Quality Management Representatives:
- Andrew Kemp – Managing Director
- Joanne Harwood – QA Manager
Nature of Business:
Design, manufacture and supply of products and services for the validation and monitoring of infection prevention and decontamination processes within healthcare and pharmaceutical facilities.
Type of Product and Service provided:
Validation and continuing monitoring software, data acquisition units, associated consumables and training services.
None of our products come under the Medical Device Directive 93/42/EEC, as amended by Directive 2007/47/EC. All our products comply with EMC or are CE marked by the manufacturer where applicable.
We operate a Quality Management System (QMS) based on ISO 13485, however this system is not certified by a Notified Body.
Isopharm supply validation and continuing monitoring software, data acquisition units, associated consumables and training services. Isopharm do not supply a range of medical devices under their own name; and therefore it is not considered necessary to certify the system at present.
Isopharm Limited’s Quality Management System:
To implement the QMS, Isopharm have:
- Identified the processes needed for the QMS and their application throughout the Company,
- Determined the sequence and interaction of these processes,
- Determined criteria and methods required to ensure the effective operation and control of these processes,
- Ensured the availability of resources to support the operation and monitoring of these processes,
- Implemented procedures to manage, monitor, measure, and analyze these processes,
- Implemented action necessary to achieve planned results and maintain the effectiveness of these processes,
- Senior Management is committed to providing adequate resources to ensure that all employees performing work which could affect product quality are competent.
Isopharm Quality Policy:
Click here to download our quality policy
To ensure that customer requirements are determined and are met, Isopharm have:
- Before accepting a contract / purchase order, we have a formal review procedure to consider our ability to meet the required specification,
- We operate a formal Supplier Approval System,
- We ensure that all our purchases are clearly specified and are sourced from reliable suppliers on our Approved Supplier List,
- We ensure that all products received meet documented specifications,
- Records are maintained for product batch and serial traceability,
- We ensure that all employees are properly trained for their roles within the organisation.
- We are not a member of any trade association or governing bodies
- We are not currently registered with the DoH Good Manufacturing Practices
- We have not sought NHS Logistics approval
- We have not sought NHS PASA approval
We have an Environmental Policy, however this is not certified by a Notified Body and does not comply with ISO 14001.
Health & Safety Policy:
We maintain a Health & Safety Policy
- All employees undergo health and safety training which is regularly reviewed
- Any accidents and hazards reported by employees are recorded and regularly reviewed
- Risk assessments are carried for typical activities undertaken by employees
We are covered by the following insurance policies, copies are available on request.
- Employers Liability
- Public Liability
- Product Liability
You are welcome to audit our Quality Management System, to book an appointment please contact our Quality Management Team