Why do you think you need one?
Informational "Context of the Organization" in ISO 9001:2015 Clause 4.1
- Thread starter Mike S.
- Start date
Why do you think you need one?
I wrote the SOP for a company and even though it explains what to put in the log, they are new to this type of standard. I can create one but they do not want to pay for consulting to create the log. So I am trying to do the right thing and give them a lof example if available so they can craft it to their company. That way, they wouldn't have to pay me as a consultant. They are struggling and their customers require them to start meeting ISO and the COTO is part of it.
btedeschi, does your client have a business plan? I ask because every business plan template or software includes the requirements of context, as in identifying your interested parties, and considering their needs and wants when planning the management system.
Jim asks why you need a log because nothing in the standard requires written documentation of Context. But a business plan, which is a wonderful thing to have in any case, would do very nicely.
Jim asks why you need a log because nothing in the standard requires written documentation of Context. But a business plan, which is a wonderful thing to have in any case, would do very nicely.
They are a small company with almost no experience in creating documents which include a business plan. They need an example of the COTO Log so they can craft it to meet a requirement requested by a customer. They have to have this doc/log in place with other docs before their customer will do business with them. They don't have the cash to pay me to do it and I have already given them work for free but can't do that any longer. I said I would ask in this forum if anyone can post an example of a COTO log so they can fulfill their customer requirement.
What is the customer's requirement exactly? I am asking because you did not state the industry or type of service provided by your client.
They are in the radiological detection instrument manufacturing business. I wrote their COTO SOP. The client said they want to see their COTO log along with it. If there is an example COTO log someone can share they can see how it needs to be formatted etc. I can't help them for free any longer. I said I would ask the community to share any COTO log so I can give it to them and let them craft it around their business.
The reason you are not getting much action is that this is an uncommon approach. I do not know of a company that has chosen to write a procedure for element 4.1, let alone one that uses a log for it. It may be easier to delete the procedure than to try to create a log that isn't required by the standard.
Yes I recommended just not reference a log. Revise the SOP. They cannot eliminate the SOP because a customer requires they have a COTO SOP as part of the requirements for doing business with them.
Stakeholders, relationships, etc. AT this point, I am going to tell them to revise the document and just take the log reference out. They can provide specific info needed on their organization to the customer in a separate report or document. They are under the impression it should take me less than one hour to write the log for them. I explained the process of learning their business systems would take time and I don't consult by the hour. I have a minimum of 16-hours to help. An hour here or there just screws up schedules I have. So I went to blocking out days for consulting so they get a fair amount of attention and I make a set standard amount of cash for my efforts. Thanks for all of your feedback.
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