I've inherited a mess - New to the Regulatory/Quality area - ISO 13485

Al Rosen

Staff member
Super Moderator
#11
Rhino said:
Thank you everyone for your help and ideas. Let me give a little more in depth breakdown of what we currently have and my thoughts on improving it. Please feel free to critique my ideas all you want. I need some healthy objective view points.

Our company designs, manufactures and sells medical devices. We are currently registered to 13485 1996. We had our audit back in Ocotober of 2004 and are scheduled for another in June I believe. We are growing company with currently just under 50 employees, but forsee a rather substantial growth phase in the next 2-3 years which will at least double the size of the company in personnel.

The current system was creataed about 8 years ago I believe and has worked, but is just very cumbersome. It does work with 13485 1996, but it is not the most streamlined system out there.

After reading some more and going to a couple of seminars, I have gained a better understanding of how our current system relates with 13485 1996 and 2003.

We have a Quality Manual Document which outlines very basically what is required by the 13485 1996, but it also contains alot of information about other areas of the company as well. It is more like a business manual than a quality manual I guess you could say. It is about 20 pages long. We also have what we call procedures which are basically the requirements of 13485 and some other company procedures that are laid out more like incomplete work instructions which also reference other documents we call work instructions. Our Quality Manual (business manual) and our Procedures make-up what should effectively be called the Quality Manual as whole. So, this document is more like 100 pages. It is fairly large when it is put together.

The way I am viewing things now is that the Quality Manual should just be the basics saying that you are compliant with 13485. I need a little clarification as to how much information this should entail. Should it just be a flow-chart or an organizational chart. I guess is the basically just a visual or I suppose a written document that shows the process flow of a product through the company, from conception?

What we are calling procedures and work instructions are actually SOP's if I am not mistaken. Clarify me if I am wrong here. There should remain as such, but be written so that we have just one type of document rather than having procedures and work instructions both.

Now, is it enough to have a simple reference line in the Quality Manual that references the appropriate work instruction/procedure which actually tells how something is done. For example, the Quality Manual will mention that we we have a CAPA system and it will mention how a CAPA is determined and then it will reference the Work Instruction/Procedure which will actually explain how the CAPA system works.

Should there be a written Quality Manual and a Process flowchart or are they basically one in the same?

I hope this clarifies my problems a little better for everyone to understand. I may not have worded everything correctly and I may have missed a few things.

Please ask me questions and give me advice and anything else. I want to know if my basic thinking is correct on this.
In my opinion, for what it is worth, having procedures and work instructions are necessary. I adhere to the documentation pyramid with the manual at the top, then SOPs (referenced in the manual), work instructions next and forms at the bottom. You may have a procedure that describes what steps you take when you perform an inspection or test, but what you inspect or how you test an individual assembly or end item is detailed in a work instruction. I have a 20 page manual and about 30 SOPs and numerous work instructions not specifically referenced in the manual. Although, we call the work instructions SOPs, a rose is a rose.
 
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Q

qualitygoddess - 2010

#12
Having just helped a company through the transition from 1996 to 2003, I can tell you without reservation that the registrar looked for a thorough quality manual that included appropriate references to the procedures that were required by the std. We even had to make statements about requirements in 7.5 that were not applicable to this manufacturer (like implantable device controls).

Then the registrar went through the procedures. Since this is a smaller company (about 60 people), they chose to make the procedures have some teeth. So, all the details were there. This company also uses work instructions to describe manufacturing, purchasing, HR processes. They also have detailed job routers that serve as both part-specific instructions and records of work done.

They passed, with only a few minors.
 
C

Calla

#13
Hopefully a little help

The quality manual serves as the company’s interpretation of the standards while you are currently interested in the compliance to ISO13485:2003 it will also include the companies interpretation of the QSR and any other regulations or standards that your company is required to meet.

The procedures no matter what you call them provide the day-to-day direction for the process. I would look to the users of these documents to review them for continued applicability and accuracy.

I think if the system was a compliant system prior to change in the standard that you will find most of the elements of the new standard in place(no not in the format of the new standard but the format is not the requirement). There will need to be additions for heightened emphasis on customer service in the updated standard and probably additions for the control of documents of external origin.

I would also look for users who are familiar with the old system. They may be able to provide some guidance to locations of the data that you need.
 
R

Rhino

#14
Ok, I'm back.

Again, correct me where I am wrong. The SOP/procedure is the who, what, when, where and why. The Work Instruction is the how. Correct?

In all of your experiences, what is the best way in which to write a procedure; simple paragraph or 2, broken down into sections such as purpose, scope, etc...?

Thanks,

Ryan
 

Al Rosen

Staff member
Super Moderator
#15
Rhino said:
Ok, I'm back.

Again, correct me where I am wrong. The SOP/procedure is the who, what, when, where and why. The Work Instruction is the how. Correct?

In all of your experiences, what is the best way in which to write a procedure; simple paragraph or 2, broken down into sections such as purpose, scope, etc...?

Thanks,

Ryan
That is correct on both points. You may wish to search the attachments in the cove and look here for some examples.
 
#16
The ISO 9000 definition of a procedure is the specified way to carry out an activity or process. That means the procedure is focused on the process. A work instruction is focused on a task.
 
P

Pataha

#17
Rhino,

I feel your pain. When I took over for this company, policies and procedures were written after FDA Audits and only enough to fill the gap that was created. It looked like a moth eaten quilt.
What helped me was a matrix that listed the requirements for FDA, Health Canada, and ISO. Turns out during our inital ISO 13485:CMDCAS, the auditor expected this for the QSM. How this helps is to see what documents support each element for each system and how you fulfill each element.
I concur with an overall internal audit.
Good luck,
Craig.

APPENDIX D —SPECIFIED REQUIREMENTS MATRIX
21 CFR 820 IS0 13485:96 ISO 9001 ISO 13485:2003 Health Canada MDR Requirement Policy/Procedures
Standard Operating Procedure
 
C

celeo

#18
cross reference QSR/13485:1996=>2003 etc

I did post this a while ago but it seems a few people found it useful, so here it is again. Fundamental difference between old and new 13485's is a systems approach and the process approach. You must understand the differences before creating a new Q-system.
 

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