Where do you actually stand?

This counts as “yes”

• A traceable overview of the external and internal issues — as a section in the scope or strategy document, a table in the management review, or a short standalone sheet.
• The issues are recognisably yours, not a template's.
• Evidence that the overview is monitored and reviewed — most naturally as a standing item of the management review.
• Since A1:2024: the climate question is answered — relevant, or secondary with a reason.

What it takes →

This counts as “yes”

• A traceable overview of the relevant parties and their QMS-relevant requirements — as a table in the context/scope document or in the management review.
• The relevance filter is visibly applied: five thought-through rows beat twenty copied ones.
• The legal and regulatory requirements of your business are captured — at least named, with an owner.
• Evidence of review — the fixed slot in the management review is enough.

What it takes →

This counts as “yes”

• A released, available written statement — intent is not enough here; the document is mandatory.
• It names the products and services and the sites the QMS applies to.
• Every non-applicability is individually justified — and the justification survives the question of whether the excluded requirement really plays no role in your product conformity.
• The statement matches reality — and what the certificate is supposed to say.

What it takes →

This counts as “yes”

• A process overview exists — the processes are named, their sequence and interplay recognisable.
• Every process has an owner — a person, not "the team".
• For every core process it can be said how working shows itself — one criterion or figure is enough at small scale.
• The documented information to the extent necessary is there and controlled — the procedures and records your processes really need.
• The overview matches reality — the processes carry the names people actually use on the floor.

What it takes →

This counts as “yes”

• The managing director can explain policy, objectives and the biggest risks in their own words — without the binder.
• The management review is carried by leadership and is recognisably their tool (decisions, resources, consequences — not mere acknowledgement).
• Resource decisions can be connected to objectives and risks.
• The QMS is recognisably the house's own system, not a consultant's.

What it takes →

This counts as “yes”

• A released, documented policy document — here the paper is mandatory.
• It recognisably contains the four required elements: fit for purpose and context, framework for objectives, commitment to meeting requirements, commitment to improvement.
• It is communicated — and the workforce can give back its core in their own words.
• It is available: internally at any time, externally as appropriate (customers do ask — a current copy on request is enough).

What it takes →

This counts as “yes”

• A traceable assignment of the key QMS responsibilities: conformity, reporting to leadership, document and product releases, customer focus, integrity through change.
• Authorities are thought through — being responsible and being allowed to decide do not fall apart.
• Deputies for critical roles are named (releases, inspections).
• The assignment is communicated — the team knows it without opening the binder.

What it takes →

This counts as “yes”

• A traceable, current overview of the most important risks and opportunities — the form is free: a section in the context or strategy document, a table in the management review, or a short standalone document.
• For each entry, visibly: what we do, who does it, by when.
• A recognisable connection to your context and objectives — the risks fit your business, not just any business.
• Evidence that effectiveness was evaluated — most naturally as a standing item of the management review.

What it takes →

This counts as “yes”

• A documented, released objectives document — the objectives themselves are mandatory documented information.
• The objectives are measurable or clearly assessable and recognisably derived from the policy.
• Per objective: actions, owner, date and evaluation criterion — the planning is half the clause.
• The status is tracked — evidenced at least in the management review, better during the year.

What it takes →

This counts as “yes”

• The recent substantial QMS changes are demonstrably planned: purpose, considered consequences, owners, dates.
• The consequences were thought broadly — not just the technology, but documents, training, inspections, responsibilities.
• The planning happened before the change, not as documentation after the fact (the dates give it away).
• The affected documents and trainings were actually brought along — promptly, not months later.

What it takes →

This counts as “yes”

• Staffing that fits the work — no chronic understaffing that eats quality; bottlenecks are anticipated.
• Critical infrastructure is maintained — the machines and tools product quality depends on have maintenance (and evidence that it happens).
• The process environment fits the product — and is visibly in order on the tour.
• Make-or-buy is conscious — what is bought in is controlled (the bridge to 8.4).

What it takes →

This counts as “yes”

• An overview of the inspection-relevant measuring equipment with calibration status and interval.
• Critical instruments are calibrated traceably — with certificate; non-critical ones demonstrably monitored.
• The instruments are identified, so validity is recognisable.
• There is a rule for the deviation case — what happens with already-released parts when an instrument turns out faulty.
• Or, if not applicable: a justification that no measurements prove conformity.

What it takes →

This counts as “yes”

• The critical knowledge is determined — it is recognisable which knowledge is essential for your products/services and where it sits.
• There is a recognisable handling of the loss risk — onboarding, documentation, deputies, the buddy principle; not everything, but something for the critical islands.
• New knowledge becomes accessible — experience flows back into documents, templates or the handbook instead of staying only in heads.
• With changes (a departure, a new process), the knowledge gap is considered — the link to 6.3 and 7.2.

What it takes →

This counts as “yes”

• The requirements of the quality-relevant activities are determined — it is recognisable what one must be able to do to set up, inspect, release.
• Evidence exists and is findable — diplomas, trainings, documented experience, internal sign-offs; here the paper is mandatory.
• New people do not work unaccompanied on critical tasks — onboarding with a recognisable completion.
• The effectiveness idea is recognisable — after an action, someone checks whether it worked (supervision, sign-off, follow-up).
• External personnel are included where they work quality-relevantly.

What it takes →

This counts as “yes”

• In conversation, employees — including external personnel under your control — can give back the policy in essence.
• They know the objectives relevant to them (not all: their own).
• They can name their own contribution — concretely, at the workstation.
• They know what a deviation means — for product, customer and company.

What it takes →

This counts as “yes”

• For the recurring quality-relevant cases it is recognisably settled who communicates how — inside and outside.
• The customer case demonstrably works: delay and complaint have a clear, lived path.
• Changes reach the affected — internal passing-on is not chance.
• Where reporting duties exist (authorities, customer agreements), the paths are known.

What it takes →

This counts as “yes”

• The current version is findable — and cannot be confused with old states (identification!).
• Review and approval before validity are evidenced — who approved, when?
• Records are protected against subsequent change — traceable, not overwritable.
• External documents are controlled with their state — the customer drawing has a known index.
• Retention is settled — periods determined, the archive accessible.

What it takes →

This counts as “yes”

• For each order or product type, flow, inspection steps and acceptance criteria are defined — available, not in someone's head.
• The records are defined: which ones are created where, and what do they prove?
• Outsourced steps such as hardening are visible in the flow and controlled (8.4) — not a no-man's-land between two stations.
• Unplanned changes — a machine swap, substitute material, a moved date — are visibly assessed, with consequences where needed.

What it takes →

This counts as “yes”

• Per order, a provable review result before the commitment — brief on a repeat order, thorough on a new part.
• Requirements captured completely: order content, delivery and post-delivery duties (certificates!), legal requirements, the unstated.
• Differences resolved before confirming — not negotiated afterwards.
• Verbal orders confirmed before production starts.
• Changes documented and communicated — shop papers updated, affected people informed.

What it takes →

This counts as “yes”

• Per project, a plan with stages, checks and responsibilities — sized to the project.
• Documented inputs before designing starts.
• Verification and validation demonstrably done — as two questions, not one.
• Results approved; changes after that with assessment and authorisation.
• A justified exclusion in the scope (4.3) — and a practice that holds up to the justification.

What it takes →

This counts as “yes”

• You know which providers are critical to your product conformity.
• For every critical provider there is a traceable reason for trust — evaluation, history, evidence; not habit alone.
• Purchase orders are complete and unambiguous — including revision level and required certificates.
• Goods-in matches the criticality — and records what it checked.
• Re-evaluation is visible: anomalies have consequences you can see.

What it takes →

This counts as “yes”

• The production or delivery process is in control (8.5.1): specifications available, equipment suitable, check points set, release settled.
• Identification and, where required, traceability (8.5.2): parts are uniquely assignable; the affected batch can be pinned down. Or justified not applicable.
• Customer property is protected (8.5.3): checked, identified, damage reported. Or justified not applicable, when no foreign goods are in your care.
• Preservation is ensured (8.5.4) — up to delivery, including handling, storage, packaging.
• Changes in the process are controlled (8.5.6): assessed, released, traceable.

What it takes →

This counts as “yes”

• The planned checks are carried out before delivery — and the result is recorded.
• The evidence shows the fulfilment of the acceptance criteria — measured values against tolerances, not just a tick.
• The releasing person is recognisable — initials, stamp or user ID.
• Who may release is regulated.
• For delivery before completed inspection there is a defined approval path — or it does not occur.

What it takes →

This counts as “yes”

• Not-OK is detected and immediately identified — on the part and in the papers.
• Mix-up is excluded: a separate, marked segregation area or equivalent securing.
• Every decision is recorded: correction, sorting out, customer info or concession — with the approving person.
• Rework is re-checked — against the same criteria as the first time (8.6).
• Errors discovered after delivery also trigger the procedure: pin down, inform, act.

What it takes →

This counts as “yes”

• It is defined what is monitored and measured, with method and rhythm.
• Customer satisfaction is tracked from at least one real source — complaints, feedback, on-time delivery.
• The data is analysed and evaluated — conclusions drawn, not just collected.
• The results reach the management review.

What it takes →

This counts as “yes”

• A programme exists and is followed: planned audits with dates and named auditors, all processes covered across the cycle.
• Impartiality is visible — the assignment shows that nobody audits their own area.
• Conducted audits have a report with findings.
• Deviations became actions with deadlines, and their implementation is followed up.
• The results reach leadership — most easily evidenced through the management review.

What it takes →

This counts as “yes”

• A management review has taken place within the intended rhythm, with top management present.
• The inputs per 9.3.2 are covered — demonstrably, not selectively.
• The report shows outputs (9.3.3): decisions on improvement, system changes, resources.
• The actions from it are tracked — and reappear next time as an input.

What it takes →

This counts as “yes”

• It is recognisable that improvement is happening — a stream of actions, not an empty declaration.
• Both directions are represented: reactive (correcting causes, 10.2) and forward-looking (10.3).
• Improvements are aligned to customer requirements and satisfaction, not an end in themselves.
• The overview lives in the management review — that is where improvements are set in motion and followed up.

What it takes →

This counts as “yes”

• On a nonconformity, the consequence is controlled first (correction) — the link to 8.7 is lived.
• Where the impact justifies it, there is a corrective action with a recognisable cause analysis.
• Every corrective action has an effectiveness check — and is closed only after it.
• Nonconformity, action and result are documented (10.2.2).
• The effort is appropriate to the impact — no 8D analysis for a scratch.

What it takes →

This counts as “yes”

• Over time a recognisable upward motion is demonstrable — not a single event, but a direction.
• There is a lived way from the idea to the action — low-threshold enough that it gets used.
• The management review (9.3) considers continual improvement as a whole, not only single cases.
• The culture bears bad news — problems are raised, not hidden.

What it takes →