Quality Management process is mandatory in ISO9001?

Pau Calvo

Starting to get Involved
#1
Dear all,

I know that the question may sound a bit silly but I will give you the context:
I have been hired in a company that distribute raw material for several industries to maintain the quality system, they already have ISO9001:2015.
My position as Quality Manager is new therefore there is no quality department and I will under the Operation department in the company scheme.

Here is where I raise my question; It can be a QMS without a process of Quality Management? It can be integrated in the Operation process? How to handle this situation?

I always have work in an industrial companies with systems established.

Thank you for your support.
 
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Tagin

Trusted Information Resource
#2
There does not have to be a separate quality department in order to conform to 9001:2015. However, it would be difficult for you to perform internal audits, since you do not have independence (see 9.2.2c) from Operations.
 

John Predmore

Trusted Information Resource
#3
ISO9001 does not define or require a quality department, it provides industry-agreed-upon quality standards for provision of products or services, and activities which support that business objective. The sections of ISO9001 are organized as Leadership, Planning, Support, Operations, Performance Evaluation, and Improvement. Your activities in support of those areas can be arranged as your company chooses. In addition to fulfillment of requirements, the auditor will look at the effectiveness of those activities to effectively meet company goals.
 
Last edited:

Pau Calvo

Starting to get Involved
#4
Thank you for your answer.
Regarding the independency to perform internal audits, it only would apply to my activities in the process not all process right?
 

Kronos147

Trusted Information Resource
#6
At least one of the processes in your system should be responsible for the requirements of 5, 6, 7, and 10, may be another way of looking at it.
 

John Broomfield

Staff member
Super Moderator
#7
Bear in mind that quality is actually delivered by the business working as a system sufficient for it to stay in business. The QMS should leverage this system by becoming part of it instead of attempting to duplicate it.

Managing quality could be a process but it would work better as a system as described above.
 

Big Jim

Super Moderator
#8
That 9.2.2c requirement is open to interpretation. A recent discussion had a number of comments that you might find useful:
Conflict of Interest if I audit the QC department?
That link goes back to a discussion to an earlier version of the standard. For the 2015 version of the standard the wording "auditors shall not audit their own work" was removed. What remained is that auditors need to be chosen that are objective and impartial. The term "independent" wasn't in the older standard and isn't in the 2015 standard either. It came from a guidance document on auditing (19011) and as such is not a requirement. Additional insight can be found in ISO 9002:2016 which is also a guidance document but for the whole standard, not just general auditing guidelines. 9.2.2 in 9002:2016 provides examples of when it is OK to audit your own work and how to ensure objectivity and impartiality.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#9
The term "independent" wasn't in the older standard and isn't in the 2015 standard either. It came from a guidance document on auditing (19011) and as such is not a requirement.
Actually, the requirement for internal audits to be independent comes from ISO 9000:2015, a NORMATIVE reference in 9001. The intent of the definitions in ISO 9000 are mandatory; otherwise the idea of standardization ceases to exist. If the definitions in ISO 9000 were not mandatory, each organization could define for themselves, things such as "corrective action", top management, management reviews, etc....

Further the issue of internal auditors auditing their own work was exhaustively debated at Informational - Internal Audits - Wear multiple hats what can and can't I audit (so I'm not auditing my own work)

And, it should not be necessary to remind people that, if we allow people to internally audit their own work in small organizations, the same latitude should be granted to large organizations as well.
 

skb76

Involved In Discussions
#10
just to share .. to simplify ... (correct me if i'm wrong..)

1) does the raw material itself have qc/qa report/documented information .. ?
2) does have raws have documented information is respect of 8.5.6 and 8.6
.
.
3) It can be a QMS without a process of Quality Management? It can be integrated in the Operation process
- 4.0 (maybe 'modify/integrated' the QM into/fit into Operation process at Business operation map)
 
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