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Purchase Audit Checklist - ISO 13485:2016

by Niraj Nemade, from the Community

10+

This Purchase Audit checklist aligns with ISO 13485:2016 and guides teams through supplier evaluation, purchasing information, and verification of purchased product for medical device quality compliance. It covers criteria for supplier selection and performance monitoring, adequacy of purchasing requirements before communicating with suppliers, change notification agreements, traceability documentation, and verification activities proportionate to risk and supplier performance. Use it to standardize purchasing controls and support compliant medical device quality management.

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Digitize any process, procedure or policy

Eliminate mistakes made by paper-based processes

Create and share professional reports instantly

Confirm accountability and compliance with a digital log

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This community page makes available free workplace checklists and templates created by other users within the SafetyCulture community. SafetyCulture has re-published this content and where possible, has credited the original author. SafetyCulture has not verified the accuracy, reliability or suitability of any community content. You agree that your use of any of this content is in accordance with SafetyCulture’s Terms and Conditions.

Template
ISO 13485 Audit Checklist for QMS Compliance
Use this ISO 13485 audit checklist to evaluate whether your quality management system aligns with ISO 13485:2016 for medical devices. The checklist covers management controls, design and development, risk management, CAPA, medical device reporting, production and process controls, supplier and purchasing controls, sterilization validation, documentation and records, customer requirements, and technical files. Ideal for quality managers preparing for third party certification audits and ongoing compliance.
by Rohan Pawar, from the Community
Downloads: 10+
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Template
ISO 13485:2016 Checklist for Medical Device QMS
This ISO 13485:2016 checklist helps quality managers evaluate and improve a medical device quality management system. Organized around clauses 4-8, it guides QMS documentation, management responsibility, resource and contamination control, product realization (design, purchasing, production, servicing, sterilization, traceability), and measurement and improvement. Use it to verify compliance, plan audits, track corrective and preventive actions, and maintain product safety and performance.
by THI XUAN TINH VO, from the Community
Downloads: 10+
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Template
ISO 13485 Audit Checklist
This ISO 13485 audit checklist helps medical device organizations evaluate the readiness and compliance of their quality management system against ISO 13485:2016. It covers management controls, quality policy and objectives, internal audits, and management review. The checklist also guides design and development controls, risk management, verification and validation, and design transfer. It includes robust CAPA and complaint handling, MDR reporting, production and process controls, supplier and purchasing controls, and sterilization validation. Documentation and records requirements, DMR, DHR, technical files, customer requirements, and traceability are addressed to support certification preparation.
by Ahmad Magableh, from the Community
Downloads: 20+
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Template
ISO 9001:2015 Purchasing Audit Checklist
Use this ISO 9001:2015 Purchasing Audit checklist to assess purchasing and supplier management against quality management requirements. The template guides auditors through process definition, inputs and outputs, records control, nonconformance handling, and policy alignment. It covers approved supplier lists, supplier selection and evaluation, critical supplier criteria, documentation of results, resource adequacy and maintenance, personnel roles and competency, required training and records, and document control and revision status. Apply it to verify compliance, capture supporting evidence, and identify opportunities for improvement in procurement and supply chain quality.
by Mark Vess, from the Community
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Purchase Audit Checklist - ISO 13485:2016

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