质量管理（QMS） 14 项
Supplier On-Site (Second-Party) Audit Checklist
此检查清单为英文版。
A checklist for conducting a second-party on-site audit of an external provider, covering QMS maturity, process control, product realization, and follow-up per ISO 9001 Clause 8.4 and IATF 16949 supplier requirements.
ISO 9001:2015IATF 16949:2016ISO 19011:2018
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Audit Preparation & Opening
- Was the audit scope, criteria, and agenda communicated to the supplier in advance? *
- Was an opening meeting held to confirm scope, method, and confidentiality? *
- Does the supplier hold a valid third-party QMS certification (e.g., ISO 9001 or IATF 16949) where required? *
QMS & Process Controls
- Are documented processes, work instructions, and control plans available and followed at the point of use? *
- Is process monitoring evidence present (SPC, first-piece, in-process checks) with reaction plans for out-of-control conditions? *
- Are special processes identified and validated with qualified personnel and equipment? *
- Is nonconforming material segregated, identified, and controlled? *
Product Realization & Traceability
- Is material identification and lot/batch traceability maintained through the process flow? *
- Are calibration and measurement system controls in place for gauges and test equipment used on your parts? *
- Is sub-tier (lower-tier) supplier control and flow-down of requirements demonstrated? *
Findings & Follow-Up
- Were findings classified (major/minor/observation) and reviewed at a closing meeting? *
- Is a corrective-action plan with root cause and timing required for each nonconformity? *
- Is supplier status (approved/conditional/disqualified) updated in the approved supplier list based on results? *
- Record overall audit score and re-audit date if applicable
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