REACH and ISO 9001:2000/13485:2003 - Never the Twain Shall Meet?

GStough

Staff member
Super Moderator
#1
Could someone please point me in the right direction on this? Does REACH documentation need to be included in a company's QMS for ISO compliance?

I have read some of the newer threads here, but didn't see anything that might indicate one way or the other. Where ISO 13485:2003 makes reference to "international or regional requirements", I'm thinking that REACH would be included in this. Am I correct?

I hope someone can help me here....:bigwave:

Thanks...
 
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Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#2
I wish I could help here Gidget but I really don't know much about REACH. I even did a search on the ASQ Discussion Boards and couldn't find anything that addressed you question.

I am sure someone will be able to help on this subject.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#3
I hope someone can help me here....
I know very little about REACH, Registration, Evaluation, Authorisation and Restriction of Chemical substances. The best website I was able to find is the "official" http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm

Also, the REACH in Brief document scope paragraph states:
REACH is very wide in its scope covering all substances whether manufactured, imported, used as
intermediates or placed on the market, either on their own, in preparations or in articles, unless they are radioactive, subject to customs supervision, or are non-isolated intermediates. Waste is specifically exempted. Food that meets the definition of a substance, on its own or in a preparation, will be subject to REACH however, such substances are largely exempted from Registration, Evaluation and Authorisation. Member States may exempt substances used in the interests of defence. Other substances are exempted from parts of REACH, where other equivalent legislation applies. The Commission will review the scope of the Regulation five years after entry into force.
So, if you work for a manufacturer of devices in the US, REACH might only affect you, in terms of potential material substitution, if your product contains a chemical that is deemed to be toxic, pretty much like ROHS.

Based on what I read, REACH is one of those statutory/regulatory requirements that might not affect you.​
 

harry

Super Moderator
#4
Could someone please point me in the right direction on this? Does REACH documentation need to be included in a company's QMS for ISO compliance?

I have read some of the newer threads here, but didn't see anything that might indicate one way or the other. Where ISO 13485:2003 makes reference to "international or regional requirements", I'm thinking that REACH would be included in this. Am I correct?

I hope someone can help me here....:bigwave:

Thanks...
I don't think there is a right or wrong way. It's all up to you. On the assumption that you need to comply to these, ultimately it is whether you comply or not.

If I need to comply with REACH/RoHS, I will group them together with ISO 14001 ( if I have such an EMS system) and reference them under the relevant section requiring you to meet legal and other requirements.

With regards to a QMS, I don't think I will reference or include them there (but there is no harm). I would like to keep everything inside there as quality related.
 

GStough

Staff member
Super Moderator
#5
I don't think there is a right or wrong way. It's all up to you. On the assumption that you need to comply to these, ultimately it is whether you comply or not.

If I need to comply with REACH/RoHS, I will group them together with ISO 14001 ( if I have such an EMS system) and reference them under the relevant section requiring you to meet legal and other requirements.

With regards to a QMS, I don't think I will reference or include them there (but there is no harm). I would like to keep everything inside there as quality related.
Harry,

We are not registered/certified to ISO 14001, just ISO 9001:2000 and ISO 13485:2003.

What you suggest makes sense, IF we need to comply with REACH/RoHS...

Thanks! :bigwave:
 
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