Standards coverage
Use only the standards that apply to the manufacturing site.
ComplyCore can help teams link pilot and evaluation records to the standard, customer requirement, legal obligation, internal rule, or requirement area behind the action.
Pilot-ready during setup
Common manufacturing standards and requirement areas
Quality, food safety, and sanitationCan be configured around ISO 9001, ISO 22000, FSSC 22000, BRCGS, SQF, HACCP, GMP, master cleaning schedules, customer requirements, complaints, traceability, recall, supplier approval, and corrective action.
Health, safety, and environmentCan be configured around ISO 45001, occupational health and safety requirements, incident investigation, hazard identification, risk control, ISO 14001, environmental aspects, obligations, waste, and emissions.
Medical, pharma, and controlled environmentsCan be configured around ISO 13485, ISO 15378, GMP, ISO 14644, cleanroom controls, validation, contamination control, complaints, and regulatory evidence.
Laboratory and calibrationCan be configured around ISO/IEC 17025, method validation, uncertainty, calibration, metrological traceability, sample handling, impartiality, proficiency testing, and result reporting.
Automotive, aerospace, and engineeringCan be configured around IATF 16949, AS9100, ISO 3834, customer-specific requirements, product safety, configuration control, welding qualification, and process evidence.
Operational excellenceCan be configured around Integrated Work Systems, OEE, lean manufacturing, standard work, shift handover, skills management, 5S, Kaizen, PDCA, and daily management routines.
Requirement areas
Make the reason for each record clear.
Documented informationSOP review, policy control, record retention, version awareness, approval, training, and evidence of implementation.
Nonconformity and corrective actionNCRs, corrections, root cause analysis, CAPAs, verification, effectiveness checks, closure, and repeat issue monitoring.
Audit and management reviewAudit findings, evidence, actions, completion status, review priorities, management reporting, and operational performance trends.
Hazard, risk, and operational controlCCP monitoring, master cleaning schedules, sanitation, hygiene, maintenance, calibration, incident reporting, supplier risk, customer complaints, and safety controls.