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ISO-IEC Guide 65
ISO-IEC Guide 65
Canoy
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ISO/IEC GUIDE 65:1996(E)
Contents Page
Scope .............................................................................................. 1
References ...................................................................................... 1
Definitions ....................................................................................... 1
IO Evaluation ........................................................................................ 7
13 Surveillance ..................................................................................... 8
0 ISO/lEC 1996
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II
0 lSO/IEC ISO/IEC GUIDE 65:1996(E)
Foreword
IS0 (the International Organization for Standardization) and IEC (the
International Electrotechnical Commission) form the specialized system for
worldwide standardization. National bodies that are members of IS0 or IEC
participate in the development of International Standards through technical
committees established by the respective organization to deal with
particular fields of technical activity. IS0 and IEC technical committees
collaborate in fields of mutual interest. Other international organizations,
governmental and non-governmental, in liaison with IS0 and IEC, also take
part in the work.
Introduction
Certification of a product (a term used to incl ude a process or service) is a
means of providing assurance t hat it complies with specified standards
and other normative documents. Some product certification systems may
include initial testing of a product and assessment of its suppliers’ quality
systems, followed by surveillance that takes into account the factory qual-
ity system and the testing of samples from the factory and the open mar-
ket. Other systems rely on initial testing and surveillance testing, while still
others comprise type testing only.
The requirements contained in this Guide are written, above all, to be con-
sidered as general criteria for organizations operating product certification
systems; they may have to be amplified when specific industrial or other
sectors make use of them, or when particular requirements such as health
and safety have to be taken into account.
type testing or examination; lSO/l EC Guide 39: 1988, General requirements for the
a)
acceptance of inspection bodies.
b) testing or inspection of samples taken from the
market or from supplier’s stock or from a combi- lSO/IEC Guide 53:1988, An approach to the utilization
nation of both; of a supplier’s quality system in third-party product
certification.
d testing or inspection of every product or of a par-
ticular product, whether new or already in use; ISO/I EC Guide 62: 1996, General requirements for
bodies operating assessment and certifica tion/regis-
d) batch testing or inspection; tra tion of quality sys terns.
e) design appraisal.
3 Definitions
For the purposes of this Guide, the relevant definitions
given in lSO/IEC Guide 2 and IS0 8402 apply, together
2 References with the following definition.
IS0 8402:1994, Quality management and quality
assurance - Vocabulary. 3.1 supplier: The party that is responsible for
ensuring that products meet and, if applicable,
IS0 1001 l-l : 1990, Guidelines for auditing quality continue to meet, the requirements on whrch the
sys terns - Part 7: Auditing. certification is based.
financial and other pressures that might influence b) ensure that the subcontracted body or person is
decisions; a structure where members are competent and complies with the applicable pro-
chosen to provide a balance of interests where visions of this Guide and other standards and
no single interest predominates will be deemed guides relevant to testing, inspection or other
to satisfy this provision; technical activities (see clause Z), and is not
involved either directly or through the person’s
0) ensure that activities of related bodies do not employer with the design or production of the
affect the confidentiality, objectivity and impar- product in such a way that impartiality would be
tiality of its certifications, and it shall not compromised;
1) supply or design products of the type it cer-
tif ies, d obtain the applicant’s consent.
the manual shall contain or refer to at least the fol- 4.6 Conditions and procedures for granting,
lowing: maintaining, extending, suspending and
withdrawing certification
a) a quality policy statement;
4.6.1 The certification body shall specify the con-
b) a brief description of the legal status of the certi- ditions for granting, maintaining and extending certifi-
fication body, including the names of its owners cation and the conditions under which certification
and, if different, names of the persons who con- may be suspended or withdrawn, partially or in total.
trol it;
d the names, qualifications, experience and terms 4.6.2 The certification body shall have procedures to
of reference of the senior executive and other
a) grant, maintain, withdraw and, if applicable, sus-
certification personnel, both internal and external;
pend certification;
an organization chart showing lines of authority,
b) extend or reduce the scope of certification;
responsibility and allocation of functions stem-
ming from the senior executive; cl re-evaluate, in the event of changes significantly
affecting the product’s design or specification, or
a description of the organization of the certifi- changes in the standards to which compliance of
cation body, including details of the management the product is certified, or changes in the owner-
(committee, group or person) identified in 4.2 c), ship, structure or management of the supplier, if
its constitution, terms of reference and rules of relevant, or in the case of any other information
procedure; indicating that the product may no longer comply
the policy and procedures for conducting man- with the requirements of the certification sys-
agement reviews; tem.
h) the operational and functional duties and services 4.7.1 The certification body shall conduct periodic
pertaining to quality, so that the extent and limits internal audits covering all procedures in a planned
of each person’s responsibility are known to all and systematic manner, to verify that the quality sys-
concerned; tem is implemented and is effective.
the procedure for the recruitment, selection and The certification body shall ensure that
training of certification body personnel and moni-
toring of their performance; a) personnel responsible for the area audited are
informed of the outcome of the audit;
a list of its approved subcontractors and the pro-
cedures for assessing, recording and monitoring b) corrective action is taken in a timely and appro-
their competence; priate manner; and
its procedures for handling nonconformities and d the results of the audit are documented.
for assuring the effectiveness of any corrective
and preventive actions taken; 4.7.2 The body’s management with executive re-
the proce dures for evaluating products and sponsibility shall review its quality system at defined
impl ement ing the certification process, includ ’ w intervals which are sufficiently short to ensure its
continuing suitability and effectiveness in satisfying
1) the conditions for issue, retention and the requirements of this Guide and the stated quality
withdrawal of certification documents, policy and objectives. Records of such reviews shall
2) controls over the use and application of be maintained.
documents employed in the certification of
products;
4.8 Documentation
the policy and procedure for dealing with appeals,
complaints and disputes; 4.8.1 The certification body shall provide (through
publications, electronic media or other means), update
n) its procedures for conducting internal audits, at regular intervals, and make available on request, the
based on the provisions of IS0 1001 l-l. following:
a) information about the authority under which the formation. The records shall be kept for a period of
certification body operates; time so that continued confidence may be demonstra-
ted for at least one full certification cycle, or as re-
b) a documented statement of its product certifi- quired by law.
cation including its rules and procedures
system,
for granting, maintaining, extending, suspending
and withdrawing certification; 4.9.2 The certification body shall have a policy and
procedures for retaining records for a period consist-
d information about the evaluation procedures and ent with its contractual, legal or other obligations. The
certification process related to each product cer- certification body shall have a policy and procedures
tification system; concerning access to these records consistent with
4.10.1.
d) a description of the means by which the organ-
ization obtains financial support and general in- NOTE 4 The question of the length of time for retention of
formation on the fees charged to applicants and records requires specific attention in the light of legal cir-
to suppliers of certified products; cumstances and recognition arrangements.
5.2.2 The certification body shall require its person- tres shall be subject to the procedures of the
nel involved in the certification process to sign a con- certification body.
tract or other document by which they commit
themselves
7.2 Each certification body shall
a) to comply with the rules defined by the certifi-
cation body, including those relating to confiden- a) keep a record of all appeals, complaints and dis-
tiality and independence from commercial and putes and remedial actions relative to _certifi-
other interest; and cation;
b) to declare any prior and/or present association on b) take appropriate subsequent action;
their own part, or on the part of their employer,
with a supplier or designer of products to the d document the action taken and its effectiveness.
evaluation or certification of which they are to be
assigned.
d) experience and training in each field of the certi- a) always complies with the relevant provisions of
fication body’s competence; the certification programme;
e) date of most recent updating of records; b) makes all necessary arrangements for the con-
f1 performance appraisal. duct of the evaluation, including provision for
examining documentation and access to all
areas, records (including internal audit reports)
and personnel for the purposes of evaluation
6 Changes in the certification (e.g. testing, inspection, assessment surveil-
requirements lance, reassessment) and resolution ‘of com-
plaints;
The certification body shall give due notice of any
changes it intends to make in its requirements for d makes claims regarding certification only in res-
certification. It shall take account of views expressed pect of the scope for which certification has been
by interested parties before deciding on the precise granted;
form and effective date of the changes. Following
decision on, and publication of, the changed require- d does not use its product certification in such a
ments, it shall verify that each supplier makes any manner as to bring the certification body into dis-
necessary adjustments within such time as, in the repute and does not make any statement regard-
opinion of the certification body, is reasonable. ing its product certification which the certification
body may consider misleading or unauthorized;
f1 uses certification only to indicate that products cl the certification body has the capability to per-
are certified as being in conformity with specified form the certification service with respect to the
standards; scope of the certification sought and, if applic-
able, the location of the applicant’s operations
9) endeavours to ensure that no certificate or report and any special requirements such as the
nor any part thereof is used in a misleading man- language used by the applicant.
ner;
h) in making reference to its product certification in 9.2 The certification body shall prepare a plan for its
communication media such as documents, bro- evaluation activities to allow for the necessary ar-
chures or advertising, complies with the require- rangements to be managed.
ments of the certification body.
9.3 The certification body shall assign personnel
8.1.3 When the desired scope of certification is re-
appropriately qualified to perform the tasks for the
lated to a specific system or type of system operated
specific evaluation. Personnel shall not be assigned if
by the certification body, any explanation needed shall
they have been involved in, or been employed by a
be provided to the applicant.
body involved in, the design, supply, installation or
maintenance of such products in a manner and within
8.1.4 If requested, additi onal application information a time period which could conflict with impartiality.
shall be provided to t he ap plicant.
12 Decision on certification which affect the conformity of the product. The certifi-
cation body shall determine whether the announced
12.1 The decision as to whether or not to certify a changes require further investigations. If such is the
product shall be taken by the certification body on the case, the supplier shall not be allowed to release cer-
basis of the information gathered during the evalu- tified products resulting from such changes until the
ation process and any other relevant information. certification body has notified the supplier accordingly.
12.2 The certification body shall not delegate auth- 13.3 The certification body shall document its sur-
ority for granting, maintaining, extending, suspending veillance activities.
or withdrawing certification to an outside person or
body. 13.4 Where the certification body authorizes the
continuing use of its mark on products of a type which
12.3 The certification body shall provide to each have been evaluated, the certification body shall
supplier offering certified products, formal certification periodically evaluate the marked products to confirm
documents such as a letter or a certificate signed by that they continue to conform to the standards.
an officer who has been assigned such responsibility.
These formal certification documents shall permit
identification of the following:
14 Use of hcences, certificates and
a) the name and address of the supplier whose marks of conformity
products are the subject of certification;
14.1 The certification body shall exercise proper
b) the scope of the certification granted, including, control over ownership, use and display of licences,
as appropriate, certificates and marks of conformity.