Medical devices — Quality management systems certification in accordance with ISO 13485 standard

ISO 13485 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 and applicable regulatory requirements. ISO 13485 standards aligns legal and other specific requirements for medical devices and brings uniform quality requirements for medical devices. The ISO 13485 Medical Quality Management System is based on ISO 9001 standard and is complemented by requirements related to the medical facilities such as comprehensive risk analysis, sterile manufacturing and product traceability. Companies certified to ISO 13485 meet the quality management system requirements in all classes established by the Medical Devices Directive 93/42/ EEC.

The goals for certification are:

• To fulfill the requirements of the ISO 13485 international standard 
• The implementation of a systematic approach to quality management for medical devices
• Improvement of quality standards for products and services in the healthcare area

Benefits for your customers

Implementation and certification of quality management system for medical devices forms precondition for improvement in the following areas :
 

Management	The systematic approach towards to quality management of medical devices within whole organisation Clear definitions for goals and rules for production and services of medical devices Your business gains systemic approach and public trust by showing that you are committed in ensuring the integrity  and excellence of provided medical devices Implementation of continuous improvement approach within the medical devices area Achieving compliance with legislation requirements for medical equipment
Quality Improvement	Determination of procedures for medical devices and services and reviewing compliance of them Improve the customer-oriented approach across the organization Verification of adherence to procedures and rules for production and services provided
Financial benefits	Process efficiency improvement of the medical devices production and service management  Elimination of economical loss caused by complaints, claims and poor medical devices delivery Longterm business prosperity and profitability
Business and marketing benefits	Increased Competitiveness on the market Improving goodwill Increasing of customer confidence

 

Added value for you

• Implementation of continuous improvement system for medical devices management system
• Eliminate chaos and organizational deficiencies and gaps in organization and management
• Expanding business opportunities and increasing your credibility
• Proper setting of the system and improving the customer-oriented approach
• An objective assessment of the current status of risks and processes related to medical devices management system