Process: Knowledge Section 7.1.6 of ISO 9001:2015

Qualygirl

Involved In Discussions
Process: Knowledge Section 7.1.6 of Iso 9001: 2015
Hello forum,
is there a template in the forum on the above topic, from which you can see the content of what should be in there?
Thanks and regards
Qualygirl
 

Johnny Quality

Quite Involved in Discussions
Qualygirl,

Organizational knowledge referred to in 7.1.6 is asking for what does information does the organization need to achieve conforming products/services.

For example, if the organization was a tyre fitter it would have knowledge on how to correctly remove a tyre, prepare the wheel rim for a new tyre, fit the new tyre, inflate the tyre to the correct pressure, know what the correct pressure should be. It would also have knowledge on how to measure its costs so it can quote customers correctly, how to procure customers, how to order tyres and how to dispose of worn tyres in accordance with the laws.

The clause does not specify that all this knowledge requires to be documented but for the vast majority I would say it's a very good idea. It will also help in maintaining the knowledge (keep it intact and up to date as technology moves forward and knowledge is gained from experience) and making it available to whomever in the organization needs it.

I hope this helps somewhat.
 

Qualygirl

Involved In Discussions
There are some (core) processes in a company: sales, development, purchasing, etc. Do you have to define the knowledge (existing, required, etc.) for each defined process and where and how?
 

Johnny Quality

Quite Involved in Discussions
The organization has to. ISO 9001 can't do it for you as it's designed to be applicable for all organizations regardless of their scope.

Get the process owners and top management around a virtual table and discuss with them.
 

Sebastian

Trusted Information Resource
1. Knowledge is one of internal issues, which have to be identified per 4.1.
I do not know organization who has done it, including mine.
2. Lost of knowledge is one of risks, which have to be determined per 6.1
[same as above]
Then you have to address this risk and now circus starts to spin.
What knowledge do we have?
Who has this knowledge?
What are probability and consequences we lost it?
How do we maintain this knowledge?
So [provocative mode=on] lost of knowledge in sales process you can afford, purchasing less but you can survive, but definitely development (of product, I guess) you can't [provocative mode = off].
3. Addressing this risk through integration in quality management system processes means "determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes;" per 4.4.1 c) and f) is also there.
So personnel owning brain storing strategical from point of organizational interest knowledge, have to be "forced" to prepare instructions where their way of operation can be read. Then we can say, that their knowledge is maintained by organization and made available for new or current members. So personnel job resignation, illness (e.g. stroke) can be less risky for organization now.

Sorry for my English, but I hope you get my point.
 

Qualygirl

Involved In Discussions
it would be great to present this with a tangible example in the form of a documentation:
I understood the hints.
 

Tagin

Trusted Information Resource
it would be great to present this with a tangible example in the form of a documentation:
I understood the hints.

The two main points needed are:
  • "The organization shall determine the knowledge necessary..."
  • "This knowledge shall be maintained and be made available to the extent necessary"
For our small company, this is what we have for 7.1.6, and it has not been an issue in any audits:
XYZ leverages its IT systems to capture organizational knowledge.
Collaboration software (SharePoint):
  • Tasks, documents and other list data:
  • Task and other list types support attachment of documents, emails, etc. to collect and retain relevant information.
  • Searchable in order to retrieve data as needed.
  • SharePoint data is retained indefinitely.
ERP software:
  • Allows attachment of documents, emails, etc. to most entry types to collect and retain relevant information.
  • Allows notes to be added to many entry types to collect additional information.
User working directories:
  • User working directories (e.g., My Documents, My Pictures, H: drive, etc.) are redirected to networked drives by Group Policy. This provides that user work will be stored in locations that will be backed up and can be retained even if a person has left the company.
Email system:
  • Email utilizes a central Exchange server for mailbox storage for all users. This allows backup, retention of emails and entire mailboxes even if a person has left the company.
 

Big Jim

Admin
You're looking for more than the standard requires.

If you have a functioning business then you have determined what knowledge is needed to run it. A requirement to document such knowledge isn't attached (thank goodness).

That knowledge should be protected. That can be accomplished with cross training. Make sure that more than one person knows how to handle any one task.

When it becomes necessary to gain additional knowledge, it is necessary to figure out how to obtain it, which is shown in the notes in 7.1.6.

Don't overthink it.
 
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