Contents Page

Foreword ........................................................................................................................................................................................................................................ i
1 Scope ................................................................................................................................................................................................................................. 1
2 Normative references ...................................................................................................................................................................................... 1
..................................................................................................................................................................................... 1
4 General requirements ..................................................................................................................................................................................... 5
................................................................................................................................................................................................. 5
4.2 Accreditation agreement ................................................................................................................................................................ 5
................................................................. 6
............................................................................................................................................................ 7
...................................................................................................................................................................... 8
4.6 Establishing accreditation schemes...................................................................................................................................... 9
5 Structural requirements .............................................................................................................................................................................. 9
6 Resource requirements ..............................................................................................................................................................................10
6.1 Competence of personnel ........................................................................................................................................................... 10
6.1.1 General................................................................................................................................................................................... 10
6.1.2 Determination of competence criteria....................................................................................................... 10
6.1.3 Competence management .................................................................................................................................... 12
6.2 Personnel involved in the accreditation process .................................................................................................... 12
6.3 Personnel records.............................................................................................................................................................................. 13
6.4 Outsourcing............................................................................................................................................................................................. 13
7 Process requirements ..................................................................................................................................................................................13
7.1 Accreditation requirements...................................................................................................................................................... 13
7.2 Application for accreditation ................................................................................................................................................... 14
7.3 Resource review.................................................................................................................................................................................. 14
7.4 Preparation for assessment ...................................................................................................................................................... 14
7.5 Review of documented information .................................................................................................................................. 15
7.6 Assessment.............................................................................................................................................................................................. 15
7.7 Accreditation decision-making .............................................................................................................................................. 16
7.8 Accreditation information.......................................................................................................................................................... 17
........................................................................................................................................................................... 19
7.10 Extending accreditation ............................................................................................................................................................... 20
7.11 Suspending, withdrawing or reducing accreditation ......................................................................................... 20
7.12 Complaints ............................................................................................................................................................................................... 20
7.13 Appeals ....................................................................................................................................................................................................... 21
................................................................................................................. 22
8 Information requirements ......................................................................................................................................................................22
............................................................................................................................................................. 22
................................................................................................................................................ 22
9 Management system requirements ...............................................................................................................................................23
9.1 General ........................................................................................................................................................................................................ 23
....................................................................................................................................................................... 24
9.3 Document control .............................................................................................................................................................................. 24
9.4 Records control.................................................................................................................................................................................... 24
9.5 Nonconformities and corrective actions........................................................................................................................ 25
9.6 Improvement ......................................................................................................................................................................................... 25
9.7 Internal audits ...................................................................................................................................................................................... 25
9.8 Management reviews ..................................................................................................................................................................... 26
Annex A (informative) Knowledge and skills for performing accreditation activities .................................27
Bibliography .............................................................................................................................................................................................................................29
Conformity assessment — Requirements for accreditation
bodies accrediting conformity assessment bodies

1 Scope

2 Normative references

ISO/IEC 17000, Conformity assessment — Vocabulary and general principles

ISO/IEC 17000 and the

ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
3.1
accreditation
conformity assessment body (3.4

[SOURCE: ISO/IEC 17000:2004, 5.6]

3.2
accreditation body
accreditation (3.1)

[SOURCE: ISO/IEC 17000:2004, 2.6]

3.3
accreditation body logo
accreditation body (3.2
3.4
conformity assessment body
accreditation (3.1)

1
3.5
conformity assessment activity
conformity assessment body (3.4
accreditation (3.1) include, but are not limited

3.6
scope of accreditation
accreditation (3.1) is sought or has been granted
3.7

scope of accreditation (3.6

conformity assessment body
(3.4 accreditation body (3.2)
3.8
accreditation scheme
rules and processes relating to the accreditation (3.1

ISO/IEC 17025, ISO/IEC 17024, ISO 17034, ISO/IEC 17043, ISO/IEC 17065, ISO 15189 and ISO 14065.

3.9
accreditation activity
individual operational tasks of the accreditation process (3.11)
Clause 7.

3.10
impartiality

accreditation body (3.2).

3.11
accreditation process
activities from application through to granting and maintenance of accreditation (3.1
accreditation scheme (3.8)
3.12
accreditation symbol
accreditation body (3.2

2
3.13
accreditation decision
decision on granting (3.14), maintaining (3.15), extending (3.16), reducing (3.17), suspending (3.18) and
withdrawing (3.19) accreditation (3.1)
3.14
granting accreditation
awarding accreditation (3.1 scope of accreditation (3.6)
3.15
maintaining accreditation
accreditation (3.1
3.16
extending accreditation
scope of accreditation (3.6)
3.17
reducing accreditation
cancelling part of the scope of accreditation (3.6)
3.18
suspending accreditation
scope of accreditation (3.6)
3.19
withdrawing accreditation
cancelling accreditation (3.1) for the full scope
3.20
complaint
expression of dissatisfaction, other than appeal (3.21 accreditation
body (3.2 conformity assessment
body (3.4), where a response is expected
[SOURCE: ISO/IEC

3.21
appeal
conformity assessment body (3.4 accreditation decision
(3.13) related to its desired accreditation (3.1) status
3.22
assessment
accreditation body (3.2) to determine the competence of a conformity
assessment body (3.4 scope
of accreditation (3.6)
3.23
reassessment
assessment (3.22) performed to renew the accreditation (3.1
3.24
assessment technique
accreditation body (3.2) to perform an assessment (3.22)

3
— remote assessment (3.26

— witnessing (3.25

— interviewing.

3.25
witnessing
accreditation body (3.2) of a conformity assessment body (3.4
assessment activities within its scope of accreditation (3.6)
3.26
remote assessment
assessment (3.22 conformity assessment body (3.4), using
electronic means

environment.

3.27
assessment programme
set of assessments (3.22 accreditation scheme (3.8) that the accreditation body
(3.2 conformity assessment body (3.4) during an accreditation (3.1
3.28
assessment plan
description of the activities and arrangements for an assessment (3.22)

3.29
accreditation body personnel
accreditation body (3.2)
3.30
assessor
accreditation body (3.2) to perform, alone or as part of an assessment team, an
assessment (3.22) of a conformity assessment body (3.4)
3.31
team leader
assessor (3.30 assessment (3.22)
3.32
technical expert
accreditation body (3.2 assessor (3.30),
scope of accreditation (3.6) to be

4
3.33
interested party
person or organization with a direct or indirect interest in accreditation (3.1)

accreditation body (3.2

bodies or other governmental services, or non-governmental organizations, including consumer organizations.

3.34
consultancy
conformity assessment body (3.4 accreditation (3.1)

4 General requirements

4.1 Legal entity

responsible for its accreditation activities.

NOTE 1 Governmental accreditation bodies are deemed to be legal entities on the basis of their status within
their government.

4.2 Accreditation agreement

5
 NOTE Such changes can concern:

accreditation.

4.3 Use of accreditation symbols and other claims of accreditation

4.3.1

e) informs its affected clients of the suspension, reduction or withdrawal of its accreditation and the

4.3.2

4.3.3

6
4.3.4

4.3.5

NOTE Suitable actions can include requests for corrective action, suspension, withdrawal of accreditation,

4.4 Impartiality requirements

4.4.1

4.4.2

4.4.3

activities.

4.4.4

4.4.5

4.4.6

arising from its relationships or from the relationships of its personnel. The process shall include
4.4.5 to advise on

a sales commission or other inducement for the referral of new clients, etc.

4.4.7

4.4.8
acceptable risk.

4.4.9
acceptable level, then accreditation shall not be provided.

7
4.4.10

to all applicants whose application for accreditation falls within the scope of its accreditation activities

violation of accreditation requirements.

4.4.11

4.4.12
4.4.11
a) different top management (see 5.7
b) different personnel performing the accreditation decision-making processes (see Clause 5

4.4.13

— arranging and participating as a lecturer in training, orientation or educational courses, provided that these

assessment standards.

4.5 Financing and liability

4.5.1

the source(s) of its income.

8
4.5.2
to cover liabilities arising from its activities.

4.6 Establishing accreditation schemes

4.6.1
document the rules and processes for its accreditation schemes referring to the relevant International
Standards and/or other normative documents.

4.6.2

the requirements included in the relevant international standards and/or other normative documents.
NOTE 1 Where international application or guidance documents are available, these can be used.

documents and/or participate in their development.

4.6.3

4.6.4
developing and extending its accreditation schemes. The following shall be considered:

g) views of interested parties.

4.6.5
following shall be considered:

5 Structural requirements

5.1

5.2

9
5.3

5.4
if applicable, and, if different, the names of the persons who control it.

5.5

5.6

accreditation process.

5.7

5.8

parties participating.

6 Resource requirements

6.1 Competence of personnel

6.1.1 General

skills relevant to the accreditation schemes and geographic areas in which it operates.

6.1.2 Determination of competence criteria

6.1.2.1
the competence criteria for personnel involved in the management and performance of assessments and
other accreditation activities. Competence criteria shall be determined with regard to the requirements

10
of each accreditation scheme and shall include the required knowledge and skills for performing
accreditation activities.

6.1.2.2
who review documents, review assessment reports and make accreditation decisions, demonstrate
knowledge of the following:

6.1.2.3
who review applications, select assessment team members, review documents, review assessment
reports, make accreditation decisions and manage accreditation schemes, demonstrate knowledge of the
following:

— accreditation and accreditation scheme requirements and relevant guidance and application

6.1.2.4
who review assessment reports, make accreditation decisions and manage accreditation schemes,
demonstrate knowledge of risk based assessment principles.

6.1.2.5
personnel who review documents, review assessment reports, make accreditation decisions and manage

6.1.2.6
knowledge and skills:

— assessment-management skills.

6.1.2.7
demonstrate note-taking and report-writing skills.

6.1.2.8 The group or individual that takes the accreditation decisions shall understand the applicable
accreditation scheme requirements and shall have competence to evaluate the outcomes of the
assessment, including where appropriate related recommendations of the assessment team.
NOTE Annex A summarizes 6.1.2.2 to 6.1.2.8.

6.1.2.9
scheme, these shall be applied.

11
6.1.3 Competence management

6.1.3.1
a) establish and implement a documented process for the initial evaluation and on-going monitoring

c) prior to undertaking accreditation activities, authorize personnel to perform those activities of the
accreditation process.

6.1.3.2

authorizing technical experts and familiarizing them with relevant requirements and procedures used in
the accreditation process. The initial competence evaluation of an assessor shall include determining the

NOTE One method of evaluating an assessor is to have competent individuals observing the assessor
conducting an assessment.

6.1.3.3
to ensure all personnel involved in accreditation processes are competent for the accreditation activities

6.1.3.4 There shall be a documented process for monitoring competence and performance of all

review and record the competence of its personnel taking into account their performance in order to

6.1.3.5
for which the assessor is authorized. The documented monitoring process of assessors shall include
a combination of on-site evaluation, review of assessment reports and feedback from personnel,

6.1.3.6 Each assessor shall be observed during an assessment at regular intervals. This shall be at

6.2 Personnel involved in the accreditation process

6.2.1
manage and support all its accreditation activities for all accreditation schemes.

6.2.2

6.2.3
documented procedures giving assessment instructions and all relevant information on the accreditation
processes.

12
6.3 Personnel records

performing accreditation activities.

6.4 Outsourcing

6.4.1

6.4.2

6.4.3
and when applicable shall have a documented procedure for outsourcing.

6.4.4

outsourced services.

6.4.5

parts of the assessment.

6.4.6
bodies that provide outsourced services used for accreditation processes, and shall ensure that records
of the competence of all personnel involved in accreditation processes are maintained.

6.2.2).

6.4.4,
6.4.5 and 6.4.6.

7 Process requirements

7.1 Accreditation requirements

assessment bodies.

13
7.2 Application for accreditation

7.2.1

7.8.3

7.2.2
information demonstrating that the accreditation requirements are addressed prior to commencement
of the assessment.

7.2.3

7.2.4

the assessment process.

7.2.5

7.3 Resource review

7.3.1

7.3.2

7.4 Preparation for assessment

7.4.1
required, a suitable number of assessors and/or technical experts for the scope to be assessed. When

assignment is appropriate. In particular, the team as a whole:

14
7.4.2

7.4.3

7.4.4

these activities are performed. These procedures shall describe the manner in which the scope of an

with the relevant accreditation criteria.

7.4.5 The procedures shall ensure that the assessment team assesses the performance of a sample of

7.4.6

7.4.7
the locations at which activities will be assessed, the personnel to be assessed where applicable and
the assessment techniques to be utilized including witnessing where appropriate or applicable. The

7.4.8
for the assessment.

7.4.9
requirements documents, previous assessment records, if applicable, and the relevant documents and

7.5 Review of documented information

7.5.1

other requirements for accreditation.

7.5.2

7.6 Assessment

7.6.1

7.6.2
the assessment with an opening meeting at which the purpose of the assessment and accreditation

15
7.6.3 The assessment team shall conduct the assessment based on the assessment plan.

7.6.4

7.6.5

7.6.6

assessment report shall be adequate to support the conclusions arising from the assessment. The

c) If the report on the outcome of the assessment [see bullet b) above] differs from the outcome

7.6.7

7.6.8

taken to resolve the nonconformities.

7.6.9

corrective actions.

7.7 Accreditation decision-making

7.7.1

7.7.2

different from those who carried out the assessment. However, where maintaining is not related to a
reassessment (see 7.9.4

16
a process which does not require an independent decision.

7.7.3 The information provided to the accreditation decision-maker(s) for review shall include the
following:

7.7.4

7.7.5

relevant.

7.7.6

with the requirements of this document.

7.8 Accreditation information

7.8.1

17
electronic media).

7.8.2 The effective date of accreditation shall be the date of or a date after the accreditation decision.

7.8.3

— product, processes, service and persons categories where relevant.

b) For inspection bodies:

requirements against which the inspection is to be performed, as applicable.

c) For calibration laboratories:

d) For testing laboratories (including medical laboratories):

equipment used.

18
f) For reference material producers:

7.8.4

7.8.3
bullets a) to h) shall be maintained and made available on request.

7.9 Accreditation cycle

7.9.1
accreditation or decision after reassessment (see 7.9.4

7.9.2

activities representative of the scope of accreditation at the relevant locations are assessed during the
7.4.4

programme.

7.9.3 The assessment programme shall ensure that the requirements of the international standards and

accreditation shall be assessed taking risk into consideration. A sample of the scope of accreditation shall

19
7.9.4

decision shall be made after the reassessment.

7.9.5

7.10 Extending accreditation

7.10.1
accreditation. Based on the risk associated with the activities or locations to be covered in the scope

7.3 to 7.9.

7.10.2
programme and planning the subsequent assessment.

7.11 Suspending, withdrawing or reducing accreditation

7.11.1
circumstances the accreditation shall be suspended, withdrawn or reduced when an accredited

7.11.2

withdrawal of accreditation.

7.11.3
accreditation.

7.12 Complaints

7.12.1

7.12.2

7.12.3
to accreditation activities that it is responsible for and, if so, shall deal with it.

7.12.4 The handling process for complaints shall include at least the following elements and methods:

a) a description of the process for receiving, validating, investigating the complaint, and deciding

20
7.12.5
with progress reports and the outcome.

7.12.6
to validate the complaint.

7.12.7
for complaints.

7.12.8

7.12.9
the complainant.

7.12.10
against the complainant.

7.13 Appeals

7.13.1
on appeals.

7.13.2

7.13.3
for appeals.

7.13.4

7.13.5 The handling process for appeals shall include at least the following elements and methods:
a) a description of the process for receiving, validating, investigating the appeal and deciding what

7.13.6

7.13.7
progress reports and the outcome.

7.13.8

7.13.9
appellant.

21
7.14 Records on conformity assessment bodies

7.14.1

7.14.2

8 Information requirements

8.1.1
management of all information obtained or created during the accreditation process. The accreditation

of responding to complaints), all other information obtained during accreditation process is considered

8.1.2

8.1.3

8.1.4

8.2 Publicly available information

8.2.1
other means, without request, and update at adequate intervals, the following:

22
b) information about accreditation process:
1) detailed information about its accreditation schemes, including its assessment and

8.2.2
7.8.1 and, where applicable, information on suspension
or withdrawal of accreditation, including dates and scopes.

8.2.3

effective date of the changes.

8.2.4

9 Management system requirements

9.1 General

9.1.1

of this document. In addition to meeting the requirements of clauses in this document, the accreditation
9.1.4) or with option B
(see 9.1.5).

9.1.2

with the requirements of this document. The management shall ensure that the policies are understood,

9.1.3

improvement.

23
9.1.4
the following, as elaborated in 9.2 to 9.8:

— management reviews.

9.1.5
in accordance with the requirements of ISO 9001, and that is capable of supporting and demonstrating

9.2 Management system

9.2.1
volume of work performed. All applicable requirements of this document shall be addressed either in a

associated documents are accessible to its personnel and shall ensure effective implementation of the

9.2.2
accordance with the requirements of this document.

9.3 Document control

9.4 Records control

9.4.1

24
9.4.2
period consistent with its contractual obligations. Access to these records shall be consistent with the

9.5 Nonconformities and corrective actions

to eliminate the causes of nonconformities in order to prevent recurrence. Corrective actions shall be
appropriate to the impact of the problems encountered. The procedures shall cover the following:

g) reviewing the effectiveness of corrective actions.

9.6 Improvement

4.4).

9.7 Internal audits

9.7.1

is implemented and maintained.

9.7.2
taking into consideration the importance of the processes and areas to be audited, as well as the results
of previous audits.

9.7.3

9.7.4

25
9.8 Management reviews

9.8.1

9.8.2 Inputs to management reviews shall include, current performance and opportunities for
improvement related to the following:

9.8.3 The outputs from the management review shall include actions related to:

26
 Annex A
(informative)

Knowledge and skills for performing accreditation activities

Table A.1

6.1.2.2 to 6.1.2.8. Table A.1

Table A.1 — Table of knowledge and skills

Accreditation activities
Application Reviewing
review assessment Manage-
Knowledge and skills including Document reports and ment of ac-
Assessment
selection of review making ac- creditation
team mem- creditation schemes
bers decisions
Knowledge of accreditation X X X X X
(6.1.2.3) (6.1.2.3) (6.1.2.3) (6.1.2.3) (6.1.2.3)
Knowledge of assessment prin- X X X
ciples, practices and techniques
(6.1.2.2) (6.1.2.2) (6.1.2.2)
Knowledge of general manage- X X X
(6.1.2.2) (6.1.2.2) (6.1.2.2)
Communication skills appro- X
priate to all levels within the
(6.1.2.6)

Note-taking and report-writing X X

skills
(6.1.2.7) (6.1.2.6)
Opening and closing meeting skills X
(6.1.2.6)
Interviewing skills X
(6.1.2.6)
Assessment-management skills X
(6.1.2.6)
Knowledge of accreditation and X X X X X
accreditation scheme require-
(6.1.2.3) (6.1.2.3) (6.1.2.3) (6.1.2.3) (6.1.2.3)
ments and relevant guidance and
application documents (6.1.2.8)

NOTE 2 Accreditation scheme requirements include ISO/IEC 17020, ISO/IEC 17021-1, ISO/IEC 17025,
ISO/IEC 17024, ISO 17034, ISO/IEC 17043, ISO/IEC 17065, ISO 15189 and ISO 14065.

27
 Table A.1 (continued)
Accreditation activities
Application Reviewing
review assessment Manage-
Knowledge and skills including Document reports and ment of ac-
Assessment
selection of review making ac- creditation
team mem- creditation schemes
bers decisions
- X X X X X
ment scheme requirements, other
(6.1.2.3) (6.1.2.3) (6.1.2.3) (6.1.2.3) (6.1.2.3)

Knowledge of risk based assess- X X X

ment principles
(6.1.2.4) (6.1.2.4) (6.1.2.4)
Knowledge of the practices and X
(6.1.2.6)
-
vironment
Knowledge of general regulato- X X X X
(6.1.2.5) (6.1.2.5) (6.1.2.5) (6.1.2.5)

NOTE 2 Accreditation scheme requirements include ISO/IEC 17020, ISO/IEC 17021-1, ISO/IEC 17025,
ISO/IEC 17024, ISO 17034, ISO/IEC 17043, ISO/IEC 17065, ISO 15189 and ISO 14065.

28
 Bibliography

[1] ISO 9000, Quality management systems — Fundamentals and vocabulary

[2] ISO 9001, Quality management systems — Requirements
[3] ISO 9096, Stationary source emissions — Manual determination of mass concentration of
particulate matter
[4] ISO 10002, Quality management — Customer satisfaction — Guidelines for complaints handling in
organizations
[5] ISO 14001, Environmental management systems — Requirements with guidance for use
[6] ISO 14024, Environmental labels and declarations — Type I environmental labelling — Principles
and procedures
[7] ISO 14065,
for use in accreditation or other forms of recognition
[8] ISO 14064-3,

[9] ISO 14066, Greenhouse gases — Competence requirements for greenhouse gas validation teams and

[10] ISO 15189, Medical laboratories — Requirements for quality and competence
[11] ISO/IEC 17020, Conformity assessment — Requirements for the operation of various types of bodies
performing inspection
[12] ISO/IEC 17021-1, Conformity assessment — Requirements for bodies providing audit and

[13] ISO/IEC 17024,

of persons
[14] ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories
[15] ISO 17034, General requirements for the competence of reference material producers
[16] ISO/IEC 17043,
[17] ISO/IEC 17065, Conformity assessment — Requirements for bodies certifying products, processes
and services
[18] ISO/IEC 17067,

[19] ISO 19011, Guidelines for auditing management systems

[20] ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and
associated terms (VIM)1)

1) Also known as JCGM 200.

29
 Organization and Objectives

ESA’s objectives are:-

Ethiopian Standards Agency

Ethiopian Standards

More Information?
Contact us at the following address.
The Head Office of ESA is at Addis Ababa.

011- 646 06 85, 011- 646 05 65

011-646 08 80
2310 Addis Ababa, Ethiopia
E-mail: info@ethiostandards.org,
Website: www.ethiostandards.org
Standard Mark