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Audits, controls & review

Guides for “Audits, controls & review” in : step by step, with the place in the menu, the steps and the limits.

Audits, controls & review

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Audits, controls & review

15 guides

Audits

Audits

QMS | base › Audits

Overview of internal, external and supplier audits with number, title, type, date, lead, status, open questions and findings (major and minor nonconformities, observations). For external audits a warning appears if the certificate has expired or is about to expire. Managers see all audits; everyone else only sees those where they are lead or auditor.

Step by step

  1. Open “Audits”; if needed, choose the type or year at the top or tick “Audits with major nonconformities”, then press “Filter”.
  2. Click a title to open the audit; with the filter “Audits with major nonconformities” it opens directly at “Findings”.
  3. As a manager, use the buttons at the top to go to the “Audit programme”, the “Checklists”, the “Auditors” or “New audit”.

Plan an audit

QMS | base › Audits › New audit

Plans an audit with its type (internal, external, supplier), title, date and, optionally, audit programme, audit lead, auditors, checklist, scope, objectives, audit criteria and the processes in scope. The system assigns the audit number and flags those responsible for the selected processes as not independent.

Step by step

  1. In “Audits”, press “New audit”, or choose “Plan an audit” in the audit programme.
  2. Enter the title, type of audit and date; for external and supplier audits also the certification body or supplier and the contact person.
  3. Set the audit lead, checklist, scope, objectives and criteria; for “Processes in scope” and “Auditors”, narrow the list with “Search options” and tick – selected items appear above and can be removed with ×.
  4. Press “Create audit”; the audit then has the status “Planned”.

Audit programme

QMS | base › Audits › Audit programme

Shows the audit programmes with a period of three years at most, their objectives and principles, the audits planned per year and the active processes that have no audit yet in the period.

Step by step

  1. Open “Audits” › “Audit programme”.
  2. As a manager, enter the name, from and to year, objectives and principles under “New audit programme” and press “Create programme”.
  3. In the programme, press “Plan an audit” to create one; the list “Processes without an audit in the period” shows what is still missing.
  4. Adjust existing programmes with “Edit”.

Auditors

QMS | base › Audits › Auditors

Lists the people with access to QMS | base with their function, role (QM lead) and qualification evidence from the competence register. The list helps you choose independent and qualified auditors.

Step by step

  1. Open “Audits” › “Auditors”.
  2. For each person, view the function, role and evidence: “Valid” or “Expired”, with a date or “unlimited”.
  3. When planning an audit, choose the audit lead and auditors accordingly.

Audit checklists

QMS | base › Audits › Checklists

Manages reusable checklists with audit questions per process or standard clause. When an audit is prepared, the questions of the chosen checklist are taken over and frozen. A checklist can also be generated from standard clauses: for each clause you choose, an audit question is created in our own words.

Step by step

  1. Open “Audits” › “Checklists”.
  2. Under “New checklist”, enter the name, description and questions (with clause and a note for auditors) and press “Create checklist”.
  3. Alternatively, on the right under “Generate from standard clauses”, enter a name, tick the clauses and press “Generate checklist”.
  4. Change existing checklists with “Edit”; inactive checklists can no longer be chosen for new audits.

Conduct an audit

QMS | base › Audits › Audit

Shows an audit with its process, checklist, findings, report and actions. The lead and auditors answer the audit questions (also offline, with reconciliation if there are conflicts), record findings and write the summary and conclusion. Major and minor nonconformities automatically create a corrective action, major nonconformities also a nonconformity. Approval files the report as a PDF in the archive; only then is the audit closed – if archiving fails, the audit stays open and the approval can be repeated. Audit changes are held while the report is being approved. After an interruption, a corrected report receives its own archive reference.

Step by step

  1. Open the audit. The “Process” box shows the next step; managers press “Prepare” (an audit lead and a checklist are required; external audits also work without a checklist).
  2. Answer the checklist questions: choose the result and enter a note and evidence. Without a connection your entries stay on the device until “Synchronise” sends them.
  3. Under “Findings”, open “Record a finding”, choose the type, text, deadline, question, process and the person responsible, and press “Record”.
  4. Press “Mark as conducted” and “To the report”, write the summary and conclusion and press “Save report”.
  5. Managers check the summary and press “Approve report and close”; if the report of a closed audit is not yet in the archive, “Archive report now” is available.

Certification and certification bodies

QMS | base › Audits › Certification

Lists the certificates from external audits with validity and a warning 90 days before expiry, as well as your certification bodies with accreditation, standards and contact details. “Request audit” creates a planned external audit with the body and, if you wish, prepares an email in your own mail program.

Step by step

  1. Under “Audits”, go to “Certification”.
  2. Open “New certification body”, enter the details and click “Add”.
  3. For the body, open “Request audit”, choose the type, standard and preferred date, and click “Create planned audit”.
  4. After the audit, enter the certificate in the report of the external audit.

Internal controls & evidence

Internal controls

QMS | base › Operations and records › Internal controls (ICS)

Periodic controls with check items, frequency and a responsible person. The responsible person carries out the control and answers each item; a “Not OK” results in a deficiency and, if desired, an action is created automatically.

Step by step

  1. Open “Internal controls” and choose a control that is due.
  2. For each check item choose “OK”, “Not OK” or “Not applicable (reason required)” and, if needed, record a remark; the summary below counts items that are OK, deficient and not applicable.
  3. Press “Carry out control”; the next due date is set automatically.

Record a control

QMS | base › Operations and records › Internal controls (ICS) › New control

Creates an internal control with objective, link to risk and process, responsible person, frequency, next due date and check items.

Step by step

  1. In “Internal controls”, press “New control”.
  2. Enter the title, responsible person, frequency and next due date.
  3. Record the check items using “Add” and save.

Operational records

QMS | base › Records

Evidences the standard’s operational requirements: review of customer requirements, development, release of the service, identification and traceability, property of customers and suppliers, and post-delivery activities. Every record has a checklist from the template for its type, which can be extended, and is approved by an authorised person.

Step by step

  1. Fill in “Create record” below: type, title, reference, customer, process and responsible person.
  2. Open the record and assess each check item as met or not met; items that are not met need a note. Items can be added or removed. Save.
  3. “Submit for review” – the quality management lead is notified.
  4. An authorised person chooses “Approve” or “Reject”; the approval note shows the person and the time.

Meetings, review & reports

Meetings

QMS | base › Meetings

Shows QM meetings with date, location, online link, agenda, minutes and participants. Below the list, open decisions from meetings and management reviews are tracked with the person responsible, due date and the status of the related action. Managers see all meetings; everyone else only sees those they are invited to.

Step by step

  1. Open “Meetings” and click a meeting; for online meetings, “Join online” leads to the link.
  2. Read the agenda and minutes; under “Decisions” you see what was decided and how far the action has got.
  3. As a manager, open “Record a decision” in the meeting, enter the decision, person responsible and due date, and save; “Edit meeting” changes the details, agenda, minutes and status.
  4. In the “Open decisions” list below the meetings, overdue decisions are marked in red.

Plan a meeting

QMS | base › Meetings › New meeting

Plans a QM meeting with title, date and time, location, online link, participants, agenda and minutes. The participants are notified.

Step by step

  1. In “Meetings”, press “New meeting”.
  2. Enter the title, date and time, and the location or online link.
  3. Choose the participants and create the agenda with “Add agenda item”.
  4. Press “Create meeting”; the participants receive a notification.

Management review

QMS | base › Management system › Annual management review

Records the regular review by top management. The system takes over consolidated figures from objectives, audits, reports, complaints, actions, risks, controls, documents and context, as well as earlier decisions; management assesses each section, records a conclusion and makes decisions, which are created as actions. Approval archives the minutes as a PDF.

Step by step

  1. Open “Management review”, choose the title, date, start of the period covered and participants on the right under “New management review”, and press “Create”.
  2. In the review, press “Take over inputs from the system”; the figures are a snapshot that can be taken over again until approval, and the texts are kept.
  3. For each section, write management’s assessment, record the “Management conclusion” and press “Save assessment”.
  4. Under “Decisions”, open “Record a decision” and enter the decision, the person responsible and the due date; each decision is created as an action.
  5. Press “Approve”; the minutes are filed in the archive and the review is read-only afterwards.

Present the management review

QMS | base › Management system › Annual management review › Open review › Presentation

Shows the management review as slides: title, for each section the figures from the system and the management’s assessment, finally the decisions – for the meeting on screen or projector.

Step by step

  1. In the review, click «Presentation».
  2. Move on with «Next», the arrow keys or the space bar.
  3. Show it in «Full screen»; Esc ends full screen.

Reports and readiness

QMS | base › Management system › Reports and certification status

Shows readiness for the certification audit as a weighted status from 14 check points linked to the standard clauses, with the next steps as well as the latest internal audit, the latest management review and the certificate. Below, you can build reports from building blocks (objectives, reports, actions, complaints, risks, controls, audits, documents, read rate, standard coverage, forms, usage) over 3 to 24 months as a chart and table, export them to Excel or CSV and save them as a template. The management manual can be printed as a PDF. Nonconformities are evidenced only with documented closure and a positive effectiveness assessment recording the person and date. All other cases remain open with a count, even without overdue actions or if rejected without this evidence.

Step by step

  1. Open “Reports and readiness” and look at the status with the “Next steps” at the top.
  2. Under “Build a report”, tick building blocks, choose the period (“Last 3, 6, 12 or 24 months”), choose a form for the “Forms” building block and press “Show report”.
  3. Export with “Excel” or “CSV”, or give a name under “Save selection as template”; saved reports appear under “Saved reports”.
  4. “Print management manual (PDF)” creates the manual from the valid manual, policy and procedure documents.

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