Quality Management System - ISO 13485
We are committed to delivering products that meet and / or exceed customer, regulatory, and industry requirements. We do this while ensuring continuous improvement of our products, processes and Quality Management System.
- RMA Cost below 1.25%
- OTD of 95% or above
- Internal OTD of 85%
- Quote turn-around in one day
The only controlled copy is the electronic master. If you are reading this on a paper copy it is uncontrolled.
ISO13485:2016 is a sector-specific quality standard for the medical device industry and improves upon and replaces our ISO9001 certification.
Why did we become certified to ISO13485?
One or our largest sectors is the Medical Device industry. Medical devices often come into close contact with patients, and range from providing minor support for various medical conditions, to supporting lifesaving capabilities. Because of this, it is imperative that the device itself — and its supporting instructions, labeling and packaging — meet a higher standard of criteria for quality processes, quickly trace errors, and provide the documentation proving accuracy. We have achieved this higher quality standard (than our previous ISO9001) in support of our customers and to aid them in the administration of their own Quality Management System (QMS).
Remember: It is always easier to implement a QMS with the support of similarly certified vendors, like Steven Label & Robinson Printing.
How does this affect our ISO9001 requirement?
Because ISO13485 is more encompassing, but still very comparable to ISO9001, this new certification enhances our commitment to your quality standard and should fit seamlessly into your quality system.
Give me the specifics!
Effective December 18, 2020 we completed our certification audit for ISO13485:2016. Our certificate from Perry Johnson Registrars is posted to our website; click here to download the PDF.
"Here at Steven Label & Robinson Printing, we strive to stay ahead of the curve, of the requisite regulations under which our customers are operating. Achieving ISO13485 is just one way we demonstrate our commitment to providing engineered, precise, manufactured products — like Labels, Product Instructions, Specialized Kitting and Folding Cartons — to our customers in the medical device, pharma and other similar industries."
-Don Chelius, Vice President of Sales
Less than 1%* of all print manufacturers in the USA have achieved ISO13485!
*according to data provided by Printing Industries of America and Perry Johnson Registrars