Regulatory Open Forum

Hello Team,

Does anybody have Change Request Form free template for process changes, assigning new controlled doc. no or revising form that comply with ISO 9001 and 13485?
We do have separate Engineering change form to capture design changes and risk associated it. 

Can single person approve the CR after initiating by anyone in org.?
or it should be two person for approval like QARA Manager and then company's President?

We are class I (non measuring, non sterile)  medical devices manufacturer with only person in QA dept. 
Would much appreciate if someone share simplest pdf form but must be complaint to ISO 9001 and 13485.

Thanks 

Hello Anonymous at Class I medical device manufacturer,

Here is a simple Change Request Form which has passed many audits. QARA Management and President is sufficient for approval.

Hello Team,

Does anybody have Change Request Form free template for process changes, assigning new controlled doc. no or revising form that comply with ISO 9001 and 13485?
We do have separate Engineering change form to capture design changes and risk associated it. 

Can single person approve the CR after initiating by anyone in org.?
or it should be two person for approval like QARA Manager and then company's President?

We are class I (non measuring, non sterile)  medical devices manufacturer with only person in QA dept. 
Would much appreciate if someone share simplest pdf form but must be complaint to ISO 9001 and 13485.

Thanks 

Hello Kristine Witzel,

Thanks for your response and providing me CR.

QARA Management or President is sufficient for approval. Is that mean?
Because your form didn't have two placeholders for QARA Manager and President.

Can we use this form for Process Change as well?

Thanks :)

Hello Anonymous at Class I medical device manufacturer,

Here is a simple Change Request Form which has passed many audits. QARA Management and President is sufficient for approval.

Hello Team,

Does anybody have Change Request Form free template for process changes, assigning new controlled doc. no or revising form that comply with ISO 9001 and 13485?
We do have separate Engineering change form to capture design changes and risk associated it. 

Can single person approve the CR after initiating by anyone in org.?
or it should be two person for approval like QARA Manager and then company's President?

We are class I (non measuring, non sterile)  medical devices manufacturer with only person in QA dept. 
Would much appreciate if someone share simplest pdf form but must be complaint to ISO 9001 and 13485.

Thanks 

Hello Kristine Witzel,

Would appreciate your valuable feedback

Thanks

Hello Kristine Witzel,

Thanks for your response and providing me CR.

QARA Management or President is sufficient for approval. Is that mean?
Because your form didn't have two placeholders for QARA Manager and President.

Can we use this form for Process Change as well?

Thanks :)

Hello Anonymous at Class I medical device manufacturer,

Here is a simple Change Request Form which has passed many audits. QARA Management and President is sufficient for approval.

Hello Team,

Does anybody have Change Request Form free template for process changes, assigning new controlled doc. no or revising form that comply with ISO 9001 and 13485?
We do have separate Engineering change form to capture design changes and risk associated it. 

Can single person approve the CR after initiating by anyone in org.?
or it should be two person for approval like QARA Manager and then company's President?

We are class I (non measuring, non sterile)  medical devices manufacturer with only person in QA dept. 
Would much appreciate if someone share simplest pdf form but must be complaint to ISO 9001 and 13485.

Thanks 

Hello Kristine Witzel,

Would appreciate your valuable feedback

Thanks

Hello Kristine Witzel,

Thanks for your response and providing me CR.

QARA Management or President is sufficient for approval. Is that mean?
Because your form didn't have two placeholders for QARA Manager and President.

Can we use this form for Process Change as well?

Thanks :)

Hello Anonymous at Class I medical device manufacturer,

Here is a simple Change Request Form which has passed many audits. QARA Management and President is sufficient for approval.

Hello Team,

Does anybody have Change Request Form free template for process changes, assigning new controlled doc. no or revising form that comply with ISO 9001 and 13485?
We do have separate Engineering change form to capture design changes and risk associated it. 

Can single person approve the CR after initiating by anyone in org.?
or it should be two person for approval like QARA Manager and then company's President?

We are class I (non measuring, non sterile)  medical devices manufacturer with only person in QA dept. 
Would much appreciate if someone share simplest pdf form but must be complaint to ISO 9001 and 13485.

Thanks 

Hello Kristine, 

Thanks for your detailed response. 

Can other manager initiate/requested by?

And QARA Manager or President Approved by?

Currently, other managers like production manager, engineering manager and SC manager are requesting the change using form and two persons are approving it (QARA Manager and President). My question is, can only QARA Manager be the approver and for Quality dept., related changes, company's president could be approver to avoid conflict of interest. 

thanks 

Original Message:
Sent: 22-Apr-2024 10:04
From: Kristine Witzel
Subject: Change Request Form - ISO 9001 and 13485

Hello Kristine Witzel,

Would appreciate your valuable feedback

Thanks

Hello Kristine Witzel,

Thanks for your response and providing me CR.

QARA Management or President is sufficient for approval. Is that mean?
Because your form didn't have two placeholders for QARA Manager and President.

Can we use this form for Process Change as well?

Thanks :)

Hello Anonymous at Class I medical device manufacturer,

Here is a simple Change Request Form which has passed many audits. QARA Management and President is sufficient for approval.

Hello Team,

Does anybody have Change Request Form free template for process changes, assigning new controlled doc. no or revising form that comply with ISO 9001 and 13485?
We do have separate Engineering change form to capture design changes and risk associated it. 

Can single person approve the CR after initiating by anyone in org.?
or it should be two person for approval like QARA Manager and then company's President?

We are class I (non measuring, non sterile)  medical devices manufacturer with only person in QA dept. 
Would much appreciate if someone share simplest pdf form but must be complaint to ISO 9001 and 13485.

Thanks