ABOUT ISO 13485; ISO 9001; CE Mark

ISO 13485:2003 and ISO 9001:2000 Quality Management Systems

ISO 13485:2003, a standard developed to specify quality management system requirements for regulatory purposes for medical device manufacturers. ISO 13485:2003 provides a framework to enable companies to meet their customer and regulatory requirements.

The primary objective of this International Standard is to provide a "harmonized" model for quality management system requirements that satisfy international medical device regulations. This is in contrast to ISO 9001:2000 where the primary focus is a satisfied customer and business improvement. Medical device manufacturers need to ensure that all medical device products are safe, fit for their intended purpose and that their products and their design and manufacturing quality management systems meet Regulatory requirements.

Organizations whose quality management system conforms to ISO 13485:2003 cannot claim conformity to ISO 9001:2000 unless their quality management systems also conforms to all the requirements of ISO 9001:2000, including the additional requirements for customer satisfaction and continuous improvement.

The benefits of an ISO 13485:2003 compliant quality management system to the thousands of companies worldwide include:

• Recognition by regulators around the world of ISO 13485:2003 as a good basis for addressing medical device design and manufacturing regulatory requirements.
• Controlled consistency of manufactured products.
• Managed productivity and efficiency, controlling costs.
• Competitive advantage and increased marketing and sales opportunities.
• Improved customer perception of the organization's image, culture and performance.
• Improved communications, morale and job satisfaction –staff understand what is expected of them and each other.

CE marking

The letters "CE" on a product are the manufacturers claim that the product meets the requirements of relevant European Directive - MDD, the Medical Device Directive 93/42/EEC.

CE marking on a product:

• Indicates to governments that the product can be legally sold within the European Union (EU) and the European Free Trade Area (EFTA).
• Ensures the product can move freely throughout the European Single Market.
• Indicates to customers that the product meets designated minimum safety standards and therefore a minimum level of quality.
• Promotes public health and safety.
• Enhances product credibility.
• Leads to improved sales and greater customer satisfaction.

CE marking is mandated by New Approach Directives. Many products are covered by these directives, and to be placed on the market in the EU, some must bear CE marking - it's a legal requirement. CE marking is the manufacturer's claim that the product meets the essential requirements of all relevant European Directives.

Benefits of CE marking:

The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives.

Often customers will look for CE marking on a product as an indication of conformance to laid down minimum standards, and therefore a minimum level of quality that other products may lack.