ISO 13485:2016 Certification – Quality Management System for Medical Devices

ISO 13485:2016 Certification is very essential Standard for medical device manufacturers.

It emphasizes on following the best quality practices for medical devices design and manufacturing companies.

ISO 13485:2016 Standard aims at enhancing production cycle times, reduce wastage, build reputation and reliability for medical products and services.

ISO 13485:2016 Standard represents the requirement of a quality management system for the design, development, production, installation, supply, and servicing of medical devices and related products.

10 Key Benefits on Implementation of ISO 13485:2016 Certification

1. Improve Credibility and Brand Image

As the standard is internationally recognized for quality management in the medical device industry, it gives the organization a competitive advantage and builds credibility in the market.

2. Gaining Customer Confidence

It builds trust among clients and customers. Customers feel assured and prefer to associate with the medical brand that is ISO 13485:2016 Certified.

Gaining customer confidence is critical for companies to sustain. In the medical field, customer trust has a significant impact on brand building for the organization.

High-quality product delivery leads to fewer complaints. It enhances customer satisfaction and helps strengthen the brand image in the market.

3. Risk Analysis

The ISO 13485:2016 Standard ensures enhanced safety and reduces the potential hazards of using medical devices.

The ISO 13485:2016 Standard helps in streamlining the design and development stage of medical devices. It aligns the design stage with the product requirement as per the end-user specifications.

The Standard emphasizes on the application of use cases & error analysis, task flow, suggestions from the intended users at the early stages.

It results in identifying possible risks and also close reviewing of each stage of development.

ISO 13485:2016 Standard help guide design decision and ultimately maximize user adoption. For each product, the team records all information that informs the design and engineering decisions in a systematic way.

4. User-centered Approach to Product Development

The ISO 13485:2016 Standard ensures to define a process for product development. It can be incorporated into device design, development and risk management processes.

The user-centered approach is to be followed by the product development stage itself to ensure product safety and usability.

5. Practice the Culture of Continuous Improvement

To stay ahead of the competition, continuous improvement is the key. With ISO 13485:2016 standard implementation, continuous improvement becomes part of the organizational culture.

Employees must practice the culture of continuous improvement to enhance their productivity and build quality products.

6. External Quality Reviews

ISO Certification helps in monitoring the performance and compliance of the quality management system by an external ISO certification partner.

It enhances the credibility and helps to benchmark your system with the industry best practices. ISO 13485:2016 is the de-facto standard for medical device makers and suppliers to develop risk-free medical devices.

7. Maintaining Consistent Quality

Patient safety depends on the quality of medical products. ISO 13485:2016 certification gives manufacturers confidence that the organization throughout the supply chain is following quality first processes and maintain compliance.

If you are a medical manufacturer of implants or any medical devices, getting ISO 13485 certification is essential and prerequisite to eliminate any chance of errors in the process. It is a must-have for contract manufactures in the medical field.

8. Risk Management

ISO 13485:2016 Standard helps in reducing the risk of reputational damage to manufactures caused by product defects. It helps in brand building and prevents any incidents leading to patient safety or device failure.

The ISO Certification has a lot of processes like gap analysis, required training for the employees, etc. to ensure quality and follow best practices.

9. Standardized Certification Globally

ISO Standards are accepted worldwide, hence for large enterprises or business with many branches across business markets, the ISO 13485:2016 standard is a game-changer.

They can get certified and be recognized as an ISO practitioner world-wide.

10. Expand to potential markets Globally

ISO 13485:2016 certification can be of advantage while looking at an export market. Matured markets like the European Union and Canada require trade partners to be ISO 13485 certified.

 Many large medical device businesses prefer to work with suppliers who are ISO 13485 certified. ISO standards are seen as indicators of an organization’s commitment to quality.

Who is ISO 13485:2016 Certification the best fit for?

Organizations involved in one or several stages of a medical device lifecycle or a supplier or other external parties providing products to such organizations

Organizations involved in stages of medical device lifecycle

  • Design and Development
  • Production
  • Storage
  • Distribution
  • Installation
  • Servicing

 Suppliers/external parties who provide products to medical organizations

  • Raw Materials
  • Components Sub-Assemblies
  • Medical Devices
  • Sterilization Services
  • Calibration Services
  • Distribution Services
  • Maintenance Services

ISO 13485 Certification has significant benefits for medical device manufacturers and suppliers in the medical field.

It systematizes processes and assures quality. It also mitigates risk by ensuring your product safety.

For any assistance on ISO 13485:2016 Certification, give us a call right away!

Contact: Aurion ISO Consultants

Share this Blog!

About the author

ISO Consultant who is expert in writing about the latest ISO Certification Standard, Business Benefits of various ISO Standards, Organizational Improvements, ISO Training, ISO Auditing, Latest ISO Certification Amendments and more.