Procedures and records

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Procedures are documents

A procedure task is a policy task: a Document task in the Policies group, like Quality Manual & Policy maintained. It names the document that answers it, a standard operating procedure (SOP) when the requirement is for a written procedure. Filtering a task list to “SOP” (1) narrows it to policy tasks, one written procedure each (2). That document is versioned and approved like any other, so approving it updates the task’s status.

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Controlled documents

Tick Controlled on the procedures your quality management system (QMS) is built on. They get a Document ID and a formal review and approval cycle, and are locked while the cycle runs and once approved.

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Give staff the procedures to read

Staff only get procedures you send. Once it’s approved, add the document to either of these:

• A checklist: Add it as a Resources item. Staff open the document and click I have read and understood the above resources, and each person’s History keeps the version and date they confirmed, which you show an auditor.
• The staff portal: Add it to the Resources tab of your staff portal, assigned to the groups who need it.

When you approve a new version, Republish options lets you move each checklist item and staff portal resource using the document to the new version.

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Records

Record tasks ask for dated proof, not a document. Each has an owner from People, and most sit in the Organisation group, shared between ISO 9001 and ISO 13485. Filtering to “record” (1) surfaces the operational records, like CAPA records maintained (2), rather than the policies behind them.

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