Quality Assurance
Kaizen has built its service offering on strict quality principles. Not only do we adhere to strict quality standards and insist that our partners do the same, we have also been providing quality standard implementation and auditing for other organisations for over 5 years.
We have implemented countless systems from self employed setups to large NHS projects. The most important aspect is creating a system that works for you and improves your organisation. Whether it be a system that drives sales or one that is to protect precious data. Our systems are tried and tested, working with industry leaders in certification. We don't simply provide toolkits with generic documents, we provide a tailored system that matches your requirements and work with you to achieve your goal.
Quality and reglatory requirements
We implement and manage Quality Management Systems covering multiple ISO standards (ISO9001, 14001, 15189, 22301, 27001) as well as regulatory required systems such as; HTA, GCP etc.
Digital Technology Assessment Criteria (DTAC)
We also assist with Digital Technology Assessment Criteria (DTAC) gap analysis and implementation. The DTAC brings together legislation and good practice in these areas. It is the national baseline criteria for digital health technologies entering and already used in the NHS and social care.
Continual management and improvement
Once you have your system running and certified we don't stop there. The most effective systems are ever evolving and we offer assistance throughout the life of yours. We offer a virtual dedicated quality manager who will be just like your own employee, a real person dedicated to you not just a name in a call centre. They manage your documentation, ensuring it is distributed where it needs to be. Any formatting and quality checks are done by them and uploaded for you.
We have a full team of auditors who specialise in each standard, we offer full internal audit schedules. These are carried out onsite where required and we also provide remote audits to gather evidence, compiled in a final report. Internal audits are key to finding improvement opportunities within your practices and address unforeseen or new vulnerabilities. Having our team assist in this process, not only gives you expert non-biased advice, it also reduces the burden and cost of removing a member of your team from their duties.
Quality assurance services
Services we can assist with:
- Study design and planning
- Consent management
- Regulatory requirements
- Consultation on quality systems
- Policy and SOP creation
- Implementation of quality systems
- Certification and accreditations
- Full management of system
- Internal and 3rd paty audits
- Digital Technology Assessment Criteria (DTAC)
- Penetration testing (including OWASP requirements)
- Cyber essential and CE+
