Project speciality: Quality Systems including ISO 9001, ISO 13485 and TickIT
Comprehensive processes and systems for the design and manufacturer of your products is a vital component in your business portfolio. Your customers, suppliers, auditors and external regulatory authorities will expect to see evidence of quality systems.
Webopius have experienced Quality Managers who have taken companies through successful ISO9001, TickIT and ISO13485 certification programmes. We can assist you in defining and implementing the processes, training your teams, selecting external quality assessors and handling external and internal audits.
Our speciality covers Software and Medical Devices specifically and our staff have successfully taken a number of companies through quality systems implementation within the telecommunications, life sciences and healthcare sectors.
If your company has ISO9001 certification it demonstrates that you have been independently audited and have a formalized set of business processes in place. You will have:
- A quality policy
- A quality management system
- Comprehensive procedures covering all business processes
- Monitoring and control systems in place to ensure that processes are effective
- Record keeping
- Defect checking
- Corrective actions to resolve defects
- Regular reviews and internal audits of your processes and their effectiveness
- Continuous improvement
TickIT is a quality-management certification programme specifically for software. It provides a framework for delivering, running and managing software development projects.
ISO 9001:2000 conformity is a pre-requisite for TickIT certification. ISO9001 and TickIT audits are usually conducted at the same time.
ISO 13485 is similar in many ways to ISO 9001 but is specifically for the design and manufacture of medical devices.
Compliance with ISO 13485 is often the first step in achieving European CE clearance. A positive external assessment of ISO 13485 conformance is authorisation to CE identify your medical device and sell it within the European Union.
Evidence of ISO 13485 is also a positive step in demonstrating compliance with the 21 CFR 820 Quality System Regulation for Medical Devices sold in the USA.
Please contact us if you would like to discuss your quality system requirements in more detail.