How to document "Exclusions" in the Quality Manual

S

SpaceCase

#1
We have excluded Section 7.3 ? Design and Development, what do I do with that section of our quality manual (we have downloaded the quickstart total package from the AS9100store.com)?
We have excluded it with this statement in the Application section (1.2):
? Justification of exclusion: products are built to Customer specifications and drawings.
As we only build-to-print and do not have any Design or Engineering Depts.

Do I just delete the section and just write in that we have excluded it and only build-to-print?

Thanks!
 
S

SpaceCase

#3
Re: Exclusions question.

That's what I figured, but didn't want to File 13 the whole section if that wasn't the correct way to go.
Thank you!
 
#4
Re: Exclusions question.

In our Quality Manual, we just put:

7.3 Design and Development
EXCLUDED – (See section 1.2)
You are missing the justifications - which is a requirement! You can't simply say "excluded" because - in particular with design - some folks try to exclude it because Engineering "didn't want to be part of ISO" (as they say). Or to save money on certification!

You should have a justification: "We are a make to print shop and our customers own the designs" for example.
 
S

SpaceCase

#5
Re: Exclusions question.

Yes, this is what I have there:

▪ Section 7.3 – Design and Development
• Justification of exclusion: products are built to Customer specifications and drawings.
 

the47guy

Starting to get Involved
#6
Re: Exclusions question.

You are missing the justifications - which is a requirement! You can't simply say "excluded" because - in particular with design - some folks try to exclude it because Engineering "didn't want to be part of ISO" (as they say). Or to save money on certification!

You should have a justification: "We are a make to print shop and our customers own the designs" for example.
The justification is in 1.2 (Justifications) of the Quality Manual. That's why we put see 1.2.
 
S

SpaceCase

#7
Re: Exclusions question.

Here is section 1.2:

1.2 Application
The Company has determined that the following requirements are not applicable to the operations at this site and are documented as exclusions:

▪ Section 7.3 – Design and Development
• Justification of exclusion: products are built to Customer specifications and drawings.

And 7.3:

7.3 Design and Development
EXCLUDED – See section 1.2.
 
S

SpaceCase

#9
Re: How to document "Exclusions" in the Quality Manual ?

I kinda figured, thanks for making sure I'm on the straight and narrow!
 

dsanabria

Quite Involved in Discussions
#10
Re: Exclusions question.

Here is section 1.2:

1.2 Application
The Company has determined that the following requirements are not applicable to the operations at this site and are documented as exclusions:

▪ Section 7.3 ? Design and Development
? Justification of exclusion: products are built to Customer specifications and drawings.

And 7.3:

7.3 Design and Development
EXCLUDED ? See section 1.2.
Nice!:applause:
 
Thread starter Similar threads Forum Replies Date
R Where to Document Exclusions per ISO 13485 and ISO 9001 ISO 13485:2016 - Medical Device Quality Management Systems 2
Raffy Exclusions Table - How do I document the Exclusion Table, such as Service? Document Control Systems, Procedures, Forms and Templates 2
Ed Panek MR Mandate Document EU Medical Device Regulations 0
C Document Index Document Control Systems, Procedures, Forms and Templates 4
K ASME, ANSI, ASTM and similar specifications and their requirements for document control. Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
H If we use agile - do we still need to document TF as a waterfall just for the notified bodies need? IEC 62304 - Medical Device Software Life Cycle Processes 2
Q ISO 9001/IATF 16949 Audit Finding Question - Document Retention IATF 16949 - Automotive Quality Systems Standard 10
B Document Issued with incorrect Document number code Document Control Systems, Procedures, Forms and Templates 2
J Requirement for Signature on Document Document Control Systems, Procedures, Forms and Templates 10
J Document Control Metrics Document Control Systems, Procedures, Forms and Templates 3
A Document Review and Document Approval --- 2 Signatures needed acc. §820.40? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance document to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
I Document Control Software Document Control Systems, Procedures, Forms and Templates 2
K 25-year lifetime of medical device - document storage period EU Medical Device Regulations 1
J UDI - Where to document it? EU Medical Device Regulations 8
T Controlling Expandable Forms in Paper-Based Document Control System Document Control Systems, Procedures, Forms and Templates 10
S Changing revision status of a reviewed document Manufacturing and Related Processes 11
shimonv Document Control Procedure Header Content Document Control Systems, Procedures, Forms and Templates 3
A Document release vs its related training. Which should come first? ISO 13485:2016 - Medical Device Quality Management Systems 18
Q Document ownerships Document Control Systems, Procedures, Forms and Templates 14
E Document Change Request forms (or no forms)? ISO 13485:2016 - Medical Device Quality Management Systems 9
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B Document Approval Matrix Benchmarking Document Control Systems, Procedures, Forms and Templates 3
J Document Approval Signature Order Document Control Systems, Procedures, Forms and Templates 10
L How to add exemption or statement to control of document procedure? ISO 13485:2016 - Medical Device Quality Management Systems 5
M What is the proper way to document measurements Measurement Uncertainty (MU) 1
P Equipment 21 CFR 820.70(g) - User Requirements Document for Off the shelf equipment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
B Do IFU designs have to be document controlled under ISO 13485? Document Control Systems, Procedures, Forms and Templates 2
C Certificate of Conformance Form - COC for each customer a controlled document? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Document "Correspondence IATF 16949 vs ISO13485" available? IATF 16949 - Automotive Quality Systems Standard 0
R Document Retention - Discard hard-copies after scanning? ISO 13485:2016 - Medical Device Quality Management Systems 2
P Mylar plot suppliers in accordance with D6-51991 document AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
A Document Change Notice vs complete System re-write Manufacturing and Related Processes 4
Q Document approval through SharePoint (without signature) Records and Data - Quality, Legal and Other Evidence 4
S What is considered a "core algorithm"? (From an FDA guidance document) Medical Information Technology, Medical Software and Health Informatics 4
U Document Approval - Software company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
O Please, help with document on ISO/ TS 17758 and (IDF 87: 1979). Thank you. Manufacturing and Related Processes 1
K Proper document of SMPS used in infant warmer for IEC 60601-1 testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
I Nitpicking on document released dates ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
I Document Control on Log Files ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Refusal to Document Complaints Customer Complaints 39
Q Tracking Procedure Revisions (Document Control) Document Control Systems, Procedures, Forms and Templates 9
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 24
I Master Document Access - ISO 9001:2015 clause 7.5.3 Document Control Systems, Procedures, Forms and Templates 5
I Can a document (form) approval record be separate? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
I Control of Documentation Distribution - Document Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T Advice needed - Environmental MS - unwritten but customer requests policy document ISO 14001:2015 Specific Discussions 5
T Control of downloaded document copies by employees Document Control Systems, Procedures, Forms and Templates 3
T Document control ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
I Is highlighting on a printed document considered a change? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4

Similar threads

Top Bottom