The ISO 13485 standard is essential in the medical product industry, enabling the creation of standardized rules for all agents that play a part in the supply chain, on top of domestic regulations.

We analyze what ISO 13485 is, the benefits of implementing it and its associated medical device packaging requirements and other medical product requirements, in addition to its similarities and differences with ISO 9001. 


What is ISO 13485?

ISO 13485 is the standard that outlines the requirements of the Quality Management System (QMS) that applies to the control of medical products and medical devices. This standard outlines the standardized procedures that manufacturers and distributors must follow for the medical products to meet customer requirements and comply with applicable regulations.

It is estimated that companies in the pharmaceutical and medical product sector have seen safety and regulatory inspections increase by 300%, according to Supply Chain Dive.

In light of this figure, companies that comply with the requirements of the ISO 13485 standard can prove that they are implementing best practices toward the quality of their medical products, and that they have the ability comply with the requirements and standards of the medical industry.

The ISO 13485 standard is aimed at all organizations from all sectors involved in the life of a medical product at any point, including:

  • Design
  • Manufacture
  • Bottling
  • Packaging
  • Writing and/or translation of instruction manuals
  • Advertisement
  • Sale
  • Distribution
  • Training in its use
  • Installation or maintenance.


Advantages of ISO 13485 

The main benefit of ISO 13485 is that it offers everyone (any company within the supply chain, as well as customers) an internationally-recognized quality standard.

> For organizations

Every year the number of companies that file for and obtain the ISO 13485 certification increases, according to Advisera. This certification provides them with the following benefits:

  • New business opportunities: some companies in the healthcare and medical device manufacturing sector demand that their vendors are certified under this standard. Therefore, getting certified implies the ability to strike business deals with these organizations.
  • Financial savings: the process optimization incentivized by ISO 13485 allows companies to establish a culture of continuous improvement and to eliminate deficiencies, with their associated expense reductions. Moreover, companies establish processes to manage risks and eliminate associated costs. 
  • Reputation: complying with the standard means being recognized as a responsible organization that is committed to quality and safety in the medical product sector. 
  • Compliance with possible domestic regulations: several countries (United Kingdom, among others) have established the ISO 13485 standard as a requirement to guarantee the safety of medical products and medical devices.

> For customers

Working with suppliers that comply with ISO 13485 means having the guarantee that the products meet quality standards that are recognized worldwide.


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ISO 13485 requirements

> For suppliers

The ISO 13485 standard establishes that suppliers must verify each phase of the development of their product. This includes the necessary equipment for processes such as packaging testing methods and others, process hygiene, product preservation and traceability.

  • More specifically, clause 7 specifies that organizations must count with plans for the entire product development process, from design to planning, production, distribution and tracking.

At this point, adequately documenting the entire process is essential, in addition to obtaining the opinion and feedback of the personnel teams involved.

  • The risk of contamination of any medical device and medical product must be controlled. This includes the specific COVID-19 protocols added in 2020. 
  • The validation process must encompass these phases
    • defining the scope and objectives; 
    • deficiency auditing and analysis; 
    • development of a project plan, including problem solving; 
    • development of the necessary documentation; 
    • training the personnel that will be involved in the processes; 
    • implementation of the QMS within 3 to 6 months; 
    • internal auditing;
    • revision in case objectives are not met;
    • and, lastly, requesting an external audit to verify the ISO 13485 certification.


ISO 11607: everything about it


> On measures and oversight

Clause 6 outlines that company managers are directly responsible for guaranteeing that requirements are met. To accomplish this, they must provide the company with resources and teams for risk management (protocols to prevent contamination), including hiring qualified teams and procuring any necessary infrastructure.

Furthermore, clause 8 specifies that medical products for end users must be reliable, long-lasting, easy to use and offer post-sale customer support. The purpose of this is to track and monitor the end user experience with the medical device, including the reception of complaints and questions. 


ISO 13485 vs. ISO 9001: similarities and differences

On one hand, both standards have the same purpose: to help companies of the medical product sector to develop quality products. As a consequence, ISO 13485 and ISO 9001 have the following things in common:

  • They are both QMS based on documentation tools, employee training, auditing and process optimization and correction.
  • The implementation of design and production-level policies to mitigate risk.

However, these standards have certain major differences, in addition to a different structure:

  • There are more terms that refer to medical products in the ISO 13485 standard.
  • The ISO 9001 standard has more requirements for monitoring supplier performance.
  • The documentation needs to be more intensive in order to comply with the ISO 13485 standard.
  • Even though both standards aim to put customers and their needs in the spotlight, the priority of the ISO 13485 standard is the safety of all medical devices. 

Do you want to know more about medical device packaging requirements and other requirements of the ISO 13485 standard, including packaging validation for medical devices? Contact us and let’s discuss how Safe Load Testing Technologies can help you.

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