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ISO 13485:2016 Medical Devices Quality Management System

What is ISO 13485?

 

The International Organization for Standardization originally released the ISO 13485 quality management system standard for companies engaged in the medical device market in July 2003. (ISO). The most recent edition of ISO 13485:2016, which replaced ISO 13485:2003, was released on March 1, 2016.

 

A corporation's ability to manage a risk-based strategy about the acquisition, production, storage, design and development, installation, distribution, and servicing operations, among other aspects of the quality management system, is the focus of ISO 13485:2016. It shares the same core principles and clause structure as ISO 9001:2015. The standard specifies requirements for companies engaged in one or more stages of a medical device's life cycle. It is generally regarded as being crucial.

 

Benefits Of ISO 13485

 

  • Maintains global recognition by utilizing the highest standards of quality from businesses that manufacture medical devices.

 

 

  • Enables organizations to operate across borders by adhering to the applicable requirements and rules.

 

 

  • It aids in establishing a structured framework that the organization can use to maintain and assess its operations and customer service.

 

 

 

 

  • Provides a structure to guarantee continuing upkeep and development of successful procedures with pertinent criteria.

 

  • Enables better performance by boosting sales, reducing the time it takes to transport goods to markets around the world, cutting expenses, reducing waste, and increasing efficiency with high-quality production.

 

  • Establishing and conducting an independent evaluation of the quality management system demonstrates compliance with European Union (EU) Directives.

 

The Certification Process

 

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The Application Process

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Let us answer you

Frequently Asked Questions

What is ISO13485?
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The ISO 13485 quality medical device standard ensures that every medical gear complies with legal and customer standards for regulatory compliance. ISO 13485 accreditation is a useful certificate to keep professionals and patients safe in clinics, hospitals, and other medical environments.
Who does ISO 13485 apply to?
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The intended users of ISO 13485 are businesses involved in creating, installing, and maintaining medical devices and related services. Especially for manufacturers, ISO 13485 is intended to ensure that manufacturers consistently design, produce and place onto the market medical devices that are safe and fit for their intended purpose.
Should I get certified?
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To take advantage of these prospects, a company must first acquire a license from the Medical Devices Authority (MDA) before it may produce, import, or distribute medical equipment in the nation. They must be certified under either the international quality management system standard ISO 13485 or the Good Distribution Practice for Medical Devices (GDPMD) for importers and distributors. The ISO 13485 certification helps to expand your business locally and in the global market and also definitely helps to impress your clients with the quality of the business and its products.
How long is the process?
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With a good understanding and the proper preparation of what is required for ISO 13485 certification, most organizations can expect a certificate within 3-6 months, depending on their size and complexity.
Suitable for which organization ?
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Any organization, large or small, regardless of its field of activity or products and services it provides, can get ISO 13485 certified.
If my organization already being certified by others certification body , can we transfer to KIWACERT ?
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Yes of course, we can transfer & continue your certification with NO GAP in your certificate validity. Also , we won't charge you extra on the transfer registration.

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Kiwa International Certifications(M) Sdn Bhd

2A, Jalan Astana 1D, Bandar Bukit Raja, 41050 Klang, Selangor

+603-3884 7813

info@kiwacert.com

Accredited to ISO/IC 17021:2015

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2022 © Kiwa International Certifications (M) Sdn Bhd. ALL Rights Reserved.

Kiwa International Certifications(M) Sdn Bhd

2A, Jalan Astana 1D, Bandar Bukit Raja, 41050 Klang, Selangor

+603-3884 7813

info@kiwacert.com

Accredited to ISO/IC 17021:2015

A Simple Image
A Simple Image

ACB QMS 28

ACB OSH 17

ACB EMS 20

ACB GMP 06

ACB FSMS 13

ACB HACCP 08

ACB MDMS 05

A Simple Image
A Simple Image
2022 © Kiwa International Certifications (M) Sdn Bhd. ALL Rights Reserved.