A documentation review against ISO 9001 at any point in the certification cycle.
A certification cycle runs three years. Each surveillance visit samples part of the management system, and procedures are revised in the months between visits. Aligntra reads the full document set against all 235 obligations whenever it is run, and again after a revision. Walkthroughs, interviews and the audit report remain with a person.
Document numbers are illustrative.
Between one visit and the next, you check the system in one of three ways.
A surveillance visit assesses the slice the registrar selected. Everything revised after it stands unassessed until the next one.
Scope is the areas the auditor selected.
Correct at the revision it was built against.
Revisions made since the last visit go unassessed.
All 235 obligations, on today’s documents.
An obligation with no document mapped to it is not reported by a sampled audit. It is reported by a full review.
Findings you can put in the file, with the paragraph they came from.
Procedures, work instructions, forms and records, as they stand. A revision is a re-upload.
Cited to the document, the page and the paragraph, and classified Major NC, Minor NC, Observation or OFI.
Who confirmed, reclassified or dismissed each finding, and when. Exported to Excel with a sign-off sheet.
What a finding looks like when it reaches you.
Prepared for this page against ISO 9001. No ISO 9001 example audit is published.
QP-08 Rev 03 defines identification, containment, disposition and correction, and closes the record at ¶ 4.4 once disposition is signed off. No step addresses whether a nonconformity of a similar nature has occurred previously, and the NCR form provides no field for prior occurrences. §10.2.1(b) requires review of existing nonconformities of a similar nature.
A reviewer in your organisation confirms, reclassifies or dismisses this before it enters the report.
Where the review stops.
No. It is the documentation review that an internal audit includes, and it produces the findings, evidence and adjudication records for that part. Walkthroughs, interviews and the audit report remain with a person.
CAPA and NCR. All other documents are classified and assessed against their applicable clauses; those two are additionally verified against the SOP that governs them.
A reviewer in your organisation. Aligntra proposes findings; each one is confirmed, reclassified or dismissed by a person before it enters the report.
One standard is included on all tiers. Pricing is on the pricing page.
Yes, against whatever documentation they provide, where a questionnaire response is not sufficient evidence.