ISO 9001audit software

ISO 9001 asks you to audit the quality management system at planned intervals and to act on what you find. Orisynx keeps the programme, the checklists, the nonconformities and the corrective actions in one place, so clause 9.2 and clause 10.2 stay connected.

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What an ISO 9001 audit asks of you

FND-0142High

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Clause: 8.4.1
Audit: Purchasing

Three of eleven active suppliers have no evaluation on file.

A risk-based audit programme

Clause 9.2 expects the programme to reflect the importance of each process and the results of earlier audits. Plan the year by process and site, and move audits when priorities change.

Supplier audits alongside internal ones

Control of external providers (8.4) often means auditing suppliers. Run them as their own audit type in the same programme.

Corrective action you can show

Clause 10.2 asks for the cause, the action and a review of its effectiveness. Each remediation action carries all three, with the evidence attached.

The clauses, in your checklist

ISO 9001:2015 follows the ISO harmonized structure. Build your templates around its requirements and every finding stays tied to the clause it was raised against.

Clause titles are shown for orientation. Use your licensed copy of the standard for the full requirements.

ISO 9001:2015

Internal audit checklist · Quality management

Context and leadership

Understanding the organization and its context4.1
Needs and expectations of interested parties4.2
Scope of the management system4.3
Leadership and commitment5.1
Policy5.2
Roles, responsibilities and authorities5.3

Planning and support

Actions to address risks and opportunities6.1
Objectives and planning to achieve them6.2
Competence7.2
Documented information7.5

Operation

Operational planning and control8.1
Requirements for products and services8.2
Control of externally provided processes8.4
Production and service provision8.5
Control of nonconforming outputs8.7

Evaluation and improvement

Monitoring, measurement, analysis and evaluation9.1
Internal audit9.2
Management review9.3
Nonconformity and corrective action10.2

Clauses 4 to 10
Harmonized structure

ISO 9001 questions

Does Orisynx come with an ISO 9001 checklist?

You can start an audit against ISO 9001:2015 and build checklist templates around its clauses, then reuse them across sites and audit cycles.

Can we record findings as major or minor nonconformities?

Every finding is graded by severity (low, medium, high or critical) and linked to the audit and the requirement it was raised against, so you can map it to your own major and minor scheme.

Will this help with a certification audit?

Orisynx gives you the records a certification body asks to see: the audit programme, completed audits, nonconformities and the corrective actions taken. Certification itself is granted by your certification body.

Other standards in the same programme

Run your next ISO 9001 audit here

Bring an audit you have already run. We will walk it through Orisynx with you, from the plan to the last closed corrective action.

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