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Interpretation of ISO/IEC 17065 7.0 and 6.2.2

PUBLIC NOTICE PRO-NT-104 Issued: 2016-4-25, Revision: 1

References ISO/IEC 17020:2012, Conformity assessment -- Requirements for the operation of various types of bodies performing inspection
ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories
ISO/IEC 17065:2012, Conformity assessment - Requirements for bodies certifying products, processes and services
Contents
1Objective
1.1The objective of this notice is to provide interpretation of ISO/IEC 17065 7.0 and 6.2.2
2Definitions
None.
3Effective Date
June 1st, 2007
4Notice
4.1Abstract
4.1.1Selective application of ISO/IEC 17025 clauses when assessing competence of external sources of testing. Applicability of ISO/IEC 17025 to manufacturer’s testing or measurement required as part of surveillance activities but not performed by the certification body. Applicability of interpretation to use of ISO/IEC 17020 and ISO/IEC 17011.
4.2Background
4.2.1It is not clear how to assess in the situation of the certification body (CB) determining that clauses of ISO/IEC 17025 are not applicable to testing from external sources. The following are the known scenarios of externally performed testing:
a)CB witnesses testing at manufacturer’s/client laboratory
b)CB witnesses testing at an independent laboratory
c)CB accepts manufacturer’s/client’s test data (not witnessed)
d)CB accepts test data from an independent laboratory (not witnessed)
e)CB accepts test data from other members in a multilateral scheme for acceptance of test data (not witnessed)
4.2.2In addition, it is not clear how to assess in the situation of the certification body itself fulfilling certain clauses of ISO/IEC 17025 for external testing that it accepts. For example:
a)The CB provides the data sheets to the external lab to guide their testing and record results. The CB fulfills ISO/IEC 17025 clauses related to data sheets or records.
b)The CB establishes the requirements and assesses the competence of staff in the lab for performance of testing. The CB fulfills ISO/IEC 17025 clauses related to staff competence requirements and assessment of staff competence.
c)The CB performs periodic audits (at least annually) of the laboratory for fulfillment of applicable ISO/IEC 17025 requirements. The CB fulfills ISO/IEC 17025 clauses related to internal audits.
4.2.3Finally, it is not clear whether the certification body is required to apply ISO/IEC 17025 requirements (in whole or in part) to testing/measurement that it requires manufacturers to perform as a part of surveillance of certified products.
4.3Interpretation
4.3.1All clauses of ISO/IEC 17025 shall be applied in the assessment of competence of external testing laboratories, OR, the certification body shall maintain documented rationales explaining its decisions that selected requirements of ISO/IEC 17025 do not apply.
4.3.2The requirements of 7.0 and 6.2.2 do not directly apply to testing/measurement that a certification body requires a manufacturer to perform within surveillance. The certification body shall determine and clearly state in its procedures what criteria applicable to the relevant certification system (ISO/IEC 17065, 7.1) are appropriate for this testing/measurement.
4.3.3The above interpretation can also be used for references in ISO/IEC 17065, 7.0 to ISO/IEC 17020 and ISO/IEC 17021.
4.4This notice is applicable to all accredited certification programs except the Telecommunication Certification Program that ANSI accredits.
4.5For further information, contact Reinaldo Figueiredo (rfigueir@ansi.org).

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