ISO 13485


Medical Quality Management System

General

The certification body [CB] No. 3002 is accredited for a certification of management quality system by producers [suppliers] of medical devices according to EN ISO 13485. The medical device industry faces a complex global market place. Affected by multiple regulatory systems, international and national standards and requirements.

This complex environment is dynamic, constantly changing, influenced by many national and international forums and initiatives, particularly the drive towards global harmonization.

Effective quality management systems like ISO 13485 are recognized as a key regulatory consideration for allowing medical device manufacturers to market their products around the world. The level of quality management system registration required will vary from market to market and dependent on the risks and hazards associated with the devices.

Whatever devices they produce medical device manufacturers have a responsibility to consistently deliver devices that are safe and effective. Several published standards are relevant to medical devices manufacturers:

A new version of ISO 13485 was published in 2003, this standard is based on the ISO 9001:2000 model. For companies registered to an earlier standard there is a three year transition period from ISO 13485:1996 and ISO 13488:1996 (which will be withdrawn).

ITC has transformed the ISO 13485 certification process into an opportunity for you to improve your company's efficiency and increase profits. Additionally, the ISO 13485 certification can open international doors into new markets because many countries require this ISO 13485 certification.The standard has a lot in common with the requirements of the Medical Directives (AIMDD, MDD, IVD). As Notified Body, ITC is able to certify the Quality Management System as well as the product-related aspect in one combined audit.

The produced certificate has the 3 years term validity . In the course of this time there is a supervision audit [once year] . Its aim is to assure that a management quality system of sanitary devices is maintained and further developed. In case of positive result of inspection, there is a confirmation of certification validity for further period.

Use ISO 13485 2003:

	To establish a quality management system that is oriented towards the design, development, production, and installation of medical devices and related services .
	To demonstrate your ability to supply medical devices and related services that meet customer expectations and comply with regulatory requirements.
	To evaluate how well your organization is able to meet customer expectations and comply with regulatory requirements.
	To become certified or registered.

ISO 13485 is not a product standard. It's a process standard.

ISO 13485 VERSUS ISO 9001

ISO 13485:2003 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, not to improve them. 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:

	When ISO 13485 wants you to document a procedure , the standard also wants you to implement and maintain it.
	EN ISO 13485 wants you to document a requirement , the standard also wants you to implement and maintain it.
	EN ISO 13485 wants you to document an activity , the standard also wants you to implement and maintain it.
	EN ISO 13485 wants you to document an arrangement , the standard also wants you to implement and maintain it.

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, whereas ISO 13485 seems to have removed some of this flexibility by insisting on the use of formal procedures.

SCOPE OF NOTIFICATION

The range of accreditation for certification of producers of medical products is defined by Certificate about accreditation issued by ITC and contents the following sections: