ISO 13485:2003 Quality Management Certification
Timestrip is proud to announce the successful certification to ISO 13485:2003 Quality Management Standard for Medical Devices in addition to our recent recertification of ISO 9001:2008.
Recognised around the world, the ISO 13485:2003 registration is based on eight quality management principles. These include: customer focus, leadership, involvement of people, process approach, system approach to management, continual improvement, fact-based decision-making and mutually beneficial supplier relationships.
The certification of the Company’s compliance with ISO 13485:2003 recognizes the policies, practices and procedures of our firm to ensure consistent quality in the products provided to our customers. With this certification, our medical and non-medical clients can be confident that Timestrip is dedicated to maintaining the highest efficiency and responsiveness achieving our ultimate goal – Guaranteed Customer Satisfaction.
Timestrip is certified as meeting the requirements of ISO:13485 for the following activities: DEVELOPMENT AND MANUFACTURING OF SMART LABELS FOR MEDICAL USE.
To maintain our certification, Timestrip will perform annual audits to ensure compliance and to assess initiatives for continued improvement. Our customers can be confident that Timestrip will continue to provide the high quality services they have come to expect well into the future.
We believe that our decision to become ISO 13485 Certified is a proactive one that not only anticipates the demands of our customers, but also demonstrates our commitment to providing quality services to all our customers in the medical industry. We strongly believe augmenting our certification offers our customers a “Best-in-Class” choice for smart labels.
The accreditation also supports our work in pharmaceutical categories, where a range of Timestrip products are used to identify temperature breaches in highly regulated cold chain environments. We are helping to protect patients and prevent unnecessary wastage of many drugs, vaccines and blood products, where the 2-8°C/46°F storage range is critical to so many products.
Timestrip indicators are leading the market in the provision of low-cost temperature indicators, as demonstrated by our blood bag temperature monitoring labels. In 2013 we launched the Timestrip Blood Temp 10 indicator, in response to the need to reduce wastage of precious blood stocks, discarded through uncertainty around temperature breaches incurred when bags are in use and removed from carefully controlled refrigeration storage units in blood banks.
In 2014, Timestrip UK Ltd announced it is working with Belgian Red Cross-Flanders to develop new blood temperature monitoring labels with a product development program looking to create optimal temperature monitoring labels for the blood collection, distribution and transfusion organisations operating within the Flanders catchment area.
Temperature monitoring labels based on the existing Timestrip Blood Temp 10 product are now being developed and reviewed in consultation with Belgian Red Cross-Flanders.
Also in 2014 we were proud to be the technology of choice for an innovative new product created to provide a wearable, low-cost vaccination reminder product for new-born children.
The Bill Gates Foundation funded Vaccine Reminder Band is currently undergoing field trials in Pakistan. Timestrip has a long history of innovation in the medical device sector and we now provide a range of products which act as invaluable visual aids to doctors, patients and healthcare workers.
For example in the UK, a number of NHS dispensing pharmacies are already using Timestrip® PLUS to monitor the cold chain for temperature-sensitive drugs such as Neulasta® and Total Paternal Nutrition (‘TPN’) products.
Timestrip is committed to quality assurance processes and procedures and we see the ISO 13485:2003 Quality Management Standard for Medical Devices accreditation as a natural progression of our work in the specialist markets in which we aim to excel.