ISO 13485 and ISO 9001:2000

International organization for Standards (ISO)

If an organization has been awarded an ISO certification, it symbolizes that strict standards of quality are being followed in the organization. In the family of certifications, the most apt and renowned is the ISO 9000: 2000. This family of standards targets the quality standards. Many people see certification as an unwanted roadblock.

However, many people do not realize that these certifications act as pertinent tools for the marketing of products. These certifications generate confidence regarding the product's quality in the minds of the customers that is incomparable to any other medium of marketing. In other cases the need to meet a medical standard such as ISO 13485 is simply required to sell products in Europe and Canada.

ISO 9000: 2000 is defined by the ANSI and International standard organization in Europe. The certification in particular defines the business quality assurance requirements. Some of the industry specific ISO certifications have been defined below:

  • ISO 13485: A medical specific standard that essentially uses the ISO 9001:2000 as the basis, but then adds medical device specific requirements which are mostly harmonized with FDA's quality system regulations.
  • ISO 16949: An automotive driven standard that is similar to ISO 13485. It utilizes ISO 9001:2000 as the foundation, then lays out specific automotive requirements for compliance.
Importance of ISO Certifications:
  • ISO Certification tells customers that the product they are purchasing is a quality product and it has passed a number of qualifications in effort to establish its quality label.
  • If the firm perceives the concept of quality as a non-dominant issue then these standards can be professed as a guide.
  • If a company desires to sell into Europe or Canada, ISO 13485 is required depending on the medical device directives the company may have to meet (e.g., MDD 93/42/EC, Canadian Medical Device Regulations, etc.).

Revised in 2003, ISO 13485 is an internationally recognized standard. It portrays the requirements for a comprehensive quality management system (QMS) in the manufacture and design of medical devices.

  • For any medical device to be sold in the European market, the only way to authenticate & confirm quality standards is the certification issued by the Conformity Assessment Notified Body. This body actually analyses the QMS in the organization and depending on the route of approval (Annex II, V per the MDD 93/42/EC) issues a CE mark with the Notified Body number next to the CE symbol. If a positive assessment is issued in the interest of the organization then, it is authorized for CE-Identification and is permitted to sell the medical devices of high quality.

Essentially, ISO 13485 can be described as a standard, not restricted to products, but the processes followed in the organization. Hence, it is not just a standard that demands establishment of QMS but it also demands fulfillment of standards related to that particular product and service.