Engineering Drawing Number Procedure Requirement - ISO 13485:2003 4.2.1 d)?

[maxwell]

Greetings: Everyone

The company I work for is a machine shop for class 1 medical instruments. When we receive an order from a customer the customer drawing is reviewed and my company generates internal drawings for fabrication of product. I am currently writting an engineering drawing and numbering procedure, However there is no standard numbering convention established and based on the fact that we base our drawing numbering on the customers drawing (add dash numbers) I do not see how to write this procedure. Is A general statement such as: internal part numbers are established using customers print number and adding dash numbers? Where is the requirements for a engineering drawing and numbering procedure? Does this fall under ISO 13485:2003 4.2.1 d) documents needed by the organization to ensure effective planning, operation and control of its processes? Any comments are greatly appreciated.

 

[GStough]

Re: Engineering Drawing Number Procedure Requirement

Hi Maxwell and welcome to the Cove!

There have been several discussion threads on this topic recently, and the general consensus has been this: whatever works best for your company and your QMS and is the simplest is what you should go with. Because each company and industry is different and each has different needs, it is nearly impossible to mandate a specific numbering system for every company.

Your numbering system can be as simple as 001, 002, 003, etc. with various and asundry prefixes and/or suffixes....Or, it can be as complicated as you'd like.

Bottom line: do whatever is the simplest and most efficient for your company's situation, keeping in mind that your customer's requirements must still be met.

 

[Wes Bucey]

Re: Engineering Drawing Number Procedure Requirement

Hi Maxwell and welcome to the Cove!

There have been several discussion threads on this topic recently, and the general consensus has been this: whatever works best for your company and your QMS and is the simplest is what you should go with. Because each company and industry is different and each has different needs, it is nearly impossible to mandate a specific numbering system for every company.

Your numbering system can be as simple as 001, 002, 003, etc. with various and asundry prefixes and/or suffixes....Or, it can be as complicated as you'd like.

Bottom line: do whatever is the simplest and most efficient for your company's situation, keeping in mind that your customer's requirements must still be met.

I agree, with this added tip:
BE CONSISTENT IN APPLYING THE SYSTEM YOU USE TO ALL DRAWINGS!

 

[Al Rosen]

Greetings: Everyone

The company I work for is a machine shop for class 1 medical instruments. When we receive an order from a customer the customer drawing is reviewed and my company generates internal drawings for fabrication of product. I am currently writting an engineering drawing and numbering procedure, However there is no standard numbering convention established and based on the fact that we base our drawing numbering on the customers drawing (add dash numbers) I do not see how to write this procedure. Is A general statement such as: internal part numbers are established using customers print number and adding dash numbers? Where is the requirements for a engineering drawing and numbering procedure? Does this fall under ISO 13485:2003 4.2.1 d) documents needed by the organization to ensure effective planning, operation and control of its processes? Any comments are greatly appreciated.

You may be confusing this with the FDA requirement for Quality system documents in 820.20 Management responsibility,

(e) Quality system procedures. Each manufacturer shall establish quality system procedures and instructions. An outline of the structure of the documentation used in the quality system shall be established where appropriate.

It is also in 13485, the last sentence of 4.2.2

The quality manual shall outline the structure of the documentation used in the quality management system.