Professional Documents
Culture Documents
Page 1 of 5
Published on Quality Digest (http://www.qualitydigest.com) Home > ISO 13485--Just the Facts, Please
In the field of medical products, devices, and components, regulatory requirements and customer expectations are demanding. Throughout the world, manufacturers and their suppliers are expected to comply with the highest standards and regulations. ISO 13485--Medical devices--Quality management systems--Requirements for regulatory purposes is the standard for organizations engaged in the manufacture of medical devices. According to the most recent survey by the International Organization for Standardization ( www.iso.org/iso/survey2006.pdf ), there were a total of 8,175 current ISO 13485 registrations across 82 countries in 2006. Approximately 30 percent of all ISO 13485 registrations were issued in the United States, compared to only 6 to 7 percent of all ISO 9001 and ISO 14001 registrations. According to the survey, the 2006 total represents an increase of 3,110 (61%) compared to 2005,
http://www.qualitydigest.com/print/4325
9/17/2013
Page 2 of 5
when there were 5,065 registrations across 67 countries and economies. Other major markets include Europe, Japan, Canada, Sweden, and Israel. Although being registered does not fulfill the requirements of the various industry regulators, such as the U.S. Food and Drug Administration (FDA), ISO 13485 is now commonly used as the basis of regulatory requirements. The standard is an essential consideration not only for exporters but for the local market, global suppliers, and subcontractors to prove that their products are of the highest quality. Its the foundation to set the quality system against, says Brad Amundson, regulatory services manager for SGS Systems and Services Certification North America of Rutherford, New Jersey. Depending on where a companys markets are around the world, they want to have this quality system in place, because after laying the foundation they have to put in the regulatory requirements for each particular country where they want to sell medical devices. The 2003 version of the standard supersedes earlier documents such as EN 46001 and EN 46002 (both published in 1997), the previous version of ISO 13485, and ISO 13488 (both first published in 1996). The standard is intended to be used by an organization that needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Registration against the standard from an appropriately approved body is now a direct requirement for some markets (e.g., Australia and Taiwan), an indirect requirement for others (e.g., Europe), or it can form the basis of good manufacturing practice (GMP) compliance in the United States. The standard is also an important part of maintaining the quality of the supply chain. If a company is a component manufacturer, then they want ISO 13485 registration, says Amundson. If their customer, a finished-device manufacturer, gets audited by a notified body or a registrar, the auditor looks back on the supply chain. When auditors ask how the company controls that supplier and whether they hold a registration , thats a good start in showing control over production of components or subassemblies.
http://www.qualitydigest.com/print/4325
9/17/2013
Page 3 of 5
Some other specific differences in requirement and emphasis between ISO 13485 and ISO 9001 include: ISO 13485 sees the promotion and awareness of regulatory requirements as a management responsibility. ISO 13485 expects controls in the work environment to ensure product safety. ISO 13485 expects a focus on risk management activities and design transfer activities during product development. ISO 13485 contains specific requirements for inspection and traceability for implantable devices and specific requirements for documentation and validation of processes for sterile medical devices. ISO 13485 states that the company needs to maintain effective processes, namely the processes specific to the safe design, manufacture, and distribution of medical devices. ISO 13485 has specific requirements for verification of the effectiveness of corrective and preventive actions.
http://www.qualitydigest.com/print/4325
9/17/2013
Page 4 of 5
process than a surveillance audit. Your initial cost may be $25,000, then it may drop down to $15,000 plus the travel and lodging cost associated with the auditor coming to your facilities, says Dicheck. Scope is another big consideration. Because ISO 13485 is specific to medical devices, a company that manufactures or services other areas, such as aerospace or industrial components, is not included in the scope. The company may then have to consider registration to ISO 9001 to cover all the bases. Something else to think about is the claim of conformity. It is important that the organization implementing the system recognizes its responsibility to ensure that its claim of conformity with ISO 13485 reflects exclusion of design and development controls. Sometimes the regulatory requirements of the market permit exclusions. This can be used as a justification for their exclusion from the quality management system. However, the regulations may also define alternative arrangements that can be addressed in the quality management system.
http://www.qualitydigest.com/print/4325
9/17/2013
Page 5 of 5
Peter_Marriott
Peter Marriott joined SGS as a quality systems auditor in the United Kingdom, managing the organizations largest registration operations. In 2005, he become part of the corporate management team in Geneva, Switzerland, leading Global Systems and Accreditation Management. Since December 2007, he has held the additional responsibility of heading up the North American registrations as Director of Systems and Service Certification North America, which is headquartered in Rutherford, New Jersey. 2013 Quality Digest Magazine. Copyright on content held by Quality Digest or by individual authors. Contact Quality Digest for reprint information.
http://www.qualitydigest.com/print/4325
9/17/2013