Quality, Environmental and Health & Safety Policies

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.

CE Compliance:

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.

ISO 13485:

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

Customer Requirements:

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.

Other Approvals/Registrations:

  • 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

Environmental Policy:

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

Insurance

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

Andrew Kemp

Managing Director