Three standards,
one toolkit.
ISO accreditation tends to be the moment small labs and startups realise they need a quality system, not just a quality intent. AccrediKit covers the three standards that come up most often — calibration and testing, general quality management, and medical devices — without forcing you to learn the standard before you can write your first SOP.
- ISO/IEC 17025. The standard for testing and calibration laboratories. Covers technical competence, traceability, measurement uncertainty, method validation, and quality control.
- ISO 9001. The general quality management system standard. Covers process control, customer focus, continual improvement — the foundation most other ISOs build on.
- ISO 13485. The medical-device-specific quality system. Covers design controls, risk management, traceability, post-market surveillance, and CAPA.
- Cross-mapped clauses. Where the standards overlap, our templates map the equivalent clauses — write a procedure once, satisfy multiple standards.
- Structured around the standards. Each template follows the clause structure of its standard, so an assessor can find what they are looking for where they expect it. The templates support your accreditation project; the decision is the assessment body's.