TS 13386
Guidance on the application of ISO/IEC Guide 65:1996 Issue 2
1.1 This Guide specifies general requirements that a
third-party operating a product certification system
shall meet if it is to be recognized as competent and
reliable.
In this Guide the term “certification body” is used to
cover any body operating a product certification system.
The word “product” is used in its widest sense
and includes processes and services; the word
“standard” is used to include other normative documents
such as specifications or technical regulations.
1.2 The certification system used by the certification
body may include one or more of the following, which
could be coupled with production surveillance or
assessment and surveillance of the supplier’s quality
system or both, as described in lSO/IEC Guide 53:
a) type testing or examination;
b) testing or inspection of samples taken from the
market or from supplier’s stock or from a combination
of both;
d testing or inspection of every product or of a particular
product, whether new or already in use;
d) batch testing or inspection;
lSO/IEC Guide 2:1996, Standardization and related
activities – General vocabulary.
lSO/IEC Guide 7:1994, Guidelines for drafting of
standards suitable for use for conformity assessment.
lSO/IEC Guide 23:1982, Methods of indicating conformity
with standards for third-party certification systems.
lSO/IEC Guide 25:1990, General requirements for the
competence of calibration and testing labora tories.
lSO/I EC Guide 27: 1983, Guidelines for corrective
action to be taken by a certification body in the event
of misuse of its mark of conformity.
lSO/IEC Guide 28:1982, General rules for a model
third-party certification sys tern for products.
lSO/l EC Guide 39: 1988, General requirements for the
acceptance of inspection bodies.
lSO/IEC Guide 53:1988, An approach to the utilization
of a supplier’s quality system in third-party product
certification.
ISO/I EC Guide 62: 1996, General requirements for
bodies operating assessment and certifica tion/registra
tion of quality sys terns.
e) design appraisal.
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About This Item
TS 13386 presents IAF guidance on how certification bodies operating product certification schemes should apply TS EN 45011 (ISO/IEC Guide 65:1996). It is a framework for understanding third-party product certification, the responsibilities of the certifying body, and how conformity is demonstrated to markets and/or regulators.
How the scope treats products, services and processes
The guide uses the word “product” in a broad sense. In general technical context, that means the same certification logic may extend beyond tangible goods to software, services, and processes where appropriate. The mention of separate annexes for service certification and process certification also signals that these areas have distinctive technical features and are not simply identical to classic product certification.
Technical context of a product certification system
The document describes the purpose of a product certification system as showing that a supplier can produce, and does produce, products conforming to a normative document. In general practice, such systems may rely on type testing, sample examination, batch inspection, or design appraisal, depending on the certification model. It also notes that inspection may form part of product certification; when it does, the inspection is carried out on behalf of the certification body, which makes the division of roles between testing/inspection and certification important.
This standard functions as an application guide for the general requirements that a certification body must meet in order to be recognized as competent and reliable. Its references place it within the wider conformity assessment infrastructure, alongside standards and guides for product certification, conformity marks, inspection bodies, laboratory competence, and quality system assessment.
- Provides IAF guidance for applying requirements to third-party product certification systems.
- Uses “product” broadly, and may include services, processes, and software where relevant.
- Highlights the distinct roles of the supplier, the certification body, and inspection activities.
- Explains the general placement of different certification approaches within one scheme.
- Publication Date: 8.01.2009
- Standard Status: H (İptal Edilmiş Standard/Withdrawn standard)
- Publisher: TSE
- Document Language: tr
- ICS Classification: 03.120.20 Ürün ve Şirket Belgelendirmesi, Uygunluk Değerlendirmesi
- Pages: 17
- Source Standard: IAF GD 5:2006
- International Equivalents: ---; ---
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