ISO 9004-2000(E)

Annex A
(Informative)

Guidelines for self-assessment

A.1 Introduction

Self-assessment is a carefully considered evaluation resulting in an opinion or judgement of

the effectiveness and efficiency of the organization and the maturity of the quality
management system. Self-assessment is usually performed by the organization’s own
management. The intent of self-assessment is to provide fact-based guidance to the
organization regarding where to invest resources for its improvement.

It also can be useful in measuring progress against objectives, and to reassess the continuing
relevance of those objectives.

Many models currently exist for the self-assessment of organizations to quality management
system criteria. The most widely recognized and used models are national and regional
quality award models, also referred to as organizational excellence models.

The self-assessment approach described in this annex is intended to provide a simple, easy-
to-use approach to determine the relative degree of maturity of an organization’s quality
management system and to identify the main areas for improvement.

Specific features of the ISO 9004 self-assessment approach are that it can

- be applied to the entire quality management system, or to a part of the quality

management system, or to any process,

- be applied to the entire organization or part of the organization,

- be completed quickly with internal resources,

- be completed by a multi-discipline team, or by one person in the organization who is

supported by top management,

- form an input to a more comprehensive management system self-assessment process,

- identify and facilitate the prioritization of opportunities for improvement, and

- facilitate maturing of the quality management system towards world-class performance.

The ISO 9004 self-assessment approach is to evaluate the maturity of the quality
management system for each major clause in ISO 9004 on a scale ranging from 1 (no formal
system) to 5 (best-in-class performance). This annex provides guidance in the form of
typical questions that the organization can ask in order to evaluate its performance for each
of the main clauses in ISO 9004.
ISO 9004-2000(E)
Another advantage to this approach is that results monitored over time can be used to
appraise the maturity of an organization.

This approach to self-assessment is neither a substitute for internal audit of the quality
management system nor for the use of existing quality award models.

A.2 Performance maturity levels

The performance maturity levels used in this self-assessment approach are shown in Table
A.1.

Table A.1 – Performance maturity levels

Maturity
Performance level Guidance
level
No systematic approach evident, no results,
1 No formal approach
poor results or unpredictable results.
Problem – or corrective-based systematic
2 Reactive approach approach; minimum data on improvement
results available.
Systematic process-based approach, early stage
Stable formal system of systematic improvements; data available on
3
approach conformance to objectives and existence of
improvement trends.
Continual improvement Improvement process in use; good results and
4
emphasized sustained improvement trends.
Strongly integrated improvement process; best-
5 Best-in-class performance
in-class benchmarked results demonstrated.

A.3 Self-assessment questions

The award models as well as other self-assessment modes have a wide range of detailed
criteria for assessing the performance of management systems. Self-assessment provides an
easy approach for evaluating the maturity of an organization based on clauses 4 to 8 of this
International Standard. Each organization should develop a set of questions for those clauses
of this International Standard that are suitable to its needs. Examples of typical questions for
self-assessment are provided below. The sub-clause numbers are given in parentheses.

:
Question 1: Managing systems and processes (4.1)

a) How does management apply the process approach to achieve the effective and efficient
control of processes, resulting in performance improvement?
ISO 9004-2000(E)

Question 2: Documentation (4.2)

a) How are documents and records used to support effective and efficient operation of the
processes of the organization?

Question 3: Management responsibility – General guidance (5.1)

a) How does top management demonstrate its leadership, commitment and involvement?

Question 4: Needs and expectations of interested parties (5.2)

a) How does the organization identify customers’ needs and expectations on a continual
basis?

b) How does the organization identify people’s need for recognition, work satisfaction,
competence and personal development?

c) How does the organization consider the potential benefits of establishing partnerships
with its suppliers?

d) How does the organization consider the potential benefits of establishing partnerships
with its suppliers?

e) How does the organization ensure that statutory and regulatory requirements have been
considered.

Question 5: Quality policy (5.3)

a) How does the quality policy ensure that the needs and expectations of customers and
other interested parties are understood?

b) How does the quality policy lead to visible and expected improvements?

c) How does the quality policy consider the organization’s vision of the future?

Question 6: Planning (5.4)

a) How do the objectives translate the quality policy into measurable goals?

b) How are the objectives deployed to each management level to assure individual
contribution to achievement?

c) How does management ensure the availability of resources needed to meet the
objectives?
ISO 9004-2000(E)

Question 7: Responsibility, authority and communication (5.5)

a) How does top management ensure that responsibilities are established and communicated
to people in the organization?

b) How does communicating quality requirements, objectives and accomplishments

contribute to improvement of the organization’s performance?

Question 8: Management review (5.6)

a) How does top management ensure valid input information is available for the
management review?

b) How does the management review activity evaluate information to improve the
effectiveness and efficiency of the processes of the organization?

Question 9: Resource management – General guidance (6.1)

a) How does top management plan for resources to be available in a timely manner?

Question 10: People (6.2)

a) How does management promote involvement and support of people for improvement of
the effectiveness and efficiency of the organization?

b) How does management ensure that the competence of people in the organization is
adequate for current and future needs?

Question 11: Infrastructure (6.3)

a) How does management ensure that the infrastructure is appropriate for the achievement
of the objectives of the organization?

b) How does management consider environmental issues associated with the infrastructure?

Question 12: Work environment (6.4)

a) How does management ensure that the work environmental promotes motivation,
satisfaction, development and performance of people in the organization?

Question 13: Information (6.5)

a) How does management ensure that appropriate information is easily available for fact-
based decision making?
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Question 14: Suppliers and partnerships (6.6)

a) How does management involve suppliers in the identification of purchasing needs and
joint strategy development?

b) How does management promote partnership arrangements with suppliers?

Question 15: Natural resources (6.7)

a) How does the organization ensure the availability of necessary natural resources for its
realization processes?

Question 16: Financial resources (6.8)

a) How does management plan, provide, control and monitor the financial resources
necessary to maintain an effective and efficient quality management system and to ensure
the achievement of the objectives of the organization?

b) How does management ensure awareness of people in the organization about the link
between product quality and costs?

Question 17: Product realization – General guidance (7.1)

a) How does top management apply the process approach to ensure the effective and
efficient operation of the realization and support processes and the associated process
network?

Question 18: Processes related to interested parties (7.2)

a) How has management defined customer-related processes to ensure consideration of

customers’ needs?

b) How has management defined other interested-party-related processes to ensure

consideration of interested parties’ needs and expectations?

Question 19: Design and development (7.3)

a) How has top management defined design and development processes to ensure they
respond to the needs and expectations of the organization’s customers and other
interested parties?

b) How are design and development processes managed in practice, including the definition
of design and development requirements and the achievement of planned outputs?

c) How are activities such as design review, verification, validation and configuration
management considered in the design and development processes?
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Question 20: Purchasing (7.4)

a) How has top management defined purchasing processes that ensure purchased products
satisfy the organization’s needs?

b) How are purchasing processes managed?

c) How does the organization ensure conformity of purchased products from specification
through to acceptance?

Question 21: Production and service operations (7.5)

a) How does top management ensure that the input to the realization processes takes
account of customers’ and other interested parties’ needs?

b) How are realization processes managed from inputs to outputs?

c) How are activities such as verification and validation considered in realization processes?

Question 22: Control of measuring and monitoring devices (7.6)

a) How does management control the measuring and monitoring devices to ensure that
correct data are being obtained and used?

Question 23: Measurement, analysis and improvement – General guidance (8.1)

a) How does management promote the importance of measurement, analysis and

improvement activities to ensure that the organization’s performance results in
satisfaction of interested parties?

Question 24: Measurement and monitoring (8.2)

a) How does management ensure collection of customer-related data for analysis, in order to
obtain information for improvements?

b) How does management ensure the collection of data from other interested parties for
analyses and possible improvements?

c) How does the organization use self-assessment of the quality management system for
improving the overall effectiveness and efficiency of the organization?

Question 25: Control of nonconformity (8.3)

a) How does the organization control process and product nonconformity?

b) How does the organization analyse nonconformity for lessons learned and process and
product improvement?
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Question 26: Analysis of data (8.4)

a) How does the organization analyse data to assess its performance and identify areas for
improvement?

Question 27: Improvement (8.5)

a) How does management use corrective action for evaluating and eliminating recorded
problems affecting its performance?

b) How does management use preventive action for loss prevention?

c) How does the management ensure the use of systematic improvement methods and tools
to improve the organization’s performance?
ISO 9004-2000(E)

Annex B
(Informative)

Guidelines for continual improvement

A strategic objective of an organization should be the continual improvement of processed in

order to enhance the organization’s performance and benefit its interested parties.

There are two fundamental ways to conduct continual process improvement, as follows:

a) breakthrough projects which either lead to revision and improvement of existing

processes or the implementation of new processes; these are usually carried out by cross-
functional teams outside routine operations;

b) small-step ongoing improvement activities conducted within existing processes by

people.

Breakthrough projects usually involve significant redesign of existing processes and should
include

- definition of the objectives and an outline of the improvement project,

- analysis of the existing process (the “as-is” process) and realizing opportunities for
change.

- definition and planning of improvement to the process,

- implementation of the improvement,

- verification and validation of the process improvement, and

- evaluation of the improvement achieved, including lessons learned.

Breakthrough projects should be conducted in an effective and efficient way using project
management methods. After completion of the change, a new project plan should be the
basis for continuing process management.

People in the organization are the best source of ideas for small-step or ongoing process
improvement and often participate as work groups. Small-step ongoing process
improvement activities should be controlled in order to understand their effect. The people
in the organization that are involved should be provided with the authority, technical support
and necessary resources for the changes associated with the improvement.
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Continual improvement by either of the methods identified should involve the following.

a) Reason for improvement: a process problem should be identified and an area for
improvement selected, noting the reason for working on it.

b) Current situation: the effectiveness and efficiency of the existing process should be
evaluated. Data to discover what types of problems occur most often should be collected
and analysed. A specific problem should be selected and an objective for improvement
should be set.

c) Analysis: the root cuases of the problem should be identified and verified.

d) Identification of possible solutions: alternative solutions should be explored. The best

solution should be selected and implemented; i.e. the one that will eliminate the root
causes of the problem and prevent the problem from recurring.

e) Evaluation of effects: it should then be confirmed that the problem and its root causes
have been eliminated or their effects decreased, that the solution has worked, and the
objective for improvement has been met.

f) Implementation and standardization of the new solution: the old process should be
replaced with the improved process, thereby preventing the problem and its root causes
from recurring.

g) Evaluation of the effectiveness and efficiency of the process with the improvement action
completed: the effectiveness and efficiency of the improvement project should be
evaluated and consideration should be given for using its solution elsewhere in the
organization.

The process for improvement should be repeated on remaining problems, developing

objectives and solutions for further process improvement.

In order to facilitate the involvement and awareness of people in improvement activities,

management should consider activities such as

- forming small groups and having leaders elected by the group members,

- allowing people to control and improve their workplace, and

- developing people’s knowledge, experience and skills as a part of the overall quality
management activities of the organization.