ISO 13485 implementation - Other required standards and guides

[wslabey]

Hi there everyone. I am a newbie to ISO 13485 but not to ISO 9001, TS 16949, and FAA regulations. Our company is ISO and TS registered and we have FAA approval to repair airplanes and make aircraft engine parts. Our company is entering the life sciences market with piece of lab equipment used in laboratory research.

I have bought a $200 copy and read ISO 13485 including the appendix and estimate there are 72 total procedures, documents and records required for ISO 13485 registration. Forty-five (45) of which are unique to ISO 13485.

I have two questions for you who have worked in the industry and know the requirements better than I do.

1. What other standards and regulations are required for implementation? So far my reading indicates the following are referred to in ISO 1385:

• ISO 14971: 2007 Medical Devices--application of risk management (see page 10 of the ISO 13485 standard under Clause 7.1)
  
• ISO 10012:2003 Measurement Management Systems (see page 17, Clause 7.6 Control of monitoring and measuring devices)
  
• ISO 9011:2007 Guidelines for quality or environmental system auditing (see page 18, 8.2.2 Internal audits)
  
• ISO/TR 14969 -- A technical report to provide guidance to applying ISO 13485 (see page 28, Appendix B 0.3.2 Relationship with ISO/TR 14969)
  
• Also found on-line in the COVE was a reference to using FDA-29-CFR 820 and FDA 21 CFR 820. I tried looking these up and the former sounds like a typo. The latter is talked about but I don't know what it really is. This leads to my next question.

2. How are medical devices classified? It does dictate the scope and by inference, the applicable standards. I know our new entre in the market is destined for lab experiments. If it fails no one dies, just an experiment might get ruined. Yes, that would be functional failure but no one is dying such as a heart valve failing.

Thanks in advance for your help.

Bill

[DannyK]

ISO 14969 is an excellent document and will help you implement the quality management system. The other document that you can purchase is ISO 14971:2007 for risk management.

Classification is different in different countries:

Europe (CE), Canada and the United States have different classifications and you must look at their classification requirements.

A good guide available on the internet for Canadian requirements is on the Health Canada website. Do a search for GD210.

Danny

[Ajit Basrur]

In Reply to Parent Post by wslabey

Hi there everyone. I am a newbie to ISO 13485 but not to ISO 9001, TS 16949, and FAA regulations. Our company is ISO and TS registered and we have FAA approval to repair airplanes and make aircraft engine parts. Our company is entering the life sciences market with piece of lab equipment used in laboratory research.

I have bought a $200 copy and read ISO 13485 including the appendix and estimate there are 72 total procedures, documents and records required for ISO 13485 registration. Forty-five (45) of which are unique to ISO 13485.

I have two questions for you who have worked in the industry and know the requirements better than I do.

1. What other standards and regulations are required for implementation? So far my reading indicates the following are referred to in ISO 1385:

• ISO 14971: 2007 Medical Devices--application of risk management (see page 10 of the ISO 13485 standard under Clause 7.1)
  
• ISO 10012:2003 Measurement Management Systems (see page 17, Clause 7.6 Control of monitoring and measuring devices)
  
• ISO 9011:2007 Guidelines for quality or environmental system auditing (see page 18, 8.2.2 Internal audits)
  
• ISO/TR 14969 -- A technical report to provide guidance to applying ISO 13485 (see page 28, Appendix B 0.3.2 Relationship with ISO/TR 14969)
  
• Also found on-line in the COVE was a reference to using FDA-29-CFR 820 and FDA 21 CFR 820. I tried looking these up and the former sounds like a typo. The latter is talked about but I don't know what it really is. This leads to my next question.

2. How are medical devices classified? It does dictate the scope and by inference, the applicable standards. I know our new entre in the market is destined for lab experiments. If it fails no one dies, just an experiment might get ruined. Yes, that would be functional failure but no one is dying such as a heart valve failing.

Thanks in advance for your help.

Bill

Hi Bill,

Answer 1 -

In addition to the ISO standards that you referred, Danny and yourself referred, you may want to take a look to ISO 14644 that talks about clean rooms environment for manufacturing certain medical devices.

29 CFR Part 820 is a typo error and should be 21 CFR Part 820. This is a very important document for device manufacturers based in US esp. You can refer to 21 CFR Part 820 HERE

Also of importance would be the Establishment Registration

The FDA website itself is a great resource for various information and I strongly recommend to have a look to understand more - www.fda.gov

Answer 2 -

Various countries have different device classifications. For example in US, there are 3 classes that are classfied based on risk as Class I, II and III and can be referred HERE

Apart from all this info, you will see that we plenty of information on related subjects - pls go through those and if you have further questions, come back

Best Luck

[wslabey]

In Reply to Parent Post by DannyK

ISO 14969 is an excellent document and will help you implement the quality management system. The other document that you can purchase is ISO 14971:2007 for risk management.

Classification is different in different countries:

Europe (CE), Canada and the United States have different classifications and you must look at their classification requirements.

A good guide available on the internet for Canadian requirements is on the Health Canada website. Do a search for GD210.

Danny

Danny,

Thank you, my listed of standards I must purchase is growing. I am still not clear on the classification system. It would be wonderful to find a primer on the subject that explains the different classes and how to classify. Who ultimately classifies is also key.

Bill

[SteveK]

For the EU classification go to Annex IX in MDD 93/42/EEC.
http://ec.europa.eu/enterprise/medic..._93-42-eec.pdf

Steve

[wslabey]

In Reply to Parent Post by Ajit Basrur

Hi Bill,

Answer 1 -

In addition to the ISO standards that you referred, Danny and yourself referred, you may want to take a look to ISO 14644 that talks about clean rooms environment for manufacturing certain medical devices.

29 CFR Part 820 is a typo error and should be 21 CFR Part 820. This is a very important document for device manufacturers based in US esp. You can refer to 21 CFR Part 820 HERE

Also of importance would be the Establishment Registration

The FDA website itself is a great resource for various information and I strongly recommend to have a look to understand more - www.fda.gov

Answer 2 -

Various countries have different device classifications. For example in US, there are 3 classes that are classfied based on risk as Class I, II and III and can be referred HERE

Apart from all this info, you will see that we plenty of information on related subjects - pls go through those and if you have further questions, come back

Best Luck

Ajit,

Thank you very much. I new there was a clean room standard, but just didn't know the details or its name and number. On-line I found two part set for ISO 14644-2007 which includes Part 1: Classification of air cleanliness and Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644. That's another $134. So far I am up to another $702 in additional standards I need to buy. The only two that seem redundant to me are ISO 10012:2003 Measurement Management Systems. Requirements for measurement processes and measuring equipment since our company already has measurement and calibration procedures that pass TS 16949 certification requirements. Likewise with ISO 9011:2002 -- Guidelines for quality or management system auditing. My concern with NOT buying these is I may miss hidden "shalls" that specify or call out intervals and methods that are different than our currently compliant quality operating system that's registered under the TS 16949 standard for manufacturing or ISO 9001 for non-manufacturing.

Regarding 21 CFR Part 820
Thanks for the link, I have not yet explored it but I will.

Regarding Classification of Medical Devices
I need a primer on the subject and your link to the FDA site seems to be it. That is, what are the different classifcations & how they are classified. I haven't read all the hyperlinks in the FDA site you referred me to but I am hopeful it will enlighten me regarding who does the classification.

Again, thank you very much.

Bill

[Roland Cooke]

Attached is Part 2 of the guidance for classification of general medical devices under the European system, it's very educational.

Europe has the following classes:
Class I - low risk.
Class IIA - low/medium risk
Class IIB - medium/high risk
Class III - high risk

Obviously there are lots of ifs and buts. In particular, there are additional compliance rules for Class I devices that are sterile and/or have a measuring function, and for Class III devices that include pharmaceutical agents or include material of animal origin.


Part 1 explains the "why" and can be found here.

[wslabey]

In Reply to Parent Post by Roland Cooke

Attached is Part 2 of the guidance for classification of general medical devices under the European system, it's very educational.

Europe has the following classes:
Class I - low risk.
Class IIA - low/medium risk
Class IIB - medium/high risk
Class III - high risk

Obviously there are lots of ifs and buts. In particular, there are additional compliance rules for Class I devices that are sterile and/or have a measuring function, and for Class III devices that include pharmaceutical agents or include material of animal origin.


Part 1 explains the "why" and can be found here.

Roland,

Thanks for scanning the appropriate pages and posting the pdf as an attachment.

Bill