Internal Audit SOP + 3 Templates — ISO 13485 & MDSAP Compliant
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
ISO 13485:2016 §8.2.4 · MDSAP Chapter 1 · Internal audit
Process Package — Internal Audit
The procedure, the annual programme, the audit plan and the audit report — four documents that turn an audit into evidence an assessor accepts.
€69
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4 documents · Word and Excel · updated May 2026
Instant download after purchase
Four ways an internal audit programme fails its own audit
The programme is a calendar. Every process gets audited once a year because every process gets audited once a year, and nowhere is there a written reason why one of them was audited twice and another one late. An assessor asks for the risk rationale and there is nothing to hand over.
The audit itself verifies that the procedure exists rather than that people follow it, so the report contains no sample and no record identifiers. Findings are graded by whoever wrote them, which in practice means everything becomes an observation, nothing crosses the threshold into CAPA, and the trend line is flat for reasons that have nothing to do with the quality system. Then the MDSAP audit arrives and the coverage of the five chapters turns out to have been an assumption rather than a tracked fact.
None of these are hard problems. They are the consequence of treating internal audit as an annual obligation rather than as a set of records you have to be able to produce on demand.
- 4 documents
- 1 procedure, 3 forms
- Microsoft Word and Excel
- 5-tier NC grading
- MDSAP coverage tracker
- Updated May 2026
Scope
What the package covers
The full cycle required by ISO 13485:2016 §8.2.4 and expected under MDSAP Chapter 1: how the programme is planned, how a single audit is run and reported, and how a finding becomes a corrective action that is verified as effective. It does not reproduce the text of ISO 13485, which is protected by copyright.
01
A programme with a rationale
Risk scoring per process, so audit frequency is the output of an argument rather than of a calendar, and the five MDSAP chapters mapped to the processes that cover them.
02
An audit that samples
Scope, criteria, team competence and independence, process owner contacts and a sample selection plan agreed before the audit rather than reconstructed after it.
03
Findings that go somewhere
A 5-tier grading methodology applied the same way by every auditor, explicit CAPA linkage for the grades that require it, and effectiveness verification at follow-up.
Contents
Four documents, in the order you use them
Audience
Who the package is for
- Quality managers who own the internal audit programme
- Internal auditors running audits against ISO 13485 and MDSAP criteria
- Manufacturers preparing for an MDSAP audit and checking chapter coverage
- Consultants and PRRC setting up a quality system for a first certification
- Small manufacturers with no dedicated audit function
It assumes you already run a quality management system, or are building one, and that you know what an audit finding is. It does not teach auditing technique, and it does not replace auditor training.
What is included
What you get when you buy
- SOP-CORE-03, the full internal audit procedure, including the 5-tier grading methodology per Annex A
- The annual programme workbook, with risk scoring, conditional formatting for status and risk level, and auto-counting statistics formulas
- The audit plan template, including the sample selection plan
- The audit report template, with findings, positive observations, closing meeting attendance and sign-off block
- Editable Microsoft Word and Excel files, not locked PDFs
- Instant download after purchase
Questions
Before you buy
Is an internal audit programme mandatory?
Yes. ISO 13485:2016 §8.2.4 requires planned internal audits at planned intervals, with a documented procedure covering planning, criteria, scope, frequency, methods, reporting and records. Under MDSAP the same programme is examined in Chapter 1, alongside management review and CAPA.
Do I need a copy of ISO 13485?
The package does not reproduce the text of the standard, which is protected by copyright and sold under licence by your national standards body. Clause references are given so you can go to the text yourself.
Does it cover MDSAP as well as ISO 13485?
Yes. The programme workbook carries a coverage tracker mapping the five MDSAP chapters to the processes that cover them, so the coverage of each chapter is a tracked fact rather than an assumption you discover is wrong during the audit.
Can I use it before I am certified?
Yes, and that is one of the common cases. A certification body will expect at least one complete internal audit cycle, with findings and their follow-up, before stage 2.
Do I have to be a qualified lead auditor to use it?
No, but the procedure sets out competence and independence requirements for the audit team, because an assessor will ask how the auditor was qualified and how you ensured nobody audited their own work. The package is documentation, not auditor training.
What is the 5-tier grading for?
It fixes what counts as a major nonconformity, a minor, an observation and so on, so that two auditors grading the same evidence reach the same result. Grading also drives what happens next: the procedure states which grades require a CAPA and which are closed on correction alone.
Are the files editable?
Yes. They are Microsoft Word and Excel files. You put your own document codes, header, revision and approval routing in, and adapt the text to your processes.
How is this different from the full ISO 13485 kit?
This package is one process, complete. The ISO 13485 kit covers the whole quality system and already contains the internal audit process among the others. Buy this one if internal audit is the gap; buy the kit if the system is the gap.
How is it delivered?
By download, immediately after purchase. There is nothing to ship and nothing to wait for.
Package and kit
The package gives you the process. The kit gives you the system around it.
Internal audit only produces useful evidence if the processes it audits are documented in the first place, and its findings only close if there is a CAPA process to receive them. If you are building the quality system rather than filling one gap in it, the Combined ISO 13485 + MDSAP Documentation Kit contains this process alongside the rest.
Process Package — Internal Audit
One procedure and three forms, in Word and Excel: risk-based programme,
MDSAP coverage tracking, 5-tier findings grading and CAPA linkage.
€69.00
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