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Quality and audits

Set up the ISO 17025 audit profile

Declare the organisation's audit scope, management-system route, accreditation references, and default period.

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

Set up the ISO 17025 audit profile

The audit profile records the organisation's declared scope for the ISO 17025 audit workspace. Obsidian Metra does not infer accreditation scope from completed calibration work, application roles, uploaded documents, or previous dossiers.

Prerequisites

  • Select the organisation whose audit evidence you are preparing.
  • Agree the laboratory activities and exclusions that belong in the declared scope.
  • Know which management-system route the organisation has selected, or leave it as Not assessed until that decision is made.
  • Create and approve an accreditation profile if accreditation details are needed. The audit profile can also be saved without one.
  • Have audit profile management permission. Read access alone does not allow changes.

Record the declared scope

  1. Open ISO 17025 audit from the Quality area.
  2. Open Readiness.
  3. Find Audit profile.
  4. Enter the Dossier title used to identify this audit context.
  5. Review the read-only Standard identifier.
  6. Enter the Declared scope summary, including the laboratory activities and exclusions covered by the profile.
  7. Select the Management-system route: Not assessed, Option A, or Option B.
  8. Select an Accreditation profile, or choose No accreditation profile. The accreditation body and laboratory reference come from the selected profile; they cannot be typed separately.
  9. Set Default audit period from and Default audit period to when a standard preparation period will be useful for dossiers.
  10. Select Save audit profile.

The selector lists approved profiles from this organisation. Check the profile name, laboratory number and revision before saving. Refresh the list after approving a new profile. If the list cannot be loaded, the existing selection is retained.

Saving records the exact selected profile and its accreditation details. Selecting a newer profile revision requires an explicit update; previously submitted dossiers keep their frozen audit information. The selection supplies accreditation metadata and does not automatically copy scope entries into the declared scope or approve audit evidence.

The default period assists later preparation. It does not freeze a dossier period or replace the scope selected when a dossier is created.

Review evidence expectations

After saving the profile, work through the Evidence applicability matrix:

  1. Review each audit topic and its guidance.
  2. Set its applicability to Applicable, Not applicable, or Not assessed.
  3. Enter an applicability rationale. A rationale is required before a topic can be marked Not applicable.
  4. Assign an owner and target date where these help manage outstanding evidence.
  5. Save each topic.

Use Not assessed while the organisation has not made an applicability decision. Use Not applicable only after an authorised person has made and documented that decision. Do not mark a topic Not applicable merely because evidence is missing.

The built-in catalogue uses short original topic descriptions and does not reproduce the standard. Review the organisation's licensed copy of ISO/IEC 17025 and any accreditation-body or sector requirements when deciding scope and applicability.

Expected result

The workspace shows a versioned organisation profile and an applicability decision for each reviewed audit topic. Readiness can then explain which applicable topics have current approved evidence and which need attention.

Warnings

  • The profile is a declaration by the organisation, not a certification or accreditation decision.
  • Selecting a management-system route does not prove that its requirements are satisfied.
  • Selecting an approved profile does not establish that all activities in the declared audit scope are accredited. Review the scope and evidence separately.
  • Saving over a newer version is blocked. If the profile changed while you were editing, refresh it, review the latest values, and apply your change again.

Permissions and separation of duties

Profile read and profile management are separate permissions. Evidence management and approval are also separate from profile management. A person who can declare scope does not automatically gain authority to approve supporting evidence or a dossier.

Owners and quality managers normally have broad audit-workspace access. Organisation administrators may have preparation access but do not receive every approval action. The Metra applies the current organisation membership, exact effective permission, record version, and separation-of-duties rules.

Next steps

Progress and recovery

The ISO audit workspace separates Readiness, Evidence library, Personnel authorisations and Dossiers into focused sections. Section links can be bookmarked. Switching sections keeps open forms; leaving with unsaved profile changes prompts a warning. Supporting choices load independently and offer Retry choices, so an unavailable member list does not hide readiness information.