Learn the steps to obtain ISO 13485 certification for medical device manufacturers. Understand the importance of a QMS in meeting regulatory standards and boosting competitive advantage.
ISO 13485 is international standard which defines the requirements for a quality management system (QMS) in medical devices organization. The pursuit of an ISO 13485 certification is a critical step for medical device manufacturers seeking to prove that they are dedicated to producing products that uphold quality and abide by applicable regulations. How to Get ISO 13485 Certified: Steps
Understanding ISO 13485 Standards and Requirements
If you are going to be a newcomer for ISO 13485 certification, the primary area to look are at the standard and its requirements. You can buy the standard from ISO (International Organization for Standards) or talk to a quality management system consultant.
Conducting a Gap Analysis for ISO 13485 Certification
When you are aware of the standard requirements, it is possible to identify any discrepancies between your QMS and ISO 13485 — this process is gap analysis. This is how you can create a roadmap to remedy any deficiencies before your certification audit.
Developing and Implementing a Quality Management System (QMS)
Develop and implement a QMS meeting the requirements of ISO 13485 according to your gap analysis. To the extent that this entails creating, and implementing policies on every part of your operation from design and sourcing right through to production and distribution.
Internal Audits: Ensuring Compliance Before Certification
Perform internal audits on your QMS to have a proof that the system is working well and is compliant with ISO 13485 before your certification audit. This should help you address any gaps as you get ready for your certification audit.
Choosing the Right Certification Body
Choose a certification body that is properly accredited by an authoritative accreditation body to conduct your certification audit. Once you have achieved this, a certification body will then look at your QMS and carry out an on-site audit to determine if you comply with ISO 13485.
The Certification Audit Process: What to Expect
Phase of the certification audit consists of two stages. First, the auditor should verify that your QMS documentation is compliant with ISO 13485. The second stage comprises a site audit at which the auditor checks to ensure that your QMS has been implemented effectively and conforms with all stipulations under the standard.
Addressing Nonconformities for Certification
If the certification audit has identified some nonconformities, it needs to be corrected prior to granting the ISO 13485 certification. Before your certification can be issued the certification body will ensure that you have taken corrective action against any nonconformities raised.
Maintaining Your ISO 13485 Certification
After you have achieved ISO 13485 certification, you need to sustain your QMS and keep it in compliance with the standard requirements. This involves carrying out internal audits at regular intervals to assess how your QMS is functioning and tackling any nonconformities it identifies.
Conclusion: Why ISO 13485 is Critical for Medical Device Manufacturers
ISO 13485 certification has become a crucial step for medical device manufacturers to show their dedication towards the quality and regulatory aspects. Following above steps, you can build and deploy QMS that complies with the standard to get your certification.
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