ISO 13485 is an ISO
standard that represents the requirements for a comprehensive quality
management system for the design and manufacture of medical devices. Though it
is tailored to the industry's quality system expectations and regulatory requirements,
an organization does not need to be actively manufacturing medical devices or
their components to seek certification to this standard. ISO 13485 applies to
design, development, production, installation and servicing of medical devices.
Compliance is a measure of your ability to meet customer and legal
requirements. The following is lists of six top reasons to implement ISO 13485
are:
Improve your company’s
credibility and image: ISO 13485 is the internally recognized gold standard for
quality in the medical device industry. Certification to this standard shows
clients and customers that your company takes quality very seriously, and that
you have a system in place to ensure it. Your QMS can be a powerful marketing
tool, and it has become a requirement in many countries for suppliers to show
compliance. This translates to more opportunity.
Improve customer satisfaction:
The ISO 13485 standard is built on a set of quality management principles, one
of which is ensuring customer satisfaction. This can be achieved by assessing customer
needs and expectations and striving to meet them. Customers know what they
want, and what they need and many of them will not even entertain a supplier
that isn’t certified. Beyond that, ensuring the satisfaction of your existing
customers keeps them coming back, and helps you sell your services to new
customers. This translates directly to increased revenue.
Improve your processes: Using
the process approach outlined in ISO 13485, it’s much easier to discover
opportunities for improvements. You’ll be able to identify and eliminate waste
within and between processes, reduce errors and avoid rework facilitating
greater efficiency and cost savings.
Improve decision-making:
Another quality management principle of ISO 13485 regards the use of
evidence-based decision making. When you use facts and data to drive your
decisions, those decisions tend to be better aligned with the strategic goals
of your company. While “gut feelings†may be appropriate in some social
situations, they can spell trouble in business. An added bonus is the increased
insight into the health of your processes, and any improvements that are made,
once you keep track of the data.
Create a culture of
continual improvement: A third quality management principle making up the
foundation of ISO 13485 is the concept of continual improvement. When adopted
as the culture in your organization, management and staff will always be on the
lookout for ways to improve on how things are done. By establishing systematic
processes for reducing problems and mitigating their effects, everyone will
spend less time cleaning up mistakes, and more time delivering quality products
and services.
Better employee
engagement: When employees are asked to help look for ways to improve their own
processes, not only will they often provide the best insight they will also be
much happier and more invested in the success of the company. The more your
employees understand their roles in delivering quality products and services,
the more engaged they are which leads to increased efficiency and productivity.
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