Hi!

I've just started at a small organisation that designs and develops a medical device, but outsources all manufacturing. I have been contracted to get the organisation ISO 13485 certified. I am actually straight out of university too and this is my first job in my field of study (operations management). I am amazed at how much information is available on this site, its proving to be extremely useful.

Just thought i'd write a post since I am using a lot of the information on this site and feel as though I should make any contributions I can.

Anna.

ps. feel free to give me your 2 cents!

Welcome to the Cove, Anna:bigwave: . Although my own limited area of expertise doesn't include medical devices, we do have some able contributors here who will be glad to help. Don't hesitate to ask a question or search the site for information, and always feel free to jump into the discussions.

Just wondering if any one has any hints as to developing a project plan to eventually obtain ISO 13485 certification.

i.e. what should we start with, etc. etc.

Thanks:biglaugh:

Start with a search here in the cove for a implementation plan or schedule (http://elsmar.com/Forums/attachment.php?attachmentid=140) and a gap analysis checklist (http://elsmar.com/Forums/attachment.php?attachmentid=1922).

I looked at those documents, thanks...the company i'm working for is quite a bit smaller, the only permanent employee is the CEO and there are 3 contracted workers (2 working on ISO).

Am I right in how I have interpreted ISO 13485:
- We need manuals for the processes in the company, in each of these manuals is required procedures, and for each procedure is the required documentation.
- Then all forms required for each procedure are included in the manual, as is a section to record all filled-in forms

Is this kind of right?

Anna.

With an organization that small, you might incorporate your procedures within your manual. There is a book by Kevin R. Grimes, ISO 9001:2000 A Practical Quality Manual Explained that you might want to look at. Although it is written for ISO 9001, you can get some ideas from it.

Hi!

I've just started at a small organisation that designs and develops a medical device, but outsources all manufacturing. I have been contracted to get the organisation ISO 13485 certified.....
Welcome to the world of Medical Devices. I have been in Quality in the Medical Device industry for the last 17 years. There is a lot of requirements and a lot of documentation. Your goal in setting up a system compliant to ISO 13485 is good and attainable but challenging for a small organization. Do not forget that you need to develope your system around the requirements of FDA 21 CFR section 820 as well.

You will be basically end up with 4 teirs within the Quality System:

Top Level Manual
Procedures
Work instruction - detailed as required
Documents - Forms.

This is a step down one to the next and so on. One tool that is good is the FDA Small Entity Compliance Guide FDA 97-4179 this will start you on the right path for gathering information.

Welcome to the world of Medical Devices. I have been in Quality in the Medical Device industry for the last 17 years. There is a lot of requirements and a lot of documentation. Your goal in setting up a system compliant to ISO 13485 is good and attainable but challenging for a small organization. Do not forget that you need to develope your system around the requirements of FDA 21 CFR section 820 as well.

You will be basically end up with 4 teirs within the Quality System:

Top Level Manual
Procedures
Work instruction - detailed as required
Documents - Forms.

This is a step down one to the next and so on. One tool that is good is the FDA Small Entity Compliance Guide FDA 97-4179 this will start you on the right path for gathering information.Why? She is in New Zealand

I work for a European Based Orthapaedic Company with Manufacturing facilities in the United States and Switzerland. I have seen the importance of making sure that a system is set up according the the requirements of ISO 13485 but with the Global scale of Medical Devices it is extremely important that companies set up their systems with compliance to the FDA requlations. The organization I work for currently out vends some of our manufacturing to facilities in China. They as well have to show compliance the the FDA reg. So when looking at setting up a system I believe it is important to look at not only the ISO but the FDA and potentially the Canadian regulations as well. So the question that has to be asked is what is the end customer base?

The current customer base is New Zealanders, although the expected result of gaining ISO certification is a greater ability to export, especially to Aussie to being with, and then US, but I realise that FDA certifications will have to be attained for this.

I have done an initial process diagram (4.1a,b) and was looking for any feedback on this. Thanks a lot for all of your information, its very useful during this process!!

Anna.

here it is....

Hi,

We have just about finished documenting section 7 of ISO 13485. I'm just wondering for when the auditor comes, do we have to show that we are actually adherring to all our procedures? I am assuming that we do have to do this, as opposed to just showing we have documented the proceedures?

Anna.

Hi,

We have just about finished documenting section 7 of ISO 13485. I'm just wondering for when the auditor comes, do we have to show that we are actually adherring to all our procedures? I am assuming that we do have to do this, as opposed to just showing we have documented the proceedures?

Anna.Yes you do. They want to see results of internal audits & management reviews, CAPA etc.

Hi!

I've just started at a small organisation that designs and develops a medical device, but outsources all manufacturing. I have been contracted to get the organisation ISO 13485 certified....
Hi Anna. Dont worry, I too am new to the ISO13485 scene and also work for a small medical device manufacturing company. I have already prepared the quality manual and associated SOP's and I am just developing the design/development dossiers for CE mark, so hopefully we can share some hints and helps etc.

Best of luck in your new post.

Welshery

I was just interested to know if the FDA requirements for medical devices are similar to what is required in ISO 13485. Also where can I view what these requirements are?

Anna.

Try this link to the FDA's website.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

Thanks that was really helpful.

What about FDA requirements for hazard analysis of medical devices? Is there any information on that?

Thanks that was really helpful.

What about FDA requirements for hazard analysis of medical devices? Is there any information on that?Search on the FDA CDRH website (http://www.fda.gov/cdrh/) or Device Advice (http://www.fda.gov/cdrh/devadvice/) for "Risk Analysis". You can find reference to it in FDA regulation 21cfr820.30(g) (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.30), Design validation.

I am currently finding it a bit challenging to see the difference between the Design History File and the Device Master Record. Currently our DHF's contain stages such as concept phase, feasibility phase etc. with requirements for documentation for each stage. A DHF is done for each version of a product, this leads to my next question...

What should be contained in our DMR's, as it seems that all requirements are covered in our DHF's?

I am currently finding it a bit challenging to see the difference between the Design History File and the Device Master Record. Currently our DHF's contain stages such as concept phase, feasibility phase etc. with requirements for documentation for each stage. A DHF is done for each version of a product, this leads to my next question...

What should be contained in our DMR's, as it seems that all requirements are covered in our DHF's?Your DHF might nclude everything in your DMR, but might also have other records such as but not limited to results of design verifications and validations. The DHF might not have inspection and test criteria which would be included in your DMR. The DMR would have all documents required to manufacture the device including, for example, process specs and instructions for inspection & test.

Hi YOUNGQUALITY - our Device History File includes all results from testing, verification, validation and also includes minutes of design development meetings, flowcharts and risk assessments etc. It is a large folder and actually extends to three files. The Device Master Record however, details the full a to z of the design and development of the products we make including drawings etc. It includes all references to tests and the results in brief with a reference also to the relevant section in the Device History File where the full results can be located. We decided to do it this way so as not to duplicate information between both files. Hope this helps.

:thanx: Thanks that was really helful.

Is it possible to combine our DHF and DMR into one folder and call it DHF?

Is DMR a requirement for ISO 13485?

:jawdrop:

:thanx: Thanks that was really helful.

Is it possible to combine our DHF and DMR into one folder and call it DHF?

Is DMR a requirement for ISO 13485?

:jawdrop:There is no requirement that the documents be in one location or "file", ours are maintained throughout our facility. We maintain a list of the locations for the DHF and DMR documents by document type such as engineering drawings, test procedures, etc. Much of the DHF can be found in lab notebooks. There is a similar requirement for 13485, commonly called a technical file.

I am interested to know whether the sterilization requirements outlined in ISO would apply to us. We are supplied our plastics and components from outsourced manufacturers and then we perform cleaning functions. Is it necessary to also perform sterilization?

Also for the procedure named 'Validation for the application of computer software', can this be documented in our DHFs?

Thanks.

I am interested to know whether the sterilization requirements outlined in ISO would apply to us. We are supplied our plastics and components from outsourced manufacturers and then we perform cleaning functions. Is it necessary to also perform sterilization?It depends. That can't be answer without knowing what your application and process are.

Also for the procedure named 'Validation for the application of computer software', can this be documented in our DHFs?Procedures are part of the Technical File, while results of inspection & testing are records included in the Device History File.

Hi i've got a quick question...

We are currently doing all of our DHF's and we're just wondering what to do when a new version of a product gets developed. For example we have completed the DHF for version 1 but now a version 2 is being developed, do we put version 2 documentation with version 1, or do we create a new folder?

Thanks for any advice you can give.

Anna.

We use another set of binders to maintain DHF documents for the subsequent versions (e.g 2.0, 2.5, 3.0 etc). DHF Index for the product is one long Excel spreadsheet, identifying all DHF documents, binder #, which version's release, which design phase (if you have phases 1, 2, 3, etc in your established Product Development Process. It comes in handy during external inspection/audit when we have to look up certain design records.

Hi,

I was just wondering if the only way to obtain the ISO standards is to purchase the standards or are they available anywhere for free?

Hi,

I was just wondering if the only way to obtain the ISO standards is to purchase the standards or are they available anywhere for free?They are copyrighted documents and we cannot promote sharing them due to the legal restrictions. You can purchase them in your part of the world from sai global. (http://www.saiglobal.com/shop/script/Search.asp)

Hi,

We manufactures a product that involves continual improvements and enhancements. Does that mean the Technical File for that particular product has to be updated whenever there is an improvement or enhancement on that product?

Cheers!

Hi,

We manufactures a product that involves continual improvements and enhancements. Does that mean the Technical File for that particular product has to be updated whenever there is an improvement or enhancement on that product?

Cheers!Of course it changes. It's dynamic, not static.

:bigwave:

Hi, I was wondering if you could name 2 or 3 companies that audits the ISO 13485 QMS. We've come in contact with SGS and TUV. But we thought that if we could have some other well-known certification service provider, then we may have a better portfolio of regulatory bodies.

:agree1: Cheers!

Thanks :biglaugh:

How about the TGA in Australia.

We use BSI.

Thank you. You're great people :agree1:

Hi, I am about to implement a Quality System in an electronic industry. At the moment no Quality system is implemented, but we do an electronic product that is part of a medical device, a company contracted us to make the sub assembly. In other words, they have designed and developed the product, but we produce it. Is necessary to implement ISO 13485 or ISO 9000?
I am new at this and this is my project to finish my Master Degree

Hi, I am about to implement a Quality System in an electronic industry. At the moment no Quality system is implemented, but we do an electronic product that is part of a medical device, a company contracted us to make the sub assembly. In other words, they have designed and developed the product, but we produce it. Is necessary to implement ISO 13485 or ISO 9000?
I am new at this and this is my project to finish my Master DegreeIf you are not marketing the medical device, then ISO 9001 would be appropriate.

If you are not marketing the medical device, then ISO 9001 would be appropriate.


I agree ISO 9001 would be apprpriate but not necessary.

I agree ISO 9001 would be apprpriate but not necessary.

What do you mean by appropiate but no necessary???
Now I am really confused!!! :confused:

What do you mean by appropiate but no necessary???
Now I am really confused!!! :confused:


What I mean is there is nothing requiring you to obtain ISO 9001:2000 Registration, unless of course your customer is demanding it, or the powers that be in your company do realize the benefits of implementing an ISO 9001 system.

What do you mean by appropiate but no necessary???
Now I am really confused!!! :confused:There is no requirement that a medical device manufacturer must purchase from an ISO 9001 or ISO 13485 registered supplier. You did not provide a lot of detail as to what the product is that you are supplying to the medical device manufacturer. Additional information such as whether it is a sub assembly, component, power supply, etc? How is it used in the end product? There may be aspects that we are not aware of that may influence which standard to use.

What I mean is there is nothing requiring you to obtain ISO 9001:2000 Registration, unless of course your customer is demanding it, or the powers that be in your company do realize the benefits of implementing an ISO 9001 system.

Well our client is demanding us any quality management system. And we have considered ISO because it is the system most used around the industry.

Well our client is demanding us any quality management system. And we have considered ISO because it is the system most used around the industry.

Did you ask your customer if they want you to be ISO registered or if they want you to be compliant?

Did you ask your customer if they want you to be ISO registered or if they want you to be compliant?

Well first and please correct me if I am wrong, be compliant is that I have made and meet all the suggestions of the QMS by ISO and be registered is to call an certified auditor and be registered.
We don't have the money to be registered so It will be to be compliant (if the above is correct)

Thanks

fsmelgar:cfingers:

There is no requirement that a medical device manufacturer must purchase from an ISO 9001 or ISO 13485 registered supplier. You did not provide a lot of detail as to what the product is that you are supplying to the medical device manufacturer. Additional information such as whether it is a sub assembly, component, power supply, etc? How is it used in the end product? There may be aspects that we are not aware of that may influence which standard to use.

We manufactures the main sub-assembies of the medical device (the electronic part). The other sub- assemblies is the case(which is made of plastic) and then the final product is tested by the company we supply.
For example, we construct all the green boards contained in a computer (the mother board, ect) and then the other parts that they have to do is to do some modifications (add some parts) to assemble it and then put it everything together in the case(tower).

Hi youngquality,

Just stumbled upon this thread when searching for small companies that did ISO 13485..

So has your company managed to attain ISO 13485 certification? Did you go through TGA?

Thanks!