ISO 13485:2016

Quality Systems for Medical Device Producers and Distributors

Medical device producers was forced to build a quality system and to certify it to meet legal obligations, to increase their productivity and to create legal assurance for potential cases in the process of adapting to European Union directives. In Europe and after the date of 13 September 2003, this study keeps to put CE sign mandatory. ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The primary objective of ISO 13485:2016 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.

Benefits of ISO 13485:2016
  • In ISO 13485, the top management.
  • Follows corporations activities systematically.
  • Determines the deficiencies of the system and gets the probability to fix it.
  • Increases customer satisfaction.
  • Keeps the continiuty of the effectiveness of the ongoing system.
With ISO 13485, the enterprise
  • Presents that it is adapted to present legal obligations.
  • Gets an effective way to mark the products with CE.
  • Increases the customer portfolia by proving that it is operating according to a well-known international standard.
  • By effective implementation, records decrease in customer complaints and product deficiencies.
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