ISO 13485 certification is an effective solution to meet comprehensive requirements for quality management systems in the medical device sector.

So, what versions of ISO 13485 certification are available? Let’s follow the article below from the ISSQ Institute for Quality.

Versions of ISO 13485 Certification

ISO 13485:2003 Standard

This version was first issued by the International Organization for Standardization (ISO) in 2003.

ISO 13485:2012 Standard

From 2011, the European Commission raised concerns regarding the presumed conformity of harmonized standards supporting the Medical Device Directives, particularly the Annexes ZA, ZB, and ZC in EN ISO 13485:2003.

As a result, CEN decided to publish a new edition of the certification (EN ISO 13485:2012). This version included a revised foreword and updated Annexes ZA, ZB, and ZC, while the core text of the standard remained unchanged.

ISO 13485:2016 Standard – the latest version

This version was issued on March 1, 2016. Therefore, the new version completely replaced the previous version ISO 13485:2003, and organizations were given three years to transition to the new version.

Most Detailed ISO 13485 Certification Process

An ISO 13485 certificate is issued by a certification body. Certification bodies operate based on the general principles of the global ISO organization and are subject to supervision and designation by the Ministry of Science and Technology.

Therefore, ISO certification must comply with legal regulations. The ISO 13485 certification process is as follows:

Step 1. Registration for certification

Enterprises wishing to obtain ISO 13485 certification need to agree with the certification body on several issues related to certification activities. The assessment and certification issuance will be agreed upon by both parties through a contract.

Step 2. Review of information and planning for certification assessment

After receiving and agreeing on information from the enterprise, the certification body will review it and develop an assessment plan to be sent to the client.

The plan will include information such as:

• Certification assessment schedule

• Assessment location

• Information about auditors

• Rated assessment content, etc.

This helps organizations and enterprises be more proactive in preparing for the assessment, ensuring the evaluation process is conducted as smoothly and effectively as possible.

Step 3. Document review and on-site certification assessment

This is an important step in the ISO 13485 certification process. Experts from the certification body will be assigned to conduct document system reviews and on-site evaluations at factories, production facilities, etc. Based on this, a detailed conclusion will be made on whether the enterprise complies with the requirements specified in ISO 13485.

During the assessment, experts will perform their tasks following principles of objectivity, independent evaluation, and strict compliance with legal regulations related to certification assessment.

Step 4. Appraisal of enterprise records and issuance of certification

After obtaining assessment results from experts, the certification body will review the enterprise’s records and issue the ISO 13485 certificate. The certificate is valid for three years, with surveillance assessments conducted at least once every 12 months.

Step 5. Periodic assessment and recertification

After being granted ISO 13485 certification, organizations and enterprises must undergo periodic assessments to maintain the validity of the certification. Surveillance audit results serve as evidence that the enterprise can maintain the effectiveness of ISO 13485 certification. Typically, periodic assessments are conducted about twice per year.

In addition, the certificate is valid for three years. Upon expiration, the certification body will conduct a recertification assessment. If all requirements are met, the enterprise will be issued a new certificate valid for another three-year period.

Applicable Scope of ISO 13485 Certification – Quality System for Medical Devices

ISO 13485 applies to all organizations regardless of type, location, scale, etc. These may include facilities, companies, factories, distributors, etc., engaged in the production and business of medical devices and healthcare services in general (for example: medical gloves, sterilized medical products, syringes, infusion sets, feeding tubes, etc.). This is a standard of voluntary nature that focuses on managing the safety of medical products.

In Vietnam, this standard is mandatory for medical device manufacturing facilities.

When an organization develops and meets ISO 13485 requirements, it can establish a safety management system that creates a safe working environment, reduces risks related to medical device safety, and ensures products are manufactured safely to meet customer needs and legal requirements.

The above information from the ISSQ Institute for Quality aims to clarify questions regarding the versions of ISO 13485 certification and related issues.

We hope this article provides useful information for you and your business.

ISSQ Institute for Quality is always ready to accompany organizations and enterprises during the period of integration and development.

Please contact hotline: +84 981 851 111 or email vienchatluong@issq.org.vn | tcvn@issq.org.vn. We are honored to serve our valued customers.

Publication date: 27/03/2023