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Quality management system standards are a great tool for organizations wanting to plan an effective and efficient quality management system.
ISO 13485, the ISO standard for medical device quality management systems, can help manufacturers to streamline QA processes, improving their effectiveness and potentially reducing costs.
Key Benefits of the ISO 13485 Standard
The ISO 13485 standard lays out a standard for implementing a QMS, adopting a risk-management approach to product development, validating quality management processes and establishing methods for managing product traceability and recalls.
The most significant benefit of ISO 13485 implementation will be in improved QMS processes. The standard lays out a process for designing, implementing, validating and reviewing these systems — helping to streamline each step of the QMS design and implementation process.
The 13485 standard requires a business’s QMS to be data-driven. This means that validation and quality assurance processes will be based on existing product information — like 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 noticeable benefits. Fewer mistakes from a streamlined process often means faster cycle times and less waste.
The creation of processes for product traceability and recalls can also be extremely valuable in the event of manufacturing error.
If a lot needs to be recalled, traceability processes usually help to reduce the scope of recall — knowing exactly when and where each product was produced and how they were shipped generally provides information necessary to identify impacted or recall-relevant products.
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 improved business credibility that the standard alone or a third-party certification offers can also drive additional sales, helping to further increase profit margins.
A manufacturer can access these benefits without even fully committing to adoption of the ISO 13485 standard. While there are additional advantages to fully implementing the standard or becoming ISO 13485 certified, the guidelines on their own can be enough to help establish an effective medical device QMS.
Simple Steps for Implementing ISO 13485
All businesses wanting to implement ISO 13485 need to follow the same few 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 businesses start with a gap analysis that compares existing QMS processes to the ISO standard. Then, businesses will develop an implementation plan that will bring QMS processes in line with that standard. At the same time, the business will also create documentation for its QMS processes.
Once these steps have been completed, the business can provide training to employees and conduct an internal audit, reviewing the effectiveness of documentation and processes in practice.
After the internal audit is complete, the business will be ready for the external auditing process. This involves a stage one audit that reviews internal documentation and training practices, and a stage two audit that reviews the function of the QMS in practice.
To begin this process, your business will need to choose a certifier to work with.
The ISO does not directly certify businesses. Instead, the organization relies on a network of third-party certifiers, called registrars or certification bodies (“CBs”), that comply with certain ISO standards on how they must operate.
The current ISO 17021:2015 conformity assessment standard sets out ISO requirements for these bodies, and describes how these certifying bodies should operate. Before an audit, it may be worthwhile to review these standards to understand how CBs function.
After the audit, your business will also need regular review of its CMS to stay certified. Typically, this review will be in the form of an annual performance or surveillance audit.
Using ISO 13485 to Streamline Quality Management Operations
Implementing this standard can be an effective way to reduce operating costs by streamlining a business’s QMS. With a standardized QMS, businesses can reduce waste, cut down cycle times and potentially limit the impact of recalls.
Preparing for an audit will also help a business to review its processes and learn more about how ISO certification works in practice.
