Hello Members,

I am new to the Cove and also to a start-up medical device company. I am trying to implement a Quality System based on ISO 13485.

I have proposed a 3 tier quality system for our company
Tier 1 -- Quality Manual
Tier 2 -- Quality Assurance Procedures (QAP)
Tier 3 -- Standard Operating Procedures (SOP) & Forms

The QAPs include procedures for purchasing, customer complaints, reworks, inspections and testing etc..(you get the idea) and the SOPs include procedures for passivating, anodizing, laser etching, calibrations etc..

I wanted to know is it conflicting that both the QAPs and SOPs are telling me WHAT and HOW to do things. Is it ok to follow this way or is it better to plug all HOW and WHAT things together in a SOPs. I am a bit confused:confused:

Your comments and inputs

Thanks:thanx:

Hello Members,

I am new to the Cove and also to a start-up medical device company. I am trying to implement a Quality System based on ISO 13485.

I have proposed a 3 tier quality system for our company
Tier 1 -- Quality Manual
Tier 2 -- Quality Assurance Procedures (QAP)
Tier 3 -- Standard Operating Procedures (SOP) & Forms


...Thanks:thanx:

Welcome to the Cove, Rajesh.:) I think the general structure for most documentation systems are similar to yours. The distinction I make between Level 2 (or Tier, as you said) vs. Level 3 (often called Work Instructions or WI's) is the level of detail involved, and how narrowly focused that detail is. For example, I can have a Level 2 document that describes the Corrective action process and how it functions for all areas of the company, but my Level 3 document may describe exactly how a CA request is processed, how the form is filled out, who takes care of and where the CA records are located, etc., etc. So in my mind Level 2 (often called Procedures) are more general overviews of a process / task / requirement, while the WI level is much more detailed, user-orientated types of documents.:2cents: Hope you find this helpful.

Welcome to the Cove, Rajesh.:) I think the general structure for most documentation systems are similar to yours. The distinction I make between Level 2 (or Tier, as you said) vs. Level 3 (often called Work Instructions or WI's) is the level of detail involved, and how narrowly focused that detail is. For example, I can have a Level 2 document that describes the Corrective action process and how it functions for all areas of the company, but my Level 3 document may describe exactly how a CA request is processed, how the form is filled out, who takes care of and where the CA records are located, etc., etc. So in my mind Level 2 (often called Procedures) are more general overviews of a process / task / requirement, while the WI level is much more detailed, user-orientated types of documents.:2cents: Hope you find this helpful.

Hello Fuzzy,

Is it possible in this case to make the Level 2 procedure detail oriented so as to avoid creating a WI for the corrective action process. I am asking this because, in the Quality Manual (Level 1), there is no need to reference both the SOP and the QAP for a particular process (in this case Corrective action)??

Rajesh

Welcome to the Cove!:bigwave:
I recently consulted for an Illinois medical device manufacturer now approved for ISO 13485 and also now has its CE mark. There aren't many "trick requirements" - the primary thing to consider is whether you have straightforward documentation of your processes (the plan and the record of actually following the plan) and proper validation of the processes which ought to be validated.

It is not a simple process, but it can be done if you and top management are in sync. If you really get hung up on the part of everyone working together (you will have a rough row to hoe if the bosses expect you to do this in a vacuum), don't hesitate to arrange a phone conference with me to help you over the rough patches.

The Quality Manual should mirror what the company actually intends to do, not what they think should be in the manual.

Hello Fuzzy,

Is it possible in this case to make the Level 2 procedure detail oriented so as to avoid creating a WI for the corrective action process. I am asking this because, in the Quality Manual (Level 1), there is no need to reference both the SOP and the QAP for a particular process (in this case Corrective action)??

Rajesh


Perfectly OK.

I may add that the QMS is a dynamic document. it changes as the company, its processes, its products change. Its much simpler from a futuristic view to separate the portions likely to change frequently into tier 2 / Tier 3 documents while the generalised instructions / policies that dont change every day stay in the higher level documents. You are the best judge for what stays where for your company.

And yes, frame your documentation based on your current practices + anything that the standard may want you to add / tweak. Dont import a set of documents and try to change your working style accordingly, or worse still, dont get into the trap of generating two sets of records - one for the management who want to see the day to day performance of the company and one for your registrar who wants to see compliance with your QMS.:nope:

Hello Mr Bucey and Mr Potdar,

My company is very small and management is not looking to expand very fast either. So I was thinking, I will add the procedures to the QAP's for now and the SOP's can include the manufacturing processes (like passivation, anodizing etc.)

I look forward to talking with you soon Mr Bucey.

Thanks

Rajesh

Rajesh,

The thing that is most important is to have meaningful documents that clearly let the employees know what they must be doing. Some of the documents will be addressing ISO and QSR regulations and some will be how to perform their job to get the process completed the same way each time.

So however you want to set up the system - as long as you accomplish those 2 things- you are doing the right thing!!!!

I've worked for a number of companies - doing different approaches - what works for one company won't necessarily for another. I always tell my people to meet the "intent" of the standard/regulation - there is always room to maneuver!

Linda

Hello Fuzzy,

Is it possible in this case to make the Level 2 procedure detail oriented so as to avoid creating a WI for the corrective action process. I am asking this because, in the Quality Manual (Level 1), there is no need to reference both the SOP and the QAP for a particular process (in this case Corrective action)??

Rajesh

As potdar replied:thanx: , yes it's perfectly OK. I have done some similar things in my system. In some cases the standard requirements are covered by statements only in the QMS Manual: there are no Level 2 or 3 documents:D . So you can tailor your document system to match the simplicity or complexity of your business. That's the beauty of ISO 9001:2000 based systems.:applause:

Thanks everyone for your valuable suggestions and tips. and please add more to this thread if you have anything else to share.

I will be firing a lot more questions in the coming days and hope all the Quality Gurus can bail me out (again)

Best Regards

Rajesh

Do whatever you want;

Call things whatever you want;

It doesn't really matter what you call them or what you do with them as long as you meet the requirements of 4.2.3 and 4.2.4.


Worry and fret over the really important stuff like actually doing it.

Everything else is dribble.

Do whatever you want;

Call things whatever you want;

It doesn't really matter what you call them or what you do with them as long as you meet the requirements of 4.2.3 and 4.2.4.


Worry and fret over the really important stuff like actually doing it.

Everything else is dribble.

I only read this thread because I saw that Randy had replied. He has the perfect answer, as usual. Keep it Simple! It is after all YOUR business so do what you want.

Okay..I just got the news that all QAPs should be converted to SOPs to avoid confusion for everyone in the company as well as any and all external auditors.

Somehow it just makes sense to me now that this should have been done in the first place :frust:

Okay..I just got the news that all QAPs should be converted to SOPs to avoid confusion for everyone in the company as well as any and all external auditors.

Somehow it just makes sense to me now that this should have been done in the first place :frust:"news" from whom? I don't know this to be true or even a common practice. I have a strong suspicion some of the folks making these "decisions" are pulling comments out of context in someone's treatise on Quality Management Systems without any sense of "big picture" vis a vis harmonizing a QMS with a Standard like ISO 13485.

Many organizations have multiple types of documents with no confusion -why should the folks at YOUR organization become confused?

I have a strong suspicion some of the folks making these "decisions" are pulling comments out of context...

I have to agree, only I don't think that's where they were pulling comments out of, if you'll excuse my grammar. :D

Many organizations have multiple types of documents with no confusion -why should the folks at YOUR organization become confused?

:agree1:I wish everyone would spend a lot less time worrying about what documents are called, and a lot more worrying about what they say.

We had a meeting regarding what to call the Procedures (QAP's or SOP's). The person making the decision seemed highly confused when i told her some are QAP's and some are SOP's. She wanted them to be consistent as SOP's since both QAP and SOP is telling a person what to do, how to do and what to use. The person i keep referring to is the company founder, who has quite a bit of Quality knowledge dealing with other companies and auditors in the past.

Thankfully for me, the format for both QAP and SOP is the same in this company and hence all I have to do is to change the Header and Footer and change the Title from "Doc 8.2.1 - Inspection and Testing" to "SOP M-0XX - Inspection and Testing"

Sounds reasonable??

We had a meeting regarding what to call the Procedures (QAP's or SOP's). The person making the decision seemed highly confused when i told her some are QAP's and some are SOP's. She wanted them to be consistent as SOP's since both QAP and SOP is telling a person what to do, how to do and what to use. The person i keep referring to is the company founder, who has quite a bit of Quality knowledge dealing with other companies and auditors in the past.

Thankfully for me, the format for both QAP and SOP is the same in this company and hence all I have to do is to change the Header and Footer and change the Title from "Doc 8.2.1 - Inspection and Testing" to "SOP M-0XX - Inspection and Testing"

Sounds reasonable??

This sounds perfect!!