Quality Manual - Description of the Interaction between Processes of the QMS

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Bunny

I have been using the same Quality Manual to address ISO 9001, 13485 and FDA Regs for over a decade now. Never before was I told that the manual did not meet the requirements because it was lacking a description of the interaction between the processes of the quality management system.

Is this truly a requirement that I have missed or did the inspector make an error?
 

Marcelo

Inactive Registered Visitor
Re: QMS description of interaction between processes

Part of the problem is the idea, which is wrongly spread, that if you pass an audit it means you are totally in conformity with the requirements.
 

insect warfare

QA=Question Authority
Trusted Information Resource
Re: QMS description of interaction between processes

[FONT=&quot]I have been using the same Quality Manual to address ISO 9001, 13485 and FDA Regs for over a decade now. Never before was I told that the manual did not meet the requirements because it was lacking a [/FONT][FONT=&quot]description of the interaction between the processes of the quality management system.[/FONT] Is this truly a requirement that I have missed or did the inspector make an error?

Perhaps you can describe to us how you were "meeting" this requirement before. That would help us determine the amount of validity in the inspector's finding.

Brian :rolleyes:
 
B

Bunny

Re: QMS description of interaction between processes

I thought the purpose of the QPM was to describe the interactions, so that is exactly how it was written. The QPM described the QMS structure and then went on the address each requirement. Here is the TOC.

1 Purpose
2 Scope
3 References
4 Quality Management System
5 Documentation Requirements
6 Management Responsibility
7 Resource Management
8 Product Realization
9 Design and Development
10 Purchasing
11 Production and Service Provision
12 Identification and Traceability
13 Customer Supplied Property
14 Measurement, Analysis and Improvement
15 Customer Satisfaction
16 Control of Nonconforming Product
17 Corrective Action and Preventive Action
18 Contract Review
19 Labeling
20 Risk Management
21 Non-Applicable Clauses
22 Revision History​
I will repeat, that this format has been used by me in 2 companies for over a decade. A multitude of top notch inspectors from highly respected companies have audited this manual and never said that it needed to be more descriptive. My intent here is not to fly under the radar and use poor quality certification firms. My intent is to understand the requirement so I fulfill it properly and not just DO what the inspector says.
 

Peter Fraser

Trusted Information Resource
I have been using the same Quality Manual to address ISO 9001, 13485 and FDA Regs for over a decade now. Never before was I told that the manual did not meet the requirements because it was lacking a description of the interaction between the processes of the quality management system.

Is this truly a requirement that I have missed or did the inspector make an error?

Yes, it is a requirement of ISO9001. But many organisations are certified without producing anything very meaningful beyond an adapted version of the "model of a process-based management system" diagram in the standard.
 

Marcelo

Inactive Registered Visitor
But many organisations are certified without producing anything very meaningful beyond an adapted version of the "model of a process-based management system" diagram in the standard

Which is even worse, because the model of the standard is only related to the way the standard is written, not to how the management system of any company in particular works :p
 

insect warfare

QA=Question Authority
Trusted Information Resource
Which is even worse, because the model of the standard is only related to the way the standard is written, not to how the management system of any company in particular works :p

Agreed. I always tell people that if the "model of a process-based management system" diagram was intended to describe your management system, then every management system would be identical. This section of ISO 9001 is perhaps the most widely-abused "escape" clause.

Brian :rolleyes:
 
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Mikishots

Trusted Information Resource
I have been using the same Quality Manual to address ISO 9001, 13485 and FDA Regs for over a decade now. Never before was I told that the manual did not meet the requirements because it was lacking a description of the interaction between the processes of the quality management system.

Is this truly a requirement that I have missed or did the inspector make an error?

I'd use a flowchart or a process map. I've also seen organizations use tree and block diagrams along with reference links within paragraphs inside procedures.

People are familiar with flowcharts, and I feel it really lends itself well in fulfilling this requirement.

The requirements are in 4.1 (b) and 4.2.2 (c)
 
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Mikey324

Quite Involved in Discussions
For what its worth, in our QM we have a list of all individual processes, the processes that provide input, and the output. For example x from receiving process goes to production process, then goes to shipping.

i think they are just requesting that linked processes and interactions be addressed.
 
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