UKAS extension to scope: Everything You Need to Know

What is a scope extension?

A UKAS scope or schedule is the list of activities for which UKAS has granted accreditation. An extension to scope is a process through which institutions may extend the scope of activities accredited by UKAS. It is also highly recommended to give UKAS advanced warning before submitting an application of scope extension.

What is the UKAS application process?

The first step of the application process is to notify UKAS by submitting the appropriate application form – for testing laboratories is the AC4 form. Within this application form the type of test and the methods, techniques and equipment used should be outlined for the materials or products to be tested. It also gives the opportunity to indicate the desired timeframe for the extension to scope assessment, including if to make it part of the next surveillance/re-assessment visit or if to process it straight away (understanding that a further assessment would be required). Lastly, if the tests are a similar method or technique to what is already on the scope of accreditation then a request for a desktop review assessment can be included.

When submitting the application, a number of documents for the requested methods must also be sent. This includes:

• Documented technical procedure
• Method validation data and validation summary
• Uncertainty of measurement budgets
• Detail of the measurement traceability chain

This paperwork will then be sent to your application manager who will review all the information to determine a suitable technical assessor to be allocated and a project number assigned. Your assessment manager then works with the laboratory to determine availability and if any further documentation is required ahead of the assessment. The assessment manager will also discuss how the addition of the extension to scope will affect the certification cycle going forward, such as additional resource.

What happens during the assessment?

The technical assessor will have a relevant expertise for the method and techniques to be able to assess the technical competence of the laboratory as well as any changes the addition of the test that would impact the quality management system, such as training, internal audits, and document control.

The assessment performed will follow the visit plan provided ahead of the assessment, however the technical assessor may have to deviate from this to adapt to evolving situations and circumstances as the assessment usually does not follow a clause-by-clause checklist. This means while reviewing one aspect of the plan, the technical assessor may lead the assessment or ask questions regarding a different aspect to be able to determine if the requirements of the standard are met.

While performing the assessment, the technical assessor may raise either mandatory or recommended findings. When a finding is raised, a discussion with the laboratory will take place to determine an agreed improvement action that would be required to show compliance against the requirements of the standard (ISO 17025) and the testing method/standard.

What happens after the assessment? 

A full report will then be provided to the laboratory outlining the assessment that took place and exactly what was assessed along with the findings raised and agreed time frames issued for the submission of the additional evidence required. The action report with the findings will be added to the UKAS portal for the laboratory to submit this evidence, as well as information on route cause and impact analysis. The technical assessor will then review everything submitted to ensure the laboratory has closed out the mandatory findings to a satisfactory level. The application will then be escalated to an independent decision maker to review the assessment documentation submitted by the technical assessor and the laboratory.

Following the assessment, once all the improvement actions raised which required evidence to be submitted to UKAS has been satisfactorily cleared and approved by the independent decision maker a grant letter will be issued for the extension to scope, along with the updated scope of accreditation once available.

UKAS extension to scope, Our experience.

At Test Labs we offer responsive and reliable medical device testing. Our guarantee is to always ensure results generated are of the highest standard, reducing the chance of rejection during assessment by a notified body.

For the benefit of medical device manufacturers, we decided to add the following medical device testing standards to our ISO 17025 UKAS scope:

BS EN ISO 15883-5:2021

• Washer-disinfectors — Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy

BS EN ISO 17665-1:2006

• Sterilisation of health care products – Moist heat – Part 1: Requirements for the development, validation, and routine control of a sterilisation process for medical devices

After interpretation of the above standards, Test Labs was ready to submit the application for the extension to scope in January 2023. Communication with UKAS was established and AC4 form sent in February 2023. Test Labs opted for the extension to scope assessment to be processed and performed along with our next surveillance visit which was scheduled for March.

The further evidence requested by UKAS to close out the findings raised was submitted by the end of May. While UKAS was reviewing this evidence Test Labs also performed a further extension to scope for the third standard in the medical device reprocessing services offered, BS EN ISO 15883-2:2009 – Washer-disinfectors – Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.

By the first week of August 2023, UKAS had issued the grant letter to Test Labs, and the first two testing standards were added to the scope of accreditation, with the last standard following closely behind at the beginning of September.

See our announcement here

Explore how we can support your medical device journey to the market