ISO 13485 Certification – QMS Consultant For Medical Device

What is ISO 13485 Certification?

ISO 13485 is a certification that sets forth the standard of medical devices. Safety and quality assurance is important, especially in the case of medical equipment. To that end, prove that your medical devices fall to the right standards with ISO 13485 certification. 

The international standard EN ISO 13485 forms the basis for the certification of quality management systems in companies that manufacture, distribute, and are involved in any life cycle activities of medical devices.

6 Steps To Obtaining ISO 13485 Certification 

1. Understand the Standard 
2. Conduct a Gap Analysis 
3. Develop a Quality Manual 
4. Implement the Medical Device Quality Management System 
5. Conduct ISO 13485 Internal Audits 
6. Obtain Certification

What Is the Difference Between ISO 13485 and EN ISO 13485?

ISO 13485 is the internationally recognized basic version of the standard, it has been harmonized/recognized for its consideration in the implementation of the regional regulatory approval procedures like EN ISO 13485, ANSI ISO 13485, and IS/ISO 13485 for India. 

By complying with a harmonized standard, a manufacturer can prove that its products or services comply with the technical requirements of the regional legislation. 

Also, read the difference between 21 CFR 820 and ISO 13485:2016

Benefits of ISO 13485:2016 Certification

• Improves company’s credibility and identity 
• Evidence-based decision making 
• Continual improvement in product process and quality 
• Increased employee involvement. 
• Enhanced customer satisfaction. 

ISO 13485 is a Non-personal Standard 

ISO is a non-personal standard. An individual cannot get certified to ISO 13485 standards. Only an organization or a company can become ISO-certified. However, there is a provision for an individual to gain the ISO 13485 certification. He can obtain an ISO 13485 Certification as a Lead Auditor after a 5-day training course. With such a certificate, he or she can audit other companies. 

To become ISO certified, your organization must conduct the following operations: 

• Implement an ISO 13485 standard’s QMS 
• Further, the Certification Body or a Registrar audits the performance of the organization as per the latest version of ISO 13485. 
• If the applicant passes the audit, the Registrar issues the ISO 13485 Certificate. This certificate demonstrates the organization has been registered to ISO 13485 for the next three financial years. 
• The ISO-certified organization must re-certify every three years to maintain the ISO certification. 

Eligibility Criteria for ISO 13485 Certification in India

Before applying for ISO 13485 Certification, you must adhere to the points specified in ISO 13485 standards. For that purpose, you need to train your organization as per this standard. 

ISO 13485 Certification Requirements

• Identify and adopt a risk management approach to product development and product realization. 
• Creation of QMS Manual, Processes, Procedures, Formats/Records. 
• Creation of Medical Device Master File. 
• Analysis of the validation of processes and procedures.

What Are the Stages of the ISO 13485 Process?

ollowing is the process to get an ISO 13485 Certificate: 

1. Creating a Quality System Plan: Planning is the initial stage in every quality system. When discussing how to develop a quality system, the Plan-Do-Check-Act (PDCA) Cycle or the Deming Cycle are frequently used as examples. To deploy modifications to your QMS, you must document the quality plans. 
2. Regulatory Requirements: After choo