The terms ISO Standards and ISO Certification get thrown around quite a lot, especially when it comes to the Medical Device Manufacturing and Pharmaceutical Industries. But what do they actually mean?
ISO or “International Organization for Standardization” is a body that determines standards and awards certifications in a variety of areas associated with business operations. The ISO 9001:2015 is the specific certification related to quality, or more specifically, how quality is managed in order to ensure that customers receive consistent, high-quality products and services.
How is ISO Certification Achieved?
ISO 9001 Certification is awarded to a business after a stringent series of audits and tests designed to examine the processes in place to ensure the business is delivering a consistent level of quality to its customers.
The process starts with understanding ISO 9001 Certification requirements and then implementing an entire Quality Management System that is ISO Compliant. This includes the processes, procedures, and Quality Manual covering: Context of the Organization, Leadership, Planning, Support, Operation, Performance Evaluation, and Improvement. If that sounds like a lot, that’s because it is, but it’s the first and most inclusive step in the certification process.
After that, a Management review meeting will need to be held to ensure that the requirements are being met, as well as the processes being measurable and repeatable. With a successful Management review, the business can then proceed to conduct an internal audit.
The final step to certification (and recertification) is having an official registrar audit, test, and certify your business. The first time a business attempts ISO Certification the whole process takes roughly 3-4 months. In order to maintain that certification, these steps must be completed successfully every year!
Why Does it Matter?
Of course, quality should truly be the focus of every business, but choosing vendors with the ISO Certification guarantees that you’ll be delivered the best quality goods and services. This is especially imperative when dealing with highly critical industries like Medical Device and Pharmaceuticals.
Specializing in these highly regulated industries means that one smudge or misprinted word and there’s much more at stake than a faulty Instructions-For-Use (IFU) or Technical Manual Booklet. The whole lot could be rejected due to one misprint or mistake, costing potentially thousands of dollars and holding up the manufacturing and delivery of equipment necessary for the operation of healthcare workers around the world. Furthermore, these devices and products often have very specific instructions which, if unable to follow properly, could result in catastrophic injury or even death.
Whether you’re in the highly regulated industries of Medical Devices dealing with MDR (and the New EU-MDR regulations), the Pharmaceutical Industry working with the FDA, an OEM or Contract Manufacturer, or a small business looking for reliable products or services, ISO certification should be an important consideration. Especially when considering an on-going relationship with a particular supplier, ISO 9001:2015 (Quality Management Systems) can give you peace of mind to know whatever it is will get done right, and your supply chain will be secure.