ISO 13485:2016Internal AuditorPractitionerAvailable in English · Spanish

ISO 13485:2016 Internal Auditor

Plan, conduct and report internal audits of a medical device quality management system

Duration: 16 hours
Modules: 8
Final exam: 75% to pass
Certificate: 36 months

$495

Lifetime access to the course and your certificate
Verifiable Certificate of Completion. Certificate valid for 36 months.
3 exam attempts
Progress saved to your account on every slide
The full course, every module, quiz and the final exam, is available in Spanish. Choose your language inside the course at any time.

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About this course

Internal audit is the one process in ISO 13485:2016 that checks every other process, and regulators read your internal audit records to judge whether your organization can find its own problems. This course trains you to do that well.

You start with the standard itself: what each clause requires, what evidence demonstrates conformity, and where the EU MDR and IVDR, the FDA Quality Management System Regulation and MDSAP add to it. Each clause comes with an auditor tip drawn from real audit practice.

You then learn the auditing fundamentals shared by every management system discipline: audit principles, auditor behaviour, planning, sampling, interviewing, evidence, nonconformity writing, root cause and follow-up.

The practice module brings it together on medical device evidence: design and development files, process validation, complaint and vigilance records, CAPA effectiveness, supplier controls, training, software validation and cleanroom monitoring, with the typical findings experienced auditors look for.

Six scenario discussions, module quizzes and a 30-question final examination confirm that you can apply what you have learned.

What you will be able to do

Interpret each clause of ISO 13485:2016 and identify the records that demonstrate conformity
Include applicable regulatory requirements as audit criteria alongside the standard and internal procedures
Plan an internal audit with a risk-based programme, clear scope, criteria and sampling approach
Gather objective evidence through document review, interviews, observation and record tracing
Audit design and development files, process validation, complaints and vigilance, CAPA, suppliers, training, software and cleanroom controls
Write nonconformities that state the requirement, the evidence and the gap, and classify them appropriately
Evaluate root cause analysis and corrective action effectiveness before closing findings
Recognize how the MDSAP audit model and grading differ from certification audits

Course outline

1
ISO 13485:2016 overview for auditors
What an internal auditor needs to know about the standard's purpose, structure, documentation demands and regulatory context before auditing against it.
About 35 minutes, then a module quiz
2
Requirements in depth: clauses 4 to 6
Clause-by-clause requirements for the QMS, documentation, management responsibility and resources, each with what an auditor looks for.
About 50 minutes, then a module quiz
3
Requirements in depth: clauses 7 and 8
Product realization and measurement, analysis and improvement: design and development, purchasing, process validation, traceability, feedback, complaints, regulatory reporting, nonconforming product and CAPA.
About 70 minutes, then a module quiz
4
Auditing fundamentals
What an audit is, the principles that make it credible, and what ISO 13485:2016 requires of internal audit at clause 8.2.4.
About 40 minutes, then a module quiz
5
The audit process
Planning, preparing, conducting and closing an audit of a quality management system, step by step, with the evidence-gathering techniques auditors rely on.
About 55 minutes, then a module quiz
6
Auditing ISO 13485:2016 in practice
How to audit the evidence that matters in a medical device organization: design files, validation, complaints and vigilance, CAPA, suppliers, training, software and cleanrooms, with MDSAP awareness and typical findings.
About 55 minutes, then a module quiz
7
Nonconformities and root cause
How to recognise, grade and write a nonconformity, and how to judge whether the corrective action under ISO 13485:2016 clause 8.5.2 has dealt with the cause.
About 45 minutes, then a module quiz
8
Audit reporting and follow-up
Writing a report people act on, verifying corrective action, closing findings, and turning audit results into input for management review at clause 5.6.
About 35 minutes, then a module quiz
Final examination and certificate
30 questions drawn from the course bank. Score 75% or higher to receive your Certificate of Completion.

Who it is for

Quality and regulatory professionals who will conduct internal audits
Engineers, production and supply chain staff joining an internal audit team
Supplier quality engineers who audit medical device suppliers
Quality managers who review internal audit reports and CAPA

Prerequisites

Working knowledge of ISO 13485:2016 or completion of Introduction to ISO 13485:2016. Some experience in a regulated quality environment is helpful.

Questions

Do I need to complete the Introduction course first?

Not if you already work with ISO 13485:2016. Modules 2 and 3 cover every clause in depth with auditor tips, so a motivated learner can start here. If the standard is new to you, the Introduction course is a gentler start.

What certificate do I receive and how long is it valid?

On passing the final examination you receive a PlanetISO Certificate of Completion for ISO 13485:2016 Internal Auditor, valid for 36 months. You have lifetime access to the course and your certificate, and you can retake the course at no charge to renew.

Is this certificate accredited by Exemplar Global, IRCA or CQI?

No. PlanetISO certificates are Certificates of Completion issued by PlanetISO. Many organizations accept them as evidence of internal auditor training under clause 6.2, together with supervised audits. Check your organization's competence requirements.

Does the course cover MDSAP and FDA inspections?

At the level an internal auditor needs. You learn how the MDSAP audit model and grading differ from certification audits and where the FDA QMSR adds requirements, so your internal audits can anticipate external ones. Full coverage of leading MDSAP and certification audits is in the Lead Auditor course.

How is the final examination structured?

You answer 30 questions drawn at random from a bank of 50, pass mark 75 percent, with up to 3 attempts. Module quizzes can be retaken as often as you like.

Will I be able to audit suppliers after this course?

The auditing skills and clause knowledge apply directly to second-party audits of suppliers. The practice module includes supplier control audits, and the Lead Auditor course adds planning and leading multi-day supplier audits.

ISO 13485:2016Introduction
Introduction to ISO 13485:2016
Understand the medical device quality management system standard and the regulations that rely on it
Duration
4 hours
Level
Foundation
$149
View course
ISO 13485:2016Lead Auditor
ISO 13485:2016 Lead Auditor
Lead certification, MDSAP and supplier audits of medical device quality management systems
Duration
40 hours
Level
Advanced
$1,295
View course
ISO 13485:2016Awareness
ISO 13485:2016 Awareness for Medical Device Employees
Why medical device quality rules are strict, and how your records, cleanliness and reporting protect patients
Duration
1.5 hours
Level
Foundation
$59
View course

About this course

What you will be able to do

Course outline

ISO 13485:2016 overview for auditors

Requirements in depth: clauses 4 to 6

Requirements in depth: clauses 7 and 8

Auditing fundamentals

The audit process

Auditing ISO 13485:2016 in practice

Nonconformities and root cause

Audit reporting and follow-up

Final examination and certificate

More ISO 13485:2016 training

Introduction to ISO 13485:2016

ISO 13485:2016 Lead Auditor

ISO 13485:2016 Awareness for Medical Device Employees