Getting started in ISO 13485

Manto

Starting to get Involved
#1
Hello all I just took a job that turned out to be to get the company certified for ISO 13485. When I was hired it was to see about being compliant to the standard. The company only makes one device Class II. but all they have is a quality manual ( that i just reviewed and corrected) and no written procedures. I feel overwhelmed. Can some one tell me where to start. They want work instructions done first but they don't even have any procedures written to back up the quality manual. They have an antiquated systems so I am having trouble just to get drawings for the part. I will have to go to multiple people to see if they have anything (tribal knowledge) so I can start writing procedures. Is there a good webiner I can see and maybe a good site to find examples of other company procedures I can built on as my own. any advice will be greatly accepted. Leaving for the night but will check this in the morning thanks in advance.
 
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Tagin

Trusted Information Resource
#2
What is your level of background/experience with 9001 or 13485, and with building a QMS from scratch?
 

yodon

Staff member
Super Moderator
#3
Agree with what I believe @Tagin is implying: if you have no experience, you're in for a lot of headaches and heartaches.

Do you have a copy of the standard?

A lot of companies offer a "QMS in a box" service. While tempting, recognize those are generally one-size-fits-all and you frequently bend to their will rather than developing a system that aligns with your company. On the other side, you can get infinitely adaptable software-based systems and they're great but you need to know how to configure to, again, make them work for you.

You'll probably want to start by learning what the current processes are. Using that, you can see where the gaps are against the standard.
 

John Broomfield

Staff member
Super Moderator
#4
Manto,

Understand what your company already does to fulfill its mission (purpose). Study its workings as a system.

Work with top management to determine the processes essential to convert customer needs into cash in the bank (the value stream). What are the opportunities and risks? Then determine with TM the processes that are essential to support (recruiting, training, purchasing for example) and verify the effectiveness of this value stream. Having done this you can agree with them the names of the employees who know most about each process; these are the process owners.

Inform everyone what is going on and why. Do not give certification as the reason, you can come up with much more noble reasons than that!

Do this with a thorough understanding of the standards (ISO 13485 and ISO 14971). Work with each of the process owners to capture what is done to fulfill the process objectives. Focus on what is actually done to prevent problems in the process. A SIPOC model and then a deployment flowchart is probably the best way of capturing this information. Ask the process owner to make sure it is accurate by obtaining review comments from process team members. Then reconcile every comment to result in an accurate documented (flowcharted with links to forms and more detailed instructions) procedure.

Search the Cove for more info on developing your process-based management system.

If you are not already trained as a lead system auditor then get yourself on class to understand business, leadership, systems, risk management, how to listen and observe well to elicit facts about the system and its processes. With any luck this training will include a lecture and workshop on developing process-based management systems too.

Keep in touch with your progress and questions.

Good luck,

John
 

Manto

Starting to get Involved
#5
What is your level of background/experience with 9001 or 13485, and with building a QMS from scratch?
I have been in Quality for 30 years and have maintained ISO 9001 for about 8 yrs at two different companies. (Semiconductor and Metal Fabrication)
I had slight exposure to 13485 but that was 15-20 years ago. I have the ISO 13485 document and will also get the ISO 14971 and ISO 14929. I do have an understanding of what I have to do. I am also a lead Auditor so this is also helpful. I appreciate that this kind of networking is available as it help me to gain knowledge and confidence in what I need to do
thank you all I will follow up with updates in the coming weeks.
 

Tagin

Trusted Information Resource
#6
I have been in Quality for 30 years and have maintained ISO 9001 for about 8 yrs at two different companies. (Semiconductor and Metal Fabrication)
I had slight exposure to 13485 but that was 15-20 years ago. I have the ISO 13485 document and will also get the ISO 14971 and ISO 14929. I do have an understanding of what I have to do. I am also a lead Auditor so this is also helpful. I appreciate that this kind of networking is available as it help me to gain knowledge and confidence in what I need to do
thank you all I will follow up with updates in the coming weeks.
That's good. I agree with @John Broomfield that a top-down approach is best. Although they may think they want work instructions first, those work instructions depend on document structures, document organization, and document controls being defined first. But those will refer to who has authoirty and responsibility, so an org chart for the QMS needs to be defined first, Also, the document numbering or labeling will likely depend on the process it applies to, so defining all processes has to come first. Etc. You need to use your expertise to make them understand that the foundation must be exist and be solid before the house can be built upon it.
 

twanmul

Involved In Discussions
#7
I used the attached document map when I was trying to first get my head around the absolute minimum procedural requirements for ISO13485. Hopefully this gives you a starting point.
As the others have said, there is maybe a more holistic piece of work, starting with the quality policy and the objectives defining what the goals are RE certification. Hope this helps.

DISCLAIMER - This isn't perfect and I wouldn't say this is a definitive article, just a starter for you.
 

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John Broomfield

Staff member
Super Moderator
#8
Manto,

You've analyzed the standard and this helps with understanding its requirements.

But you still need to analyze the way your organization works as a system as I have described above. Then you end up with a high degree of ownership and respect for the management system documented just enough to be effective.

Back in the 1980's many implementors would make a list of work instructions then write them and then impose them on their colleagues. Many consultants had these docs ready made for "find replace" adjustments on their laptops.

...and then we wondered why top management didn't support the so-called ISO system which may even have secured certification.

John
 

Manto

Starting to get Involved
#9
Manto,

You've analyzed the standard and this helps with understanding its requirements.

But you still need to analyze the way your organization works as a system as I have described above. Then you end up with a high degree of ownership and respect for the management system documented just enough to be effective.

Back in the 1980's many implementors would make a list of work instructions then write them and then impose them on their colleagues. Many consultants had these docs ready made for "find replace" adjustments on their laptops.

...and then we wondered why top management didn't support the so-called ISO system which may even have secured certification.

John
Yes John I agree with your post. As I have only been here a few days, I will be looking at how they do things I will be meeting with the department heads so we can all be on the same page..
 

levatorsuperioris

Involved In Discussions
#10
I hope your company is small. If its a a medium enterprise with processes already in place it will be very difficult to get compliant without previous experience. In my experience the smaller the firm the easier it is to implement.

I have seen a company (20-50 person firm) take two years two finally get 13485 certified with help from a QS Manager who recently retired from a large Medical Device firm. This firm only manufactured springs to be used in Medical devices for higher risk classification.
 
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