Quality Support
We know that having a robust series of quality processes is fundamental for IVD manufacturers and economic operators. Building and maintaining a Quality Management System (QMS) is an ongoing journey and it grows to reflect the changes to the industry and your organisation. We can help you at every stage of this journey
Supporting You
Educate
Help you understand the principles of quality
Evaluate
Identify areas of risk and opportunity
Execute
Implementing your quality plans
Sustain
Independent quality audits and external audit support
Implementation…
Implementing an effective Quality Management System is key to the efficient running of an organisation.
We can help implement a paper-based or software based solution with you in mind.
Our expert auditors can provide an independent review of your QMS, help you prepare for an audit, or support with non-conformance remediation.
ISO13485
ISO9001
Risk Management
Independent Internal Audits
External Audit in-room or back-room support
Case Studies of Customers we have supported
UK Medical Device Manufacturer
This manufacturer had a paper based ISO13485 Quality Management System, which had grown with the company. Due to the increase in head count, and growing complexity of the organisation, the paper-based approach was slowing down changes to processes and product design. We used their existing procedures and utilised a QMS using an eQMS software. Once implemented the team developed their understanding and maintained the system, with our ongoing ad-hoc support.
Growing start-up, North America
As a small software based company, the team knew how to design software, but needed additional support to understand how to implement international standards including ISO13485, ISO14971 and ISO27001. We worked with the team to understand the requirements, and how they could implement them into their existing processes to support ISO certification.
UK IVD Manufacturer
After designing their original device and placing on market, this company had a great understanding of ISO13485, however did not have the sufficient knowledge within the team to perform independent internal audits as required by the standard. We take on the responsibility of the internal audit with twice yearly audits covering the entire standard, and reporting back any deficiencies and opportunities for improvement to the management team. This improves the quality system, and reduces the risk of non-conformances being identified by their conformity assessment body.