What is ISO 13485?

ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical.

Who needs to be certified?

ISO 13485, Medical devices – Quality Management Systems – requirements for regulatory purposes, is an internationally recognized standard for organizations involved in the medical device industry. Companies are using compliance to this standard to obtain the certification of their Quality Management System.

Benefits of becoming certified

  • To reach high levels of reliability in production, quality standards are essential.
  • The benefits of adhering to ISO 13485, which outlines quality management system standards for medical devices, include efficient cycle times, less waste and a reputation for reliability that can permeate throughout the medical industry.
  • Internationally acceptance on quality parameter

What is the certification process?

  • Application for certification
  • To send a quotation
  • Aceptance by client
  • Confirming scheduling for Stage 1 & Stage 2 audit

Initial Certification Audit

The assessment process is based on a 2 stages approach as follows:

Stage 1 – a basic audit to check whether the organisation is in a state of readiness for the stage 2 audit and involves the following:

  • Confirm that the quality manual conforms to the requirements of the ISO 13485
  • Confirm the scope of certification including any justifiable exclusions
  • Production of an assessment plan and confirm a date for the stage 2 assessment visit.
  • Check legislative compliance
  • Agree a corrective action plan if required.

Stage 2 – the purpose of this visit is to confirm that the quality management system fully conforms to the requirements of ISO 13485 in practice and involves the following:

  • Undertake sample audits of the processes and activities defined in the scope of assessment
  • Produce an audit programme and confirm a month and year for the first surveillance visit
  • Document how the system complies with the standard
  • Report any non-compliances or observations

Why choose GSCS?

GSCS is providing ASCB accredited certificate to clients. They choose us because they like our fair and practical approach throughout the entire certification process and how we understand and meet each individual client’s needs. We are providing-

  • Network of Overseas Strategic Partners
  • Fixed Cost & Competitive Quotations
  • Accredited Certification
  • International Accepted Certificates
  • Industry Experienced Audit Team
  • Defined & Agreed Project Timescales
  • 24/7 Help Desk

Contact us

  • For more information about ISO 13485 please contact us by phone +88 02 5508 6965 or emailinfo@gscsbd.com. We will be pleased to assist you.