Human Tissue Authority

The regulator for human tissue and organs

Assessing Compliance

As part of the regulatory framework, the HTA licenses establishments and reviews their compliance against sector-specific standards. We will also assess compliance against these standards as part of a new application process.

For licensed premises, there are three main forms of checks:

1. Inspections

We carry out inspections of premises licensed in the Anatomy, Human Application, Post mortem, Public Display and Research sectors.

Information about the standards you will be inspected against is contained in the sector-specific pages of this section.

You can also access general guidance on HTA inspections here.

When you have a planned inspection coming up, we will send you a draft timetable for the day. We will usually also send you a document review checklist, relevant to your sector:

In most cases, you will be notified in advance of your inspection. However, we may also carry out an unannounced inspection if we think it is necessary.

2. Audits

We carry out audits of establishments licensed in the organ donation and transplantation sector.

We audit establishments against specific assessment criteria and gather evidence through a combination of an audit of the premises, review, and interviews with staff involved in each aspect of the ‘organ pathway’.

In most cases, you will be notified in advance of your audit. However, we may also carry out an unannounced audit if we think it is necessary

3. Compliance updates

We collect compliance information every two years from establishments licensed in the Anatomy, Organ Donation and Transplantation, Post mortem, Public Display and Research sectors.

We will contact DIs and named contacts directly to notify you when you need to submit compliance information.

Last updated on: 8 Aug 2019