ISO/TS 21095

Guidelines for the selection of quality management system

consultants and use of their services
FOREWORD
This Committee Draft (CD2) is issued for comment. It has been developed based on the
Italian New Work Item Proposal to ISO/TC176/SC3, using standard UNI 10836 as a starting
point. Although originally conceived as a guidance standard for the qualification of quality
management system consultants, ISO/TC176/SC3/WG9 felt that it was more appropriate to
provide guidance to organizations wishing to use the services of a quality management
systems consultant, to help them in the selection of such consultants and effective use of their
services. It is recognized that some countries may wish to adopt, or have already adopted,
registration schemes for quality management system consultants. It is recognized that local
cultures and situations may play an important role in the criteria to be defined in such
schemes. Whilst this document does not aim to be prescriptive, some guidelines are presented
as an Annex, in order to provide basic input for the harmonization of these registration
schemes.

It is planned to publish this document as an ISO Technical Specification

Copyright

This ISO/TC176/SC3 document is a Working Draft. All rights are copyright-protected.

Neither this draft nor any extract from it may be reproduced, stored in retrieval system or
transmitted in any form or by any means, electronic, photocopying, recording or otherwise,
without prior written permission by ISO/TC176/SC3 secretariat.

TABLE OF CONTENTS

0 INTRODUCTION

1 SCOPE

2 NORMATIVE REFERENCES

3 TERMS AND DEFINITIONS

4 SELECTION OF A QUALITY MANAGEMENT SYSTEM CONSULTANT

4.1 Typical QMS consulting services
4.2 Selection of a consultant
4.2.1 General
4.2.2 Personal attributes
4.2.3 Competence
4.2.4 Work experience
4.2.5 Ethical considerations
5 USE OF QMS CONSULTANTS SERVICES

6 MAINTENANCE OF COMPETENCE

ANNEX A (informative)
TYPICAL STEPS OF QMS CONSULTANTS’ ACTIVITIES
A.1 Example of proposal and contract requirements
A.2 Typical example of the process for realization of a quality management system
A.2.1 Basic development
A.2.2 Implementation support

ANNEX B (informative)
EVALUATION OF THE QMS CONSULTANT (useful criteria)
B.1 Example of work experience for a QMS consultant
B.2 Competence evaluation methods
B.3 Evaluation of competence maintenance

ANNEX C (informative)
STANDARDS OF THE ISO 9000:2000 FAMILY (as at June 2001)

INTRODUCTION

In realization of a quality management system, organizations may choose to rely on their own
resources, but many will use the services of external consultants. The selection of a
consultant by an organization can be a critical factor in determining the success of the
realization process, in order to ensure that the resulting quality management system is capable
of meeting the organization’s planned objectives and that this is achieved in the most efficient
and economical manner.

This document aims to provide guidance on the important factors to be taken into
consideration when selecting a consultant. It may be used in the following situations:
o By organizations, in order to select a consultant who is able to meet their specific needs
and objectives
o By consultants themselves, as a guide to the desirable attributes to be developed
o By bodies operating qualification schemes for consultants.
o By consulting organizations for selection of personnel.

Note: The focus of this technical specification is the consultant as an individual, and not the
organization providing consultancy.

1 SCOPE

This technical specification provides guidance for the selection of consultants, and for the use
of their services, who can demonstrate competence in understanding and providing strategic
and/or operational guidance to meet the organization’s objectives in the realization of a
quality management system.
Note: It is recognized that many organizations will wish to base their quality management
system on the requirements of ISO 9001:2000 and the guidelines of ISO 9004:2000. This
technical specification addresses those needs, but at the same time could be used for the
realization of any other quality management system.

2 NORMATIVE REFERENCES

ISO 9000:2000 Quality management systems – Fundamentals and vocabulary

ISO 9001:2000 Quality management systems – Requirements

ISO 9004:2000 Quality management systems – Guidelines for performance improvements

3 TERMS AND DEFINITIONS

For the purposes of this technical specification the terms and definitions given in ISO
9000:2000 apply, unless superseded by definitions given below.

3.1 organization: for the purpose of this technical specification, the term “organization”
means the organization that intents to use or is using the services of the quality management
system consultant.

3.2 quality management system realization: this is defined as the process of initial
appraisal, identification of goals and objectives, design and development, implementation,
evaluation, ongoing maintenance and improvement or parts thereof, as applicable to quality
management systems. (hereinafter QMS realization)

3.3 quality management system consultant: a professional with the competence necessary
to assist organizations with the realization of a quality management system. The consultant is
an individual, who may be an independent consultant or a member of a consulting
organization (hereinafter QMS consultant).

4 SELECTION OF A QUALITY MANAGEMENT SYSTEM CONSULTANT

4.1 Typical QMS consulting services

The QMS consultants may provide services in the following phases of a QMS realization
process:
o initial appraisal,
o identification of goals and objectives,
o design and development,
o implementation,
o evaluation,
o ongoing maintenance,
o improvement.
Advice from a QMS consultant should be appropriate in each or all of these phases, according
to the needs of the organization. For the organization to achieve its overall objectives for the
quality management system, it is essential that due importance be given to the selection and
utilization of a competent QMS consultant and use of his services.
4.2 Selection of a consultant

4.2.1 General
When evaluating the competence and suitability of a consultant, consideration should be
given to the following:
o Personal attributes, as outlined in subclause 4.2.2
o Competence necessary to meet the organization’s overall objectives for the quality
management system, as outlined in subclause 4.2.3
o Ethical considerations, as outlined in subclause 4.2.5
o Relevant credentials

4.2.2 Personal Attributes

Personal attributes contribute to the successful performance of a QMS consultant. A QMS

consultant should be:
a) ethical - fair, truthful, sincere, honest and discreet;
b) open minded - willing to consider alternative ideas or points of view;
c) diplomatic - tactful in dealing with people;
d) observant - constantly and actively aware of organizational culture and values, physical
surroundings and activities;
e) perceptive - instinctively aware of and able to understand the need for change and
improvement;
f) versatile - able to adapt to different situations and provide alternative solutions;
g) tenacious - persistent, focused on achieving objectives;
h) decisive - confident in providing accurate advice and conclusions based on logical
reasoning and analysis;
i) self-reliant - acts and functions independently while interacting effectively with others.
j) communicative - able to listen to and interface with all levels of an organization,
confidently, considering organisations’ environment;
k) practical – realistic in approach with good time management and leadership abilities
(concerned with actual facts and experiences).

4.2.3 Competence

4.2.3.1 General
A QMS consultant should have competence appropriate to the scope of the consultancy
services to be provided. The QMS consultant should have appropriate education, knowledge,
skills and work experience according to the following clauses of this technical specification.

4.2.3.2 Required abilities

QMS consultants should be able to demonstrate abilities such as:
- illustrate the concepts concerning quality management in a clear and understandable way
throughout the organization, paying special care to the understanding and adoption of the
quality management principles;
- communicate with the relevant personnel within the organization, at all levels, to involve
them actively in the quality management system realization;
- guide the organization in identifying the appropriate processes needed for its quality
management system and defining the relative importance, sequence and interaction of
those processes;
- assist the organization in identifying documents which are needed to ensure the effective
planning, operation and control of its processes;
- lead the organization in the implementation of a process approach to its quality
management system, that is suited to its own culture, characteristics, and specific business
environment;
- evaluate the effectiveness and efficiency of the quality management system processes and
stimulate the organization to look for opportunities to improve them;
- promote continual improvement of QMS within the organization, through the adoption of
suitable methods such as self assessment, management review, systematic use of the
PDCA cycle and others;
- identify the training needs and train appropriate employees in the organization to be able
to continue the maintenance of the QMS after the consultant has finished his task;
- where necessary, assist the organization to identify the relation between its quality
management system and any other management systems (such as environmental, or health
and safety management systems), and facilitate the integration of these systems.

4.2.3.2 Education
QMS consultants should have appropriate education needed to acquire the knowledge and
skills relevant for the consultancy services to be provided.

4.2.3.3Knowledge and skills

4.2.3.3.1 Knowledge of relevant standards

QMS consultants should have knowledge and understanding of the following International
Standards in order to apply these as appropriate to the overall objectives of the organization:
- ISO 9000:2000 (Quality management systems – Fundamentals and vocabulary)
- ISO 9001:2000 (Quality management systems – Requirements)
- ISO 9004:2000 (Quality management systems – Guidelines for performance
improvements)
- ISO 19011:2002 (Guidelines for quality and/or environmental management systems
auditing)
- Relevant ISO standards as listed in Annex C

Additionally, should have knowledge of other standards that are necessary for the scope of the
consultancy services.

NOTE 1: Typical examples include, but are not limited to:

- Sector-specific standards
- Measurement control systems standards
- Laboratory, and management system accreditation criteria
- Conformity assessment standards
- Risk management standards

Additionally consultants should have knowledge of official ISO guides related to ISO
9000:2000 family (e.g. “Introduction and Support Package”, “Transition Planning Guidance”,
“Frequently Asked Questions”, ISO Handbook for small business).

4.2.3.3.2 Knowledge of standardization and conformity assessment processes

QMS consultants should have relevant knowledge of:

• the standardization, certification and accreditation systems at national and international
level;
• the processes and procedures for national certification of products, systems and personnel.

4.2.3.3.3 Knowledge of general quality management principles, methodologies and

techniques

QMS consultants should have knowledge of and be able to apply appropriate QMS principles,
methodologies and techniques such as:
o Quality assurance principles
o Quality management principles
o Improvement processes
o Appropriate statistical techniques
o Auditing methodologies and techniques
o Economics of quality
o Team work techniques
o PDCA (Plan-Do-Check-Act) cycle
o Policy deployment
o Process mapping
o Prevention tools and techniques
o Problem solving techniques
o Techniques for monitoring customer satisfaction
o Brainstorming techniques

4.2.3.3.4 Knowledge of statutory and regulatory requirements

QMS consultants should not be expected to know all the statutory and regulatory
requirements that are relevant to the organization’s activities prior to initiating the contract.
They should, however, be aware of the need to review the existence of, and be able to access
and understand the significance of, relevant local, regional, national or international statutory
and regulatory requirements applicable to the organization’s activities. :
Basic knowledge in this area should include, but not be limited to the statutory and regulatory
requirements for the organization’s product, as required by ISO 9001:2000, but it should also
include the following aspects, as appropriate, to meet the organization’s overall objectives for
its quality management system:
- Contracts and agreements
- Labour, workplace safety and working conditions
- International treaties and conventions
- Environment

4.2.3.3.5 Knowledge of organizational, methodological and technological situations

QMS consultants should not necessarily have a detailed knowledge of the organization’s
products and processes prior to initiating the consultancy contract, but should understand the
key factors relevant to the product sector in which they operate. They should be able to apply
this knowledge to:
• identify the critical characteristics of the organization’s processes and related products.;
• understand the sequence and interaction of the organization’s processes and their effect on
meeting product requirements;
• understand the language and terminology of the specific sector;
• understand the nature of the structure, functions and relationships within the organization.
• Understand the basic technology behind the organization’s processes.

4.2.3.3.6 Knowledge of business management

QMS consultants should understand how the quality management system integrates and
interacts with the overall management of the organization. Therefore consultants should have
knowledge of relevant business management practices.

4.2.4 Work experience

The consultant should have relevant experience in managerial, professional or technical

situations involving the exercise of judgement, problem solving and communication with all
interested parties. The consultant should have experience in sufficient depth and breadth to be
able to give advice that enables the organization to make its own decisions regarding its
quality management system. The relevance of a QMS consultant’s experience may include a
combination of some or all of the following factors:
- Practical work experience
- Experience in management
- Experience in implementing a quality management system, in one or more of the
following capacities:
o As top management of an organization
o As a management representative
o As a member of the quality assurance function
o As a consultant
- Experience of auditing quality management systems

NOTE: The organization should beware of selecting QMS consultants based only on
academic qualifications or specific in-depth product knowledge.

4.2.5 Ethical considerations

The organization should consider the QMS consultant’s code of ethics, which should include:
- avoiding and/or declaring any conflict of interest that may affect the work to be carried out,
- respecting the confidentiality of information provided by or acquired from the organization,
- avoiding conflicts between the consultancy services and assessments carried out for quality
management system certification or accreditation purposes,
- impartiality in recommendations for certification bodies/registrars,
- providing realistic forecasts of the budget requirements for the consultant’s services, based
on the scope, nature and extent of the services to be provided,
- avoiding the creation of dependence on the services of the QMS consultant,
- avoiding the provision of services where the consultant does not have the required
competence.

5. USE OF QMS CONSULTANTS SERVICES

Organizations that utilize the services of a QMS consultant should ensure that the consultant’s
services are used for the maximum benefit of the organization. Organizations should also
ensure that the contract with the QMS consultant is clearly defined in scope of work including
outputs and duration is realistic and understandable. The resulting quality management system
should be understandable and applied throughout the organization using internal resources,
without the need for an exclusive dependence on the continued services of the consultant.
Therefore, both the organization and the consultant should ensure that the quality
management system:
• Meets the organization’s overall objectives and needs.
• Is cost-effective in meeting the needs of the customer and other interested parties.
• Does not generate bureaucracy and excessive documentation.

The QMS consultant should ensure that the organization’s top management is aware of as
follows:
• the fact that the success of the quality management system depends on the involvement
and commitment of top management, and not on the consultant alone,
• the need to involve employees at all levels in order to integrate the quality management
system within the organization’s overall operations,
• the empowerment of the consultant to interact with the organization’s management and
employees at all levels in order to appraise the organization’s processes,
• the opportunity to use the quality management system as an effective and efficient
management tool, even if the initial implementation was in response to contractual or
market requirements,
• the potential for the quality management system to provide a basis for continual
improvement of the organization’s performance,
• the advantages that can be derived by addressing the needs and expectations of all
interested parties involved in the most advantageous way for the organization, using the
ISO 9000 family of standards.

Prior to finalizing the contract with the QMS consultant, a project plan should be established.
The organization employing the consultant should assign a staff member (usually the person
who will eventually manage the system) to coordinate and monitor the consultant’s activities.

Regular meetings should be held to evaluate the progess in implementing the system. At each
of this meetings progress against the inplementation time table and the project budget should
be reviewed. Progress should be reported to the top management.

6 MAINTENANCE OF COMPETENCE

Each QMS consultant should ensure that key maintain their competence. The means which
this is done would typically include:
o participation in conferences, seminars etc.;
o attendance at relevant training courses;
o participation in audits of quality management systems;
o establishment of quality management systems in a number of different organizations.

ANNEX A (informative)
TYPICAL STEPS OF QMS CONSULTANTS’ ACTIVITIES

A.1 Example of proposal and contract requirements

A.1.1 Initial needs analysis of the organization, comparing its present managerial and
operational methods with relevant contractual clauses and compliance with relevant
regulations in force (regulations, laws and/or contractual terms and conditions).
A.1.2 Identification of organization objectives by the top management of the organization.
A.1.3 Provisional project: specification of the actions needed to achieve the compliance of
the quality management system with relevant contractual clauses, relevant regulations
in force as per A.1.1, and organizational objectives as identified in A.1.2.
A.1.4 Carrying out of a technical and economical proposal to implement the actions as
defined in A.1.3, to be agreed with the top management of the organization to achieve
the formalization of the contract. The contract, further to the description of the
interventions and methods of implementation, should clearly define:
- provisional planning of the activities;
- the consultant and the organization’s commitments and responsibilities
respectively;
- internal resources within the organization to be committed;
- analysis of the cost the organization will be need in order to support the
consultant’s activities;
- methods for monitoring and/or measuring the progress of the project and updating
of the plan;
- methods for the management of contract modifications;
- confidentiality;
- applied standards.
A.1.5 Signing of the contract by the consultant and by the organization.

A.2 Typical example of the process for realization of a quality management system

A.2.1 Basic development

 Description of activity Responsibility

1. Make the top management of the Consultant

organization aware of the main
requirements of the relevant
standard and the relationships set
out in Clause 5 of this Technical
Specification.
2. Analysis of the needs and Organization top management (the consultant
expectations of the organization’s provides assistance).
customers and other interested
parties.
NOTE: The results of the initial appraisal
are generally used:
• to establish the organization’s strengths
and weaknesses, opportunities and threats
• to understand and help in defining its
quality policy and objectives,
• as a basis for planning the quality
management system
• to assess the availability of the resources
needed to implement the quality
management system.
• as a basis for auditing and for
establishment of measurable indexes
needed for improvement and to satisfy
the needs of interested parties.
3. Appointment of a management Organization top management (the consultant
representative and definition of provides assistance).
policy, objectives and commitments
for quality.
Such objectives shall be referred to
appropriate levels and functions of
the organization.
4. In-depth analysis of organizational Consultant and management representative,
structure, processes, channels of with the co-operation of the persons in charge
communication and existing of the various functions within the
interfaces. organization
Identification of the processes and
responsibilities needed for
achieving quality objectives.
Definition of sequence and
interactions among such processes
5. Planning of activities with Consultant and Management representative.
definition of the quality
management system architecture
and of a plan for identifying and
developing the procedures needed
for the quality management system.
The plan should provide appropriate
moments for re-examination of the
work carried out in order to assess,
in conjunction with the
organization::
- consistency between what has been
prepared and developed and the
contractual objectives;
- work progress;
- organization satisfaction (with
regard to the services provided by
the QMS consultant).

6. Review of the results of the analysis Consultant and organization top management.
carried out and of the plan prepared
in advance.

7. Identification of internal resources Organization (consultant provides assistance).

needed to achieve the organization’s
quality objectives.
8. Training of the person responsible Consultant and Management representative
for developing the project and of the
organization’s other personnel
(“facilitators”) involved.
9. Definition of interelated processes Management representative. (Consultant
and preparation of the necessary provides assistance)
documented procedures, work
instructions and relevant records.

Preparation of Q.M.S. Management representative and organization’s

documentation. managers. (Consultant provides assistance)

Cross-checking between interelated Consultant and Management representative.

 processes and relevant procedures to
avoid any inconsistency, gaps and
overlaps.

Elaboration of the final version of Management representative

the quality manual.
10. Training/Information of all
personnel on the new quality
management system prepared.
11. Implementation of the quality
system.
(Consultant provides assistance).
Consultant (or Management representative and
the Consultant provides assistance).
Organization.
(Consultant provides assistance)

A.2.2 Implementation support

1. Training of Internal Auditors. Consultant (or other provider of auditor

training appointed by the organization).

Definition of a program for internal Consultant and Management representative.

audits.

Carrying out a first series of internal Consultant.

audits, together with internal
auditors, to provide them with
additional training including writing
reports, formalization of non-
conformities and assistance in
defining corrective actions and
relevant results.

Review of the quality system by the Organization Top Management.

top management. (Consultant provides assistance).

2. Continual improvement. Organization Top Management. (Consultant

may supply assistance, when provided for in
the contract)

ANNEX B (informative)
Evaluation of the QMS consultant (useful criteria)

B.1 Example of work experience for a QMS consultant

The organization may use the following work experience table, as appropriate, in selecting
QMS consultants as shown in the example presented in Table 1. This work experience is only
suggestive, not appropriate in all circumstances and should depend on the scope of the
consultancy. In some cases additional competencies may be required.
 Table 1: Suggested Education / Work Experience of QMS consultant

Work experience QMS consultants

segments
Level 1 Level 2 Level 3

2 years with 4 years with 6 years with

university* education university * education university * education
Total work experience
(any one of) 4 years with 6 years with 8 years with
secondary** secondary** secondary**
education education education
At least 1 year At least 2 years At least 4 years
experience in the experience in the experience in the
Work experience in
design and design and design and
Quality Management
implementation of implementation of implementation of
QMS QMS QMS
QMS implementation Completed at least 3 Completed at least 6
Not required
experience QM systems QM systems

* NOTE 1: University education is a part of the national education system and comes after
the secondary level education with a duration of at least 3 years.

** NOTE 2: Secondary education is a part of the national education system and comes after
the primary or elementary level, but that is completed prior to entrance the degree level
education.

B.2 Competence evaluation methods

The evaluation should be based on the examination of objective evidence related to each
clause of this technical specification.

Personal characteristics and professional capabilities may be evaluated considering:

• the success of organizations with which the consultant has been involved in achieving
certification of their quality management systems;
• the declaration of satisfaction from organizations with regard to the suitability of the
quality management systems implemented with help from the consultant;
• the possible publication of books, articles, dealing with quality;
• the respect of professional ethics (see clause 4.4 of this Technical Specification).

The evaluation process should include some of following methods:

• evaluation of the documentation of the quality management system developed and/or

supported by the consultant;
• interview with organizations that have used the consultant’s services (assessment of
satisfaction level);
evaluation of the time period during which the consultant’s professional experience was
acquired including experience and knowledge of the relevant industry;
• considerations on the consultant’s certifications and professional qualifications;
• interview with the consultant for the assessment of his/her competence;
B.3 Evaluation of competence maintenance

Competence maintenance should be assessed at least every 3 years using some of the methods
laid down in B.2

ANNEX C (informative)
STANDARDS OF THE ISO 9000:2000 FAMILY
(as at June 2001, the list will be uptaded at the stage of DIS)
All standards are subject to revision, therefore concerned parties are requested to follow up
their development.
ISO 9000:2000 QMS – Fundamentals and Vocabulary
ISO 9001:2000 QMS – Requirements
ISO 9004:2000 QMS– Guidelines for performance improvements
ISO 9000-3:1998 Quality management and quality assurance standards – Guidelines for
the application of ISO 9001:1994 for the development, supply,
installation and maintenance of computer software
ISO 9000-4:1995 Quality management and quality assurance standards – Guidelines for

ISO 9004-4:1995 Quality management and quality system elements -

Part 4: Guidelines for quality improvement
ISO 10005:1996 Quality management – Guidelines for quality plans
ISO 10006:1999 Quality management – Guidelines for quality in project management
ISO 10007:1997 Quality management - Guidelines for configuration
management
ISO 10011-1:1994 Guidelines for auditing quality systems – Auditing

ISO 10011-2:1994 Guidelines for auditing quality systems - Qualification criteria for
quality systems auditors
ISO 10011-3:1994 Guidelines for auditing quality systems – Management of audit
programmes
ISO 10012-1:1994 Quality assurance requirements for measuring equipment -
Metrological confirmation system for measuring equipment
ISO 10012-2: 1997 Quality assurance for measuring equipment – Guidelines for control of
measurement processes
ISO/DIS 10012 Measurement control systems
ISO/TR 10013:2001 Guidelines for developing quality management system documentation
ISO/TR 10014:1998 Guidelines for managing the economic effects of quality
ISO 10015:1999 Quality Management – Guidelines for Training
ISO/TR 10017:1999 Guidance on statistical techniques for ISO 9001:1994