Quality system consulting from a practising Lead Auditor
Gap assessments, remediation, supplier audits, mock audits and internal audit programmes for ISO 13485, ISO 9001, AS9100D, FDA QMSR and five more standards.
One auditor takes the engagement from the first call to handover: writing procedures with your process owners, building records, running audits and sitting in the debrief. The Aligntra platform does the document reading and checks each fix, so the auditor's time goes on the work itself.
Six services
Each is priced per engagement and scoped in writing before work starts. Most first engagements are a gap assessment, and supplier audits run on their own or across your approved supplier list.
Gap assessment
The auditor assesses your quality system against the standard, with the platform doing the document reading. You get a findings report cited to the paragraph and a prioritised remediation plan, on a fixed fee.
Supplier audits
Second-party audits of your suppliers, run by the auditor on your behalf. The supplier's documentation is reviewed before the visit, and you get a written report with findings cited to the supplier's own procedures. Priced per supplier, or scheduled across your approved supplier list.
Remediation
After the assessmentProcedures rewritten with your process owners and records built in your document control, at new revision numbers. Training on the changes is included, and each fix is checked before it is closed.
Mock audits
Per proposalA full audit run the way your registrar will run it, with a written findings report and a debrief with your team.
Internal audit programme
AnnualYour internal audit schedule planned and run by the auditor, which meets the independence requirement in ISO 13485, ISO 9001 and AS9100D. Reports in the form your registrar expects.
Fractional QA/RA
Monthly retainerSenior quality and regulatory support on a monthly retainer, with hours you can adjust from month to month.
Three ways to buy them
Which services each one covers, how it is priced, and how long it runs.
| Attribute | Project Most common | Retainer | Programme |
|---|---|---|---|
| Best for | A defined outcome with an end date: certification readiness, a remediation programme, the response to an audit finding, a single supplier audit | Ongoing senior QA/RA support for a company that needs the function without a full-time hire | Internal audits and supplier audits that recur across a year |
| Covers | Gap assessment, remediation, mock audits, supplier audits | Fractional QA/RA | Internal audit programme, supplier audit calendar |
| Priced | Fixed fee against a written scope | Monthly, for an agreed block of hours you can adjust month to month | Annually, against a schedule agreed up front |
| Runs for | One to two weeks for an assessment; two to six months for a typical certification programme | Month to month | Twelve months |
| Who | The same auditor throughout | The same auditor each month | The same auditor for each audit |
Built by someone who audits for a living
The same Lead Auditor who assesses your system writes the fixes, on a written scope and a fixed fee, inside your own document control.
One person from start to finish
The auditor who scopes the work writes the procedures, runs the audits and delivers the training. You never explain your system twice.
Written for the audit you will face
A practising Lead Auditor knows what a certification audit asks for, and writes each procedure and record to answer it.
A fixed fee before work starts
Each engagement is quoted in writing. The gap assessment is a fixed fee, and the remediation quote is built from its findings, so the size of the fix is known before you buy it.
Built inside your document control
Procedures go in at your revision numbers and records are built on your forms. Your team is left running a system it already recognises.
How an engagement runs
Five steps from the first call to handover. The assessment is the first engagement; remediation is scoped and quoted from its findings as a separate piece of work.
Scoping call
Thirty minutes. You tell us the standard, your audit date if you have one, and what you already have in place. We quote the assessment in writing.
Assessment
The auditor assesses your quality system against the standard. You get a findings report cited to the paragraph and a prioritised plan.
Proposal
The work that follows is quoted from the assessment, as a fixed fee with a written scope. The report and the plan are deliverables of the assessment and stay with you.
The work
Procedures written with your process owners, records built, audits run, training delivered. Each fix is checked before it is closed.
Handover
Your revised documents at their new revision numbers, the audit reports and the closed findings. A mock audit before your audit date if you want one.
What a gap assessment report looks like
Findings cited to the document, page and paragraph, and each one closed against the revised document. We publish a complete example: 29 documents, 36 findings, so you can see the format before you call.
Common questions
Which service do we need?
| Going for certification for the first time | Gap assessment, then remediation |
| An audit date in the next few months | Gap assessment, then remediation or a mock audit |
| Responding to a finding from your registrar or an inspector | Remediation |
| Qualifying a new supplier, or re-qualifying a critical one | Supplier audit |
| Already certified and needing independent internal audits | Internal audit programme |
| No QA or RA person in house | Fractional QA/RA |
| Moving to a new standard or a new revision of one | Gap assessment |
What does an engagement cost?
The gap assessment is a fixed fee, quoted in writing after the scoping call. Remediation is quoted from the assessment's findings, also as a fixed fee. Supplier audits are priced per supplier. Retainers are a monthly fee for an agreed number of hours. We do not publish prices.
How long does certification readiness take?
The gap assessment takes one to two weeks. Remediation depends on what it finds. A typical certification programme runs two to six months, and a shorter timeline is possible with more of the auditor's time booked.
What do we need to give you?
Your documents as they are: procedures, forms and records in whatever format you keep them. A folder of PDFs on a shared drive is fine. Nothing needs reformatting first.
What is not included?
The certification audit itself, which only an accredited certification body or notified body can carry out. Travel and expenses for on-site work, which are quoted separately.
Do you certify us?
No. We are not a certification body and have no relationship with yours. We prepare you for their audit.
Who does the work?
A practising Lead Auditor, the same person from the scoping call to handover.
Do we have to buy the software?
No. The auditor works on the Aligntra platform during the engagement and you have access to it for the duration. The reports and exports are yours to keep. Continuing on the platform afterwards is a separate decision.
Book a scoping call
Thirty minutes, no charge. Tell us which standard you are working to and when your audit is, and we will come back with a written quote for the assessment.