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Quality and audits

Manage the controlled evidence library

Upload, approve, revise, and link organisation-supplied PDF evidence while retaining document history.

Audit readiness For Owner, Administrator, Quality manager, Calibration manager

Manage the controlled evidence library

New documents and revisions use a short-lived secure transfer. Storage acceptance is not approval or even creation of the controlled record: Metra first verifies the file, then saves the draft and its audit metadata. Retry verification when prompted rather than selecting and transferring the file again.

The Evidence library controls organisation-supplied quality documents used in audit preparation. A controlled document keeps stable metadata while each uploaded PDF becomes a numbered revision with its own status and retained history.

Prerequisites

  • Select the organisation that owns the evidence.
  • Prepare a readable PDF containing only the evidence intended for the organisation's audit workspace.
  • Decide the document identifier, title, category, owner, important dates, and retention category.
  • Use an active site when the document belongs to a specific site, or leave site scope empty for organisation-wide evidence.
  • Have audit evidence management permission to create or revise documents.
  • Arrange for a different authorised user with audit evidence approval permission to review controlled evidence where separation of duties applies.

Create a controlled document

  1. Open ISO 17025 audit.
  2. Open Evidence library.
  3. Start a new controlled evidence document.
  4. Enter the Document identifier and Title.
  5. Select the document category.
  6. Choose the document owner and site when applicable.
  7. Enter the effective date, review date, and expiry date where they are controlled by the organisation.
  8. Select the retention category.
  9. Choose the PDF file.
  10. Save the document and its first revision.

The uploaded revision begins as draft evidence. Creating a document does not make its contents approved and does not make an audit topic ready.

Review and approve a revision

  1. Open the document in the Evidence library.
  2. Check the title, identifier, owner, category, site, controlled dates, and retention category.
  3. Download or inspect the draft PDF.
  4. Confirm that the revision is legible, complete, and appropriate for its stated purpose.
  5. Use the available approval action when you are an independent authorised approver.

An approved revision becomes the current controlled evidence for the document. Its file metadata, checksum, uploader, revision number, approval information, and dates remain retained.

The uploader or preparer must not treat file upload as approval. When the application blocks self-approval, another authorised evidence approver must complete the review.

Add a replacement revision

  1. Open the existing controlled document rather than creating a duplicate identifier.
  2. Start the action to add a revision.
  3. Select the replacement PDF.
  4. Record the reason for the revision.
  5. Save the new draft revision.
  6. Have the new revision independently reviewed and approved.

Approval makes the new revision current and retains the earlier approved revision as superseded history. Do not delete or overwrite the previous PDF to hide a correction.

Editing document metadata is version controlled. If someone else changes the document while you are editing, refresh and review the latest values before trying again.

Link approved evidence to an audit topic

  1. Open Readiness.
  2. Find the topic in the Evidence applicability matrix.
  3. Select Link evidence.
  4. Choose the Uploaded controlled evidence document from the approved revisions offered.
  5. Enter the Purpose, briefly explaining why the evidence is relevant.
  6. Confirm Link evidence.

Only current approved controlled evidence is offered for linking. A link identifies relevant evidence; it does not prove that the audit topic is satisfied. Remove an obsolete link deliberately and replace it with the correct approved revision when needed.

Expected result

The Evidence library contains a controlled document with a traceable current approved PDF and retained prior revisions. Relevant audit topics can refer to that approved revision, and readiness can evaluate its status and controlled dates.

Warnings

  • The audit evidence library accepts controlled PDF evidence. Calibration certificates use their separate calibration-event workflow.
  • Uploading, approving, or linking a document does not determine conformity or validate the adequacy of its contents.
  • Expired, superseded, draft, or otherwise non-current evidence can cause a topic to need attention.
  • Do not upload passwords, access tokens, unrestricted storage links, or unrelated personal information.
  • Do not create duplicate documents to conceal an earlier revision or approval decision.

Permissions and separation of duties

Reading evidence, managing documents, and approving evidence use distinct permissions. Managing a document does not automatically permit approval. Dossier preparation and dossier review are separate again.

The Metra checks organisation ownership, site ownership, PDF validation, document lifecycle, current version, and approver independence. If an action is absent, confirm the document status and your effective permissions with an owner or quality manager.

Next steps