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ISO 22870 Consultancy

ISO 22870 QUALITY MANAGEMENT SYSTEMS FOR POINT OF CARE TESTING

Our simple approach to ISO 22870 compliance:

Diagnosis
Design
Develop
Implement

Are you interested in becoming ISO 22870 certified?

ISO 22870 is the recognised standard for quality and competence in point of care testing (POCT). It 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 accreditation. If you are already pursuing ISO 15189 and intend to offer POCT, please continue reading to find out more about the UKAS accreditation process and how QFactorial can help you gain ISO 22870 approval alongside ISO 15189. For help with ISO 22870 or to speak with an ISO 22870 consultant, use the enquiry button at the bottom of the page. 

What is ISO 22870 and why is it important?

ISO 22870 is an internationally recognised standard for quality and competence in point of care testing (POCT). It can be applied to any type or size of operation. Its clauses define the baseline requirements for a QMS in functional terms, i.e. it describes what you need to control without telling you how to run your business. The importance of ISO 22870 derives from its universal recognition as a badge of commitment to quality and competence. Of all the quality programmes available, ISO 22870 is the most suitable for SMEs entering POCT sector, including setting up as a Covid-19 point of care test centre.

Already certified but need to simplify or modernise?

If you are one of those more mature businesses for whom ISO 22870 has long been a fact of life, we invite you to consider if your current quality management system has evolved with your business and taken advantage of the changes in the ISO 15189 and ISO 22870 standards that allow a more integrated approach. QFactorial is adept at modernising and simplifying legacy quality management systems to meet the changing needs of organizations as their business context evolves and stakeholders, regulators and other interested parties become more demanding. 

Benefits of ISO 22870, quality management systems and accreditation

Most business leaders answer this in terms of customer and market demand. “I need ISO 22870 to prequalify for a tender process” or “In this market we are up against competitors who already have ISO 22870, and this seems to give them an edge.” Even if neither are true, you may have an opportunity to get ahead of the competition by being the first to be awarded an ISO 22870 certificate. But the certificate is only half the story. The real value is in having a management system that ensures quality and competence in your tests and results.

Key features and requirements of the ISO 22870 standard

ISO 22870 contains management and technical requirements, many of which overlap with ISO 15189, the standard it is designed to supplement. The management requirements in both standards are based closely on ISO 9001. Therefore, if you already comply with ISO 9001 the step up to ISO 15189 with ISO 22870 may be easier. The key technical features of ISO 22870 are: personnel; accommodation and environmental conditions; equipment; pre- and post-examination processes; examination processes; quality and reporting of results.

Accreditation

Third party accreditation is carried out directly by the United Kingdom Accreditation Service (UKAS). UKAS is the national accreditation body for the UK, appointed by the Government, to assess organisations that provide certification, testing, inspection and calibration services. Unlike ISO 9001 and related certifications which work via third party certification on a 3-year cycle with annual surveillance audits, direct UKAS accreditation is valid for 4 years, again with annual surveillance audits. 

Choosing an ISO 22870 consultant

There are many good reasons for partnering with an experienced and knowledgeable consultant when implementing ISO 22870. The first is that it is very easy to over-egg the ISO pudding if you try to implement the standard clause by clause instead of using a risk-based approach. You must also avoid consultants who clone solutions from templates or impose standard documentation that doesn’t look or feel like the way you want the business to run. A good consultant will translate and interpret the jargon of ISO 22870 into business language in the most cost-effective and pragmatic way for your business. A good consultant will give you the tools to make your QMS work and show you how to use them. Finally, a good consultant will challenge you during internal audits and be your advocate in external audits. 

Working with your ISO 22870 consultant - the QFactorial approach

At QFactorial we have a very simple approach to ISO projects, regardless of the size or type of client, the maturity of your QMS or the complexity of your systems and processes. We use our unique Q!Diagnostic method to generate a detailed and specific Quality Roadmap. This will be our guide through the collaborative design, development and implementation of your new or revised quality management system.

Stage 1 ISO accreditation – passing the desktop audit

All certification bodies follow a two-stage model, starting with the Stage 1 documentation audit. This is often known as a desktop audit as it mainly consists of the auditor visiting your premises to read and review the documents that describe and demonstrate your technical and management system controls. The general approach during the ISO 22870 Stage 1 audit is “explain how you have implemented each element of the standard and where you have documented it in your QMS”. Questions will be asked at this stage, but detailed investigation and evidence of the QMS in action is reserved for Stage 2.

Stage 2 ISO accreditation – passing the physical audit

Having established the theoretical compliance of the QMS with ISO 22870 during the Stage 1 audit, Stage 2 is more about checking that the QMS is fully and consistently implemented in practice. Typically, this will involve interviews with members of your team at all levels of the organisation, sampling from a range of processes and functions. The general approach during the ISO 22870 Stage 2 audit is “tell me how this works, take me to where it happens, introduce me to the people, show me the evidence”.

Special process for Covid-19 testing laboratories

Due to the urgency to increase testing capacity to cope with the Covid-19 coronavirus pandemic, UKAS is operating a fast-track scheme to allow laboratory-based testing services to quickly become operational in a safe and approved manner. Instead of the usual two stage process, which can take typically 6 months to achieve full accreditation, the new scheme is in three stages. Stage 1 is a self-declaration against a minimum standard set by UKAS and the Department of Health and Social Care (DHSC). Passing Stage 1 allows the applicant to join the UK Government's published list of providers. For Stage 2 the applicant completes a gap analysis against 13 key requirements and submits this for UKAS appraisal within 4 weeks of Stage 1 completion. Stage 3 is the full accreditation audit to demonstrate that all the submissions at Stage 1 and 2 are implemented and evidenced in practice. This must take place within 4 months of gaining Stage 2 appraisal. 

Remote ISO consultancy and remote audit under Covid-19 restrictions

During the coronavirus pandemic the ISO audit process has moved online with both all taking place via MS Teams, Zoom or other video conferencing tools. These have become widely known as remote audits and are considered just as valid as the site visits previously undertaken. Now that remote auditing has been proven to work, it is expected to remain as part of the UKAS toolbox.

Next steps

To learn more about gaining ISO 22870 accreditation or upgrading your quality management system, simply click the enquiry button and a QFactorial consultant will contact you to discuss your specific needs.

Interested in gaining ISO 22870 certification?

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