Quality Management Systems and Regulatory Affairs

Article Index

Quality Management Systems and Regulatory Affairs

Quality Management System Registration 

ISO 9001, ISO 14001, ISO 13485, OHSAS 18001, TS 16949

Medical Device:

ISO 15883, MDD 93/42/EEC, ISO 14971, ISO 15223

Water pollution prevention:

EN 1717, WRAS, DWG W540, KTW W270, NSF 61

ISO 9000

ISO9000 is an internationally recognized standard for business management which ensures that businesses are
operating to the same standards of meeting customers’ requirements. There are many benefits for the business
certified to ISO 9001. The major benefit is a significant competitive edge over competitors. ISO 9001 can also be a
cost-effective way to demonstrate customers that quality assurance is of paramount importance to your organization
and through proper preventive measures you can save waste that can be passed on to your customers.

ISO 14001

ISO14001 is an internationally recognized Standard for evaluating how an organization manages its environmental
matters. ISO14001 certification means complying with environmental legislation. Many customers and other
stakeholders may require their suppliers to be accredited.

ISO 13485

It is the regulatory standard for medical devices. It is based on ISO 9001 but has some additional requirements
typical for medical device industry. It is required by legislation. Canada, EU and other countries require the
manufacturers and distributors to be ISO 13485 certified. In order to sell medical devices internationally, it is a must
for organizations to have ISO 13485 certification: It is mandatory for CE mark and Canadian Medical Device Licence.

OHSAS 18001

This is a safety standard, to enable businesses to measure and demonstrate their commitment to Occupational
Health and Safety. OHSAS 18001certification confirms that safety procedures are within the requirements of the law,
the business operates to accepted high standards of safety, ensures legal and regulatory compliance, reduces the
probability of workplace accidents, and helps control insurance premiums.