At Swiss Technologies of New England and Stone Medical, it’s that time of year when our audits and re-certifications are in full swing. From recertification's to customer audits, we welcome all with open arms. Swiss Technologies of New England and Stone Medical are both ISO 9001:2015 and ISO 13485:2016 Certified by NQA as well as ITAR Registered.
ISO 9001:2015 Certification ensures all processes are documented and reviewed in the Quality Management System (QMS). This will help ensure all products are up to the customer's standards.
ISO 13485:2016 Certification proves that your manufacturing company meets FDA medical industry standards and has implemented a QMS (Quality Management System) to keep all products & processes in compliance.
After our annual Internal Audit a couple of weeks ago went as smooth as a sleigh, we owe it to our quality team that built our internal system and procedures to follow and to run accordingly.
As the countdown begins for our second re-certification audit, it is important to pass and know our quality management system inside and out. Making our employees and most importantly our customers feel confident in their medical device manufacturer.
Kristi our Business Operations Manager says “audits give another set of eyes to look over your work. They're there to proof your work to make sure you're doing the right thing and following your processes in place. It's a helpful working tool, they're not trying to work against you. What better way to record how you're doing by having a third-party auditor come in and check your work.”
Here at Swiss Technologies and Stone Medical, we look at audits as not something to fear but to use as a way to improve checks and balances for our procedures and processes. As we all know, there is always room for improvement!