ISO 13485 states: The supplier shall maintain records of all customer complaint investigations. When the investigation determines that the activies at REMOTE PREMISES contribute to the customer complaint, relevant information shall be communicated between the supplier and the remote premises.
I am looking for a definition of REMOTE PREMISE. Is it the customer site or is it another division of the parent company?
hershal 3/5/2003
You should be able to find some help by reading ISO Guide 62 which deals with Registrars, and ISO Guide 58 which deals with Accreditation Bodies.
The more detailed answer is that a Registrar, testing laboratory, calibration laboratory, personnel certification agency (e.g. ASQ) can become accredited, altough to different standards. In terms of an heirarchal structure these organizations are all at the same level.
The next level up is the Accrediting Bodies (ABs). In the U.S. there are about 150 ABs, mostly Government entities. A handful are - for lack of a better term - in the commercial arena. IAS, A2LA, NVLAP, AIHA accredit primarily laboratories and inspection agencies, and are signatories to NACLA. Additionally, IAS, A2LA, and NVLAP are signatories to APLAC and ILAC. There are several other ABs that are not yet signatories. For personnel certification, there is ASQ and RAB operating in the U.S., in the quality world.
NACLA, APLAC, and ILAC are known as MRAs, or Mutual Recognition Arrangements. NACLA is the National Cooperation for Laboratory Accreditation. APLAC is the Asia Pacific Laboratory Accreditation Cooperation. ILAC is the International Laboratory Accreditation Cooperation. There is a similar MRA for Registrar ABs. The MRAs are in place because there is not a specific organization that accredits the accrediting bodies. The MRA provides a structure with specific guidelines and the ABs provide resources to the MRA organization to perform audits of signatory and applicant ABs. Usually this is not an issue, as most countries have only one AB per economy (country). The MRA signatory status allows accreditations from one AB to be recognized as "equivalent to their own" by another signatory AB.
ABs that are outside the U.S. "come to power" by Government decree. They are chartered, started, sponsored, call it what you will, by the national government or one of its agencies. There are a few exceptions, but only a few. In the U.S., it is different. RAB is not governmental, it was created by a professional association. NVLAP is the NIST AB, IAS is a subsidiary of the International Code Council. A2LA, L-A-B, and a few others are technically corporations. Others like AASHTO are direct branchs of a government entity. Put another way, there is no one single answer as to how they come to be.
Hope this helps. If you have any other questions, feel free to contact me.
Hershal