Explaining the misnomer of 'GS1 compliance'
GS1 global standards are one of the enablers of an interoperable healthcare system, providing tools to support the need for digitisation and more connected care. The increased use and reference to these standards has been significant, however for those who are less familiar with the specifics of the standards, or who may in fact be trying to request use of a service GS1 Australia provides, the term ‘GS1 compliance’ is being used as a generic term instead of more specific requests.
The point that needs clarification is that GS1 provides a ‘tool kit’ of open, global, voluntary standards across the identification, capturing and sharing of data related to people, products, places and processes. The framework this provides is developed and managed in conjunction with member organisations and industries we work with around the world to ensure that the standards reflect the needs or our members and industries. Often the standards are then contextualised into industry guidelines to help support consistent use, and may in fact be reflected within other global standards such as International Standards Organisation (ISO), however unless regulated in some way the standards are still voluntary.
So if there is reference to ‘GS1 compliance’ what does this mean?
It can relate to one of many things, so our primary recommendation is understand the context of the compliance and ask the requestor for clarification. Some of the most common instances are explained a little further below, however we would reinforce that if this phrase appears it is important that you understand specifically what is required and ideally any requirements should be explained in detail versus using this phrase.
- Identification of products – The GS1 standard for identifying products or traded items is the Global Trade Item Number (GTIN), also referred to in some instances as ‘EAN’, ‘APN’ or ‘UPC’. Products can be identified at all levels of their hierarchy where they can be clearly defined.
- Unique Product Identification – Where a specific instance of a product needs to be identified, as is the case for many medical devices, Unique Product Identification (or Unique Device Identification (UDI)) is enabled by using the GTIN plus additional attribute data such as serial number and batch.
- Physical marking of products to enable data capture – To support data capture, GS1 identifiers can be encoded into barcodes or EPC RFID. The type of ‘data carrier’ is normally defined by the process that needs to be supported so there are detailed guidelines to help explain this further. Barcoding and RFID is often referred to as Automatic Identification and Data Capture (AIDC).
- Identification of places/parties/locations – The GS1 standard for identifying places, parties or locations is the Global Location Number (GLN). This can be used within systems to identify ‘locations’, can be used in data capture , is used within electronic messages between organisations, and can be used within ‘event’ data to support traceability.
- GS1 Australia Industry Solutions/Services – In healthcare the main services include the National Product Catalogue (NPC), Recall Health and Locatenet. These services include use of GS1 standards, but have been developed to support broader specific requirements to share data or support process improvements. Links to further information have been provided in the text above.
- Anyone wishing to ensure that GS1 standards are followed within their organisation or supply chain should be specific regarding requirements.
- If GS1 compliance is mentioned in a contract, ensure there is clarification of exactly what is being requested.
- If you need assistance with understanding how to define your requirements or in how to meet those specified by others, please contact the GS1 Australia Healthcare team
As a standards organisation, GS1 provides both technical and business process guidelines, as well as user case studies where possible to assist in implementation.
All global standards and guidelines are openly available to the user community at no cost either via our global or local offices and their websites.