The word traceability is used in many industries, from food to the systems and software development sector and even in forestry. The National Institute for Standards and Technology (NIST) uses the words “documented unbroken chain” to describe traceability.
In every use of traceability, the beginning origin must be known for the product or system to be traceable. The same is true for the serum industry. With serum, traceability is the capability to discover information about where a product originated, to be able to follow an unbroken paperchain through every stage of production - from where it originated to the end user. This process is the law and a core component of the ISIA ethos. What you see on the label must be a true and accurate description of what is in the bottle.
ISIA traceability certification is based on an independent third-party audit. These audits are only conducted by ISIA approved and trained auditors with an approved audit plan. Any nonconformities identified are categorized and reported to the auditee in a timely manner.
Traceability certification is not available for purchase, nor can it be transferred under any circumstances. Purchase of material from a certified company, or processing of material by a certified company, confers no right to claim or imply traceability certification.
Initial certification requires an audit of at least one year of data and is granted for three years. Recertification audits review the last three years of data. ISIA will not comment on claims made prior to the formation of the Association.
Each audit covers all aspects of the product, at every step - from the abattoir to the end user, including all transactions within the company. Ordering and shipment details for companies who are distributors may be included. While it is not a financial audit, review of invoices and other financial records are essential to determine quantities of material moved and evidence that payments have been made.
Companies are certified for the piece of the process they perform. This may be one step or, for vertically integrated companies, it may be every step.
The ISIA Standardization Team is in the process of updating this information.