ASTM E1905-97

An American National Standard
Designation: E 1905 – 97
Guide for
General Requirements for Assessment and Accreditation of
Certification/Registration Bodies
This standard is issued under the fixed designation E 1905; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
The requirements contained in this guide are written, above all, to be considered as general
requirements for bodies operating accreditation systems. This guide, however, is in three sections so
that if used by organizations other than accreditation bodies concerned with recognition of
competence, Sections 1–3 and 5 apply, and users need simply replace accreditation by recognition.
tation and implementation of standards, each accreditation body should
1. Scope
encourage technical cooperation and exchange of experience among
1.1 This guide specifies general requirements for a body to
bodies accredited by it, and it should be prepared to exchange information
follow if it is to be recognized at a national or international
on accreditation procedures and practices with other accreditation bodies.
level as competent and reliable in assessing and subsequently
Certification and certification/registration body standards often contain
accrediting certification bodies or registration bodies. Confor- nonspecific requirements, such as “staff shall be competent”. Mutual
recognition of accreditation requires harmonization of interpretation of
mitytotherequirementsofthisguidewillpromoteequivalence
such clauses.
of national systems and facilitate agreements on mutual rec-
ognition of accreditations between such bodies.
2. Referenced Documents
1.2 The primary objective of this guide is to describe
2.1 ISO Standards:
accreditation as providing, by means of assessment and sub-
ISO 8402:1994, Quality Management and Quality Assur-
sequent surveillance, an assurance that the market can rely on
ance–Vocabulary
certificates issued by the accredited bodies. However, organi-
ISO 1001 1–1: 1990, Guidelines for Auditing Quality Sys-
zations other than accreditation bodies, concerned with recog-
tems–Part 1: Auditing
nition of competence, also may use it by replacing accredita-
ISO 1001 1–2: 1991, Guidelines for Auditing Quality Sys-
tion by recognition.
tems–Part 2: Qualification Criteria for Quality Systems
1.3 In some countries, bodies which verify conformity of
Auditors
products, processes, services, or systems to specified standards
2.2 ISO/IEC Standards:
are called certification bodies, in other countries registration
ISO/IEC Guide 2:1996, General Terms and Their Defini-
bodies, and in still others assessment bodies. For ease of
tions Concerning Standardization and Related Activities
understanding, this guide always refers to such bodies as
ISO/IEC Guide 25:1990, General Requirements for the
bodies. This should not be understood to be limiting, as this
Competence of Calibration and Testing Laboratories
guide also may be applicable to the assessment and accredita-
ISO/IEC Guide 27:1983, Guidelines for Corrective Action
tion of conformity assessment bodies other than certification or
to Be Taken by a Certification Body in the Event of
registration bodies, such as inspection bodies.
Misuse of Its Mark of Conformity
NOTE 1—It is recognized that agreements on mutual recognition of
ISO/IEC Guide 28:1982, General Rules for a Model Third-
accreditations aiming at the removal of barriers to cross-border trade may 2
Party Certification System for Products
have to cover other aspects not explicitly specified in these general
ISO/IEC Guide 40:1, General Requirements for Bodies
requirements, such as the exchange of staff or training programs. In
Operating Product Certification Systems
particular, with a view to create confidence and harmonize the interpre-
ISO/IEC Guide 62:1996, General Requirements for Bodies
This guide is under the jurisdiction of ASTM Committee E-36 on Conformity
Assessment and is the direct responsibility of Subcommittee E36.60 on Accredita-
tion Bodies. Available from American National Standards Institute, 11 W. 42nd St., 13th
Current edition approved Oct. 10, 1997. Published April 1998. Floor, New York, NY 10036.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E1905–97
Operating Assessment and Certification/Registration of the participation of all parties significantly concerned in the
Quality Systems development of policies and principles regarding the content
and functioning of the accreditation system;
3. Terminology
4.2.6 Ensure that each decision on accreditation is taken by
3.1 Definitions— For the purposes of this guide, the rel-
a person or persons different from those who carried out the
evant definitions provided in ISO/IEC Guide 2 and ISO 8402
assessment;
apply.
4.2.7 Have rights and responsibilities relevant to its accredi-
tation activities;
4. Requirements forAccreditation Bodies
4.2.8 Have adequate arrangements to cover liabilities aris-
4.1 Accreditation Body—General Provisions:
ing from its operations and/or activities;
4.1.1 The policies and procedures under which the accredi-
4.2.9 Have the financial stability and resources required for
tation body operates shall be nondiscriminatory and they shall
the operation of an accreditation system;
be administered in a nondiscriminatory manner. Procedures
4.2.10 Employ a sufficient number of personnel having the
shall not be used to impede or inhibit access by applicant
necessary education, training, technical knowledge, and expe-
bodies other than as specified in this guide.
rience for performing accreditation functions relating to the
4.1.2 The accreditation body shall make its services acces-
type, range, and volume of work performed, under a respon-
sible to all applicants whose activities fall within its declared
sible senior executive;
field of operation. There shall not be undue financial or other
4.2.11 Have a quality system, as outlined in 4.4, giving
conditions.Access shall not be conditional upon the size of the
confidence in its ability to operate an accreditation system for
applicant body or membership of any association or group, nor
certification/registration bodies;
shall accreditation be conditional upon the number of bodies
4.2.12 Have policies and procedures that distinguish be-
already accredited.
tween accreditation and any other activities in which the
4.1.3 The accreditation criteria against which the compe-
accreditation body is engaged;
tenceofanapplicantbodyisassessedshallbethoseoutlinedin
the ISO/IEC Guides 40 and 62 or other normative documents 4.2.13 Together with its senior executive and staff, be free
from any commercial, financial, and other pressures, which
relevant to the function performed. If an explanation is
required as to the application of these documents to a specific might influence the results of the accreditation process;
accreditation program, it shall be formulated by relevant and
4.2.14 Have formal rules and structures for the appointment
impartial committees or persons possessing the necessary
and operation of any committees which are involved in the
technical competence, and published by the accreditation body.
accreditation process; such committees shall be free from any
4.1.4 The accreditation body shall confine its requirements,
commercial, financial and other pressures that might influence
assessment, and decisions on accreditation to those matters
decisions (see Note 2);
specifically related to the scope of the accreditation being
NOTE 2—Astructurewheremembersarechosentoprovideabalanceof
considered.
interests, where no single interest predominates, will be deemed to satisfy
4.2 Organization— The structure of the accreditation body
this provision.
shall be such as to give confidence in its accreditations. In
4.2.15 Ensure that activities of related bodies do not affect
particular, the accreditation body shall do the following:
the confidentiality, objectivity, or impartiality of its accredita-
4.2.1 Be impartial;
tions and shall not offer or provide, directly or, indirectly, the
4.2.2 Be responsible for its decisions relating to the grant-
following:
ing, maintaining, extending, reducing, suspending, and with-
4.2.15.1 Those services that it accredits others to perform;
drawing of accreditation;
4.2.3 Identify the management (committee, group, or per- 4.2.15.2 Consulting services to obtain or maintain accredi-
son), which will have overall responsibility for all of the tation;
following:
4.2.15.3 Services to design, implement or maintain a certi-
4.2.3.1 Performance of assessment and accreditation as
fication scheme (see Note 3);
defined in this guide;
NOTE 3—Otherproducts,processes,orservicesmaybeoffered,directly
4.2.3.2 Formulation of policy matters relating to the opera-
or indirectly, provided they do not compromise confidentiality or the
tion of the accreditation body;
objectivity or impartiality of its accreditation process and decisions.
4.2.3.3 Decisions on accreditation;
4.2.16 Have policies and procedures for the resolution of
4.2.3.4 Supervision of the implementation of its policies;
complaints,appeals,anddisputesreceivedfrombodiesorother
4.2.3.5 Supervision of the finances of the accreditation
parties about the handling of accreditation or any related
body; and,
matters.
4.2.3.6 Delegation of authority to committees or individu-
als, as required, to undertake defined activities on its behalf; 4.3 Subcontracting— When an accreditation body decides
4.2.4 Have documents, which demonstrate that it is a legal to subcontract work related to accreditation, for example,
entity; audits, to an external body or person, a properly documented
4.2.5 Have a documented structure, which safeguards im- agreementcoveringthearrangements,includingconfidentiality
partiality, including provisions to assure the impartiality of the and conflict of interests, shall be drawn up. The accreditation
operationsoftheaccreditationbody.Thisstructureshallenable body shall do the following:
E1905–97
4.3.1 Take full responsibility for such subcontracted work 4.4.3.6 Information on procedures for handling complaints,
and maintain its responsibility for granting, maintaining, ex- appeals, and disputes;
tending, reducing, suspending, or withdrawing accreditation;
4.4.3.7 A directory of accredited bodies including their
locations,describingthescopeofaccreditationgrantedtoeach;
4.3.2 Ensure that the subcontracted body or person is
competent and complies with the applicable provisions of this 4.4.3.8 The operational and functional duties and services
guide and is not involved, either directly or through its pertaining to quality, so that the extent and limits of each
employer, with the design, implementation or maintenance of a person’s responsibility are known to all concerned;
certification or certification/registration scheme in such a way 4.4.3.9 The policy and procedures for the recruitment and
that impartiality could be compromised; and, training of accreditation body personnel (including auditors)
and monitoring their performance;
4.3.3 Obtain the consent of the applicant or accredited body.
4.4.3.10 A list of its subcontractors and details of the
NOTE 4—Requirements as stated in 4.3.1 and 4.3.2 also are relevant, by
procedures for assessing, recording, and monitoring their
extension, when an accreditation body uses, for granting its own accredi-
competence;
tation, work provided by another accreditation body with which it has
4.4.3.11 Itsproceduresforhandlingnonconformitiesandfor
signed an agreement.
assuring the effectiveness of any corrective actions taken;
4.4 Quality System:
4.4.3.12 The policy and procedures for implementing the
4.4.1 The management of the accreditation body with ex-
accreditation process, including:
ecutive responsibility for quality shall define and document its
(a) (a) The conditions for issue, retention and withdrawal
policy for quality, including objectives for quality and its
of accreditation documents;
commitment to quality. The management shall ensure that this
(b) (b) Checks of the use and application of documents
policy is understood, implemented, and maintained at all levels
used in the accreditation;
of the organization.
(c) (c) The procedures for assessing and accrediting appli-
4.4.2 The accreditation body shall operate a quality system
cants;
in accordance with the relevant elements of this guide and
(d) (d)The procedures for surveillance and reassessment of
appropriate to the type, range, and volume of work performed.
accredited bodies;
This quality system shall be documented and the documenta-
4.4.3.13 The policy and procedures for dealing with ap-
tion shall be available for use by the staff of the accreditation
peals, complaints, and disputes; and,
body. The accreditation body shall ensure effective implemen-
4.4.3.14 The procedures for conducting internal audits
tation of the documented quality system procedures and
based on the provisions of ISO 1 001 1–1.
instructions. The accreditation body shall designate a person
4.5 Conditions for Granting, Maintaining, Extending, Re-
with direct access to its highest executive level, who irrespec-
ducing, Suspending and Withdrawing Accreditation:
tive of other responsibilities, shall have defined authority to do
4.5.1 The accreditation body shall specify the conditions for
the following:
granting, maintaining, extending, and reducing accreditation,
4.4.2.1 Ensure that a quality system is established, imple-
and the conditions under which accreditation may be sus-
mented, and maintained in accordance with this guide;
pended or withdrawn, partially or in total, for all or part of the
4.4.2.2 Report on the performance of the quality system to
accredited body’s scope of accreditation. In particular, the
the management of the accreditation body for review and as a
accreditation body shall require the body to notify it promptly
basis for improvement of the quality system.
ofanyintendedchangestothequalitysystemorotherchanges,
4.4.3 The quality system shall be documented in a quality
which may affect conformity.
manual and associated quality procedures, and the quality
4.5.2 Theaccreditationbodyshallhaveprocedurestodothe
manual shall contain or refer to at least the following:
following:
4.4.3.1 A quality policy statement;
4.5.2.1 Grant, maintain, withdraw, and suspend accredita-
4.4.3.2 Abrief description of the legal status of the accredi-
tion;
tation body, including the names of its owners, if applicable,
4.5.2.2 Extend or reduce the scope of accreditation; and,
and if different, the names of the persons who control it;
4.5.2.3 Conduct reassessment in the event of changes si
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