[2003 vs 2016] Clause 4.2.4 Control of Documents

Jmathieu188

Registered
Clause 4.2.4: Does the 2016 version match the 2003 version word-for-word? (I cannot find a reasonably priced copy of 13485:2003)

If not, I am very curious to know if they originally used document control requirements that resembled ISO9001:2000.

There's more to the story. However, for now I'd appreciate a simple yes or no (gut feeling is no).


Much appreciated,
John
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
13485:2016 It does resemble 9001 for this section but has been amended for current regulatory practices. If you are in any way regulated by FDA just add the requirements of part 11 and be able to provide FDA with hard copy records for their review.
 

Jmathieu188

Registered
13485:2016 It does resemble 9001 for this section but has been amended for current regulatory practices. If you are in any way regulated by FDA just add the requirements of part 11 and be able to provide FDA with hard copy records for their review.
Thanks for the response. Would you happen to know if 13485:2003, Clause 4.2.4? (Control of Documents) is exactly the same wording as 13485:2016, Clause 4.2.4?
 

LUFAN

Quite Involved in Discussions
Clause 4.2.4: Does the 2016 version match the 2003 version word-for-word? (I cannot find a reasonably priced copy of 13485:2003)

If not, I am very curious to know if they originally used document control requirements that resembled ISO9001:2000.

There's more to the story. However, for now I'd appreciate a simple yes or no (gut feeling is no).


Much appreciated,
John

line g is different as well as "but not less than the retention period of any resulting record..."
 
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