ISO 13485 VERSUS ISO 9001
ISO 13485:2007 is based on the ISO 9001:2000 quality management standard. Both standards are organized in the same way and use basically the same numbering system. In addition, most of the ISO 13485 requirements are taken directly from ISO 9001 without modification.

However, some ISO 9001 requirements were modified and others were excluded. Of course, ISO 13485 also includes a special set of requirements specifically related to the supply of medical devices and related services. In general, ISO 13485 is made up of two kinds of requirements: old ISO 9001 requirements and new requirements that are specifically related to medical devices and associated services.

ISO 13485 excludes ISO 9001 requirements related to continual improvement and customer satisfaction. Continual improvement is excluded because most medical device regulations require organizations to maintain their quality management systems. And customer satisfaction is excluded because committee members thought it was too subjective.

When ISO 9001 wants you to document a procedure, it also wants you to implement and maintain it. Section 4.2.1 of ISO 13485 expands on this idea by including requirements,
activities, and special arrangements. More precisely:

ISO 13485 also places a greater emphasis on the use of procedures to regulate and control how activities and processes should be performed. In this sense, ISO 13485 is somewhat more prescriptive than ISO 9001. ISO 9001 often leaves it up to you to decide how work should be controlled,

If you are looking to enter the European market, you will need the services of a Notified Body (NB). A NB is an accredited organization that is recognized by the European Union to audit quality systems and test devices to make sure the company/product meets applicable standards (example: ISO 13485) and directives (example: Medical Devices Directive). Upon successfully audit or passing the testing, NB issues a report or certificate that demonstrates the company's compliance with applicable European laws. Companies pursuing the European market require an NB's involvement to acquire the coveted "CE Marking" certificate.

Before going farther, we should clarify the difference between a Notified Body and a Certification Body. Both are used interchangeably but do differ. An EU Notified Body is authorized to conduct ISO 13485 audits and issue the CE Marking certificate based on the applicable Medical Device Directives. A Certification Body also is authorized to perform ISO 13485 audits but cannot issue a CE certificate. Many companies have been unpleasantly surprised by Certification Body that charged a good price on their ISO 13485 registration audit, only to find out later that a Certification Body could not issue CE certificates or get a company licensed in Canada. To ease further complication in future, best advice to organization before appointment of Notifying Body, ask relevant Notifying Body of their Notifying Body registration number. DQS recognise by many country regulatory body ie FDA in USA, Health Canada, PAL in Japan, MDB in Malaysia and etc, beside being a Notifying Body ( NB# 0297) in Europe.

SCHILLER is a leading international manufacturer and supplier of electrocardiographs, long-term ECG and blood pressure recorders, spirometers, medical IT solutions, patient monitors and external defibrillators. Whilst Schiller Asia Pacific and Schiller Malaysia are responsible on distribution and supply of medical devices in Asean countries. Both companies recently selected DQS as their certification partner for their ISO13485 & ISO9001certification scheme. The certification scheme is vital for Schiller to expand their presence in Asean since DQS being recognise as a Notifying Body in many part of the world.