ISO 14155:2011 - The meaning of the term "Should"

J

--Jen--

#1
Greetings forum readers!
I have an unbelievabily embarassing question.

what does the word "should" really mean, as used in ISO14155/ICH EC GCP?

Why do I ask? take the sentence: 'Task A should be done before task B'
is it a requirement or a recommendation (ie optional) that task A be done first.

thank you!
:eek: jen
 
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Sidney Vianna

Post Responsibly
Staff member
Admin
#2
Re: ISO14155 / ich e6 gcp

ISO 14155:2011 contains 219 instances of the word shall and 21 of the word should. So, it seems to me that the authors know the distinction very well. Thus, the term "should" typically means a preferred method, without being a mandatory requirement.
 

Jim Wynne

Staff member
Admin
#3
Re: ISO14155 / ich e6 gcp

ISO 14155:2011 contains 219 instances of the word shall and 21 of the word should. So, it seems to me that the authors know the distinction very well. Thus, the term "should" typically means a preferred method, without being a mandatory requirement.
They should know the distinction, be we shall see. :tg:
 

Wes Bucey

Prophet of Profit
#4
I tend to agree with Sidney on this - "should," especially when referring to the order of performing actions, usually can be interpreted "the preferred, but not mandatory, schedule is"
(think of a work instruction for putting on shoes and socks in a clean room:
"The operator should put on both socks first, then shoes."
No one would gripe if the operator put on left sock and shoe, then right sock and shoe OR right sock and shoe then left sock and shoe, since it makes no difference in the outcome of having socks on feet inside the shoes.)

In any regard, no auditor of my acquaintance has ever written a nonconformance against a "should," but I suppose some guy still stuck in "Kwality Kop" mode might. If he does, an appeal should remedy the requirement for a corrective action.
 
#5
The verbal forms used in this standard conform to usage described in Annex G of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:

− “shall” means that compliance with a requirement or a test is mandatory for compliance with this standard;

− “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard;

− “may” is used to describe a permissible way to achieve compliance with a requirement or test.
That is from the foreword to 606o1-1 but, I believe, applies to all of the modern IEC or ISO standards.
 
J

--Jen--

#7
Good morning!
Thank you all for your helpful perspective and reference!

Hopefully this puts an end to a debate that resorted to dictionaries!
(should is the past tense of shall - and shall means must - yada, yada, yada)

:tg: jen
 

Big Jim

Super Moderator
#8
I noticed something today while reading the Forward in AS9101D, the standard that governs 3rd party auditing for AS9100C. I think this may shed some light on the topic as well.

In this International Standard, the word “shall” indicates a requirement and the word “should” a recommendation to meet
the intent of the standard. Words “typical”, “example”, or “e.g.” indicate suggestions given for guidance. Information
marked “NOTE” is for guidance in understanding or clarifying the associated requirement.

It is also worth noting that the word "should" is used extensively in standards that you cannot get registered to, including ISO 9004:2009, IWA 2 Education Guidance, and ISO 19011:2004.
 
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