5D Health Protection Group Ltd

The quality management systems (QMS) of the 5D Health Protection Group underpins all activities that are undertaken in all our laboratories and offices. Our external accreditations and certifications of all the relevant regulations and standards ensures that all work undertaken by 5D is of the highest standard for all our customers.

Fundamental to our company’s success is a complete commitment to providing a total quality service to all our customers. 5D's total quality assurance expertise ensures that our customers technologies, innovations and products are tested against the quality standards they require and expect from a world class microbiology support services provider. In order to maintain our high quality certifications, as well as external quality audits, we undertake regular internal audits. Consequently our quality systems are regular maintained and we are constantly updating our methods and test procedures.

Certifications and Accreditations

5D is certified to ISO 9001, ISO 13485, accredited to the CPD certification services and ISO 17025 (10779).

ISO 9001:2015

ISO 9001 is an internationally recognised standard that highlights what is required for a QMS. The standard demonstrates that an organisation provides services that meet customer and regulatory requirements. Certification means that a company conforms to the standard, meets customer requirements including statutory and regulatory requirements and constantly maintains documentation. ISO 9001 ensures that processes, tasks and also responsibilities are clear throughout the organisation. A ISO quality management system means companies monitor and manage quality across the organisation enabling it to continually improve and develop to growing customer needs and requirements.

ISO 13485:2016

ISO 13485 is a stand alone international quality management system for organisations that want to demonstrate their ability to provide medical devices and services that comply with regulatory requirements and customer needs. Medical devices are products such as machines, instruments, implants and in vitro diagnostic devices that are used for the diagnosis, prevention and also the treatment of diseases and medical conditions. ISO 13485 is generally harmonised with ISO 9001, but it is more prescriptive in nature than ISO 9001 and requires a more thoroughly documented quality management system. ISO 13485 certificates are recognised and trusted by the medical device industry including manufactures and suppliers world wide. This standard communicates to customers and also regulatory bodies that a company is committed to quality. Whilst ISO 9001 is an international standard for a quality management system in any organisation ISO 13485 places a significant focus on regulatory compliance in the medical device sector.

ISO 17025:2017

ISO 17025 is an international standard which sets out the general requirements for the competence of testing laboratories. The standard contains the requirements that laboratories need to meet to demonstrate they are technically competent and have the ability to generate results that are considered technically valid. Whilst ISO 9001 is used to recognise that an effective management system is in place in an organisation ISO 17025 recognises the technical competence of laboratories. Accreditation to the ISO 17025 standard is a formal declaration by an Accreditation Body such as the UK’s National Accreditation Service (UKAS), after assessment and confirmation, that a laboratory is effective in meeting the requirements of ISO 17025 to perform certain tests according to its accredited scope. ISO 17025 is often considered good for a testing organisation as it is thought to help to increase customer confidence in the validity results when they are generated against certain standards. 5D are audited by UKAS on an annual basis to ensure compliance with the requirements of ISO 17025 in conjunction with our accreditation to perform BSI EN 1276 for disinfectant suspension testing.

CPD Certification

Continuing Professional Development (CPD) is an on-going expectation and requirement for individuals in an array of different professions. It a term that is used to describe the learning of new skills and knowledge by professional to further enhance their abilities and knowledge. The CPC Certification Service is an organisation that assists organisations in formalising their knowledge into a structured format that is recognised globally. Courses and workshops that are CPD approved have been formally and impartially accredited by CPD assessors. By undertaking CPD training this ensures that individuals continually enhance their skills that do not become out-dated. Courses that are accredited means that courses and training programs have reached a required CPD standard and benchmark. At 5D, we have a wide array of different courses that are CPD approved. The courses we provide are based on the requirements of our customers. These range from back to basic courses such as an introduction to microbiology to biofilms to an introduction to wound healing and wound infections.