CONSULTANCY SERVICES

Industry Specific Standards

ISO 13485

Introduction

The international standard ISO 13485:2003, which was based on the ISO 9001:2000 process model approach, was published in July 2003. This international standard specifies requirements for a quality management system that can be used by an organization for the design, production, installation and servicing of medical devices. Internal and external parties, including certification bodies can also use it to assess the organization’s ability to meet customer and regulatory requirements.

The primary objective of ISO 13485 is to specify quality system requirements that specifically address the requirements of the medical devices industry that are not addressed by the generic quality management system standard ISO 9001.

Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements and to gain entry into the European market. The conformity of Medical Devices and In-vitro Diagnostic Medical Device to the European Economic Community (EEC) decrees 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted. The means to prove conformity is usually by way of certification of the Quality Management System according to ISO 9001 and/or ISO 13485, ISO 13488, or ISO 14971 by a Conformity Assessment Body (CAB).

Benefits of Implementation

IISO 13485 provides uncountable benefits - both tangible and intangible. A typical organisation would enjoy the following:

• fulfil one of the conditions of supply to European Union clients
• gain customer recognition and approval and open doors to the worldwide markets
• have a systematic approach to control all its processes and proven methods that will help to improve product quality levels
• greater transparency and consistency in its output
• and ultimately, a reduction in customer complaints and retention of customers

Frequently Asked Questions (FAQs)

How different is ISO 13485 from ISO 9001?

As ISO 13485 is developed based on ISO 9001, it is quite similar. A fundamental difference, however, is that ISO 9001 requires the organization to demonstrate continuous improvement, whereas ISO 13485 requires only that they demonstrate that the quality system is implemented and maintained. Other differences are requirements that are specific to the medical devices industry such as making management responsible for the promotion and awareness of regulatory requirements, controls to ensure product safety, specific requirements for inspection and traceability for implantable devices and specific requirements for documentation and validation of processes for sterile medical devices.

Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. The conformity of Medical Devices and In-vitro Diagnostic Medical Device according to EEC-decrees 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted. The preferred method to prove conformity is the certification of the Quality Management System according ISO 9001 and/or ISO 13485, ISO 13488, or ISO 14971 by a Conformity Assessment Body (CAB). The result of a positive assessment is the authorisation for the CE-identification and the permission to sell the high quality medical device in the European Union.

Is ISO 13485 compatible with environmental and occupational health and safety management system standards?

As ISO 13485 is developed based on the ISO 9001:2000 model, it is also compatible with the environmental and occupational health and safety management system standards of ISO 14001 and OHSAS 18001 that were similarly based on ISO 9001.