ISO 13485:2016 Medical Device QMS Certification

What is ISO 13485?

ISO 13485 is a stand-alone Quality Management Systems (QMS) standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series that is 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 are 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.

What is ISO 13485 Certification?

ISO 13485 Certification is an independent third party confirmation that your organization conforming the requirements of ISO 13485 Standard, however certificate of compliance issued for 3-year validity whereas continual improvement maintain by periodic surveillance audit.

How can approach to acquire the ISO 13485 Certification?

Review the organization prerequisite and requirements with latest updated ISO 13485 Standard. Contact with CB (BISCE Certification) for assessment of fulfillment of ISO 13485 requirements. Elementary requirements are given below.

Example of documents:

  • Quality policy & specific-measurable objectives and procedures according to requirement of ISO 13485 Standard.
  • An effective management training manual including of continuous professional development (CPD) Program.
  • Effective planning and operational control of documentation including risk assessment of all process.
  • Quality plan for your products, process or designs and others documents that relevant to the ISO 13485 requirements

Example of Records:

  • Records of Management reviews, audits, measuring, Inspection, monitoring, verification and validations.
  • Records of trainings, training needs and assessment of effectiveness of trainings.

Why 13485 Certification is important for business?

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 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.

Business Advantages:

  • 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
  • Export advantage and enhances organizations public image

Economic Advantages:

  • Increase efficiency, cut costs and monitor supply chain performance
  • Reduction of defective product and customer complaints
  • Increase Quality, productivity, efficiency and Conformity Excellence
  • Reduce cost of operation by improving productivity and reducing rejection

Advantages to Organizations Management:

  • Increase access to more markets worldwide with certification
  • Outline how to review and improve processes across your organization
  • Demonstrate that you produce safer and more effective medical devices
  • Meet regulatory requirements and customer expectations
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