Your practical guide through the maze of ISO standards
QFactorial is your one-stop shop for ISO support. Our experience and expertise includes the ‘big four’ generic standards – ISO 9001, ISO 14001, ISO 27001 and ISO 45001 – and the big four medical technology, laboratory and POCT standards – ISO 13485, ISO 17025, ISO 15189 and ISO 22870.
ISO 9001 Consultancy – Quality management systems for every organization
ISO 9001 is the foundation standard for most management systems. Use the standard to bring structure, process and consistency to the way you work. Use your QMS to improve the quality of your products, services, projects and operations.
ISO 14001 Consultancy – Environmental management systems
ISO 14001 can be the first step on the road to sustainable operations. Use it to bring structure, process and consistency to your sustainability programme. Your EMS will focus on the environmental aspects and impacts associated with your business, including a product/service lifecycle approach.
ISO 27001 Consultancy – Information security management systems
ISO 27001 could be the most important risk management tool in your ISO toolbox. Information security is not just about IT: use your ISMS to embed InfoSec resilience in people, processes, physical arrangements and technology applications.
ISO 45001 Consultancy – Occupational health and safety management systems
ISO 45001 integrates health and safety compliance into your business processes, encouraging everyone to take responsibility for health and safety in their day-to-day behaviours and decision-making. Your HSMS will demonstrate compliance and commitment to all stakeholders.
ISO 13485 Consultancy – Quality management systems for medical devices
ISO 13485 takes the foundation of ISO 9001 and adds stricter, more detailed requirements for quality assurance and control in the design, manufacture, testing and distribution of medical devices of all kinds. Enhance your QMS with this standard if you are entering the medical device market or supply chain.
ISO 17025 Consultancy – Quality management systems for testing and calibration laboratories
ISO 17025 provides robust management system for your laboratory and proves that your organisation has the technical competence to produce valid and reliable results. Use the standard to develop a QMS that demonstrates and assures competence, impartiality and consistent operation.
ISO 15189 Consultancy – Quality management systems for medical laboratories
ISO 15189 is similar to ISO 17025 but focuses specifically on medical laboratories. Use the standard to develop a QMS that demonstrates and assures competence, impartiality and consistent operation. Combine with ISO 22870 for point of care testing (POCT) including on-premises Covid-19 testing.
ISO 22870 Consultancy – Quality and competence in point of care testing (POCT)
ISO 22870 is focused specifically on point of care testing (POCT) and is used in conjunction with ISO 15189. If your medical laboratory, medical centre, clinic, hospital, surgery or pharmacy intends to carry out POCT (e.g. for Covid-19) you will be required to meet ISO 15189 and ISO 22870 and obtain UKAS approval.
Speak with a QFactorial expert