What Is ISO 13485?

In July of 2003, the ISO 13485 quality management system standard for businesses operating in the medical device industry was first introduced by the International Organization for Standardization (ISO). On March 1, 2016, the latest version of ISO 13485:2016—which took the place of ISO 13485:2003—was published.


ISO 13485:2016 is a rule that concentrates on how a corporation could handle a risk-based approach related to the purchase, production, storage, design and development, installation, distribution, and servicing activities, and other facets of the quality management system. It is built on the same fundamental ideas and clause schema as ISO 9001:2015. The standard outlines standards for businesses involved in one or more phases of the life cycle of a medical device. It is frequently seen as an essential first step in ensuring design and manufacturing processes continually result in high-quality goods that satisfy regulatory standards.

Objective Of ISO 13485

ISO 13485 may also be used by importers or appointed distributors that ship in and issue medical devices and may be needed to set up a quality management system under local regulations.


The main goal of ISO 13485:2016 is accelerating the harmonisation of medical device regulatory standards for quality management systems. Because of this, it contains particular standards for medical equipment and leaves out some of the ISO 9001 requirements that are unsuitable for regulatory criteria. Due to these exemptions, organisations that have achieved ISO 13485 certification cannot assert that their quality management systems are under ISO 9001 unless they do so.

Benefits Of ISO 13485


  • Assists in maintaining global recognition with the best quality practices from companies within the medical device industry.
  • Enables organisations to work within various countries by complying with necessary regulations and obligations.
  • It helps to create an organised framework for the organisation to maintain and evaluate its processes and customer handling.
  • Provides a framework to ensure ongoing maintenance and improvement of effective processes with applicable requirements.
  • Enables improved performance through increased sales, shorter timelines in getting products to the global marketplace, lowered costs, less waste, and higher productivity with quality production.
  • Demonstrates compliance to the European Union (EU) Directives through establishing and independently assessing the quality management system.

Why Become ISO 13485 Certified In Malaysia?

ISO 13484 is intended for corporations engaged in producing, designing, installing, and maintaining medical devices and related services.  The advantages of ISO 13485 cannot be emphasized enough. Organizations of all sizes have seen considerable savings in time, cost, and other improvements brought about by an adequate Quality Management System.

Here Are The Top Six Reasons Your Business Should Adopt ISO 13485

  • Boost the reputation and credibility of your business. ISO 13485 is the medical device industry's internal gold standard for quality.
  • Increase client satisfaction. Assuring customer satisfaction is among the number of quality management principles upon which the ISO 13485 standard is constructed.
  • Enhance your procedures. Finding areas fo growth is significantly simpler when using the process approach described in ISO 13485. By reducing errors and avoiding rework, you'll be able to find and eliminate waste both within and between processes. This will lead to increased productivity and saving costs.
  • Execute better decisions. Evidence-based decision-making is yet another quality management standard of ISO 13485. Your choices are more likely to align with your company's strategic goals based on facts and statistics.
  • Establish a culture of continuous growth. The ongoing improvement principle is a third quality management concept that forms the basis of ISO 13485.
  • Better loyalty from employees. Your staff will be more engaged and work more efficiently and productively if they know their responsibilities in providing high-quality goods and services.
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Frequently Asked Questions

1What is ISO13485?
The quality medical device standard is ISO 13485, which guarantees that all medical equipment satisfies both client and legal requirements for regulatory compliance. To keep professionals and consumers safe in clinics, hospitals, and other medical settings, ISO 13485 accreditation is a valuable credential.
2Who does ISO 13485 apply to?
Organizations engaged in producing, designing, installing and maintaining medical devices and related services are intended users of ISO 13485.
3What benefits will it bring to my business?
The advantages of ISO 13485 cannot be emphasized enough. Organizations of all sizes have seen considerable savings in time, cost, and other improvements brought about by an adequate Quality Management System. Here are the top six reasons your business should adopt ISO 13485:
  • Boost the reputation and credibility of your business. ISO 13485 is the medical device industry's internal gold standard for quality.
  • Increase client satisfaction. Assuring customer satisfaction is among the number of quality management principles upon which the ISO 13485 standard is constructed.
  • Enhance your procedures. Finding areas for growth is significantly simpler when using the process approach described in ISO 13485. By reducing errors and avoiding rework, you'll be able to find and eliminate waste both within and between processes. This will lead to increased productivity and saving costs.
  • Execute better decisions. Evidence-based decision-making is yet another quality management standard of ISO 13485. Your choices are more likely to align with your company's strategic goals based on facts and statistics.
  • Establish a culture of continuous growth. The ongoing improvement principle is a third quality management concept that forms the basis of ISO 13485.
  • Better loyalty from employees. Your staff will be more engaged and work more efficiently and productively if they know their responsibilities in providing high-quality goods and services.
4Should I get certified?
Any company that produces, imports, or issues medical equipment in the country must first obtain a licence from the Medical Devices Authority (MDA) to reap the benefits of these opportunities.
They must hold certification with either Good Distribution Practice for Medical Devices (GDPMD) for importers and distributors or ISO 13485, an international quality management system standard.
The head of SIRIM QAS management system certification, Md Zaini Md Jai, stated that the ISO 13485 certification "validates that MDA licence holders manufacture medical devices in compliance with worldwide criteria of safety and efficacy."
"With this accreditation, manufacturers may satisfy Malaysia's set criteria and have their equipment accepted on the global market," he added.
5How long is the process?
With a good understanding and the proper preparation of what is required for ISO22301 certification, most organizations can expect a certificate within 3-6 months, depending on their size and complexity.
6What is the cost?
The cost varies depending on your device (category), complexity of the process and company / organization size.

Steps To Certification

  • 1Request for Quotation

    Call us now and select a package that fits your budget.
  • 2Make Appointment with Our Consultant

    Receive your first-round free consultation
  • 3Introduction to ISO Training

    Help your organization to demonstrate commitment towards quality and customer satisfaction.
  • 4Documents Preparation & Implementation

    Identify documents that are needed for your Quality System and Production or Service Processes; start to implement.
  • 5Internal & External Audit

    To confirm that your Management System (QMS) is properly established and maintained while meeting the international standard.
  • 6Get Certified & Impress Your Client

    Show off your certificate on your website and sales collateral.
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