Industry Specific Certifications

There is quite a bit of overlap with the industry specific certifications and ISO 9001. Like ISO 9001, the below certifications need to be renewed every 3 years. Some manufacturers will tackle both ISO 9001 and their industry specific certification at the same time, while some prefer to space them out to reduce the workload for achieving the certification.

Medical

ISO 13485 focuses far more on documentation and safety requirements than ISO 9001. This is critical for medical devices which must be clean and free from contamination. So manufacturers save and record more information with regards to traceability, material certification, manufacturing conditions and personnel training. Often medical devices will be tracked to the serial number level and the manufacturer will maintain a record of material certs for the raw material used to manufacturer the product and a record of the serial numbers for purchased components in the final product. Many medical devices or components are also manufactured in clean rooms, where their personnel need special training for correct procedures in handling items manufactured in clean rooms.

Automotive

IATF 16949 overlaps so closely with ISO 9001 that is implemented as a supplement to ISO 9001. However, there are a few key items that come along with 16949 that are specific to the automotive industry. These include Advanced Product Quality Planning (APQP), Failure Mode and Effects Analysis (FMEA), Statistic Process Control, SPC, Measure Systems Analysis (MSA) and Production Part Approval Process. While many other industries do similar processes, the above tools are standardized and well defined across the global automotive industry. With the high expense and low margins in the automotive industry there is very little room for waste or error, so parts go through a thorough quality approval process to make sure that assembly of the vehicle goes as smoothly as possible.

Aerospace

AS9100 is also based on ISO 9001, but this time the certification has specific requirements that are aligned with DOD, NASA and FAA. While the standard is the same globally, you’ll often find the first two digits change according to country or region. For example, in Europe it is called EN9100. AS9100 tends to focus on traceability and part certification, much like the medical certification. There is also a big emphasis Methodology for design, production, testing and certification of all parts. I suppose in a way you could say AS9100 is a bit of a blend of Medical and Automotive requirements – high traceability with high approval processes.

Whatever your industry focus, you’ll want to keep an eye that all your manufacturers have current certifications. While it doesn’t guarantee that you’ll get a high quality product, it certainly reduces the risk of not getting a high quality product. I’ve always said, good quality won’t make you sell more product, but bad quality will make you go out of business.