Quality management system standards are a great tool for organizations that want to plan an effective and efficient quality management system.
ISO 13485, the ISO standard for medical device quality management systems, can help manufacturers streamline quality assurance processes, improving their efficiency and potentially reducing costs.
Key benefits of the ISO 13485 standard
The ISO 13485 standard establishes a standard for implementing a QMS, adopting a risk management approach to product development, validating quality management processes and establishing methods to manage traceability and product recalls.
The most significant benefit of implementing ISO 13485 will be the improvement of QMS processes. The standard establishes a process to design, implement, validate and review these systems, which helps streamline every step of the QMS design and implementation process.
The 13485 standard requires that a company’s QMS be data-driven. This means that quality assurance and validation processes will be based on existing product information, such as the frequency of certain quality defects or the potential impact of complications if a product fails in a certain way.
A more effective QMS will also have notable benefits. Fewer errors from a simplified process often means faster cycle times and less waste.
Creating processes for traceability and recall can also be extremely valuable in the event of a manufacturing error.
If a lot needs to be recalled, traceability processes generally help narrow the scope of the recall – knowing exactly when and where each product was produced and how it was shipped generally provides the information needed to identify the products affected or relevant to the recall.
In the event of a recall, this can save a significant amount of money and generally reduce the impact of the recall itself.
The expanded market access and enhanced business credibility offered by the standard alone or a third-party certification can also lead to additional sales, helping to further increase profit margins.
A manufacturer can access these benefits without even fully committing to adopting ISO 13485. While there are additional benefits to fully implementing the standard or obtaining ISO 13485 certification, the guidelines alone may be sufficient to help establish a Effective QMS for medical devices.
Simple steps to implement ISO 13485
All businesses want to implement ISO 13485 you must follow the same steps. How they are implemented will vary depending on the product you produce and the quality management processes you already have in place.
For this reason, most companies start with a gap analysis that compares existing QMS processes with the ISO standard. The companies will then develop an implementation plan that will align the QMS processes with that standard. At the same time, the company will also create documentation for its QMS processes.
Once these steps have been completed, the company can provide employee training and conduct an internal audit, reviewing the effectiveness of the documentation and processes in practice.
Once the internal audit is completed, the company is ready for the external audit process. This involves a stage one audit that reviews internal documentation and training practices, and a stage two audit that reviews the role of the QMS in practice.
To begin this process, your company will need to choose a certifier to work with.
ISO does not directly certify companies. Instead, the organization relies on a network of external certifiers, called registrars or certification bodies (“CBs”), who adhere to certain ISO standards on how they should operate.
The current Conformity assessment standard ISO 17021: 2015 establishes the ISO requirements for these bodies and describes how these certification bodies should operate. Before an audit, it may be worth reviewing these standards to understand how POs work.
After the audit, your company will also need a regular review of its CMS to stay certified. Typically, this review will take the form of an annual performance or monitoring audit.
Using ISO 13485 to optimize quality management operations
Implementing this standard can be an effective way to reduce operating costs by optimizing a company’s QMS. With a standardized QMS, companies can reduce waste, shorten cycle times, and potentially limit the impact of recalls.
Preparing for an audit will also help a company review its processes and learn more about how ISO certification works in practice.