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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 alternative.

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

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