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How to implement ISO 13485 Certification

​To get Implementation of ISO 13485 Certification to your organization follow the steps listed below:
Product conformity is important across all industries but it’s especially crucial for medical devices. To maintain consistency in the quality of medical devices from batch to batch, ISO 13485 a quality management system (QMS) standard designed specifically for medical devices. To ensure the appropriate level of quality control an organization needs to comply with the relevant standards.
One of these standards is ISO 13485 Certification helps the organization to solve the issues of safety by the customers or patients by regulatory compliance and a company’s ability to succeed in the industry.

What is ISO 13485 Certification?

ISO 13485 is a quality management standard for the manufacturing of medical devices. This standard is based on the ISO 9001 Certification requirements for manufacturing, installing, and servicing medical devices. ISO 13485 Certification aims to improve the quality management system, taking a risk-based approach, validating process, and comply with legal requirements of the nation or country.


ISO 13485 also helps companies involved to install manufacture and service medical devices. The International Organization for Standardization (ISO) published the ISO 13485 standard to ensure quality management system (QMS) for medical devices with process improvement, operational efficiency, and product improvement. ISO 13485:2016 is the latest version of the standard.
Although ISO 13485 is based on the principles and requirements of ISO 9001 Certification does not mean you are automatically compliant with the other, by just implementing one of the standards.

Benefits of ISO 13485 Certification

Complying with ISO 13485 certification benefits the companies and as well as the user.

  1. Legal compliance with local or national regulation
  2. Helps to enhance Risk Management in the organization
  3. Helps in reduction of Cost
  4. Better access to new technology and techniques
  5. Enhance business reputation
  6. Ability to win more business and increase the market value
  7. Opportunity to take the business to international level
  8. Assistance with the compliance of ISO 9001 Certification

Also, Check —>> ISO 13485 Certification in Sri Lanka

Steps to acquire ISO 13485 Certification

ISO 13485 contains requirements for various types of organizations operating as part of a medical devices or related supply chain. It’s especially vital for organizations that manufacture use this standard for:

  • Medical device manufacturers
  • Companies that provide raw material to produce products
  • Organizations that provide medical services to manufacturers of the product

1. Apply by filling the application form for the ISO 13485 Certification

Once you’ve determined that ISO 13485 is the right standard to be implemented in your organization, fill up the application form to start your journey towards ISO 13485 Certification.


2. Conduct a Gap Analysis

One of the most important steps when implementing ISO 13485 Certification is studying your organization in detail to fill up the gap between your company’s current system and the system you will need to establish to reach compliance.


3. Provide training and implementation plan in the organization

After studying the organization the next step is to start creating a plan to address the gaps you discovered. This plan should include clearly defined, quantifiable objectives with realistic deadlines.The plan can be implemented if the right guidance is provided to the employees at each level stating the importance of ISO 13485 in the organization. The employees should be aware that your organization is going to implement ISO 13485 far enough in advance.


4. Develop and maintain the documentation

To effectively implement ISO 13485, you need to develop documentation to control your processes. This documentation will help you to prove your compliance and will help guide your processes including a quality manual and various documented procedures, and add further documentation as needed.


5. Conduct Internal Audit

Before you can undergo the third-party audits you must conduct a management review. These processes will help you evaluate how your system and aids in improvement. The consultancy you choose will help you to provide evidence that your processes are working correctly and meeting the requirements.


6. Certification body Audit and issuance of Certificate

When the required audits are completed, the Certification body reviews your entire documentation and conducts an external audit to verify the compliance of the standard. If all are in order the Certification Body issue a Certificate. In case, if they find any audit findings then you need to correct them to meet the scope of ISO 13485 Certification.



This post first appeared on What Is ISO Certification And Its Benefits?, please read the originial post: here

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