ISO 9001:2015: Need the List of documents required

Hi all, I have been reading through website after website, post after post but just cannot wrap my head round this all..

I am very new to quality management systems so please bear with me.

I work for a small building services consultants and we are going for ISO certification, being the document control manager I have been tasked with it.

I've purchased a copy of the standard and have been reading it through but was wondering if there is a definitive list of documents which are required - or if anyone has any pointers?

Thanks

 

Thanks Andy,

I currently have a
-policy statement
-quality objectives
-QMS scope

But it's just trying to figure out what clauses and records of documented information is specifically required

 

Yeah I have a copy of the standards, but if I'm honest that's more confusing then it helps ha!

 

One of the difficult parts is 7.5.1 b) which states: "documented information determined by the organization as being necessary for the effectiveness of the quality management system." This means what documentation that is required for one company, might not be required for a different company. For example, your company might not need any documentation at all to control purchasing, but my company might need 2 separate procedures and 15 different forms.

My advice is to determine what documents and records your company needs to prevent pain, or optimize your processes. Also look at parts where the standard requires you to either maintain or retain documented information. That should be your list.

 

Great that's a super help

 

Hi Darren,

One very useful document when you're first starting out is a list of the "key processes". This is the set of things that your team does in order to have happy clients. In our company it includes sales, design, purchasing, fabrication and installation.

Then describe how each of those key processes are carried out. But don't do that yourself. Have the person responsible for each process do it. They can do it with text, flow charts, outlines, or whatever is easiest. The result will be your company's main procedures. As your team describes them, compile and list those other docs that you need or produce when doing the work.

You will then need procedures for maintaining and improving your quality. These are what the standard prescribes: Document control, training, continuous improvement, etc.

Soon you'll have the list of docs that you seek. But keep in mind that the list will change as your system improves. And, if your system is working, that will be often.

 

Thanks everyone for the help, one thing I'm struggling to determine is what could be determined as a process - I work in a building services consultants so would I be right in thinking that a process would be:
Design process - we take the clients requirements and design the systems to comply with the clients requirements and the regs.
Review & compliance process - we act oh behalf of a client to ensure a designed system is compliant to the regs.

Am I on the right track?

 

Seems to me like you are on the right track. The delivery of different services may indeed each be a distinct process.

But you may also want to think about another possibility: cutting up the services in another direction. Different processes are often led by different folks or done by different departments. That could be one clue about what the processes are.

Say, for example, your Design Service could involve "Preliminary Design", "Detail Design", "Design Review", "Contract Management", "Invoicing and collection", etc. In this case, the "Design Review", "Contract Management" and "Invoicing and collection" processes could apply to both your "Design" service and your "Review & Compliance" service.

 

Welcome aboard QFO.

I think this attached document came from a moderator of this forum. I hope they do not mind if I share this with you.

 

The following ISO website provides many useful guidance documents on the new ISO 9001:2015 standard. Take a look.
http://isotc.iso.org/livelink/livelink/open/tc176SC2public

 

Any useful template regarding QMS? Thanks in advance.

 

A great way to determine needs is to go through the Standard and highlight anyplace it says "Shall" - that is everything you need to do & document, to the extent that your company needs it and to the extent your external auditors say you need to have.

 

ISO9001:2015 document specifies SHALL "MAINTAIN DOCUMENTS= Mandatory Documents" and "RETAIN DOCUMENTS= Mandatory Records". These are the "definitive list" of documents and records that are AUDITABLE, You determine what other documents and records you must keep to control your own processes. I hope this helps.

 

I definitely hear you Andy, thank you, but the issue is when the external auditors come in to do the audit, if you don’t have what you do documented they will ask you questions on ‘how’ you address all those ‘shalls’.
The "shall's" in the 2015 Standard do not lay down any auditing instructions or requirements, they are a roadmap for better leadership, planning, support, operation, evaluation and improvement.