ISO Certification - Whats Mandatory and Whats Not
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As a business considering an ISO certification, it is important to know which
industries require certifications and in which instances compliance is an
AS 9100 is the Aerospace Quality Management System. Its foundation is ISO
9000:2000, with additional requirements specific to aerospace manufacturers.
This is for companies that supply and work with the aerospace industry. Most
companies that become registered are companies that work with the aerospace
industry and are mandated to become AS9100 registered by their suppliers.
Once you are AS9100 certified, you're listed in the OASIS database as part of
your registration. The OASIS database is the Online Aerospace Supplier
Information System. Once you're listed in OASIS, any potential supplier in the
aerospace industry will be able to find your name and can contact you. OASIS
also has the results from your audits and information on your company. This is
part of the requirements for Aerospace registration, but your company OASIS
administrator can decide whether you want potential suppliers to see all the
information about your audits or just specific details.
ISO 13485 is the Medical Quality Management System. Again, the foundation is
ISO 9000:2000 with additional requirements that are specific to medical device
manufacturers such as requirements for packaging, cleanliness, and sterility. In
this industry, you want to be sure that any medical device was manufactured with
strict requirements. Organizations currently manufacturing private label medical
devices must have ISO 13485 registration if they sell their product in the
European Union. Organizations that manufacture in vitro diagnostic medical
devices, and want to be prepared for future regulatory requirements, would want
to be registered to this standard also. As in the aerospace industry, all
products produced need to be able to be traced back to their manufacturer. For
example, if a company experiences some difficulty, and they find that one of
their products does not meet standards, they need to know where that product
went, who bought it, and what it went into.
The automotive industry also mandates registration. First tier suppliers for
automotive must be registered to TS16949. The old former standard QS-9000 is no
longer a requirement as of December 14, 2006. Although there are some companies
that were not required to become TS16949 that want to maintain compliance with
the QS-9000 standard. They feel the QS-9000 was good enough to keep, regardless
of the new TS standard.
When you are not required to have an ISO certification, you can consider a
compliance status or unaccredited registration. A compliance audit is an audit
performed to the standard, but the certificate does not have an accreditation
body listed on it. For those groups listed above, many companies MUST have an
accredited audit and registration/certification. However, some companies do not
require accreditation and would accept an unaccredited registration.
Unaccredited registration/certifications are performed in the same way as an
accredited audit, but without being accredited by another party. This type of
audit can also be called a compliance audit with follow up. The same auditors
are used, paperwork, etc. You still have a documentation review, initial
assessment audit then surveillance audits yearly for maintenance. The rates can
be lower, since the registrar does not have to pay fees to another body.
A compliance audit is the same as an initial unaccredited audit but is
usually a one shot audit. It is a picture in time, and the certificate shows
that as of that date the company met the requirements.
About the Author
Sandy Tokola works for DAC Audit Services which has been in business for
fourteen years. DAC is a client-based, service oriented company that will direct
you through the world of internationally accredited certification or regular
certification. Whether you need a 3rd party, registration, ICOP, or 2nd party
registration, DAC can help!
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Article Published/Sorted/Amended on Scopulus 2008-02-15 14:38:24 in Business Articles