ISO 13485 Certification

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What is ISO 13485 Certification?

ISO 13485 is the internationally recognized quality management system standard for medical device manufacturers. ISO 13485 Certification ensures that medical devices manufactured by an organization are of the highest quality and safety standards. This certification is recognized around the world, and is imperative for companies that wish to manufacture medical devices for sale in other countries.

ISO 13485 Certification

Why Get an ISO 13485 Certificate in Philippines?

The ISO 13485 Certification is widely accepted and recognized throughout the world. Many countries, including the United States, Australia, and Japan, require ISO 13485 Certification for companies that wish to manufacture medical devices for sale in their markets. Obtaining this certification demonstrates to regulators and customers that your company takes quality and safety seriously.

How Can Organizations Benefit from ISO 13485 Certificate?

ISO 13485 Certification can help organizations achieve the following benefits:

  • Improved quality and safety of products
  • Demonstrates to customers that the company is committed to providing safe and effective medical devices.
  • Reduced manufacturing costs
  • Reduced product recalls and liability claims
  • Increased customer satisfaction and loyalty
  • Improved market access and competitiveness

Which Organizations Can Apply?

Any organization that wants to demonstrate their quality management system meets the requirements of ISO 13485 should apply for certification. This includes:

  • Medical device manufacturers
  • Pharmaceutical companies
  • Contract manufacturers

How to Get ISO 13485 Certified in Philippines?

The certification process has 2 auditing stages, which include:

1] Stage 1 Audit (Preliminary audit) – The first stage of a Certification audit is to assess an organization’s readiness for Stage 2 (a Certification audit). It begins with a detailed knowledge of the company’s policies, procedures, objectives, and risks. On-site auditing is used to see whether the firm’s management system has met the requirements of the standard by looking at paperwork and interviewing their personnel.

2] Stage 2 Audit (Certification audit) – The ISO 13485 certification process concludes with an organization’s entire management system being examined and audited to determine whether it follows the ISO 13485 standard. The length of the audit in stage 2 is determined by a company’s size, the number of facilities it has, and the functions it contains.

The certification body will issue an ISO 13485 certificate after both audit phases are completed successfully and all non-conformities have been addressed.

Get ISO 13485 Certified in Philippines Through IAS

IAS is a global certification body that offers ISO 13485 Certification to medical device manufacturers in the Philippines. We have over 15 years of experience in issuing ISO certifications and are recognized for our stringent audit processes and uncompromising quality standards. If you’re looking for ISO 13485 certification in Philippines, then approach IAS for expert guidance.

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

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