Purchasing & Supplier Control · ISO 7101:2023
A completed, worked procedure for ISO 7101:2023 Clause 8.8
ISO 7101:2023 asks something no other management system standard does: that you write down, in advance, the criteria that would disqualify a provider. This template is a completed, worked example that carries that requirement and the ones around it, in plain language.
Clause 8.8 a) requires criteria for disqualifying external providers, defined alongside the criteria for evaluating, selecting and monitoring them. It is uncomfortable to write while entering a relationship, which is exactly why it belongs in a procedure rather than a conversation: at the moment a provider fails, the service is running and the pressure is to decide that this instance does not count. A criterion written a year earlier meets that moment honestly.
Clause 8.8 reaches partnering and funding stakeholders — governmental, non-governmental and funding partners — so donations and grant-funded provision are inside scope precisely because they bypass procurement entirely. A donated device that was never bought is invisible to a system that watches money, and visible to one that asks what the provision does.
Healthcare organizations certified to — or preparing for — ISO 7101:2023 who receive clinical and non-clinical provision, including donations, grants and partner-funded supply.
A complete, worked purchasing and supplier control procedure — in editable Word, ready to adopt into your own document control.
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Diana Lynn is President and Principal ISO Consultant at Management Systems International (MSI), a consulting firm she co-founded in 1998. With 28 years of experience, MSI has supported 80+ certifications, attended 200+ audits, and trained 600+ professionals across manufacturing, technology, medical device, government, healthcare, and other regulated industries. MSI is veteran-owned and female-owned.
To talk through your own purchasing and supplier controls, call 760-434-9141 or visit msi-international.com.
This template is general guidance and does not replace ISO 7101:2023, any applicable regulation, or the judgement of a competent professional. Standards are revised, amended and withdrawn; confirm the current status of your standard at iso.org before relying on clause references.
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