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ISO/TC 176/SC 2

GUIDANCE FOR HANDLING REQUESTS FOR INTERPRETATION


OF THE REQUIREMENTS OF ISO 9001
1. INTRODUCTION
This document provides guidance to ISO Member Bodies for handling
requests for interpretation of the requirements of the ISO 9001 standard.
The elements described in this document cover
The communication bet!een the requester and a Member Bod"#
The communication bet!een a Member Bod" and ISO$T% 1&'$S%
(.
The ISO$T% 1&'$S% ( Secretar" !ill onl" accept requests for interpretation
from Member Bodies and onl" on ISO 9001.
2. HANDLING OF REQUESTS FOR INTERPRETATION BY A MEMBER BODY
)ach Member Bod" is encouraged to set up a process for handling
requests for interpretation* to tr" to provide a response to an enquir".
The requester should be advised to consult the ISO 9000 series of
standards and other published support documents* as !ell as the listing of
ISO$T% 1&'$S% ( approved Interpretations +see !!!.iso.org$tc1&'$sc(,
before submitting a request.

If the Member Bod" is able to provide a satisfactor" response* this should
be sent to the enquirer and also be copied to the ISO$T% 1&'$S%(
Secretariat for future reference.
If the Member Bod" is not able to provide a response then it should submit
a request to ISO$T% 1&'$S% ( using the -.equest for Interpretation- form.
3. PREPARING A REQUEST FOR INTERPRETATION TO ISO/TC176/SC2
The Member Bod" should prepare a request in the follo!ing manner.
The question should be a request for interpretation* not for information. It
should see/ to clarif" !hat is required in the standard* and not ho! the
requirement+s, could or should be ful0lled. Therefore* the overall strategic
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intent is to provide interpretations related to Wha is required and not
H!" to implement a requirement and to con0rm the original intent of the
standard.
The question should
be formulated in a !a" that it can be ans!ered !ith a Y#$ or N!. If
possible* the question should read 12oes clause 3"4 require that
5.6#
%! be &!%'((!%a) +the use of leading !ords li/e !hen* if* etc.
should be avoided,#
be limited to a $(%*)# ($$+## multiple issues on the same sub7ect
should be submitted as separate requests#
ma/e a &)#a, and &!,,#& ,#-#,#%&# to the clause of the ISO 9001
standard#
be *#%#,(&* i.e. regardless of product* t"pe and si4e of organi4ation*
countr" or situation#
be accompanied* if necessar"* b" bac/ground scenario describing
the situation that gave rise to the question* in order to ma/e the
request &)#a,# and
be communicated in the manner and format speci0ed b" the
Member Bod".
.. E/AMPLES ON FORMULATING INTERPRETATION REQUESTS
The e3amples belo! are sho!n to clarif" !hich t"pes of request have been
presented in a format that can or cannot be responded to b" the ISO$T%
1&'$S% (.
E/AMPLES OF QUESTIONS THAT CAN BE ANSWERED BY ISO/TC 176/SC 2
Q+#$(!%0 2oes sub8clause &.9.1 b, allo! the organi4ation to decide on
the need* appropriateness and e3tent of the revie!* veri0cation and
validation to be carried out at each design and development stage:
Q+#$(!%0 2oes sub8clause ;.(.9 a, require that documents required for
the <MS be revie!ed as !ell as approved prior to issue:
E/AMPLES OF QUESTIONS TO BE SENT BAC1 TO THE REQUESTER
WITHOUT INTERPRETATION
Q+#$(!%0 Should the design of the pac/aging necessar" to preserve the
conformit" of product up to destination be part of the output activities
+&.9.9,:
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U%a&&#2a3)# 3#&a+$#0 It is not possible to provide a generic
interpretation in response to this request. It is an implementation question
+=o! to do,.
Q+#$(!%0 In the last line of the second paragraph of clause ;.(.;* !e
consider that the term 1disposition6 needs to be clari0ed. In !hich conte3t
should this term be used:
U%a&&#2a3)# 3#&a+$#0 This is a terminolog" and implementation issue.
It is not a question on a requirement of the standard.

4. WHERE REQUESTS FOR INTERPRETATION SHOULD BE SENT
ISO Member Bodies should send requests for interpretation on the
Interpretation .equest >orm* dul" completed in accordance !ith the
preceding instructions* b" e8mail to
Mr. %harles %orrie
Secretar" ISO$T% 1&'$S% (
charles.corrie?bsigroup.com
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