ISO 13485 is a widely recognized medical equipment standard in the world, which can help institutions of all sizes.

 

What is medical device quality management system certification?

ISO 13485, as a quality management system standard in the medical device industry, originates from the ISO 9000 series quality management system standards recognized by the International Accreditation Forum (IAF). ISO 13485 adopts the process method of ISO 9000, which combines the "Plan,Do,Check,Act" (PDCA) cycle and risk-based thinking. Its purpose is to comply with regulations, support medical device organizations to establish and maintain a quality management system that meets the requirements of medical device regulations, and ensure the continuous safety of the design, development, production, installation and delivery of medical devices.

ISO13485 certification is based on the basic principles of medical device production and quality management, which is applicable to the quality management of medical device organizations, and ensures the safety of devices by improving and ensuring the quality level of products; ISO13485 certification provides confidence for the stability of enterprise product quality, which is conducive to enhancing product competitiveness, improving product market share, and enabling enterprises to obtain greater economic benefits; It is conducive to eliminating trade barriers and entering the international market.

 

What is the scope of ISO13485 quality system certification?

Iso13485:2016 standard was issued in 2016. This standard specifies the requirements of quality management system, which can be adopted by organizations participating in one or more stages of the life cycle of medical devices, including the design and development, production, storage and sales, installation, service, final shutdown and disposal of medical devices, as well as the design, development or provision of related activities (such as technical support). The requirements of this international standard can also be used by suppliers or other external parties providing products (such as raw materials, accessories, components, medical devices, sterilization services, calibration services, distribution services and maintenance services). Suppliers and external parties may voluntarily choose to comply with the requirements of this international standard or in accordance with the requirements of the contract.

 

Relationship between ISO13485 and ISO14971 system certification and current regulations

NCE certification integrates the current "medical device production quality management specification" and the appendix and inspection guiding principles of corresponding products, as well as iso14971:2019 "Application of medical device risk management to medical devices" into the scope of management system certification audit. It is clear that iso13485:2016 and ISO14971 standards and integration into current regulations are effective solutions to meet the comprehensive requirements of QMS and RMS. The certification of ISO 13485 and ISO14971 provides a practical basis for certified enterprises to meet medical device directives, regulations and commitments to product safety and quality.

ISO 13485 and ISO14971 certification can help you improve the overall quality system and risk system level, control the post marketing risk of medical devices within an acceptable range, continuously improve quality management and product risk control and expand market opportunities by collecting post marketing information. Obtaining this certification is the quality commitment of the organization to customers and regulators.

As an independent quality management system standard, ISO 13485 originates from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adopts the model of ISO 9000 process and is applied to the regulatory medical device manufacturing environment. Although ISO 13485 is based on the concept of "Plan, Do, Check,Act " of ISO 9001 process model, it is established for regulatory compliance. It is more regulatory in nature and requires a more detailed documented quality management system. The purpose of preparing ISO 13485 is to support medical device manufacturers to design quality management systems and establish and maintain the effectiveness of their processes. It ensures that the design, development, production, installation and delivery of medical devices are continuously safe in their intended use.

 

Pass ISO 13485 certification and maintain system compliance

ISO 13485 standard is an effective solution to meet the comprehensive requirements of QMS. Through ISO 13485 certification, it provides a practical basis for manufacturers to meet medical device directives, regulations and commitments to product safety and quality.

NCE has many system auditors all over the world. The ISO 13485 certificate issued by NCE is recognized and trusted by competent authorities, suppliers and manufacturers all over the world in the medical device industry.

Advantages of ISO 13485 certification

ISO 13485 certification can help you improve the overall quality system level, eliminate uncertainty and expand market opportunities. Obtaining this certification is the quality commitment of the organization to customers and regulators.

• Outline how to evaluate and improve the process

• Improve efficiency, cut costs, and monitor performance

• Prove that you produce safe medical devices

• Compliance with regulatory requirements and customer expectations

 

Third party certification services provided by NCE

Necessity Certification (Beijing) Co., Ltd. has enough leading experience in management system solutions, and our professional audit team has rich experience, which can help you explore how to actively integrate ISO 13485 certification with other management systems. We can also act as a one-stop service provider to provide you with various quality certification requirements, including integrated product testing and certification services.

In addition to providing comprehensive assessments and reports, we can also provide you with CE/FDA certification and labeling technical services to meet the export certification needs of enterprises in a one-stop manner.

 

Steps to pass ISO 13485 certification

Before starting the certification process, your company needs to implement the quality management system according to the requirements of ISO 13485 and fully record the relevant effectiveness.

 

1. Document review: NCE evaluates your documents and company records

2. On site audit: NCE audits whether your actual activities comply with the requirements of ISO 13485 and the company's records.

3. Narrow the gap: Your company develops and implements corrective actions to eliminate the root cause of any nonconformance identified by the audit

4. Certificate issuance: NCE issues ISO 13485 certification and certification mark

5. Supervision audit: Complete the annual audit to ensure the effectiveness of the certification (surprise audit may be carried out under special circumstances)

6. Temporary additional audits required by the company (such as simulated flight inspection, Pre-audit before system assessment, etc.), supplier audits required by the company, etc.