ISO 13485 Certification

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What is ISO 13485 Certification?

ISO 13485 Certification is a quality management system certification that is specific to the medical device industry. It validates that an organization has successfully met the ISO 13485 standard requirements. It also provides assurance to customers and regulators that a medical device manufacturer has implemented comprehensive quality management system requirements that are specific to medical devices.

ISO 13485 Certification

Why Get ISO 13485 Certification in Sri Lanka?

There are many reasons to get ISO 13485 Certification in Sri Lanka. One of the most important is that it can help your organization win more business. Many buyers, especially those in the medical device industry, require suppliers to have ISO 13485 Certificate. By becoming ISO 13485 certified, you can demonstrate to potential customers that you have a commitment to quality and that you meet the highest industry standards. It can also help you improve your operations by providing a framework for improving quality throughout your organization.

How ISO 13485 Certification is Beneficial?

  • Enhances the quality management system of an organization
  • Helps to establish a systematic and standardized approach across all departments
  • Increases customer satisfaction by ensuring that products and services meet their requirements
  • The efficiency of the organization is optimized
  • Helps to create a positive image of the organization in the market
  • Employee morale and motivation are boosted
  • Increases profitability by reducing wastage and rework

Which Organizations Should Apply?

Any organization that manufactures medical devices should apply for ISO 13485 Certification. This includes:

  • Medical device manufacturers
  • Pharmaceutical companies
  • Laboratories
  • Contract manufacturers

Audit Procedure

The certification process has 2 auditing stages, which include:

  • Stage 1 Audit (Preliminary audit) – The ISO 13485 Certification audit begins with determining whether an organization is prepared to go on to Stage 2 (a Certification audit). A thorough understanding of the company's rules, processes, goals, and threats is needed. On-site auditing is used to see whether the management system fulfills the requirements by examining the documents and interviewing employees.
  • Stage 2 Audit (Certification Audit) – At the conclusion of the ISO 13485 certification process, an organization's entire management system is inspected and audited to ensure that it satisfies the ISO 13485 requirements. The amount of time it takes a firm to go through stage 2 of the ISO 13485 audit is dependent on its size as well as the number of locations it has. An ISO 13485 certificate will be granted following the successful completion of these two audit phases.

Get ISO 13485 Certified in Sri Lanka Through IAS

If you are looking to get ISO 13485 certified in Sri Lanka, IAS can help. We are a leading certification body with years of experience in the medical device industry. We have helped numerous organizations achieve ISO 13485 Certification and can help you do the same.

Kindly contact us to have a free discussion about ISO 13485 certification in Sri Lanka for your organization! Request a quote now!

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