ISO 13485 and ISO 9001:2000

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International organization for Standards (ISO)

If an organization has been awarded an ISO certification, it hints that strict standards of quality are being followed in the organization. In the family of certifications the most apt and renowned one is the ISO 9000: 2000. This family of standards pin points the quality standards. Many people see certification as an unwanted corporate boondoggle. But what many people don’t realize is that these certifications act as pertinent tools for the marketing of the 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 for example 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 much like the ISO 13485, utilizes ISO 9001:2000 as the foundation but then lays out specific automotive requirements for compliance.

Usefulness of ISO Certifications:

Quality is one expectation of customer on the basis of which the sales & in turn production of the product are greatly effected. Some aspects of ISO certification are defined below:

• All those firms, whose customers completely rely on the standards of quality followed in the organization for buying that product, must have ISO Certification. It helps in people making better assessments in a proficient manner.
• Also, organizations that perceive the ISO certification as a marketing tool must have the ISO certifications as it undoubtedly affects the customer’s decisions.
• Also, if the firm conceptualizes 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.).

INTRODUCTION TO ISO 13485:

Revised in 2003, ISO 13485 is an internationally recognized standard. It completely portrays the requirements and need 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.
  

Uses of ISO 13485

• Establishment of a QMS that is completely dedicated towards designing, developing, producing & installing medical devices and related medical services.
• Facilitation in the organization to be able to supply medical services and devices, which meet the expectations of the customers & complies with the regulatory requirements.
• Evaluation of the organization; how well it is able to meet the customer’s expectations and comply with the rigid needs.
• The honor of becoming Certified & registered
  

Basically, 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 also, fulfillment of standards related to that particular product and service.