ASTM E1884-97
(Guide)Standard Guide for General Requirements for Bodies Operating Assessment and Certification/Registration of Quality Systems (Withdrawn 2004)
Standard Guide for General Requirements for Bodies Operating Assessment and Certification/Registration of Quality Systems (Withdrawn 2004)
SCOPE
1.1 This guide specifies general requirements for a third party body operating quality system certification/registration to meet if it is to be recognized as a competent and reliable in the operation of quality system certification/registration.
WITHDRAWN RATIONALE
This guide specifies general requirements for a third-party body operating quality system certification/registration to meet if it is to be recognized as competent and reliable in the operation of quality system certification/registration.
Formerly under the jurisdiction of Committee E36 on Conformity Assessment, this guide was withdrawn in May 2004 due to lack of interest and support for continued use.
General Information
Standards Content (Sample)
An American National Standard
Designation: E 1884 – 97
Standard Guide for
General Requirements for Bodies Operating Assessment
and Certification/Registration of Quality Systems
This standard is issued under the fixed designation E 1884; 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
Certification/registration of a supplier’s quality system is one means of providing assurance that the
certified/registered supplier is capable of supplying products or services that meet specified
requirements.
This guide specifies requirements, the observance of which is intended to ensure that certification/
registration bodies operate third-party certification/registration systems in a consistent and reliable
manner, thereby facilitating their acceptance on a national and international basis. This guide should
serve as a foundation for the recognition of relevant national systems in the interests of international
trade.
This guide is intended for use by bodies, however described, which carry out the functions of
assessment and certification/registration of quality systems. For convenience of drafting, such bodies
are referred to as certification/registration bodies. This wording should not be an obstacle to the use
of this guide by bodies with other designations which undertake activities which it covers. Indeed, this
guide should be usable by any body involved in quality system assessment.
The requirements contained in this guide are written, above all, to be considered as general
requirements for organizations operating quality system certification/registration programs, therefore
the requirements may have to be supplemented when specific industrial or other sectors, for example,
health and safety, make use of it.
Quality system certification/registration involves only the assessment of a supplier’s quality system
and not the certification of products, processes, or service. Evidence of conformity to the appropriate
quality system standard and any supplementary documentation will be in the form of a certification/
registration document or a quality system certificate.
While this guide is intended for use by bodies concerned with recognizing the competence of
certification/registration bodies, many provisions contained herein may be useful in second-party
assessment procedure.
requirements contained in this guide are written-above all, to be consid-
1. Scope
ered as general requirements for any body operating certification/
1.1 This guide specifies general requirements for a third-
registration of quality systems.
party body operating quality system certification/registration to
Table of Contents
meet if it is to be recognized as competent and reliable in the
Section Title
1 Scope
operation of quality system certification/registration.
2 Referenced Documents
NOTE 1—In some countries, the bodies which verify conformity of 3 Terminology
4 Certification/Registration Body
quality systems to specified standards are called certification bodies,in
4.1 General Provisions
others registration bodies, in others assessment and registration bodies or
4.2 Organization
certification/registration bodies and in still others registrars. For ease of
4.3 Sucontracting
understanding, this guide always refers to such bodies as certification/
4.4 Quality System
registration bodies. This should not be understood to be limiting. The
4.5 Conditions for Granting, Maintaining, Extending, Re-
ducing, Suspending, and Withdrawing Certification/
Registration
4.6 Internal Audits and Management Reviews
This guide is under the jurisdiction of ASTM Committee E-36 on Conformity
4.7 Documentation
Assessment and is the direct responsibility of E36.20 on Terminology.
4.8 Records
Current edition approved May 10, 1997. Published April 1998.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
E1884–97
Configuration Management
Table of Contents
Section Title
ISO 1001 1–1:1990, Guidelines for Auditing Quality Sys-
4.9 Confidentiality
tems–Part 1: Auditing
5 Certification/Registration Body Personnel
5.1 General ISO 1001 1–2:1991, Guidelines for Auditing Quality Sys-
5.2 Selection Procedure
tems–Part 2: Qualification Criteria for Quality Systems
5.3 Contracting of Assessment Personnel
Auditors
5.4 Assessment Personnel Records
5.5 Procedures for Audit Teams
ISO 1001 1–3:1991, Guidelines for Auditing Quality Sys-
5.6 Changes in the Certification/Registration Requirements
tems–Part 3: Management of Audit Programs
5.7 Appeals, Complaints, and Disputes
ISO 10012–1:1992, Quality Assurance Requirements for
6 Requirements for Certification/Registration
6.1 Application for Certification/Registration
Measuring Equipment–Part 1: Metrological Confirmation
6.2 The Application
System for Measuring Equipment
6.3 Preparation for Assessment
ISO 10013:1995, Guidelines for Developing Quality Manu-
6.4 Assessment
6.5 Assessment Report
als
6.6 Decision on Certification/Registration
6.7 Surveillance and Reassessment Procedures
6.8 Use of Certificates and Logos 3. Terminology
6.9 Access to Records of Complaints & Suppliers
3.1 Definitions—For the purposes of this guide, the relevant
7 Keywords
definition given in ISO/IEC Guide 2 and ISO 8402 and the
2. Referenced Documents
following definitions apply:
3.1.1 supplier,, n—the party that is responsible for the
2.1 ISO Standards:
product, process, or service and is able to ensure that quality
ISO/IECGuide2:1996 GeneralTermsandTheirDefinitions
assurance is exercised. This definition may apply to manufac-
Concerning Standardization and Related Activities
turers, distributors, importers, assemblers, service organiza-
ISO 8402:1994, Quality Management and Quality Assur-
tions, etc.
ance–Vocabulary
3.1.2 certification/registration body,, n— a third party that
ISO 9000–1:1994, Quality Management and QualityAssur-
assesses and certifies/registers the quality system of suppliers
ance Standards–Part 1: Guidelines for Selection and Use
with respect to published quality system standards and any
ISO 9000–2:1993, Quality Management and QualityAssur-
supplementary documentation required under the system.
ance +s–Part 2: Generic Guidelines for theApplication of
3.1.3 certificate/registration document,, n— document indi-
ISO 900 1, ISO 9002 and ISO 9003
cating that a supplier’s quality system conforms to specified
ISO 9000–3:1991, Quality Management and QualityAssur-
quality system standards and any supplementary documenta-
ance Standards–Part 3: Guidelines for the Application of
tion required under the system.
ISO 9001 to the Development Supply, and Maintenance of
3.1.4 certification/registration system,, n— system having
Software
itsownrulesofprocedureandmanagementforcarryingoutthe
ISO 9000–4:1993, Quality Management and QualityAssur-
assessmentleadingtotheissuanceofacertification/registration
ance Standards–Part 4: Guide to Dependability Program
document and its subsequent maintenance.
Management
ISO 9001:1994, Quality Systems–Model for QualityAssur-
4. Certification/Registration Body
ance in Design, Development, Production, Installation,
and Servicing
4.1 General Provisions:
ISO 9002:1994, Quality Systems–Model for QualityAssur-
4.1.1 The policies and procedures under which the
ance in Production,Installation and Servicing
certification/registration body operates shall be nondiscrimina-
ISO 9003:1994, QualitySystems–ModelforQualityAssur-
tory, and they shall be administered in a nondiscriminatory
ance in Final Inspection and Tests
manner. Procedures shall not be used to impede or inhibit
ISO 9004–1:1994, Quality Management and Quality Sys-
access by applicants other than as specified in this guide.
tem Elements–Part 7: Guidelines
4.1.2 The certification/registration body shall make its ser-
ISO 9004–2:1991, Quality Management and Quality Sys-
vices accessible to all applicants. There shall not be undue
tem Elements–Part 2: Guidelines for Services
financial or other conditions. Access shall not be conditional
ISO 9004–3:1993, Quality Management and Quality Sys-
upon the size of the supplier or membership of any association
tem Elements–Part 3: Guidelines for Processed Materials
or group, nor shall certification/registration be conditional
ISO 9004–4:1993, Quality Management and Quality Sys-
upon the number of suppliers already certified/registered.
tem Elements–Part 4: Guidelines for Quality Improve-
4.1.3 The criteria against which the quality system of an
ments
applicant is assessed shall be those outlined in the quality
ISO 10005:1995, Quality Management–Guidelines for
system standards or other normative documents relevant to the
Quality Plans
function performed. If an explanation is required as to the
ISO 10007:1995, Quality Management–Guidelines for
application of these documents to a specific certification/
registration program, it shall be formulated by relevant and
impartial committees or persons possessing the necessary
technical competence and published by the certification/
Available from American National Standards Institute, 11 W. 42nd St., 13th
floor, New York, NY 10036 registration body.
E1884–97
4.1.4 The certification/registration body shall confine its from any commercial, financial, and other pressure that might
requirements, assessment, and decision on certification/ influence decisions (see Note 2);
registration to those matters related specifically to the scope of 4.2.15 Ensure that activities of related bodies do not affect
the certification/registration being considered. the confidentiality, objectivity, or impartiality of its
certifications/registrations and shall not offer or provide those
4.2 Organization— The structure of the certification/
registration body shall be such as to give confidence in its services that it certifies/registers others to perform, consulting
services to obtain or maintain certification/registration, and
certifications/registrations. In particular, the certification/
registration body shall do the following: services to design, implement or maintain quality systems (see
Note 3); and,
4.2.1 Be impartial;
4.2.16 Have policies and procedures for the resolution of
4.2.2 Be responsible for its decisions relating to the grant-
complaints, appeals, and disputes received from suppliers or
ing, maintaining, extending, reducing, suspending, and with-
other parties about the handling of certification/registration or
drawing of certification/registration;
any other related matters.
4.2.3 Identify the management (committee, group, or per-
son) which will have overall responsibility for performance of
NOTE 2—Astructurewheremembersarechosentoprovideabalanceof
assessment and certification/registration as defined in this
interests, where no single interest predominates, will be deemed to satisfy
guide, the formulation of policy matters relating to the opera- this provision.
tion of the certification/registration body, decisions on
NOTE 3—Otherproducts,processes,orservicesmaybeoffered,directly
or indirectly, provided they do not compromise confidentiality or the
certification/registration, supervision of the implementation of
objectivity or impartiality of its certification/registration process and
its policies, supervision of the finances of the certification/
decisions.
registration body, and, delegation of authority to committees or
individuals, as required, to undertake defined activities on its
4.3 Subcontracting—When a certification/registration body
behalf.
decidestosubcontractworkrelatedtocertification/registration,
4.2.4 Have documents, which demonstrate that it is a legal for example, audits, to an external body or person, a properly
entity;
document agreement covering the arrangements, including
4.2.5 Have a document structure, which safeguards impar- confidentiality and conflict of interests, shall be drawn up. The
tiality, including provisions to assure the impartiality of the certification/registration body shall take full responsibility for
operations of the certification/registration body; this structure such subcontracted work and maintain its responsibility for
shall enable the participation of all parties significantly con- granting, maintaining, extending, reducing, suspending, or
cerned in the development of policies and principles regarding withdrawing certification/registration; ensure that the subcon-
the content and functioning of the certification/registration tracted body or person is competent and complies with the
system; applicable provisions of this guide and is not involved, either
4.2.6 Ensure that each decision on certification/registration directly or through its employer, with the design, implementa-
tion or maintenance of a quality system in such a way that
istakenbyapersonorpersonsdifferentfromthosewhocarried
out the assessment; impartiality could be compromised; and, obtain the consent of
the applicant or certified/registered supplier.
4.2.7 Have rights and responsibilities relevant to its
certification/registration activities;
NOTE 4—Requirements also are relevant, by extension, when a
4.2.8 Have adequate arrangements to cover liabilities aris-
certification/registration body uses, for granting its own certification/
ing from its operations and/or activities;
registration, work provided by another certification/registration body with
which it has signed an agreement.
4.2.9 Have the financial stability and resources required for
the operation of a certification/registration system;
4.4 Quality System— The management of the certification/
4.2.10 Employ a sufficient number of personnel having the
registration body with executive responsibility for quality shall
necessary education, training, technical knowledge, and expe-
define and document its policy for quality, including objectives
rience for performing certification/registration functions relat-
for quality and its commitment to quality. The management
ing to the type, range, and volume of work performed, under a
shall ensure that this policy is understood, implemented, and
responsible senior executive;
maintained at all levels of the organization. The certification/
4.2.11 Have a quality system, as outlined in 4.4, giving
registration body shall operate a quality system in accordance
confidence in its ability to operate a certification/registration
with the relevant elements of this guide and appropriate to the
system for suppliers;
type, range, and volume of work performed. This quality
4.2.12 Have policies and procedures that distinguish be-
system shall be documented and the documentation shall be
tween supplier certification/registration and any other activities
available for use by the staff of the certification/registration
in which the body is engaged;
body. The certification/registrat
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