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First edition
2005-01-15

Guidelines for the selection of quality

management system consultants and use
of their services

Lignes directrices pour la sélection de consultants en systèmes de

management de la qualité et pour l'utilisation de leurs services

Reference number
ISO 10019:2005(E)

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ISO 10019:2005(E)

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ISO 10019:2005(E)

Contents Page

1 Scope .................................................................................................................................................... 1
2 Normative references .......................................................................................................................... 1
3 Terms and definitions .......................................................................................................................... 1
4 Selection of a quality management system consultant ................................................................... 2
4.1 Input to the selection process ........................................................................................................... 2
4.2 Competence of the consultant ........................................................................................................... 3
4.3 Ethical considerations ........................................................................................................................ 6
5 Use of the quality management system consultant's services ....................................................... 7
5.1 Consultant's services ......................................................................................................................... 7
5.2 Contract for consultant's services .................................................................................................... 7
5.3 Useful considerations for consultant's services .............................................................................. 7
Annex A (informative) Typical activities of quality management system consultants .......................... 9
Annex B (informative) Evaluation of quality management system consultants ................................... 12
Bibliography ............................................................................................................................................... 13

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ISO 10019:2005(E)

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of 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 of electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO 10019 was prepared by Technical Committee ISO/TC 176, Quality management and quality assurance ,
Subcommittee SC 3, Supporting technologies .

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ISO 10019:2005(E)

Introduction
In the realization of a quality management system, some organizations choose to rely on their own personnel
but some use the services of external consultants. The selection of a consultant by an organization is important
for ensuring that the resulting quality management system is capable of meeting the organization's planned
objectives in the most efficient and effective manner. Even when using the services of a quality management
system consultant, the involvement and commitment of the organization's top management are key factors for a
quality management system realization.

This International Standard aims to provide guidance on the factors to be taken into consideration when
selecting a quality management system consultant. It can be used by organizations in the selection of a quality
management system consultant who is able to meet their specific needs, expectations and objectives in the
realization of quality management system. It can additionally be used by

a) quality management system consultants as guidelines to quality management system consulting, and

b) consulting organizations for the selection of quality management system consultants.

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INTERNATIONAL STANDARD ISO 10019:2005(E)

Guidelines for the selection of quality management system

consultants and use of their services

1 Scope

This International Standard provides guidance for the selection of quality management system consultants and
the use of their services.

It is intended to assist organizations when selecting a quality management system consultant. 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.

NOTE 1 This International Standard is not intended to be used for certification purposes.

NOTE 2 This International Standard addresses the realization of a quality management system but, at the same time,
could be used with appropriate adaptation for the realization of any other management systems.

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced document
(including any amendments) applies.

ISO 9000:2000, Quality management systems — Fundamentals and vocabulary

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 9000 and the following apply.

3.1
quality management system realization
process of establishing, documenting, implementing, maintaining and continually improving a quality
management system

NOTE Quality management system realization can include the following:

a) identifying the processes needed for a quality management system and their application throughout the organization;

b) determining the sequence and interaction of the identified processes;

c) determining criteria and methods needed to ensure that both the operation and control of the identified processes are
effective;

d) ensuring the availability of resources and information necessary to support the operation and monitoring of the identified
processes;

e) monitoring, measuring and analysing the identified processes;

f) implementing actions necessary to achieve planned results and continual improvement of the identified processes.

3.2
quality management system consultant
person who assists the organization on quality management system realization, giving advice or information

NOTE 1 The consultant can also assist in realizing parts of a quality management system.

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ISO 10019:2005(E)

NOTE 2 This International Standard provides guidance on how to distinguish a competent quality management system
consultant from one who is not competent.

4 Selection of a quality management system consultant

4.1 Input to the selection process

4.1.1 Organization's needs and expectations

When selecting a quality management system consultant, the organization should identify its needs and
expectations of the quality management system consultant, based on its overall objectives for the realization of
a quality management system. Top management should be involved in the process of evaluation and selection
of the quality management system consultant.

4.1.2 Role of the consultant

The selection process should take into account the role of the quality management system consultant in the
quality management system realization (see Annex A). The consultant's role generally includes the following:

a) assisting the organization to ensure that the design and the implementation of the quality management
system is suited to the organization's culture, characteristics, level of education and specific business
environment;

b) illustrating the concepts concerning quality management in a clear and understandable way throughout the
organization, paying special attention to the understanding and adoption of quality management principles;

c) communicating with all relevant individuals, at all levels, involving them actively in the quality management
system realization;

d) advising and supporting the organization in identifying the appropriate processes needed for its quality
management system and defining the relative importance, sequence and interaction of those processes;

e) assisting the organization in identifying needs for documentation essential to ensure the effective planning,
operation and control of its processes;

f) evaluating the effectiveness and efficiency of the quality management system processes to stimulate the
organization to look for opportunities for improvement;

g) assisting in promoting a process approach and continual improvement of the quality management system
within the organization;

h) assisting in identifying the training needs to enable the organization to maintain the quality management
system;

i) assisting the organization, where applicable, to identify the relationship between its quality management
system and any other relevant management system (e.g. environmental or occupational health and safety)
and facilitate the integration of such systems.

4.1.3 Evaluation of the competence of the consultant

When evaluating the competence and suitability of a consultant, due consideration should be given to

a) personal attributes (see 4.2.2),

b) relevant education (see 4.2.3),

c) knowledge and skills necessary to meet the organization's overall objectives for the quality management
system (see 4.2.3, 4.2.4 and 4.2.5),

d) work experience (see 4.2.6), and

e) ethical behaviour (see 4.3).

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ISO 10019:2005(E)

4.2 Competence of the consultant

4.2.1 General

When selecting a quality management system consultant, the organization should evaluate whether the
consultant maintains the competence appropriate to the scope of the consulting services to be provided.

The concept of the competence of a quality management system consultant is illustrated in Figure 1.

NOTE Competence is defined in ISO 9000 as the demonstrated ability to apply knowledge and skills.

Figure 1 — Concept of competence of a quality management system consultant

4.2.2 Personal attributes

Personal attributes contribute to the successful performance of a quality management system consultant. A
quality management system consultant, generally, should be

a) ethical: fair, truthful, sincere, honest and discreet;

b) observant: constantly and actively aware of organizational culture and values, physical surroundings and
activities;

c) perceptive: aware of and able to understand the need for change and improvement;

d) versatile: able to adapt to different situations and provide alternative and creative solutions;

e) tenacious: persistent, focused on achieving objectives;

f) decisive: capable of reaching timely conclusions based on logical reasoning and analysis;

g) self-reliant: able to act and function independently while interacting effectively with others;

h) communicative: able to listen to, and effectively interface with, all levels of an organization, confidently and
with sensitivity to its culture;

i) practical: realistic and flexible with good time management;

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ISO 10019:2005(E)

j) accountable: able to take responsibility for his/her own actions;

k) facilitative: able to assist an organization's management and employees through the quality management
system realization.

4.2.3 Education, knowledge and skills

Quality management system consultants should have the appropriate education needed to acquire the
knowledge and skills relevant for the consulting services to be provided. A typical example is provided in
Annex B.

NOTE In this context, knowledge and skills are related to generic scholastic ability, such as linguistic ability and knowledge
of basic science and humanities.

4.2.4 Knowledge and skills specific to quality management

4.2.4.1 Relevant standards

Quality management system consultants should be able to understand and apply relevant International
standards that can affect the organization, such as

— ISO 9000, Quality management systems — Fundamentals and vocabulary ,

— ISO 9001, Quality management systems — Requirements ,

— ISO 9004, Quality management systems — Guidelines for performance improvements ,

— ISO 19011, Guidelines for quality and/or environmental management systems auditing, and

— other relevant International Standards as listed in the Bibliography.

In addition, the consultant should have knowledge of other standards that are necessary for the consulting
services.

NOTE Typical examples include

a) sector-specific standards,

b) measurement control systems standards,

c) accreditation standards,

d) conformity assessment standards,

e) product standards,

f) dependability management standards, and

g) standards related to safety aspects.

Quality management system consultants should also have knowledge of the ISO guidance documents
[16]
developed as part of the ISO 9000 family introduction and support package .

4.2.4.2 National and international certification/registration and accreditation systems

Quality management system consultants should have general knowledge of

a) the standardization, certification and accreditation systems at national and international level, and the
requirements for certification for such systems (e.g. ISO/IEC Guide 62), and

b) the processes and procedures for national certification of products, systems and personnel.

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