conditions o f its validity (e.g. dimensions, temperature range, hardware platform/operating
system, market conditions, resource availability or quality management systems certification/
registration status).
6.3 Quality plan inputs
It can be necessary to list or describe the inputs to the quality plan (see 5.2 ), to facilitate, for example:
a) re ference to inputs by users o f the quality plan;
6
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ISO 10005:2018(E)
b) reviewing consistency with inputs during maintenance o f the quality plan;
c) reviewing changes to inputs for impact on the quality plan.
The quality plan should include or make re ference to the requirements to be met for the specific case.
A simple overview o f the requirements may be included to help users to understand the context o f
their work, for example an outline o f a project. In other cases, a comprehensive list o f requirements
developed from input documented in formation can be used.
6.4 Quality objectives
The quality plan should state the quality objectives for the specific case and how they will be achieved.
Quality objectives may be established, for example, in relation to:
a) quality characteristics for the specific case;
b) important issues for satis faction o f the customer, organization or other interested parties;
c) opportunities for improvement.
These quality objectives should be expressed in measurable terms. Any required measurement
processes needed to determine achievement o f the quality objectives should be included or re ferenced
in the quality plan.
6.5 Quality plan responsibilities
The quality plan should identi fy people within the organization who are responsible for:
a) ensuring that the activities and resources required for the quality plan or contract are planned,
implemented and controlled, and their progress monitored;
b) reviewing quality plan inputs, recording these reviews and resolving conflicts and ambiguities;
c) communicating requirements to all a ffected departments and functions, external providers and
customers, and resolving problems that arise at the inter faces between such groups;
d) reviewing the results o f any audits conducted;
e) reviewing and authorizing changes to, or deviations from, the quality plan.
Reporting lines o f those involved in implementing the quality plan may be presented in the form o f an
organizational chart.
6.6 Control of documented information
6.6.1 For documented information applicable to the specific case, the quality plan should state:
a) how the documented in formation will be identified;
b) by whom the documented in formation will be reviewed and approved;
c) how distribution o f, and access to, the documented in formation will be controlled;
d) how the documented in formation will be maintained and protected.
6.6.2 The quality plan should define what documented information should be retained to provide
evidence o f con formity with requirements. Such documented information can include quality plan inputs,
design and development reviews, inspection and test results, process monitoring and measurement
© ISO 2018 – All rights reserved
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7
ISO 10005:2018(E)
o utp uts , wo rk o r s ervice o rders , drawings , minutes o f meetings , as s es s ment and audit rep o rts . M atters
to be considered include:
for
how long evidence o f con form ity wi l l b e re ta i ne d;
a)
how, where a nd
b)
what the c u s tomer, s tatutor y and regu lator y re qu i rements are, and how they wi l l b e appl ie d;
c)
be
used
con form ity i s pro te c te d
what
me tho d s
wi l l
from
to
en s u re
that
do c u mente d
i n formation
re tai ne d
as
of
evidence
u n i ntende d a lteration and made avai lab le when re qu i re d;
d)
what do c umente d i n formation wi l l b e s uppl ie d to the c u s tomer, when and b y what me an s;
e)
where appl ic able, i n wh at la nguage,
format and
me d i a do c umente d i n formation wi l l b e provide d .
typ e
amou nt
6.7 Resources
6.7.1
T he
Provision of resources
qua l ity
pla n
i mplementation
provide d
s hou ld
o f the
pro ce s s e s ,
s p e ci fy
qua l ity
the
pla n .
pro duc ts
or
T he s e
s er vice s ,
a nd
re s ou rce s
of
c an
i n fra s truc tu re
re s ource s
i nclude
and
ne e de d
p e ople,
for
for
envi ron ment
s ucce s s fu l
the
i nterna l ly
the
or
e xterna l ly
op eration
of
pro ce s s e s , mon itori ng and me a s u rement re s ource s , and s p e ci a l i z e d knowle dge a nd exp er ti s e .
6.7.2
Materials, products and services
Where there are s p eci fic charac teris tics
for
required materials , pro duc ts and s er vices , the s p eci fications
or s tandards to which thes e resources need to con form should b e s tated or re ferenced in the quality plan.
6.7.3
T he
People
qua l ity
pla n
s hou ld
s p e c i fy,
where
appl ic able,
the
comp e tence
re qu i re d
for
defi ne d
role s
or
ac tivitie s with i n the s p e ci fic c as e . T he qua l ity plan s hou ld defi ne any s p e ci fic tra i ni ng , organ i z ationa l
knowle dge or o ther ac tion s re qu i re d
for,
for
p ers onnel . T h i s s hou ld i nclude:
and trai n i ng o f, new p ers onnel;
a)
the ne e d
b)
the tra i ni ng o f e xi s ti ng p ers on nel i n new or revi s e d op erati ng me tho d s .
T he ne e d or appl ic abi l ity o f i nd ividua l le arn i ng , te am development and mo tivationa l s trate gie s s hou ld
a l s o b e con s idere d .
NO TE
6.7.4
T he
Tra i n i n g i n the u s e o f qu a l ity p l a n s i s add re s s e d i n 7. 2
.
Infrastructure and environment for the operation of processes
qua l ity pl an
as s o c iate d
s hou ld
uti l itie s ,
s tate
the
works p ace,
re qu i rements
to ol s
and
o f the
e quipment,
s p e c i fic c a s e
i n formation
with
a nd
regard
to
bu i ld i ngs
com mu n ic ation
and
te ch nolo g y,
s upp or t s er vice s and tran s p or tation .
Where the op erationa l envi ron ment h as a d i re c t e ffe c t on pro duc t, s er vice or pro ce s s qua l ity, the
qua l ity pl an s hou ld s p e c i fy the releva nt envi ron menta l ch arac teri s tics to b e con s idere d .
6.7.5
T he
Monitoring and measuring resources
qua l ity
plan
s hou ld
s p e c i fy
the
re s ou rce s
ne e de d
to
en s ure
va l id
a nd
rel i able
re s u lts
when
monitori ng or me a s u ri ng to veri fy the con form ity o f pro duc ts and s er vice s to re qu i rements .
8
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ISO 10005:2018(E)
T he
qua l ity plan
i ntende d
shou ld
for u s e for the
s p e ci fy the
control s
to
be
used
for
s p e ci fic c as e, i nclud i ng re qui rements
mon itori ng and
for c a l ibration
me a s uri ng re s ou rce s
or veri fic ation, or re ference
to relevant do c u mente d i n formation .
Gu id a nce o n the m a n agement o f me a s u rement s ys tem s c a n b e
NO TE
fou nd
i n I S O 10 01 2 .
6.8 Customers and other interested parties communication
T he qua l ity pl an s hou ld s tate or ma ke re ference to:
for
a)
who i s re s p on s ible
b)
the me tho d s to b e u s e d
c)
when the com mu nic ation i s ne e de d;
d)
the pro ce s s to b e
e)
the do c u mente d i n formation that s hou ld b e re tai ne d
re ceive d
from
com mu n ic ation with c u s tomers a nd o ther i ntere s te d p ar tie s;
for
fol lowe d
com mun ic ation;
when c u s tomer
fe e db ack i s
re ceive d;
from
com mu n ic ation s and/or on compl ai nts
c u s tomers and o ther i ntere s te d p a r tie s .
6.9 Design and development
6.9.1
Design and development process
T he qua l ity pl an s hou ld re ference appl ic able pla n(s)
for
de s ign a nd development.
T he qua l ity pl an s hou ld ta ke account o f appl ic able s p e c i fic ation s , co de s , i ndu s tr y s tandard s , qua l ity
cha rac teri s tic s , s tatutor y and regu lator y re qu i rements .
I t s hou ld s p e ci fy the c riteri a by wh ich the
accep te d ,
a nd
how,
at wh at s tage(s) ,
a nd
de s ign a nd development i nputs
by whom,
the
outputs
s hou ld
be
and outputs
reviewe d,
s hou ld b e
veri fie d
a nd
va l idate d .
I n s ome c as e s , de s ign a nd development i s a comple x pro ce s s a nd guidance s hou ld b e s ought
from
appropri ate s ou rce s , i nclud i ng i nterna l do c u mente d i n formation on de s ign a nd development. I n o thers ,
the level o f complexity wi l l b e low but s ti l l re qu i re a pla n ne d pro ce s s to en s u re that ri sks as s o c iate d
with the us e o f de s ign and development outputs are control le d . For proj e c ts , the de s ign a nd development
pro ce s s c a n b e appl ie d to the e s tabl i sh ment a nd s ub s e quent cha nge control o f proj e c t pla n s , as wel l a s
to the i ntende d re s u lt o f the proj e c t.
I n the s er vice s e c tor, the de s ign and development pro ce s s c a n apply to the development o f a s er vice
s p e ci fic ation wh ich
form s
the b a s i s
for
s ub s e quent s er vice provi s ion . H owever, where s er vice s are
u nique to a s p e c i fic c u s tomer tra n s ac tion,
for
exa mple re s e arch and advi s or y s er vice s , the de s ign a nd
development pro ce s s c an b e appl ie d to the enti re s er vice provi s ion pro ce s s .
NO TE
I S O/ T S 9 0 0 2 p ro vide s genera l g u id a nce on the de s ign a nd develop ment pro ce s s . I S O/ I E C 9 0 0 0 3 a nd
I S O/I E C/ I E E E 2 474 8 -5 p rovide s p e c i fic gu id a nce
6.9.2
for
the s o ftwa re s e c tor.
Control of design and development changes
T he qua l ity pl an s hou ld s tate:
for
a)
how re que s ts
ch ange s to the de s ign and development outputs wi l l b e control le d;
b)
who i s authori z e d to i n iti ate a cha nge re que s t;
c)
how ch ange s wi l l b e reviewe d i n term s o f thei r i mp ac t;
d)
who i s authori z e d to approve or rej e c t cha nge s;
© ISO 2018 – All rights reserved
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9
ISO 10005:2018(E)
e)
how the i mplementation o f change s wi l l b e veri fie d .
I n s ome c a s e s , there m ight b e no re qu i rement i n the qua l ity plan
the
organ i z ation
m ight ne e d
to
control
ch ange s
to
plan ne d
for
de s ign a nd development. H owever,
de s ign
and
development outputs ,
for
example to approve the u s e o f a lternative materia l s , re s p ond to cha nge s i n avai lable re s ou rce s or adj u s t
s er vice outputs to me e t s p e c i fic c u s tomer ne e d s .
6.10 Externally provided processes, products and services
T he qua l ity pla n shou ld s p e ci fy:
a)
the c ritic a l ch arac teri s tics o f ex terna l ly provide d pro ce s s e s , pro duc ts a nd s er vice s th at c an a ffe c t
the s p e c i fic c a s e;
b)
how tho s e charac teri s tics wi l l b e com mu nic ate d to ex terna l providers;
c)
the
me tho d s
to
be
used
for
the
eva luation
and
control
o f e xterna l
providers
i nclud i ng ,
when
ne ce s s ar y, a lternative or s upplementa r y e xterna l providers;
d)
re qui rements
for,
a nd
re ference
to ,
ex terna l
provider
qua l ity
plan s
or
o ther
pla n s ,
where
appropri ate;
e)
the
me tho d s
to
be
used
to
s ati s fy
the
re qu i rements ,
i nclud i ng
s tatutor y
and
regu lator y
re qui rements , that apply to ex terna l ly provide d pro duc ts and s er vice s;
f)
how the organ i z ation i ntend s to veri fy that e xterna l ly provide d pro duc ts and s er vice s con form to
s p e ci fie d re qu i rements .
6.11 Production and service provision
P ro duc tion and s er vice provi s ion, to ge ther with the relevant mon itori ng a nd me as u rement pro ce s s e s ,
com mon ly
form
the ma i n p ar t o f the qua l ity pla n . T he pro ce s s e s i nvolve d wi l l var y, dep end i ng on the
nature o f the work. T he i nterrelation s h ip b e twe en the va riou s pro ce s s e s i nvolve d c an b e e ffe c tively
expre s s e d th rough the prep aration o f pro ce s s map s or flow cha r ts .
P ro duc tion and s er vice pro ce s s e s m ight ne e d to b e va l idate d to en s ure they are c ap able o f del iveri ng
the re qu i re d output, e s p e c ia l ly i f the pro ce s s output c an no t b e veri fie d b y s ub s e quent mon itori ng or
me a s u rement.
T he qua l ity pl an shou ld s p e ci fy the i nputs , pro ce s s e s a nd outputs re qu i re d
for
c a rr yi ng out pro duc tion
and/or s er vice provi s ion . T he organ i z ation shou ld apply ri sk-b a s e d th i n ki ng when de cid i ng whe ther to
include or refer to:
a)
the pro ce s s s tep s;
b)
releva nt do c u mente d i n formation;
c)
the to ol s , e qu ipment, s o ftwa re, i n formation te ch nolo g y plat form and me tho d s to b e u s e d to ach ieve
the s p e c i fie d re qu i rements , i nclud i ng de tai l s o f any ne ce s s a r y materi a l, pro duc t, s er vice, pro ce s s ,
s o ftware appl ic ation, cer ti fic ation or va l idation;
d)
re qui re d control le d cond ition s to me e t pla nne d arra ngements , me tho d s
for
veri fyi ng compl i ance
with s uch cond ition s , i nclud i ng a ny s p e ci fie d s tati s tic a l or o ther pro ce s s control s;
for
comp e tence a nd/or qua l i fic ation (s e e 6 .7. 3 ) ;
e)
re qui rements
f)
c riteri a
g)
appl ic able s tatutor y and regu lator y re qu i rements;
h)
i ndu s tr y co de s and prac tice s;
10
for
the accep tance o f pro duc ts , s er vice s and/or o ther pro ce s s outputs;
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ISO 10005:2018(E)
i)
i mplementation o f ac tion s to prevent hu man error;
j)
a rrangements
for
rele as e, del iver y a nd p o s t- del iver y ac tivitie s .
Where i n s ta l l ation or com m i s s ion i ng i s a re qu i rement, the qua l ity pla n s hou ld s tate how the output
wi l l b e i n s ta l le d and wh ich ch arac teri s tics ne e d to b e veri fie d and va l idate d at that ti me .
Where the s p e ci fic c a s e i nclude s p o s t- del iver y ac tivitie s (e . g. ma i ntenance, s upp or t or tra i n i ng s er vice s) ,
the
qua l ity pla n
shou ld
s tate
how
the
organ i z ation
i ntend s
to
as s u re
con form ity with
appl ic able
re qu i rements , s uch as:
—
s tatute s and re gu l ation s;
—
i ndu s tr y co de s and prac tice s;
—
the comp e tence o f p ers on nel , i nclud i ng tra i ne e s;
—
the avai labi l ity o f i niti a l a nd on- goi ng te ch nic a l s upp or t duri ng the agre e d ti me p erio d .
NO TE
6
.
1
2
I S O 10 0 0 6 p rovide s gu id a nce o n p roj e c t m a n agement pro ce s s e s
I
d
e
n
t
i
f
i
c
a
t
i
o
n
a
n
d
t
r
a
c
e
a
b
i
l
i
for
pro duc tio n a nd s er vice pro vi s ion .
t
y
Where identi fic ation o f outputs i s appropri ate to en s u re re qu i rements
for
the s p e ci fic c as e are me t, the
qua l ity pla n s hou ld s p e c i fy me tho d s to b e u s e d . Where trace abi l ity i s a re qu i rement, the qua l ity pla n
shou ld defi ne its s cop e a nd ex tent, i nclud i ng how a ffe c te d outputs wi l l b e identi fie d .
T he qua l ity pl an s hou ld s tate:
a)
how contrac tua l, or o ther relevant trace abi l ity re qu i rements are identi fie d and i ncorp orate d i nto
do c u mente d i n formation;
b)
wh at
do c u mente d
i n formation
is
to
be
re tai ne d
to
provide
evidence
o f me e ti ng
trace abi l ity
re qu i rements , and how it wi l l b e control le d;
c)
s p e c i fic
outputs.
NO TE
re qui rements
I denti fic ation
a nd
a nd
me tho d s
trace abi l ity
is
for
the
part
of
identi fic ation
con figu ratio n
o f the
i n s p e c tion
m a n agement.
For
a nd
te s t s tatu s
fu r ther
gu ida nce
of
on
co n figu ration m a n agement s e e I S O 10 0 0 7.
6.13 Property belonging to customers or external providers
T he qua l ity pl an s hou ld s tate:
a)
how
pro duc ts
and
s er vice s
provide d
by
c u s tomers
or
ex terna l
providers
a re
identi fie d
a nd
control le d;
b)
the me tho d s to b e u s e d to veri fy that the s e pro duc ts and s er vice s me e t s p e ci fie d re qu i rements;
c)
how noncon form i ng pro duc ts a nd s er vice s wi l l b e control le d .
NO TE 1
Cu s tomer ’s or e x ter n a l p rovider ’s pro p er ty c a n i nclude m ater i a l s , comp onents , to ol s a nd e qu ipment,
prem i s e s , i ntel le c tu a l pro p er ty a nd p ers o n a l d ata .
NO TE 2
I S O/I E C 2 70 0 2 p rovide s gu ida nce o n i n for m atio n s e c u r ity.
6.14 Preservation of outputs
T he qua l ity pl an s hou ld s tate:
a)
re qu i rements
for
pre s er vation a nd how the s e re qui rements wi l l b e me t;
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11
ISO 10005:2018(E)
b)
where the organ i z ation i s re s p on s ib le
for
del iver y, how the output wi l l b e del ivere d i n a man ner
th at wi l l en s u re th at its re qui re d ch arac teri s tics are no t degrade d .
NO TE
P re s er vation
can
i nclude
identi fic atio n ,
h a nd l i ng ,
co nta m i n atio n
control ,
s to rage ,
p ackagi ng
a nd
del i ver y, tra n s m i s s io n o r tra n s p o r tation a nd p ro te c tion .
6.15 Control of nonconforming outputs
T he qua l ity pl an s hou ld defi ne how noncon form i ng outputs wi l l b e identi fie d and control le d to prevent
un i ntende d u s e, u nti l prop er d i s p o s ition or accep tance by conce s s ion i s comple te d .
T he qua l ity plan m ight ne e d to defi ne s p e ci fic l i m itation s , s uch a s the degre e or typ e o f rework or rep ai r
a l lowe d , and how s uch rework or rep ai r wi l l b e authori z e d .
Where
s er vice
provi s ion
is
c arrie d
out
at
noncon form i ng s er vice outputs m ight no t b e
the
i nter face
fe as ible .
with
the
c u s tomer,
preventi ng
use
of
Where appl ic able, the qua l ity plan shou ld defi ne
or ma ke re ference to the ac tion s a nd com mu nic ation s th at are appropri ate to the e ffe c ts , or p o tenti a l
e ffe c ts , o f s uch noncon form itie s .
6.16 Monitoring and measurement
M onitori ng and me as u rement pro ce s s e s s hou ld defi ne how obj e c tive evidence o f con form ity wi l l b e
ob tai ne d . I n s ome i n s tance s , c u s tomers re que s t s ubm i s s ion o f mon itori ng and me a s urement plan s
(s ome ti me s terme d “i n s p e c tion and te s t plan s ” ) , without o ther qua l ity pl an i n formation, as a b as i s
for
monitori ng con form ity with s p e ci fie d re qu i rements .
T he qua l ity pla n shou ld s p e ci fy:
a)
pro ce s s and output mon itori ng a nd me as u rements to b e appl ie d;
b)
the s tage s at wh ich they shou ld b e appl ie d;
c)
the cha rac teri s tic s to b e mon itore d a nd me a s u re d at e ach s tage;
d)
the accep ta nce criteri a to b e u s e d;
e)
any s tati s tic a l pro ce s s control me tho d s to b e appl ie d;
f)
where i n s p e c tion s or te s ts a re re qu i re d to b e witne s s e d or p er forme d b y i ntere s te d p ar tie s ,
for
e xa mple:
1)
a te s t, or s erie s o f te s ts (s ome ti me s re ferre d to as “typ e te s ts ” ) , d i re c te d toward s the approva l
o f a de s ign and conduc te d to de term i ne i f the de s ign i s c ap able o f me e ti ng the re qu i rements o f
the pro duc t a nd s er vice s p e ci fic ation;
g)
2)
s ite te s ti ng i nclud i ng accep tance;
3)
pro duc t a nd s er vice veri fic ation;
4)
pro duc t a nd s er vice va l idation;
where , when a nd ho w the o rga n i z atio n i ntend s to u s e e x ter na l pro viders to p er fo r m i n s p e c tio n s
o r te s ts ;
h)
the criteri a
NO TE
for
rele a s e o f pro duc ts , s er vice s or o ther outputs .
I S O/ T R 10 017 p rovide s gu id a nce on the s ele c tio n o f s tati s tic a l me tho d s .
6.17 Audits
T he qua l ity pla n s hou ld s p e ci fy the typ e o f aud its to b e p er forme d
for
the s p e ci fic c a s e, the natu re and
extent o f s uch aud its and how the re s u lts o f the aud its shou ld b e u s e d .
12
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ISO 10005:2018(E)
Audits may be used for several purposes, such as:
a) to monitor the implementation and e ffectiveness o f quality plans;
b) to monitor and veri fy con formity with specified requirements;
c)
or surveillance o f external providers to the organization;
f
d) to provide independent objective assessment, when required, to meet the needs o f customers or
other interested parties.
NOTE
ISO 19011 provides guidance for the auditing o f management systems.
7 Operation and control of the quality plan
7.1 Review and acceptance of the quality plan
The quality plan should be reviewed for adequacy and e ffectiveness, and should be formally approved
by an authorized person or a group that includes representatives from relevant functions within the
organization.
In contractual situations, a quality plan might need to be submitted to the customer by the organization
or review and acceptance, either as part o f a pre-contract consultation process or a fter a contract has
been awarded. Once a contract is awarded, the quality plan should be reviewed and, where appropriate,
revised to reflect any changes in requirements.
f
Where a project or contract is conducted in stages, the organization might be expected to submit a
quality plan to the customer for each stage, prior to the start o f that stage.
7.2 Implementation and monitoring of the quality plan
In the implementation and monitoring o f the quality plan, the organization should consider the
following issues:
a) distribution o f the quality plan to all relevant people; care should be taken to distinguish between
copies that are distributed under the control provisions for documented in formation (to be updated
as appropriate), and those that are supplied for in formation only;
b) training in the use o f quality plans; in some organizations (e.g. those engaged in project
management) quality plans may be used as a routine part o f the quality management system, while
in others, quality plans may be used only occasionally (in this case, special training could be needed
to assist users in applying the quality plan correctly);
c) monitoring con formity with quality plans; the organization is responsible for monitoring
con formity with each quality plan that it operates, which can include:
1) operational supervision o f the planned arrangements;
2) milestone reviews;
3) audits.
Audits are generally undertaken on a sampling basis, especially where many short-term quality plans
are used.
Where quality plans are submitted to customers or other interested parties, these interested parties
might establish provisions for monitoring con formity with the quality plans.
Whether carried out by internal or external interested parties, such monitoring can assist in:
— assessing the commitment o f the organization to the e ffective implementation o f the quality plan;
© ISO 2018 – All rights reserved
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13
ISO 10005:2018(E)
— evaluating the practical implementation o f the quality plan;
— determining where risks can arise in relation to the requirements o f the specific case;
— taking corrective action where appropriate;
— finding opportunities for improvement in the quality plan and associated activities.
7.3 Revision of the quality plan
The organization should revise the quality plan:
a) to reflect any changes to quality plan inputs or risks, including:
1) the specific case for which the quality plan is established;
2) the processes for production and service provision;
3) the organization’s management system;
4) statutory or regulatory requirements;
b) to incorporate agreed improvements to the quality plan.
An authorized person or persons should review changes to the quality plan for impact, adequacy and
e ffectiveness. Revisions to the quality plan should be made known to users, customers, interested
parties and/or external providers. Communication with customers and other interested parties should
be consistent with the requirements for externally provided products and services. Any documented
in formation that is a ffected by changes in the quality plan should be revised as necessary.
The organization should consider how and under what circumstances the organization would authorize
a deviation from the quality plan, including:
— who will have the authority to request such deviations;
— how such a request will be made;
— what in formation will be provided and in what form;
— who will be identified as having the responsibility and authority to accept or reject such deviations.
7.4 Feedback and improvement
Where appropriate, experience gained from the application o f a quality plan should be reviewed and
evaluated. The organization can also review the application o f the quality plan in consultation with
customers, external providers and other relevant interested parties.
Lessons learned should be used to improve the organization’s quality plan(s) and the respective
management system(s).
14
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ISO 10005:2018(E)
Annex A
(informative)
Examples of formats for quality plans
This annex provides examples o f some o f the formats in which quality plans may be presented.
The examples shown should not be taken as being complete in relation to the quality plan contents
described in Clause 6 .
Actual quality plans may be more complex. It would normally be expected that all the processes
applicable to the specific case would be covered.
Presentation o f quality plans may be in any format deemed suitable for meeting the agreed
requirements. A textual presentation rather than a diagrammatic one may be more appropriate in
certain circumstances. Similarly, a diagrammatic format may be supplemented with text. Other formats
better suited to a specific case may be used.
Where the quality plan is available electronically, re ferenced documented in formation, such as standard
operating procedures (SOPs) or process management so ftware, may be accessible via hyperlinks.
The following examples include:
— Example 1: A “text” type o f quality plan; this could be used, for example, as a template for a quality
plan for an engineering project;
— Example 2: A “table” type o f quality plan; this could be used, for example, as a quality plan for
processed materials;
— Example 3: A “Flow chart” type o f quality plan; this could be used, for example, as a quality plan for
a service.
© ISO 2018 – All rights reserved
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15
ISO 10005:2018(E)
EXAMPLE 1 A template for a “text” type o f quality plan.
1. Introduction
1.1 Purpose and scope o f the project quality plan
The purpose o f this project quality plan is to document the quality processes that XYZ will follow in order
to e ffectively manage project quality from planning to delivery. It defines the procedures, processes and
management systems to be used for the management o f engineering and project management services.
[Describe relationship to project management plan, XYZ quality management system, etc.]
1.2 Project overview
[Include a description of the project including planned stages and schedule]
1.3 Scope o f services
[Define the scope o f the services included in the project quality plan]
1.4 Specific project risks
[List/describe specific project risks e. g. unusual characteristics related to client context, project context, pro ject partners, requirements, deliverables, resources, communications, confidentiality]
2. Resourcing and communication
2.1 Roles, responsibilities and authorities
[Define roles, responsibilities and authorities – consider table to summarize]
2.2 Communication
[Define communication pathways and authorities, especially where multiple parties are involved in the project]
2.3 Competence, awareness and training
[To be included where there are specific competence, awareness and training needs for the project]
3. Quality management
3.1 Quality policy and QMS
A copy o f the XYZ quality policy statement is included in Appendix A.
[Define application o f XYZ quality management system to this project quality plan]
3.2 Quality objectives and KPIs
The key quality objectives for this project are to…
Key per formance indicators (KPIs) are listed in…
3.3 Audits
To ensure that the project is delivered in accordance with the XYZ quality management system, the project
will be audited as part o f the internal audit programme.
[If project audits are planned as part of the project control process, outline the intended schedule]
3.4 Noncon formity management
Noncon formity records (NCRs) are retained in the...
Summaries and reviews for corrective action and continual improvement are maintained and updated by
the project team in accordance with…
16
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ISO 10005:2018(E)
4. Project delivery
4.1 Project inputs
[Define handling and management o f project inputs]
4.2 Scope changes
Any changes to the scope o f the work shall be addressed via the change management process. It is the
responsibility o f all team members to noti fy the project leader o f any potential or actual changes to the scope
o f the work.
4.3 Project control
[Include a description of the processes used for project control]
4.4 Manage project deliverables
[Describe or list deliverables, together with responsibilities for controlling completion]
4.5 Check, review, veri fy and approve
[Describe processes and responsibilities for checking (including checking o f methods and application o f
standards/previous design solutions/validation strategies), reviews, verification and approval]
5. Documented information management
5.1 Computer network file structure
A computer network file structure has been adopted for this project within XYZ…
5.2 Documented in formation management process
[Describe/list how different types o f documents are controlled]
5.3 Inputs, outputs and transmittals
[Describe/list how different types o f documents are controlled. Define how incoming documents, change requests,
outgoing documents and transmittal records are managed and registered]
6. Project deliverables
[Include description, list or table of deliverables and related information]
7. Approval requirements
[XYZ and client approval requirements, plus relationship to other interested parties where applicable]
8. Distributing the deliverables
[Define the process for transmittal o f deliverables and the documented in formation to be retained]
9. Change management
[Define internal and external change management requirements, including changes occurring a fter delivery o f
documented information]
1
0
.
I
d
e
n
t
i
f
i
c
a
t
i
o
n
a
n
d
t
r
a
c
e
a
b
i
l
i
t
y
[Define or reference identification and retention requirements for quality plan outputs]
Appendices
For example:
—
—
Appendix A - XYZ quality policy
Appendix B - Contract management plan table of contents
© ISO 2018 – All rights reserved
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17
ISO 10005:2018(E)
EXAMPLE 2 A “table” type quality plan
QPL - 005 Product/product line:
chemicals
S
p
e
c
i
f
i
c
Activity
Scope
Quality objectives
Management
responsibilities
Documentation
Records
Resources
Resources
Resources
Requirements
review/
Customer
s
p
e
c
i
f
i
c
a
t
i
o
n
s
Customer
communication
18
Provided by IHS Markit under license with ANSI
a
t
i
o
n
g
r
a
d
Originated by: Approved by:
Rev:
Date:
e
Description
Document/
Procedure
This quality plan is applicable to the processes
o f production and distribution o f
—
specification-grade chemicals.
Our quality objectives are yield (93 %); on-time QSP - 005
delivery (+/−1 day).
Job descriptions and organization charts o f the
responsibilities of personnel involved in the
planning, executing, controlling and monitoring
the progress o f the activities covered by this
plan are to be found in re ferenced documents.
There are no special document control require ments. Contractual documents will be retained
for a minimum o f five years.
Identifiable and retrievable records will be
maintained to furnish evidence o f activities
a ffecting quality. Records will be retained for a
minimum o f five years.
The requirements for storage, process and
transportation o f raw materials and compo nents are specified in //VSB\materials.doc.
All sta ff are required to have success fully completed training on the handling o f the materials
specified in the contract.
No special in frastructure or work environment
conditions apply.
All quotations given and all customer specifications and orders received will be reviewed
prior to acceptance, to ensure that the require ments are properly defined, all di fferences satis factorily resolved, and the company has the
capacity to meet the requirements involved.
Customer feedback is collected either by visiting the website or using form SOP-190F1 and
is discussed at monthly meetings between the
customer and the contract management team.
Area/
Dept.
—
Various
QSP - 020
SOP - 800
MGMT/
HRS
QSP - 050
TSS
QSP - 055
QA
QSP - 020
MGMT
SOP - 810
HRS
SOP - 100
SOP - 110
SOP - 120
MKT/
TSS/
MFG/QA
SOP - 150
SOP - 190
MKT
© ISO 2018 – All rights reserved
ISO 10005:2018(E)
All accepted customer specifications that di ffer
significantly from regular company specifications require review and approval (SOP-200).
This may require customer prototype approval,
and process verification and validation.
All critical products purchased by the company
are subject to receiving inspection and testing
as required in the current raw material and
package specifications. Bulk tank cars will not
be unloaded until all required testing is satis factorily completed. Noncon forming materials
may be approved by concession, disposed o f, or
Design and
development
Purchasing
returned to the supplier.
Production
traceability
I
d
e
n
t
i
f
i
c
a
t
i
o
Standard operating procedures apply.
n
a
n
d
Standard operating procedures apply.
SOP - 200
SOP - 220
TSS
SOP - 300
SOP - 310
SOP - 400
SOP - 470
SOP - 490
PUR/
MAT
SOP - 500
SOP - 440
SOP - 540
MFG
MAT/
MFG
Customer specifications and proprietary test
methods will be processed and protected
Customer property through the formal specification system to pre - SOP - 110
serve their integrity and ensure the confidentiality o f the in formation contained therein.
Standard operating procedures apply to special
packaging materials provided by the customer. SOP - 410
Storage and
handling
Nonconforming
products
Monitoring and
measurement
Purchased materials, intermediates and finished products will be stored in secure con-
tainers, tanks and warehouse facilities. Care ful
handling methods will be used to prevent
damage, deterioration or contamination o f the
product. Bulk products will be shipped in
dedicated tank cars.
Products failing to pass the final lot acceptance requirements will be diverted to a special
quarantine area or tank. A written concession
from the customer will be required be fore any
noncon forming product can be shipped.
Sampling and testing plans exist or will be pre pared to cover all product realization processes.
© ISO 2018 – All rights reserved
Provided by IHS Markit under license with ANSI
MKT/
TSS
MAT/
MFG
SOP - 400
SOP - 700
SOP - 750
MAT
SOP - 570
SOP - 580
SOP - 590
MFG/
TSS/QA
SOP - 600
QA
19
ISO 10005:2018(E)
Inspection and
testing equipment
Audit
Key
The company maintains a range o f measuring
and testing equipment to cover the scope o f its
development, production and control activities. SOP - 610
All required calibration is done in-house or by
the equipment manu facturer.
The facilities may receive internal, customer
SOP - 675
and regulatory audits.
QA
QA
HRS: human resources
MAT: materials control
MFG: manu facturing
MGMT: top management
MKT: marketing and sales
PUR: purchasing
QA: quality assurance
QSP: quality system procedure
SOP: standard operating procedure
TSS: technical services
20
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© ISO 2018 – All rights reserved
ISO 1 0005 : 2 01 8(E)
EXAMPLE 3 A “flowchart” type quality plan
F
i
g
u
© ISO 2018 – All rights reserved
Provided by IHS Markit under license with ANSI
r
e
A
.
1
—
E
x
a
m
p
l
e
o
f
a
“
f
l
o
w
c
h
a
r
t
”
t
y
p
e
q
u
a
l
i
t
y
p
l
a
n
21
ISO 10005:2018(E)
Annex B
(in formative)
Schematic representation of a process approach applied to
quality plans
Figure B.1 — Schematic representation of a process approach applied to a quality plan
22
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© ISO 2018 – All rights reserved
ISO 10005:2018(E)
Annex C
(in fo rmative)
Correlation matrix between the clauses in this document and
those in ISO 9001:2015
Table C.1 — Correspondence between the clauses in this document and those in ISO 9001:2015
Clause in
this document
Clause in
ISO 9001:2015
Heading
C l au s e 5
D e velop ment o f a qu a l ity p l a n
4.1 , 4. 2 , 6 .1 , 7.1 .1 , 8 .1
C l au s e 6
C ontent o f the qu a l ity p l a n
7, 8 , 9, 10
6.1
6.2
8.1
G enera l
S cop e o f the qu a l ity p l a n
4. 3 , 8 . 2
6.3
Qu a l ity p l a n i nputs
8 .1 , 8 . 2 , 8 . 6 , 9.1 .1
6 .4
Qu a l ity ob j e c tive s
6 . 2 , 9.1 .1
Qu a l ity p l a n re s p o n s ibi l itie s
5.3
C ontrol o f do c u mente d i n fo rm ation
7. 5
6.5
6.6
Resources
6 .7
7.1
6 .7.1
P rovi s io n o f re s ou rce s
6 .7. 2
M ater i a l s , pro duc ts a nd s er vice s
6 .7. 3
Pe op le
6 .7. 4
I n fra s tr uc tu r e a nd e nv i ro n me n t
6 .7. 5
M on ito r i n g a nd me a s u r i n g re s o u rce s
7.1 . 5
I ntere s te d p a r ty co m mu n ic ation
7. 4, 8 . 2 .1 , 8 . 4. 3
6 .9
D e s ign a nd de velo pment
8.3
6 .9.1
D e s ign a nd de velo pment pro ce s s
8 . 3 .1 to 8 . 3 . 5
6 .9. 2
C ontrol o f de s ign a nd develop ment ch a n ge s
8. 3 .6
E x ter n a l l y p rovide d p ro ce s s e s , p ro duc ts a nd s er vice s
8 .4
P ro duc tion a nd s er vice p rovi s io n
8 . 5 .1 , 8 . 5 . 5 , 8 . 5 . 6
processes
6.8
6.10
6.11
6.12
7.1 .1
8.2
7.1 . 2 , 7. 2 , 7. 3
fo r
the o p e r atio n o f
I denti fic ation a nd trace abi l ity
7.1 . 3 , 7.1 . 4
8.5.2
6 .1 3
P rop er ty b elo ngi ng to c u s tomers o r e x ter n a l p roviders
8.5.3
6 .14
P re s er vatio n o f outputs
8 . 5 .4
6.15
6.16
Control of nonconforming outputs
M on ito r i n g a nd me a s u rement
Audits
6 .17
8 .7, 10 . 2
8 .1 , 8 . 6 , 9.1
9. 2
C l au s e 7
O p eratio n a nd co ntro l o f the qu a l ity p l a n
7, 8 , 9, 10
7.1
Re view a nd accep ta nce o f the qu a l ity p l a n
7. 5 . 2 , 8 .1 , 8 . 2 .1 , 8 . 2 . 3
7. 2
I mp lementation a nd mon ito r i n g o f the qu a l ity p l a n
7. 2 , 7. 3 , 7. 5 . 3 , 8 .1 , 9.1 . 3 , 9. 2
7. 3
Re vi s io n o f the qu a l ity p l a n
7. 5 . 3 , 8 . 2 . 4, 8 . 5 . 6
Fe e db ack a nd i mpro vement
9. 3 , 10 .1
7. 4
NO TE
C o r re s p o nde nce b e twe en cl au s e s do e s no t i mp l y co n fo r m it y.
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23
ISO 10005:2018(E)
Annex D
(in fo rmative)
Correlation matrix between the clauses of this document and the
quality management principles from ISO 9000:2015
Table D.1 — Correlation between the clauses of this document and the quality management
principles from ISO 9000:2015
Clause
No.
C l au s e 4
Clause title
ImCustom- Leader- EngageProcess provement
er focus ship of people approach ment
Evidence Rela-based tionship
decision- managemaking ment
Us i n g a qu a l ity p l a n
Re a s o n s
4.1
Quality management principle
fo r
using a
qu a l ity p l a n
Y
N
Y
Y
N
N
Y
Y
Y
Y
Y
Y
Y
Y
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
N
Y
Y
Y
Y
Y
Y
Re que s ti n g
e x ter n a l p rovider
4. 2
qu a l ity p l a n s
N
N
N
N
N
Y
M a n agi ng e x tern a l
pro vider qu a l ity
4. 3
plans
C l au s e 5
D e velop ment o f a qu a l ity p l a n
5.1
5.2
C onte x t o f the
qu a l ity p l a n
Y
qu a l ity p l a n
Y
Inputs to the
D e fi n i ng the s cop e
5.3
o f the qu a l ity p l a n
5 .4
P rep a ratio n o f the qu a l ity pl a n
5 . 4.1
I n iti ation
Y
D e fi n i ng the
N
5 . 4. 2
qu a l ity p l a n
Y
5 . 4. 4
C l au s e 6
6.1
6.2
N
N
N
N
N
N
N
N
N
Y
Y
Y
Y
Y
Y
Y
Y
C ontent o f the qu a l ity p l a n
N
S cop e o f the qu a l ity
Y
6.3
Qu a l ity p l a n i nputs
Y
6 .4
Qu a l ity ob j e c tive s
Y
6.5
Qu a l ity p l a n
24
mente d i n for m atio n
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Y
N
N
plan
6.6
Y
Y
N
P re s entatio n a nd
responsibilities
Control of docu-
N
N
Y
N
Y
G enera l
N
Y
Y
N
comp atib i l ity
structure
N
N
Y
N
C on s i s tenc y a nd
5 . 4. 3
N
Y
Y
Y
Y
N
Y
Y
Y
N
N
N
Y
Y
Y
Y
Y
Y
N
N
N
© ISO 2018 – All rights reserved
ISO 10005:2018(E)
Table D.1 (continued)
Clause
No.
6 .7
Quality management principle
Clause title
ImCustom- Leader- EngageProcess provement
er focus ship of people approach ment
Resources
P ro vi s ion o f
6 .7.1
resources
N
N
M ateri a l s , pro duc ts
N
N
N
N
N
N
N
N
6 .7. 2
a nd s er vice s
6 .7. 3
Pe o p le
I n fra s tr uc tu re a nd
6 .7. 4
environment for
f
processes
the op eratio n o
Y
Y
N
N
N
Y
Y
Y
N
N
Evidence Rela-based tionship
decision- managemaking ment
N
Y
N
N
N
N
N
N
N
N
N
N
N
N
N
Y
Y
M on itor i ng a nd
me a s u ri n g
6 .7. 5
resources
6.8
I ntere s te d p a r ty
6 .9
D e s ign a nd de velop ment
co m mu n ic ation
D e s ign a nd de velop
6 .9.1
ment process
Control of design
Y
-
a nd de velop ment
6 .9. 2
ch a n ge s
6.10
E x ter n a l l y p ro vide d
p ro ce s s e s , pro duc ts
N
N
N
Y
N
N
Y
Y
N
N
N
N
N
N
Y
Y
Y
Y
Y
N
N
Y
N
Y
Y
N
Y
a nd s er vice s
6.11
P ro duc tion a nd
6.12
I denti fic atio n a nd
service provision
trace ab i l ity
N
N
N
N
N
N
N
N
N
Y
P ro p er ty b elongi ng
to customers or
6 .1 3
6.15
6.16
6 .17
outputs
Control of nonconforming outputs
M on itor i ng a nd
me a s u rement
Audits
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Y
Y
Y
Y
N
N
N
Y
Y
N
N
Y
Y
N
N
e x ter n a l pro viders
P re s er vation o f
6 .14
Y
Y
Y
N
N
Y
N
N
Y
Y
Y
N
N
Y
N
N
N
Y
Y
Y
Y
Y
25
ISO 10005:2018(E)
Table D.1 (continued)
Clause
No.
C l au s e 7
Quality management principle
Clause title
ImCustom- Leader- EngageProcess provement
er focus ship of people approach ment
Evidence Rela-based tionship
decision- managemaking ment
O p eratio n a nd co ntrol o f the qu a l ity p l a n
-
Re view a nd accep t
a nce o f the qu a l ity
7.1
plan
Y
I mp lementation a nd
7. 2
monitoring of the
Y
Y
N
N
Y
N
N
N
Y
Y
Y
Y
Y
qu a l ity p l a n
Revision of the
7. 3
qu a l ity p l a n
Y
Fe e db ack a nd
7. 4
26
improvement
Provided by IHS Markit under license with ANSI
Y
Y
Y
Y
N
N
N
Y
Y
N
Y
Y
Y
© ISO 2018 – All rights reserved
ISO 10005:2018(E)
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[12]
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[15]
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1) Under revision.
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Provided by IHS Markit under license with ANSI
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