ISO 20387 Toolkit – Biobanking Quality & Competence Implementation

The toolkit is designed for biobanks, biospecimen repositories, research organizations, quality managers, laboratory and storage teams, data governance professionals, internal auditors, consultants, and accreditation preparation teams implementing ISO 20387.

It includes editable Word procedures and plans, Excel registers, matrices and checklists, and PowerPoint review and workshop presentations covering governance, impartiality, ethics, competence, facilities, equipment, providers, collection, transport, accessioning, traceability, processing, quality control, storage, continuity, LIMS, access, distribution, nonconformity, audit and management review.

The supplied document index is organized into 20 implementation parts with 158 templates covering the biobanking lifecycle from governance and scope through specimen acquisition, storage, access, distribution, corrective action, audit, performance review, and programme closeout.

Yes. The page provides a detailed document index so you can review the included document names and file types before purchase. The standard Index File, Payment Guide, and Free Sample options from the template page are also retained.

Yes. It includes scope and applicability documents, gap assessments, evidence matrices, internal audit checklists, quality indicators, management review tools, corrective action registers, and implementation closeout records to support structured accreditation preparation.

Yes. Dedicated templates cover provider and user agreements, human biospecimen ethics, consent and use restrictions, consent withdrawal, ethics approvals, approved uses, and related decision records.

Yes. It includes role based competence matrices, qualification and training records, critical task authorization registers, supervision planning, training effectiveness, and requalification tracking.

Yes. The equipment section includes lifecycle and qualification procedures, IQ/OQ/PQ and release checks, maintenance and repair records, calibration and measurement traceability, and post repair release controls.

Yes. Dedicated templates cover accessioning, unique identifiers, source to processing to aliquot traceability, barcode and label verification, chain of custody, specimen movement, and biological material to associated data consistency.

Yes. It includes processing, aliquoting and preservation procedures, preanalytical time and condition controls, method qualification and change control, batch records, critical parameter logs, reagent traceability, and processing deviation controls.

Yes. It includes QC and characterization plans, method validation and verification, release criteria, identity and integrity testing, viability and concentration records, microbial contamination and authenticity testing, trend analysis, and release decision registers.

Yes. It includes storage and cryopreservation procedures, freezer and cryotank registers, temperature and liquid nitrogen monitoring, inventory movement, reconciliation, storage excursions, backup readiness, emergency transfer, business continuity, and incident exercises.

Payment is processed securely through PayPal. Depending on availability in your country, payment may be made using a PayPal account or supported major credit and debit cards.

After payment is completed, the toolkit is provided through the site's download process. We recommend downloading the archive promptly and keeping a secure backup together with the purchase confirmation.

Yes. The supplied index includes enterprise and multi site scope, gap assessment, site and collection registers, governance tools, provider controls, storage records, data governance, and site acceptance resources that can be tailored across multiple biobanking locations.

Yes. The structure is suitable for consultants and advisors supporting ISO 20387 gap assessment, governance design, process documentation, competence systems, traceability, QC, storage controls, data governance, internal audit, and accreditation readiness.

Yes. Dedicated templates cover LIMS and metadata governance, privacy, access and de identification, record retention, data integrity, metadata dictionaries, interface maps, pseudonymization, user access, audit trails, and specimen data consistency.

Yes. It includes procedures and registers for nonconforming biological material and data, specimen recall and withdrawal, destruction authorization, root cause, corrective action, effectiveness review, and change control impact.

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