Being assessed to the revised ISO 15189 Standard:  A Lead Assessor and Member perspective

Member News September 11, 2023
Being assessed to the revised ISO 15189 Standard:  A Lead Assessor and Member perspective
NATA team

NATA is now assessing to the revised ISO 15189 Standard and to help those Members preparing for their 15189 assessments, we spoke to a NATA Lead Assessor and a recently assessed facility on their experience as well as securing insights on the key differences to the old Standard and how to best manage the new assessment  process. 

Supporting members for this change, we have provided a key resources page on our website. You can find it here .

NATA Lead Assessor Claire Lillee on assessing to the revised Standard

Q: What are your insights about the new 15189:2022 Standard and how it differs from the old one.  

A: The majority of the Standard is very similar to the previous version but in a different order which aligns well with other ISO standards. This means that it has become less prescriptive for laboratories, so they can make their own decisions on the best way to achieve outcomes. Additionally, there is a focus on patient care, as well as a more proactive approach to risk management, with a refocus to risk-based thinking. 

Q: What are the changes in assessment criteria? 

A: There are several new criteria. For example, the release of information and continuity of service. The new standard is also combined with Point of Care (PoC) testing and gives laboratories the opportunity to use ISO 9001 (if they are certified). There are also some changes to existing criteria to focus on organisation structure, authorisation and the validity of results. Good laboratories already address many of the changes in their system, they are now just documented as part of the new standard. 

Q: What should facilities be aware of in the lead up to their next assessment? 

A: GX Laboratories will need to complete an implementation checklist prior to their next reassessment and provide evidence that they have taken action to address each new and changed clause. The checklist is available on the NATA website and can be downloaded at any time. 

Q: How has the new Standard impacted your role? 

A: So far, my role has not been impacted too much. There is a little more prep work in reviewing the implementation checklist and associated evidence, as well as completing a document review of the facilities updated quality manual.  

Q: What do you think are the benefits and / or limitations of the revised Standard for facilities? 

A: The benefit for the facility is that it is less prescriptive. This offers the facility the freedom to decide on the best way for them to meet the requirements of the Standard (keeping in mind that they still need to meet the relevant NPAAC standards). 

Q: What do you think are the benefits and / or limitations of the revised Standard for patient care? 

A: There is definitely a focus on patient care which is fantastic. Patients should have the right to comment, ask questions and make complaints. They also need to have the confidence that the laboratory testing their sample is meeting the standard to get the correct result. 

Thank you for taking the time to share your experience and insights 

Alfred Pathology (APS): Being assessed to the revised Standard 

Q: How much preparation/research/training had you/the team done ahead of being assessed to the new Standard? 

A: We purchased the new Standard from ISO in February 2023 to start to review. Prior to this we had listened to a presentation from Dr David Ricketts (Health Service Laboratories – UK) who presented on “ISO15189 (2022) an introduction to the new Standard” and read his accompanying executive briefing on the new Standard. 

Q: What was your education process to prepare? 

A: We attended the NATA course ‘Understanding ISO 15189’ in April 2023, as well as a webinar and Q&A sessions from Gillian Treloar – “Introduction to ISO 15189”. This webinar was then circulated and links to the Q&A sessions to all our senior staff and team of internal auditors for them to attend/ listen to become more familiar with the new Standard. 

We also conducted discussions and information sharing at our monthly pathology Quality Focus Meetings, including details of areas of focus and changes to the Standard, our transition plan to ensure we align with the Standard including details of our completed Implementation Checklist (required by NATA as part of pre-assessment information). 

While not mandatory for the new Standard, we reviewed and rewrote our overarching Laboratory Manual to align with new format of ISO 15189:2022 using this as a gap analysis method to ensure we had systems and processes in place to cover off requirements. 

Our education continues for senior staff and internal auditors as we update our internal audit checklists to ensure we are auditing to the new standard in our Internal Audit Program.  

Q: What do you feel will be the main differences between your previous assessments against the old standard and those against the new Standard? 

A: Questioning is more focused on patient/ consumer outcomes, and there’s more risk-based thinking applied (a lot was in place for us with NPAAC anyway) – One example which was documenting a process we were already doing as part of our Quality Focus Meetings but the testing of business continuity plans has now been codified as a result of the change in Standard. For us it’s been closing the loop on a lot of what we were doing, and it’s helped make us think about things differently, including making more information publicly available for patients. 

Q: Were there any surprises or challenges along the way? 

A: No real surprises or challenges, but the process has ensured that we have now documented things that we had in place but weren’t previously documented.  

Q: How does accreditation against this Standard support your organisation and patient care? 

A: It’s ensured that everyone is focused on patient outcomes, engagement and access to information about the pathology service and processes. We’ve expanded the information we make publicly available about our complaint’s process procedure, which is directly referenced in the Standard. We always had a place for providing feedback, but now it has a clear framework behind it.  

Q: Any advice for other facilities about to go through the process? 

A: We used it as a way to review and improve our Quality Manual and systems and ensure we met the new requirements.

Thank you for taking the time to share your experience and insights