ISO 13485 Certification Quality Management System (Medical Devices)

ISO 13485 Certification Quality Management System (Medical Devices) 

Maintain quality assurance of your Medical Devices by obtaining ISO 13485 Certification in Sri Lanka

What is ISO 13485 Certification

ISO 13485 Standard is the quality management system for medical devices for the improvement and development of the devices. It is an optimal device standard, which ensures that all medical devices and equipment meet the proper regulatory compliance of the local law and regulation and meet customer needs. ISO 13485 Certification is a valuable credential developed by the International Standardization for Organization, with the amendments made in the year 2016. This ISO 13485 standard is put in place to keep professionals and customers safe in clinics, hospitals, and other medical settings.

ISO 13485:2016 is based on the ISO 9001 process with the High-Level-Structure model approach. ISO 13485 Quality Management system for Medical Devices is a management systems standard specifically developed for the manufacturer, dealer, trader, or seller dealing in medical devices. Its primary motto is to facilitate harmonized medical device regulatory requirements of the particular region’s law. This standard allows companies to reduce safety and legal risks involved in the process of the devices while creating more economical work and achieve environmental enhancement.

Benefits of ISO 13485 Certification

  1. Addresses the regulatory requirements
  2. Reduces trade barrier to enter into international and new markets
  3. Guarantees high quality of Products and Services
  4. Increases effectiveness across the whole world
  5. Reduces Operational Costs 
  6. Reduces Risks and Errors
  7. Tightly controlled documentation processes
  8. Business processes to remain Competitive
  9. Customer Satisfaction

Requirements for ISO 13485 Certification

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 and applicable regulatory requirements. Basic Requirements are:

  • Determine and adopt a risk management approach system to analyze risk for product development and product realization 
  • Analysis and implement verification and validation processes 
  • Compliance with Regulatory requirements and guidelines of the standard and local authority
  • Proper maintenance, control, and timely repair of wear and tear of medical devices
  • Effective and quick product traceability in case of any errors
  • Enhancement and continual improvement in devices and services through advancement in technology 
  • Conduct an Internal Audit of the organization

What is the purpose of ISO 13485 Certification?

As an internationally recognized and admissible standard of the maintenance of quality and safety for the medical device. Having an ISO 13485 certificate helps companies to get recognized as more reputable, trustworthy providers for their requirements. This helps in providing an indispensable foundation on which to build your business. 

ISO 13485 Certification process

Strength of Ascent ASSOCIATES

  • We Ascent provide relevant training to all levels of employees about the implementation and knowledge of ISO 13485 Certification.
  • We Ascent guide on the road map to ISO 13485 Certification by our experienced and qualified team for all businesses throughout the ISO 13485 Certificate supply chain.
  • We Ascent have been providing ISO 13485 Certificate for the past 10+years to achieve the highest available ISO 13485 standards.
  • Ascent ASSOCIATES experts are on hand to serve you at any time 24X7, anywhere in the world.
  • Our services can be provided as evidence and help you with the closure of Non-Conformities and offer you the best help you to improve the efficiency of the ISO 13485 standard.
  • With Ascent achieving ISO 13485 Certifications is just considered as a cup of tea.

Get a quote today to achieve a non-binding offer to acquire ISO 13485 Certification with no extra charges further.

Frequently Asked Questions

Who needs ISO 13485 certifications?

ISO 13485 contains requirements for compliance with the standard and local regulations that are essential for any organization for smooth operating and functioning at the manufacturer level, supplier level, or any tier in the medical equipment and pharmaceutical supply chain.

What is the cost of applying for ISO 13485 certification in Sri Lanka?

The cost of this standard is a little higher than the cost of other standards related to quality management as it is a very crucial standard dealing with the safety of medical devices and consumers’ life. It depends on the type of device you are dealing with and the need to acquire Certification.

IS ISO 13485 certification mandatory?

ISO 13485 certification is mandatory in some countries for some of the kinds of products. But obtaining ISO 13485 certificate is safer and effective to deal with medical products.

How long does it take to acquire ISO 13485 certification?

Depending upon the strength of an organization it approximately takes 3-6 months for companies.

How long ISO 13485 certification valid?

ISO 13485 certification is reviewed for a timeline of 3 years. When an ISO standard is up for revision, they generally announce well in advance and require a technical committee to work on it.

What are class 1, 2, 3 medical devices?

Medical devices according to FDA or as per EU Regulations are divide into various Categories based on Product Risks ex. CAT 1 / CLASS I (Devices with low-moderate risk to the consumer requires general control; CAT 2 / Class II (Devices with moderate-high risk requires special controls); CAT 3 / Class III( Device with high risk supporting life or sustaining life).

What is the difference between ISO 9001 and ISO 13485?

ISO 9001 Certification is an international standard for Quality Management systems for all types of industries whereas ISO 13485 certification is a Quality Management System for medical devices.

Is it necessary for an organization to have ISO 13485 if they want to apply for the CE mark of any medical device?

ISO 13485 is the QMS standard accepted as the basis for CE marking medical devices. CE Marking is the product Certification and ISO 13485 is the basic requirement for an organization.


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