Audit a medical device quality system: design, risk, purchasing, production, complaints and CAPA.
Scope / period: ___ | Prepared by: ___ | Reviewed by: ___ | Date: ___
Checklist for an internal audit of a quality management system for medical devices. Use this with the current text of the standard and the organisation's own documented procedures; clause wording and requirements change between editions, so check the edition you are audited against. Record evidence seen, not only answers given. Regulatory requirements for devices are separate; check the current rules that apply to your products and markets.
Raise each "No" as a nonconformity or observation under the organisation's own grading and corrective action procedure. Auditor: ________ | Auditee: ________ | Date: ________
This template follows the format published by the Institute of Chartered Accountants of India (ICAI) in the AASB Audit Working Paper Templates (June 2023), the authoritative reference for Indian statutory-audit documentation. Fill in your firm’s letterhead and the engagement details on the form above, click Download Word file, and you’ll get a fully formatted .docx ready to use.
Everything is generated in your browser and on a stateless API endpoint — no account, nothing stored on our servers. We’ll ask for a work email once before your first download so we can send you the file and the occasional relevant update; after that, downloads on this device are instant. Edit freely in Word, Google Docs or Pages before sending to your client.
