What is ISO 13485? Easy-to-understand explanation

What is ISO 13485? Easy-to-understand explanation

What is ISO 13485?

In order to be “ISO 13485 Certified,” a company must have established an ISO 13485 Quality Management System and successfully completed all the requirements of ISO 13485. A medical device’s safety and efficacy are the primary focus of ISO 13485’s Quality Management System evaluations.


To begin designing the Quality Policy, Quality Objectives, and Quality Manual, you’ll first need the cooperation of your management and the needs of your customers.

The Quality Management System’s overall scope and implementation are defined by this grouping. To ensure that your product or service is correctly created and delivered, you will also need to build the essential and additional processes or procedures. Take a look at the article for a further explanation of this.


What are the ISO 13485 Requirements?

For the sake of clarity and ease of implementation, we’ve broken down the ISO 13485:2016 standards. The most recent version of ISO 13485 is ISO 13485:2016. Clause 8 of the ISO 13485 standard has 8 supporting subclauses.

Your quality management system is covered in clauses 4-8. Your company must meet the requirements in paragraphs 4-8 of ISO 1485:2016, as well as customer and applicable statutory and regulatory requirements, to properly implement the standard.


ISO 13485:2016 is an updated version of ISO 9001:2008 that includes medical device-specific standards laid out in an eight-clause structure (whereas ISO 9001:2015 is based on a 10-clause format).

If you’re interested in an integrated management system, compare ISO 13485:2016 with ISO 9001:2015 to discover more about how to harmonize the two. FDA 21 CFR Part 820 is addressed in ISO:13485:2016, which has a slew of additional common standards.

A formal announcement was made by the United States Food and Drug Administration (FDA) to replace elements of the current Quality System Regulation (QSR) with the international standard: ISO 13485:2016.


To market your ISO 13485:2016 certification, you must first meet the requirements of ISO 13485:2016 and receive certification.


The Benefits of ISO 13485

There are numerous advantages to implementing ISO 13485. As a result of establishing an ISO 13485 quality management system, you will see a significant increase in operational efficiency, sales, and customer satisfaction.


This standard has been adopted by the Global Harmonization Task Force (GHTF) and is widely used in the medical industry and major global marketplaces.


Your hard work and investment in the Quality Management System will pay off in the form of increased profits from a well-run business. The financial performance of QMS-certified companies has been found to be superior to that of their non-certified counterparts. Organizations can benefit from having an ISO 13485 QMS in place:


Accomplish all applicable legal, contractual, and marketing obligations

Product safety has been boosted.

However, the FDA’s Quality System Regulations (QSR) and an ISO 13485 Quality Management System (QMS) are quite similar (read more: Harmonizing ISO 13485 and FDA QSR 21 CFR 820)


Higher Levels of Customer Retention

Getting ISO 13485 registration shows customers that a company has a good Quality Management System, which is a big selling point for them (QMS).

An effective Quality Management System (QMS) can help a firm satisfy customer expectations more effectively than an organization without one. This is due to the fact that the QMS’s goals and objectives are based on the demands of the consumer.

The business spends less time focusing on the goals of separate departments and more time working together to address the needs of the customer as a result of this shift in focus.


Increasing Internal Efficiency by Streamlining Existing Procedures

The focus of ISO 13485 is on audits, management reviews, and process improvements based on data collected. Improvements are meticulously planned and performed based on data and a system of documentation and analysis.

Your company’s operations, performance, and profitability will all improve as a result of this process.


Enhancement of top-level Management Participation and Decision-making

The organization’s Quality Objectives are in focus now that the QMS is in place and working for it. As a result, management can observe how well or how poorly they’re doing toward their goals and take appropriate action.

Management Reviews (Clause 5.6) follow a predetermined, scheduled procedure, which assures that this type of assessment is carried out. On a scheduled basis, it provides the ability to evaluate performance versus goals and take action depending on the results.


Organizations often experience an increase in the participation of top management in the Quality Management System because of the needs covered in the Standard.

The Quality Policy (Clause 5.3) and Quality Objectives and Goals are the first steps in this process.

A key part of this cycle is the Management Review, which examines data from the QMS and takes steps to ensure that Quality Objectives are fulfilled, new Objectives are created, and continuous improvement occurs. As a result of the quality policy, any time a defect is discovered, immediate action is performed.


Involvement of Employees

Employees must be aware of their responsibilities under ISO 13485 Section 6.2. Employee productivity and engagement rise as a result of better training and education.

Consistent performance and minimal scrap and rework can be achieved by better documentation or management of processes. Workers have more information to troubleshoot problems on their own, and new workers can obtain the information they need to follow procedures with fewer late-night troubleshooting calls.

As a result of ISO 13485, the workplace becomes a more open forum for employees to voice their opinions and suggestions about how to improve existing procedures.


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