EU REACH Regulation - is ISO17025 accreditation required for internal labs?

[Bulksupplier]

REACH - acronym for Registration, Evaluation and Authorisation of Chemicals – is a new EU Regulation with the main objective of ‘ensuring adequate protection of human health and the environment’. The regulation will require that companies who manufacture or import more than 1te per year of a substance will have to register it, including all analytical and toxicological data.

My question is - will the analytical data be accepted if the internal laboratory that produces it is not ISO 17025 accredited? If so, will ISO 9001 be required?

We are currently developing a plan for REACH, and if ISO 17025 is required we need to prepare now to meet the June 2008 deadline for pre-registration.

 

[Hershal]

Finishing the plan and achieving accreditation is certainly a good move.....as to whether it is required of an internal lab, others here are likely more qualified than me for the response to that question.

Hershal

 

[harry]

From what I had read so far (there are mountains of documents to read), it was specified that GLP (good laboratory practices) is needed. But recognised (by the commission) International standards will be considered (I suppose ISO 17025 comes under this).

According to 2004/10/EC, Good Laboratory Practice (GLP) is defined as a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. The main objective of GLP is to ensure test data produced by different laboratories can be mutually recognized so as to avoid repeat testing. GLP provides an assurance to regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments. Member States of the European Union have to take measures to comply with the principle of GLP when evaluating chemicals safety according to 67/548/EEC.

In addition to chemicals, GLP applies to all non-clinical health and environmental studies for registering or licensing cosmetic, pharmaceuticals, pesticides as well as food and feed additives.

For those interested, attached is an FAQ document which contain some of the answers.

 

[amanbhai]

REACH - acronym for Registration, Evaluation and Authorisation of Chemicals – is a new EU Regulation with the main objective of ‘ensuring adequate protection of human health and the environment’. The regulation will require that companies who manufacture or import more than 1te per year of a substance will have to register it, including all analytical and toxicological data.

My question is - will the analytical data be accepted if the internal laboratory that produces it is not ISO 17025 accredited? If so, will ISO 9001 be required?

We are currently developing a plan for REACH, and if ISO 17025 is required we need to prepare now to meet the June 2008 deadline for pre-registration.

ISO 17025 is little bit more stringent in technical requirements which ISO 9001 lacks.
It is specially designed for Testing & calibration labs.
2008 is a good target acheiveable i beleive.

 

[amanbhai]

my experince says that once your accreditated to ISO 17025 you no longer need ISO 9001.

 

[Bulksupplier]

Thanks for all these useful replies

I guess the best plan is to go for a joint GLP/ISO 17025 accreditation, since there is a 70% overlap, and ISO 17025 is recognised by ISO/TS 16949.

Only problem then is cost - it will take auditors from 2 different government agencies to perform the joint audit. Why wasn't ISO/IEC 17025 written to cover all GLP requirememts?

 

[harry]

Thanks for all these useful replies

I guess the best plan is to go for a joint GLP/ISO 17025 accreditation, since there is a 70% overlap, and ISO 17025 is recognised by ISO/TS 16949.

Only problem then is cost - it will take auditors from 2 different government agencies to perform the joint audit. Why wasn't ISO/IEC 17025 written to cover all GLP requirememts?

As had been discussed here many times, a QMS is meant for the sole use of a particular organization and it must suit their purpose. From which I would infer that you can have an ISO 17025 system incorporating the other elements of GLP not covered by it. Afterall, ISO 17025 is just a guideline only and you tailor your QMS to suit your purpose and needs. Maybe experts like Hershal would like to share their views.