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Quality management system standards are a great tool for organizations that want to plan an effective and efficient quality management system.
ISO 13485 is the ISO standard for the quality management system of medical devices, which can help manufacturers simplify the QA process, improve efficiency and potentially reduce costs.
Main advantages of the ISO 13485 standard
The ISO 13485 standard establishes standards for implementing QMS, adopting risk management methods for product development, verifying quality management processes, and establishing methods for managing product traceability and recall.
The biggest benefit of ISO 13485 implementation will be to improve the QMS process. The standard specifies the process of designing, implementing, verifying and reviewing these systems-helping to simplify every step of the QMS design and implementation process.
The 13485 standard requires that the company’s QMS be data-driven. This means that the verification and quality assurance process will be based on existing product information-such as the frequency of certain quality defects, or the potential impact of complications if the product fails in some way.
A more effective QMS will also bring significant benefits. Simplifying the process with fewer errors usually means faster cycle time and less waste.
In the case of manufacturing errors, creating a product traceability and recall process is also very valuable.
If a large number of products need to be recalled, the traceability process usually helps to narrow the scope of the recall-knowing exactly when and where each product was produced and the method of transportation can often provide the information needed to identify the affected or related products.
If a recall occurs, this can save a lot of money and usually reduces the impact of the recall itself.
The expanded market access and improved business reputation provided by a separate standard or third-party certification can also drive additional sales and help further increase profit margins.
Manufacturers can even reap these benefits without fully committing to the ISO 13485 standard. Although there are other advantages to fully implementing the standard or obtaining ISO 13485 certification, these guidelines alone are sufficient to help establish an effective medical device QMS.
Simple steps to implement ISO 13485
All business Want to implement ISO 13485 The same few steps need to be followed. The way they are implemented will vary depending on the products you produce and your existing quality management processes.
For this reason, most companies start with gap analysis and compare existing QMS processes with ISO standards. The company will then develop an implementation plan to make the QMS process comply with the standard. At the same time, the company will also create documentation for its QMS process.
After completing these steps, the company can provide employees with training and conduct internal audits to review the effectiveness of documents and processes in practice.
After the internal audit is completed, the company will prepare for the external audit process. This involves the first phase of audits that review internal documents and training practices, and the second phase of audits that review the functions of the QMS in practice.
To begin this process, your business needs to choose a certification body to work with.
ISO does not directly certify companies. Instead, the organization relies on a network of third-party certification bodies, called registrars or certification bodies (“CBs”), which comply with specific ISO operating standards.
Currently ISO 17021:2015 conformity assessment standard Develop ISO requirements for these agencies and describe how these certification agencies should operate. Before the audit, it may be worth reviewing these standards to understand how the CB works.
After the audit, your company will also need to periodically review its CMS to maintain certification. Usually, this review will take the form of an annual performance or supervisory audit.
Use ISO 13485 to simplify quality management operations
By simplifying the enterprise’s QMS, the implementation of this standard can be an effective way to reduce operating costs. Through a standardized QMS, companies can reduce waste, shorten cycle time and potentially limit the impact of recalls.
Preparing for an audit will also help companies review their processes and learn more about how ISO certification works in practice.
