Conformity Assessment
The terms certification,
registration and accreditation
are often used interchangeably in relation to independent assessment
of a quality system, product compliance with a standard, or servicing
competence. Approval is also incorrectly
used. Peter Unger of A2LA has kindly provided the following clarification
of the correct word that should be used for each aspect of "conformance".
Definitions
The process of determining whether products, processes,
systems or people meet specified requirements has been given the
name, conformity assessment. ISO's Committee on Conformity Assessment
(CASCO) provides several ISO guides on the subject. The tools of
conformity assessment are listed in the order of their emergence
in Table 1 with an asterisk to indicate usage by first
parties (suppliers), second parties (customers, regulators, or others
who demand compliance with requirements) and third parties (bodies
independent from both suppliers and their customers).
| |
First Party
|
Second Party
|
Third Party
|
| Manufacturer's declaration |
*
|
|
|
| Inspection |
*
|
*
|
*
|
| Testing |
*
|
*
|
*
|
| Auditing |
*
|
*
|
*
|
| Certification |
|
|
*
|
Table 1-- The
"tools" of conformity assessment and who uses them.
Manufacturer's declaration
of conformity
Commonly called self-certification it is, according to the definition
under ISO/IEC Guide 2, what a supplier (first party) does in giving
written assurance that its product meets specified requirements
(e.g. a standard specification for the product). It is the earliest
and most common form of conformity assessment and may be supplemented
by the other forms of conformity assessment: typically inspection
and/or testing (including calibration) of the product, auditing
of related product production systems and processes, and more recently,
certification (or registration) of the supplier's quality
system. ISO/IEC Guide 22 covers manufacturer's declaration of conformity
principles.
Certification
This is defined in Guide 2 as a procedure by which a third party
gives written assurance that a product, process, or service conforms
to specified requirements.
Inspection, testing and auditing are tools used by first,
second or third parties.
ISO CASCO has issued several guides related to inspection bodies
(Guide 39 and 57), testing (and calibration) laboratories (Guide
25), and certification bodies (Guides 62 and 65).
With the growing use of these conformity assessment tools has come
the need to assure the competence of the conformity assessment bodies
in order to enhance confidence in the results of conformity assessment
processes. Thus, we have accreditation.
Accreditation
This is defined in Guide 2 as a procedure by which an authoritative
body gives formal recognition that a body or person is competent
to carry out specific tasks.
Accreditation of laboratories is perhaps the oldest and most widespread
type of conformity assessment accreditation. Requirements for laboratory
accreditation bodies are addressed in Guide 58. More recently, accreditation
bodies for certification bodies (both product certifiers as well
as management system registrars) is covered by Guide 61. At the
moment (August 1998) there is no ISO/IEC Guide for those providing
accreditation of inspection bodies; one is currently being drafted
based on a combination of Guides 58 and 61. The European cooperation
for Accreditation (EA) has recently issued a document on this subject,
EAC/EAL-G28, EAC-EAL General Requirements for Bodies Providing Accreditation
of Inspection Bodies.
Further Advice
In a similar vein, the ISO also has something to say about these
often interchanged words in their Magical Demystifying Tour
article.
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