Do you know what is the role of ISO Standards in Medical Device Registration, Any manufacturer can expect better control of the manufacturing process and quality management using the ISO guidelines. The objective of ISO certification is the holistic development of the whole system that contributes to producing a particular product. This is the Role of ISO Standards in Medical Device Certification.

What Is The Role Of ISO 13485?

ISO 13485 includes definitive guidelines more inclined toward documenting each process that contributes to the manufacturing of Medical Devices.

Also, it gives a framework for ensuring a streamlined Quality Management System (QMS), which allows for the consistent quality production of medical devices.

This standard can be leveraged by Any establishment engaged with the design, production, installation, and servicing of medical-based devices. The External certification bodies can also use this standard as a checklist for audits.

Advantages Of Securing ISO Standards in Medical Devices Registration Certification

An ISO certificate is not necessary; it can lend the following advantages for getting ISO Certification for Medical Devices:

• It can reduce the process complexities by rendering details on how things should be done.
• Certification holders can expect better production volume & unprecedented quality by incorporating ISO guidelines.
• It can enable the manufacturer to quicken the production process without reducing the quality.
• Since ISO certification has global recognition, the manufacturer can witness a demand increase for their products in overseas and domestic markets.
• ISO guidelines are better at determining the process bottlenecks, if any, and keeping everything streamlined and transparent.
• It can help certification holders save time and resources a great deal.

Who is Eligible to Get ISO 13485?

ISO 13485 is suitable for every organization that deals with designing, producing, deploying, servicing, storing, and distributing medical devices, irrespective of their size or type. Certification to any company operating at any level in the medical device or pharmaceutical industry chain is achievable.

Even if it is unnecessary, companies that wish to demonstrate compliance with regulatory quality requirements and establish confidence in their customers require this certification.

Steps to Get the ISO Standards in Medical Device Registration Certification

Here is a simple outline to get your medical device manufacturing company certified with ISO 13485.

1. Learn about the specific requirements of the standard with the support of a consulting partner

2. Perform a complete gap analysis and determine where your current quality management approach needs to meet the standard requirements.

3. Depending on the findings of the gap analysis, plan the steps for implementing a QMS which would align thoroughly with the requirements of ISO 13485

4. Provide training to the staff and help them to learn about their responsibilities regarding the QMS

5. Document the QMS processes or functions as they are intended to be implemented in the manufacturing cycle

6. Implement the QMS, ensuring the requirements of the standard and matching with the documentation

7. Conduct an internal audit of your QMS to ensure its compliance with every need of the standard

8. The Registration of the certificate with an accredited body

9. Get the external certification audit done and accomplish the ISO 13485 certificate

How To Secure ISO Standards in Medical Devices Registration Certification?

Before getting into the certification process, you should document the entire process and deploy corrective measures to stay compliant with the underlying standards. The steps below are the detailed blueprint on how to proceed for Medical Devices ISO certification.

Step 1: Establish A Management System

• Determine all the processes that contribute to the manufacturing of medical devices.
• Document processes with the support of the concerned staff.
• Authorize, vet, and share the documents with the related staff member.

Step 2:  Follow Your System

• Ensure every procedure takes place as per the documented guidelines.
• Ensure in-depth training is received by the staff members concerning operations they are engaged with.
• Establish an apt reporting system relevant to the inspection, testing, meeting, corrective measures, goal tracking, statistical techniques, etc.
• To analyze the capability of your processes, Leverage measurable data.
• To obliterate the process bottleneck, vet and take corrective measures.

Step 3: Check System Effectiveness

• Conduct an in-depth audit and scrutinize the processes for compliance and effectiveness. Refer to the sample records and interview people associated with processes in one way or another.
• Pinpoint and report the bottleneck(s) of the system of management.
• Take related actions to keep everything in check and streamlined.

Step 4: Register Your System

• For external certification, approach a reliable certification agency or service provider.
• For vetting, you need to submit your management system document.
• Allow the external auditor to examine the whole system for compliance and effectiveness.

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List of Most Important ISO Standards In Medical Device Registration Industry

• ISO 13485: Medical Devices – Quality Management Systems
• ISO 14971: Medical Devices – Risk Management Application to Medical Devices
• ISO 9001: Quality Management Systems
• ISO 11607: Standard Packaging Terminally Sterilized Medical Devices
• ISO 15223-1: Medical Devices – Symbols to be Used in Labels of Medical Device, Labeling, and Information to be Supplied

Critical aspects of ISO Standards in Medical Devices Registration Certification:

• ISO 13485 Standard
• Risk Management
• Quality Management System (QMS)
• Regulatory Compliance
• Product Lifecycle Management
• Document Control and Records Management
• Supplier Management
• Internal Audits and Management Reviews
• Certification Process