Page 4 - Sept NL 2016a
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A2LA Updates
New Explanations of ISO/IEC Requirements
By Teresa Barnett, A2LA Senior Director, Quality & Communications
Since the last issue of A2LA Today, RESPONSE: For all types of inspection RESPONSE: For the purposes of A2LA
the A2LA Criteria Council voted to bodies, top management is considered accreditation, accredited Inspection
publish several new explanations of to be those individuals who have the Bodies are required to own or have
the ISO/IEC 17020:2012 requirements authority and can provide the resources direct access to, and have under their
as well as one revised and several necessary to make changes to any aspect document control system, current
new explanations of the ISO/IEC regarding the inspection activities. versions of the normative documents
17065:2012 requirements. These and Although it is up to the organization that are vital to maintaining their
other explanations may be found on the to identify top management, it is accreditation and to perform their
A2LA website under the “Documents” important that these individuals lead inspection activities.
header. the management review and that it be
clear in the records. These documents include all relevant
ISO/IEC 17020:2012 Explanations: regulations, standards and/or
QUESTION: Per Section 8.2.2 of technical methods, etc. related
QUESTION: Per Section 5.1.4 of ISO/ ISO/IEC 17020, what constitutes to the inspection activities.
IEC 17020, who determines the “evidence of commitment” by top Additionally, ISO/IEC 17020:2012,
adequacy of my organization’s liability management? general A2LA policy documents, and
coverage arrangements? the specific A2LA program requirement
RESPONSE: For either independent documents relating directly to their
RESPONSE: In some cases there may be or in-house inspection bodies of larger field of accreditation. A2LA does not
contractual obligations which detail the organizations, top management is consider “terminology documents,”
minimum amount of coverage or there considered to be those individuals who such as ISO/IEC 17000 and the VIM,
may be requirements imposed by the have authority and can provide the to be normative documents that an
regulators for which the inspections are resources necessary to make changes organization must control within their
being performed or by the inspection to any aspect within the inspection system.
scheme owners. body. It is, therefore, important
that these individuals participate For inspection bodies the A2LA
In the absence of such requirements, in the management review, stress normative documents are as follows:
the inspection body is responsible for the importance of meeting customer
determining what “adequate” levels requirements and ensure integrity of R301 – General Requirements:
are with respect to having liability the management system. Evidence Accreditation of ISO/IEC 17020
coverage arrangements. As exemplified that proper resources are allocated to Inspection Bodies
in this clause, such arrangements can the performance of appropriate and
include insurance or cash reserves. effective internal audits, management R102 – Conditions for Accreditation
A2LA assessors may raise questions reviews, etc. could also be considered
about the adequacy of the coverage and evidence of top management’s R105 – Requirements When Making
how the organization arrived at the commitment to its management system. Reference to A2LA Accredited Status
decision this was adequate coverage. As a result, records demonstrating top
Additionally, A2LA assessors may management’s participation in these P102 – A2LA Policy on Metrological
raise questions about coverage for functions could be considered evidence Traceability (only when inspections
certain aspects of the inspection of compliance with this particular require the use of traceable measuring
activities which are normally excluded section of the standard. equipment) or
from insurance policies and write a
deficiency if the policy will not cover QUESTION: Per Section 8.3.1 of P113 – A2LA Policy on Measurement
accredited activities; an example of this ISO/IEC 17020, what does A2LA Traceability for Life Sciences
would be a policy that did not cover consider to be external documents that Testing and Forensic Conformity
data breaches for an organization that my organization must control under Assessment Bodies (CABs) (for Forensic
provides cyber security assessments. our document control procedure? organizations)
QUESTION: Per Section 8.2.1 of ILAC P15-Application of ISO/IEC
ISO/IEC 17020, who is considered to be 17020:2012 for the Accreditation of
“top management”? Inspection Bodies (This document can
be found at ILAC.org)
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