A
Andy:
I hope this information will be useful to you.
A Document is any material, electronic, hardcopy, video or pictorial that outlines a process, guides or instructs, and requires revising. This incldes Master Forms or Templates.
Samples:
Internal Documents requiring control are Work Instructions, Quality Manual, Processes, etc.
External Documents requiring control are MSD Sheets, Ministry of Labour Health and Safety Manuals, Manufacturer Specifications, etc.
These require revising by the body forwarding them to you, however once you receive the update it is your responsibility to ensure the old is replaced with the new.
Once you take a document and add substance and a signature (objective evidence or proof of an action)it then becomes a record.
You probably could get away with a retention period of 12 years right across the board. This would depend on the company. I generally advise my clients to take a hard look at their records and put into place what they actually do. For instance it might be wise to keep an employment record for 1 year past employee termination. A service record for a certain period of years after the warranty is up, etc.
Any document or literature that does not require revising and is therefore used for reference only is not considered a Controlled Document. Possibly some of what you term as 400 masks could be considered as Reference Only.
In ISO 9001/2/3:1994 wherever 4.16 and in ISO 9001:2000 4.2.4 are mentioned are the areas requiring a record to be kept.
Sample:ISO 9001:1994
4.1.3 Management Review
The record is the minutes taken.
4.4.6 Design Review.
The record of the review.
4.4.7 Design Verification.
The record of the verification.
4.9 Process Control
The records are those showing qualified processes, equipment(maintenance sheets, etc.) and personnel(training records).
A Controlled Document List would include:
all documents Internally Controlled, such as Master Forms, Templates, Quality Manual, Procedures (listed individually if each has a separate Authorization),etc.
all documents Externally Controlled
include their revision level.
all Software and their version, such as Auto Cad 16, etc.
Any questions please contact me.
awk
I hope this information will be useful to you.
A Document is any material, electronic, hardcopy, video or pictorial that outlines a process, guides or instructs, and requires revising. This incldes Master Forms or Templates.
Samples:
Internal Documents requiring control are Work Instructions, Quality Manual, Processes, etc.
External Documents requiring control are MSD Sheets, Ministry of Labour Health and Safety Manuals, Manufacturer Specifications, etc.
These require revising by the body forwarding them to you, however once you receive the update it is your responsibility to ensure the old is replaced with the new.
Once you take a document and add substance and a signature (objective evidence or proof of an action)it then becomes a record.
You probably could get away with a retention period of 12 years right across the board. This would depend on the company. I generally advise my clients to take a hard look at their records and put into place what they actually do. For instance it might be wise to keep an employment record for 1 year past employee termination. A service record for a certain period of years after the warranty is up, etc.
Any document or literature that does not require revising and is therefore used for reference only is not considered a Controlled Document. Possibly some of what you term as 400 masks could be considered as Reference Only.
In ISO 9001/2/3:1994 wherever 4.16 and in ISO 9001:2000 4.2.4 are mentioned are the areas requiring a record to be kept.
Sample:ISO 9001:1994
4.1.3 Management Review
The record is the minutes taken.
4.4.6 Design Review.
The record of the review.
4.4.7 Design Verification.
The record of the verification.
4.9 Process Control
The records are those showing qualified processes, equipment(maintenance sheets, etc.) and personnel(training records).
A Controlled Document List would include:
all documents Internally Controlled, such as Master Forms, Templates, Quality Manual, Procedures (listed individually if each has a separate Authorization),etc.
all documents Externally Controlled
include their revision level.
all Software and their version, such as Auto Cad 16, etc.
Any questions please contact me.
awk