ISO 13485 – An Overview

    ISO 13485 is a global standard for quality management systems (QMS) reserved exclusively for medical device manufacturers. It gives organizations a structure to meet customer and regulatory demands effectively. It extends to the entire lifecycle of a product, including its design and development, production processes as well as post-delivery requirements are in scope.

    The Differences between ISO 13485 and ISO 9001

    The difference between ISO 9001 and ISO 13485 is that the former works everywhere, while the latter is just fine-tuned for medical devices; they are like two twin(s) in different clothes. Key differences include:

    One of the most important differences about ISO 13485 is its close relationship with regulatory requirements and risk management for medical devices, also known as Regulatory Focus.

    Documentation & Records: ISO 13485 mandates extensive documentation and record-keeping.

    Customer Focus: ISO 9001 requires customer satisfaction and continual improvement results, while the focus in ISO 13485 is on product safety & efficacy.

    Why use ISO 13485 for Medical Device Manufacturers?

    ISO 13485 is used by medical device manufacturers to establish a quality management system which controls their products is safe, useful and meets regulatory standards. Key reasons include:

    It means that Regulatory Compliance: the Conformity with ISO 13485 is a frequent marketplace for the sales of goods on world markets.

    Threat Management: It helps producers to plot and mitigate threats at some point in the existence cycle of their product.

    Boost Customer Confidence: When certified, you show your customers that it is important to deliver products and services of the highest quality in a safe environment.

    Disadvantages of ISO 13485

    While this is good in itself, it has some possible drawbacks if ISO 13485 were to be implemented:

    • Price: Standard implementation and support can be costly.
    • High Resource Requirements – It takes a lot of staff time to keep up with!
    • Complex regulatory burden: There are complex and often cumbersome regulations to follow.

    Countries Accepting ISO 13485

    The International Organization for Standardization approved in many countries, as the United States of America (USA), Canada and European Union member states, Japan or Australia. These countries accept ISO 13485 as a standard for quality management systems in medical devices which results in market access of certified organizations.

    Why ISO 13485 Consultants?

    Additionally, when you hire ISO 13485 consultants, they will be present to help guide you during the implementation & certification process which is beneficial. Consultants will be a specialist in ISO 13485 requirements and best practices. Can cut through the implementation process thus saving time and resources.

    Consultants are useful in ensuring full compliance with regulatory standards, minimizing the risk of any non-conformities.

    Benefits of Hiring an ISO 13485 Consultant

    When you do this, there are a few advantages to appointing such a consultant:

    • Insights: Consultants offer a fresh perspective and can lend an objective view of current processes and systems.
    • Bespoke Solutions: They provide bespoke services that suit the individual needs of your organization.
    • Training & Support Consultants often have training / ongoing support to assist with implementation and maintenance once a solution has been designed.

    Implementation Timeline for ISO 13485

    Given the organization’s size, complexity and existing QMS maturity level, an implementation timeline for ISO 13485 Varies. Typically, the average process might last between 6-18 months. Key stages include:

    Gap Analysis: Evaluate systems against ISO 13485 and you should make a detailed plan of the execution and creation of processes, procedures and documentation followed by conducting internal audits to verify nonconformities.

    Timeline of ISO 13485 Certification

    The ISO 13485 certification process typically involves the phases following and could be done within 3 to six months:

    Apply to the relevant certification body

    Stage 1 Audit: A Preface Inspection (an initial review of the organization and its documentation)

    Stage 2 Audit: This is a detailed audit of the QMS to ensure it has been implemented and if so, how effective it is.

    Certification Decision: The Certification body reviews the audit findings and then makes a certification decision. Surveillance audits: Periodic auditing to maintain your status.


    ISO 13485 is a critical step for medical device manufacturers on the path to establishing product quality, safety and regulatory compliance. Despite the high prices and intricacies, such an option has plenty of value that significantly trumps any obstacles. By utilizing the knowledge of ISO 13485 Consulting service from I3CGLOBAL, organizations can reduce the time for implementing it and become certified within a lesser period to save from shrinking in global alignments.

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