ISO 13485 Certification provides a comprehensive framework for medical device designers, manufacturers, suppliers, service providers, and distributors to assure quality, safety, and regulatory compliance. ISO 13485 is a distinctive QMS (Quality Management System) standard evolved from the globally recognized standard - ISO 9000.
ISO 13485 Certification implies that a company has met all the requirements and has effectively implemented an ISO 13485 QMS focusing on the efficacy and safety of medical devices. The certification follows the PDCA framework wherein the applicant must establish and implement quality management in accordance with the ISO 13485 standard. Following the implementation of the QMS, the applicant needs to approach an accredited notified body for the audit of the organization. The accredited notified body performs an audit to assure that the firm can continuously meet and sustain quality standards and issue the certification.
Usually, it takes around 6-9 months to complete the ISO certification process.
Designers, Manufacturers, Suppliers and Service providers and Distributors of Medical devices can apply for ISO-13485 certification.
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Define the scope of the ISO 13485 Certificate Initially, it is necessary to envision the objectives of your organization and the scope for the certification. |
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Select notified body |
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Establish QMS and prepare necessary documents. |
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Implement the PDCA cycle and work in accordance with your QMS. |
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Prepare and optimize audit |
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Conduct Internal and pre-assessment audit |
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Proceed for a certification audit by a notified body. The notified body will audit your company for two to ten (or even more) days depending on the size of your organization. Finally, the notified body will issue the certificate(s) if the organization passes the audit successfully. |
The fees for ISO 13485:2016 certification vary depending upon the size and scope of the certificate.
The validity for the certificate depends upon the notified body that they approach.
6 to 9 months
It is essential to establish a clear QMS before the certification audit.
Every stakeholder must be trained to understand the ISO 13485 standard and compliance requirements.
Internal audit must be performed before the external audit to ensure compliance and correct any deviations if noted.
A few of the significant roadblocks to keep in mind are inadequate and unqualified resources and insufficient records.
A culture of compliant attitude is often the biggest roadblock in procuring the license and must be avoided or corrected before you go for an audit.
After the internal audit, the management should perform a pre-assessment review of the quality management system to meet the necessary requirements.
The organization's team should be well trained and work according to SOPs.
Ensure that computerized systems too have been adequately checked and validated.
Ensure that external suppliers have also been audited.
No, GMP and ISO 13485:2016 are separate requirements. GMPs are a legally mandated regulatory obligation whereas ISO is a voluntary certification that an organization can obtain to demonstrate that its processes adhere to certain standards.
ISO 13485 implements QMS with a higher level of control. It focuses on safety and stringent regulations that ensure medical devices' quality and safety
No. An ISO 13485 certification is mandatory to comply with regulatory requirements if you require a certified QMS (see question 1)
The most recent revision of ISO 13485 for medical device QMS was released in March 2016.
ISO 13485 was designed primarily for organizations engaged in the medical device industry.
There are no testing requirements, but there are some minimum standard requirements that must be met.
