01
Where it fits and where it does not
Use these four checks before committing implementation time.
- Use it when
- Biobank quality systems, capability assessment, accreditation preparation, partner qualification, and governance of materials intended for research and development.
- Limits
- The current edition is under revision, so contracts and assessments must pin the exact edition. Its scope excludes biological material intended for food, feed, or therapeutic use.
- Best for
- Biobanking and Laboratory and Discovery teams working across Plan → Acquire → Harmonize → Exchange.
- Maturity
- EstablishedSuitable for production assessment. Pin the exact release and any implementation profile.
02
See it in the workflow
This view shows the input, the change the standard introduces, and the resulting output.
- InputWhat starts
Biobanking and Laboratory and Discovery source data, metadata, and local mappings
- ISO 20387What changes
Use ISO 20387 as a pinned standard across Plan → Acquire → Harmonize → Exchange
- OutputWhat becomes possible
A handoff the next system or team can validate against the same release
03
A concrete example
A biobank defines its scope, competence, impartiality, operating controls, and quality evidence against the 2018 edition, records nonconformities, and maintains a transition plan for the replacement edition.
Why it matters: Strengthens provenance and operational consistency around source material, but conformance does not certify that a derived dataset is representative, statistically valid, or ready for a model.
04
What it fits with
Provides the organizational and quality-system layer around MIABIS metadata and SPREC preanalytical coding; those artifacts support evidence and exchange but do not replace ISO 20387 requirements.
- Metadata profileREMBI
Both support Laboratory and Discovery work and meet around Plan, Acquire, Harmonize, Exchange. Compare their roles before treating them as interchangeable.
Explore relationship - Metadata profileMIABIS
Both support Biobanking and Laboratory work and meet around Plan, Acquire, Harmonize, Exchange. Compare their roles before treating them as interchangeable.
Explore relationship - Metadata profileExpmeta
Both support Discovery and Laboratory work and meet around Plan, Acquire, Harmonize, Exchange. Compare their roles before treating them as interchangeable.
Explore relationship - Data model / schemaAllotrope
Both support Laboratory and Discovery work and meet around Acquire, Harmonize, Exchange. Compare their roles before treating them as interchangeable.
Explore relationship
05
Implementation starter
Start with one bounded handoff. Pin, test, and review it before scaling.
Define one handoff, its accountable owner, and the decision ISO 20387 must support.
Pin the exact version and companion artifacts: 2018 Edition 1 · published · replacement revision at FDIS.
Map one representative input to the required standard artifacts.
Test the result against the canonical source and record every exception.
Preserve the source data, mappings, and review evidence before scaling.
06
Test the main limitation
The current edition is under revision, so contracts and assessments must pin the exact edition. Its scope excludes biological material intended for food, feed, or therapeutic use.
Run one representative end-to-end pilot and record exactly where ISO 20387 loses context, needs an extension, or depends on another standard.
Machine-readable output may still be unfit for analysis or ML.
Test the output for missing context, provenance, terminology alignment, time leakage, and the intended downstream decision. Strengthens provenance and operational consistency around source material, but conformance does not certify that a derived dataset is representative, statistically valid, or ready for a model.
07
Official resources
Specifications, diagrams, examples, and guides from the organizations that maintain them.
ISO 20387:2018 catalogue record
Official publisher or steward guidance for this standard profile.
- Publisher
- ISO/TC 276 Biotechnology