ISO 13485 – Quality Management Practices in the Medical Sector

The ISO 13485 is a standard measure that is more or less like ISO 9001 but simply acts as a criterion to measure best management practices in the health sector. The certification provides a different kind of approach in the manufacture and distribution of medical equipments and there is no doubt that many medical practitioners have preferred equipment from providers who have been certified by the ISO 13485. The standardization criteria is simply a global initiative that aims at creating a more professional medical equipment production through world class management practices that are all within the ISO 13485 charter.

The rational that is taken in the audit for compliance involves manufacturing and distribution of medical equipment, as well as taking into account the potential risk that is involved in their use. The certification allows medical equipment manufacturers to meet global standards of safety in developed countries and comply with the existing legislation in those nations. The standard initiates management systems to analyze the production of medical equipments and to come up with instructions on how to strengthen weaknesses in the system.
The requirements for ISO 13485 certification are very basic and all aim at promoting high safety standards in the production and distribution of medical equipments.

Among the basic and fundamental requirements the following are the most significant ones:

  • ISO 13485 requires that organizations develop and establish a quality medical equipment management practice and system in all sectors of production and distribution.
  • Calls for organizations to conduct comprehensive assessments of their production system to determine the strengths and weaknesses of their existing management system and further move on to develop possible solutions in regard to their findings.
  • Requires detailed presentation of the organization management system in order to make sure that all needs have been taken into close consideration.
  • The standardized measure also requires companies to implement and evaluate an internationally recognized quality management system in the production of their medical equipment.
  • Maintain and evaluate your medical equipment management system, documentation of procedures as well as development of an effective manual.
  • Promotes proper documentation of medical service and equipment management practices.

The benefits of implementing ISO 13485 management systems are diverse and will be seen in all departments of your company. The following are some of the benefits that you should take into consideration:

  • ISO 13485 allows your organization to meet the customer requirements in the production of medical equipment.
  • Provides necessary ideas to standardize quality management in the medical equipment fields.
  • Critical in providing a competitive edge for your organization

Our approach

QSE’s “Ten Step Approach” to Registration is designed and perfected to cost- effectively prepare facilities for successfully passing Certification Audits with minimum or no nonconformities. QSE emphasizes on developing Simplified Documented Management Systems to meet or exceeds the requirements of any ISO Standard requirements. This 10 Step Approach has a built-in discipline to involve all employees including top management right from the beginning to achieve long-term desired results. Our approach is so complete that we have helped over 600 companies obtain certification, of which, majority have obtained certification with zero deficiencies. Please contact us for details…….

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