Use of "Shall" versus "Should" in Procedures

SGquality

Quite Involved in Discussions
#1
I am back with this basic question for an ISO 13485 QMS documentation - the 21 CFR Part 820 and ISO 13485 have requirements as "Shall" so when we create procedures that are aligned with the regulatory and ISO requirements, should we be using "Shall" or we use "Should"?
 
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Jean_B

Trusted Information Resource
#3
The regulations require processes or procedures to achieve a purpose, and sometimes explicitly include specific checks, authorities or record-keeping.
Your people should understand when in such procedures something must be done or when it is optional/preferred etc in any which way that works for your personnel.
If you use shall and should, and your people don't really care about that type of language-use you will have gained little to nothing.
No regulation or standards says you shall use shall and should (and must, and can, and may, and might, and will) in your procedures.
 

John Broomfield

Staff member
Super Moderator
#4
Simply use the present tense to describe the process as it is meant to happen.

Your policy document can make it clear that documented procedures, instructions and forms specify requirements.
 

Jim Wynne

Staff member
Admin
#8
Straight form the ISO so everything else is guesstimation

— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability
Those definitions apply to the standard and don't apply to the organization's documents unless the organization so chooses.
 

Tidge

Quite Involved in Discussions
#9
Straight form the ISO so everything else is guesstimation

— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability
Those definitions apply to the standard and don't apply to the organization's documents unless the organization so chooses.
Management with Executive Responsibility is going to have a lot of explaining to do if the employees are treating "shall" as a recommendation.
 

Randy

Super Moderator
#10
Well lets just say "ya gotta do it" or "you can do it if ya wanna"...................... Better?

If many of y'all reviewed as many different organizations and and their documents like I do you have a tendency to ask..."What do you mean by this?" When you get the answer that's what you go by.
 
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