ISO 13485: Definition, Compliance, Tools, and Certifications

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ISO 13485: Definition, Compliance, Tools, and Certifications


A Medical Device is any product or machine that is intended to use in the diagnosis, prevention, and treatment of a disease or any other medical condition. 

“Safety and Quality”, are two things that can not be jeopardized in the medical device industry. So, for the organizations involved in this industry of designing, producing, installing, and maintaining medical devices, ISO 13485 was formed. ISO 13485 is an internationally agreed quality management system that sets out the requirements for quality management specifically in the medical device industry. 

Purpose of ISO 13485:

ISO 13485 was developed by the International Organization of Standardization (ISO) in order to outline the standards for Quality Management Systems (QMS) that must be kept in mind while designing and developing medical products.

The standard ISO 13485 helps the organizations define a framework for a quality management system for the development of medical equipment and devices and further encourages the development process to move in the right direction. It is not like another addition to complications. It is actually more of a helping hand for standardizing and systemizing the development of medical devices. ISO 13485 also helps in streamlining the processes and position of the organization for a better future with regulated outcomes. 

A survey conducted by the ISO 13485-certified organizations shows that the companies that have adopted the standard continue to show a positive trend in the market on a global level. 

Characteristics of ISO 13485:

The latest ISO-13485 2016 version has some updates in comparison with the 2003 version. The major changes include a focus on risks, certification of management responsibilities, clarification on training responsibilities, improvement in facility requirements, better design alignment, more emphasis on supplier control, and more. 

There are overall 8 clauses in the new ISO-13485 with 77 mandatory documents and records. The newer version would bring:

  • Alignment of the global regulatory requirements
  • Incorporation of risk management decisions throughout the quality management system
  • Additional clarity on design activities, verification, and validation
  • Enhanced focus on feedback mechanisms
  • Adding more explicit requirements for software validation for different applications

Requirements for adherence to ISO 13485:

Adoption of ISO 13485 may look complex and daunting but is quite easy. All you have to do is stick to the necessary documents and requirements. The mandatory documents include:

  • Control of documents
  • Control of records
  • Internal audit
  • Control of non-conforming products
  • Corrective and preventive actions
  • Validation of computer software
  • Customer specifications (for manufacturing, inspection, packaging, and delivery)
  • Monitoring and measurement
  • Servicing and installation (if applicable)
  • Management review
  • Work environment and contamination control
  • Design and development
  • Validation of sterilization and sterile barrier systems (if applicable)
  • Identification and traceability
  • Preservation of product
  • Calibration or verification for measuring equipment
  • Feedback and complaint handling
  • Reporting to regulatory authorities
  • Advisory notices rework, data analysis.

Steps to Adopt ISO 13485:

There are 4 simple steps to adopting ISO 13485 standard.

  1. Learn about what ISO 13485 actually is. If you know what exactly are you working on, it will be easier to manage the team properly. 
  2. Perform Gap Analysis. This is for organizations that have already been working according to ISO 13485. Now, they must align their developing developed systems to the requirements of ISO 13485 and identify the gaps between them. 
  3. Now, develop all the processes to meet the requirements of the standard. Once the development is done, the team needs to document the progress and changes in proper form for QMS. 
  4. Now, work on QMS. once all the changes and documentations are in place, the team can actively use QMS for some time before applying for audits or certifications. This will help identify additional gaps in QMS. 

ISO 13485 Certification:

In order to be able to achieve the ISO 13485 certification, the QMS of an organization must satisfactorily pass the Medical Device Single Audit Program (MDSAP) which is performed by a third party. For an organization to be able to meet the certification of ISO 13485, it must already be certified to ISO 9001:2008 and should also be able to meet the additional medical device requirements. The organizations that complete the certification will be able to demonstrate to the regulator’s full comprehension of the standard. 

In order to pursue the ISO 13485 certification, an organization must follow the steps to successfully implement ISO 13485 quality management system. After that, the organization can contact the certification body and request an audit for analyzing the company’s performance in accordance with the ISO 13485 standards. We suggest you re-certify every three-year gap to maintain the current status of your organization. 

Visure Requirements ALM Platform:

Visure Requirements ALM Platform is currently working hard toward providing industry-specific solutions in the field of Requirements Engineering allows us to identify, propose and support the new trends of increasingly competitive markets. We intend to reach a compromise between our clients’ current needs and the technology required to meet these. Our customers trust us to Save their time and guarantee consistency by performing complete change impact analysis through end-to-end traceability and suspect links and also deal with the complexity of product lines and variants through component reuse. Our constantly-growing customer base across many countries over the world spans the aerospace, automotive, finance, pharma, medical devices, and software industries. 

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