Compare ISO 13485:2016 to ISO 13485:2003

The current ISO 13485 standard is ISO 13485:2016, which was a big change for the medical device industry, with the last revision being ISO 13485:2003.

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A brief history:

ISO 13485:2003 evolved from ISO 9001:2000, with specific requirements created for the medical device industry. ISO 13485 is an internationally agreed standard, that helps regulate and manage medical device industries. Although it is not a mandatory, many companies aim to be certified, to show customers that they have a great quality management system. 13 years later, ISO 13485:2016 was published to address the changes in the industry, and to help address risk management and risk-based decision making.  

Format Change

As ISO 9001: 2015 has changed to an Annex High Level Structure with ten clauses rather than eight, along with many other standards, ISO 13485:2016 did not follow, and is rather based off of ISO 9001:2008 (yes, 2008).

Key Changes in requirements:

There are several key changes between ISO 13485:2016 and ISO 13485: 2003, we will discuss 11 of the key changes here, which were changed to align with the FDA.

  1. Clause 4.1 General Requirements

The first big change is is that ISo 13485 now requires application of a risk based approach in establishing and maintaining a QMS.

  1. 4.2 General Requirements

Within 4.2, there are two major changes. First, there is a change regarding confidential health information, and second a large change is how to deal with deterioration and the loss of documents.

  1. 6.2 Human Resources

ISO 13485:2016 expands upon 2003, requiring more processes to identify that individuals are competent, that they are provided with any necessary training, and make sure that personnel, and their roles are documented.

  1. 7.2 Customer-related processes

ISO 13485:3016 adds new terms in regards to communicating with regulatory authorities relating to product information, customer feedback, and advisory notes.

  1. Clause 7.3 Design and Development

The 2016 version of 13485 has better aligned with the FDA.

  1. 7.3.8-Design and Development Transfer

Another big change, is that this new revision has specific requirements for the transfer of products and design.

  1. 7.3.10 Design and Development Files

ISO 13485:2003 had no criteria regarding the requirements for maintaining documentation regarding design and development, in the new revision, ISO 13485:2016, these requirements are defined.

  1. 7.4 Purchasing

There are several new requirements as it relates to purchasing. New requirements address the following:

  • Monitoring and re-evaluating suppliers
  • Actions to be taken when purchasing requirements are not met
  • Notifying of any change in regards to purchased products
  • Purchasing verification
  1. 7.4.8 Identification

The new standard now requires that procedures are documented as it relates to production identification and status.

  1. 8.2.2 Complaint handling

In the previous standard there was no clause addressing complaints. This has changed with the new 2016 standard.

  1. 8.2.3 Reporting to regulatory authorities

ISO 13485:2003 did not address this issue, and in the new standard there are regulations regarding ISO 13485:2016

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