7 questions against ISO 9001:2015. See where you stand, then get the document pack to close the gaps. We never promise a pass. We get you ready.
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Have you written down what your quality management system covers, and the internal and external issues and customer needs that shape it?
Do you have a quality policy signed by your most senior person, with roles and responsibilities for quality clearly assigned?
Have you identified the risks and opportunities to your quality, and set measurable quality objectives with plans to meet them?
Do you control your documents and records with version control, and keep a record of the competence your people need?
Are the processes that deliver your product or service planned, controlled and recorded, including the suppliers you rely on?
Do you monitor and measure your quality performance, run internal audits, and hold a management review?
Do you record things that go wrong, take corrective action with a look at the root cause, and show your quality improving over time?
What an assessor wants to see against ISO 9001:2015, and the mistake that gets firms bounced, for every criterion in the check above. Readiness only. The assessor makes the call, never us.
Have you written down what your quality management system covers, and the internal and external issues and customer needs that shape it?
What good looks like: A documented scope and boundaries, a short review of the issues that affect quality, a register of interested parties such as customers and regulators, and a map of your core processes.
Watch out: No documented scope, or a scope copied from another company that does not match the work you actually do.
Do you have a quality policy signed by your most senior person, with roles and responsibilities for quality clearly assigned?
What good looks like: A signed, dated quality policy, visible engagement from the top, and a matrix showing who is responsible for what across the system.
Watch out: A policy not signed by top management, or quality roles left unassigned with no one clearly owning the system.
Have you identified the risks and opportunities to your quality, and set measurable quality objectives with plans to meet them?
What good looks like: A risk and opportunity register, measurable quality objectives, and plans with named owners to achieve them.
Watch out: No objectives at all, or objectives so vague they cannot be measured or are never reviewed.
Do you control your documents and records with version control, and keep a record of the competence your people need?
What good looks like: A competence matrix, a procedure for controlling documents and records, and a plan for how quality matters are communicated.
Watch out: Documents with no version control or approval, or gaps where people lack the competence for their work.
Are the processes that deliver your product or service planned, controlled and recorded, including the suppliers you rely on?
What good looks like: Documented operational controls, checks on suppliers and subcontractors, and change control with records to show it is followed.
Watch out: Work that gets done but is not controlled or recorded, so there is no evidence the day-to-day runs to a standard.
Do you monitor and measure your quality performance, run internal audits, and hold a management review?
What good looks like: An internal audit programme with recorded results and minutes of a management review that acts on what it finds.
Watch out: An audit programme or management review named on paper that clearly never actually runs.
Do you record things that go wrong, take corrective action with a look at the root cause, and show your quality improving over time?
What good looks like: A nonconformity log, corrective actions with root-cause analysis, and evidence that the system improves over time.
Watch out: Corrective actions raised but never closed out, or no record of nonconformities at all.
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