ISO 9001 गुणवत्ता प्रबंधन किट

Management system scope (cl. 4.3): 4.1 issues incl. climate and AI role, 4.2 parties, scope sentence (QMS and ISO 42001 examples), interfaces, exclusions

Quality policy: purpose and context, signed commitments incl. quality culture and ethics (ISO 9001:2026), objectives framework, communication, review

Objectives register (ISO cl. 6.2): objectives traced to policy or risk, metric, baseline, target, action plans with resources, review log, communication

Harmonized structure documents, standard-specific templates with editions, non-ISO frameworks and regulations, edition watch list, coverage register

Documented procedure (ISO cl. 7.5): document control, purpose, scope and interfaces, RACI, flow diagram matched to steps, exceptions, KPIs, records

Controlled document master: header, approvals, revision history, distribution, body, records produced, change control, clause 7.5 control map, numbering, status lifecycle

Controlled SOP: document control, RACI, prerequisites and safety, numbered steps with checks, flow, records, deviations, training

KPI definitions and bands, weighted scorecard with trend, corrective actions and SCAR, relationship plan, re-evaluation decision for external providers

Complaints handling + trend analysis

Problem statement, containment, Pareto, target, fishbone with cause tests, 5 Whys, countermeasures, check, standardisation, ISO 9001 clause 10.2 link

Audit schedule + report with findings

Management review minutes: inputs mapped to ISO 9001:2026, ISO/IEC 27001:2022 and 42001:2023, conclusions, results, action log

Nonconformity and CAPA record: description, containment, root cause, similar nonconformities check, actions, effectiveness, closure; ISO 13485 and QMSR notes