Our reputation is built on achieving consistently superb quality outcomes on every project, no matter how unique, unusual, or complex. We insist on strict monitoring of product quality by incorporating measurement, testing, and logging capabilities across all our manufacturing control systems.
QUALITY ASSURANCE
We call it “Quality Reassurance”
At Forme Technologies, quality is a no-compromise, de facto reality.
It’s quite simple, quality comes first.
ISO 13485 and ISO 9001 Accredited Business +
Forme Technologies runs under the guidelines of both ISO 13485:2016 and ISO 9001:2015 certifications. These certifications are proof of our commitment of delivering the best outcomes to both our Medical and Non-medical customers.
Meeting the regulatory requirements of our clients’ industries is a must. Many of the components manufactured at Forme perform critical functions and therefore they require from us to always meet the specifications.
We have the team, the experience and equipment that allow us to achieve this.
Process Validation
At Forme, we use tools as mould flow simulation software CAE (Computer-aided engineering), PFMEAs (Process Failure Mode and Effect Analysis), DOE (Design of experiments), SPC (Statistical Process Control), PPAP (Production Part Approval Process) among others, to make sure that our processes are in control and running optimised.
For our clients in the medical industry, we can perform IQ (Installation Qualification), OQ (Operation Qualification) and PQ (Process Qualification), to demonstrate that the process runs consistently, and the parts are to specification.
It is not by accident that our current quality score is around 98% for delivery of on time quality - something that we constantly endeavour to improve.
Quality ethos
Our reputation is built on achieving consistently superb quality outcomes on every project, no matter how unique, unusual, or complex. We insist on strict monitoring of product quality by incorporating measurement, testing, and logging capabilities across all our manufacturing control systems.
Built on achieving consistently
Latest Equipment
With state of the art metrology, monitoring, mechanical testing, and material analysis equipment to support our quality processes.
Culture of Excellence
Both our ISO 9001 and ISO 13485 quality systems demand from us that all our processes are monitored and documented. At Forme, we fulfill our customer’s unique requirements of traceability, documents retention and control, and accountability during the entire project life cycle.
FAQ's
How do local and international customers rate your quality and delivery standards?
Forme Technologies is ranked in the top percentile for quality and delivery standards with local and international customers.
How would you describe the quality of the products you manufacture?
Our reputation is built on achieving consistently superb quality on every project, no matter how unique, unusual or complex. We insist on strict monitoring of product quality by incorporating measurement, testing and logging capabilities into all our manufacturing control systems.
What can a client expect in terms of accountability?
We have a company-wide culture of excellence. All our processes are documented and support our customer’s unique requirements of traceability, retention and accountability during the entire project life cycle. One of our core strengths is Delivery in Full on Time (DIFOT).
What is your Quality Assurance?
We have built an excellent reputation for achieving superb quality on every project, no matter how unique, unusual, or complex. We are ranked in the top percentile for quality and delivery standards with our local and international customers. We are both ISO 9001 and ISO 13485 accredited business.
What type of accreditation do you have as a business?
We are an ISO 9001 and ISO 13485 accredited business. ISO 13485 is the standard required for the manufacturing of medical devices.
