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2026 Statistics

Key Facts: PECB ISO 13485 Foundation Exam

40 Questions

Official Exam Format

PECB List of Exams (Foundation exams)

60 Minutes

Exam Time Limit

PECB Training Catalog 2026 (Foundation exams: 1 hour)

70%

Passing Score

PECB Certification Rules

Closed Book

Exam Delivery Mode

PECB Exam Rules and Policies

3 Options

Answer Choices per Official PECB Multiple-Choice Question

PECB Foundation Candidate Handbooks

No AMF

Foundation Certificates Require No Maintenance

PECB Certification Maintenance Policy

Clauses 4–8

ISO 13485:2016 Requirements Scope

ISO 13485:2016 Structure

Feb 2, 2026

FDA QMSR Effective Date (incorporates ISO 13485:2016)

FDA QMSR Final Rule

PECB ISO 13485 Foundation is PECB's entry-level credential for medical device quality management systems. The official exam consists of 40 closed-book multiple-choice questions in 60 minutes with a 70% passing score, testing MDQMS fundamental concepts and the ISO 13485:2016 requirements across Clauses 4–8. PECB's own items carry three options; this free bank uses four-option English MCQs as an independent study aid rather than a simulation of the exam's format.

Sample PECB ISO 13485 Foundation Practice Questions

Try these sample questions to test your PECB ISO 13485 Foundation exam readiness. Each question includes a detailed explanation. Start the interactive quiz above for the full 100+ question experience with AI tutoring.

1What is the full official title of ISO 13485:2016?

A.Medical devices — Quality management systems — Requirements for regulatory purposes

B.Medical devices — Risk management — Application of risk management to medical devices

C.Quality management systems — Requirements for all healthcare organizations

D.Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied

Explanation: ISO 13485:2016 is titled 'Medical devices — Quality management systems — Requirements for regulatory purposes'. The title itself signals that the standard exists to support regulatory compliance for medical device quality management systems.

2Which edition of ISO 13485 is the current version against which organizations are certified?

A.ISO 13485:2016 (third edition)

B.ISO 13485:2003 (second edition)

C.ISO 13485:2012

D.ISO 13485:2021

Explanation: ISO 13485:2016 is the third and current edition of the standard. Certification schemes, the EU MDR harmonization process, and the FDA Quality Management System Regulation all reference the 2016 edition.

3What is the primary purpose of a Medical Devices Quality Management System (MDQMS) based on ISO 13485?

A.To demonstrate an organization's ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements

B.To certify that an individual medical device model is safe for clinical use

C.To replace national medical device regulations with a single international law

D.To provide a marketing label that guarantees zero product defects

Explanation: ISO 13485 specifies requirements for a QMS that enables an organization to consistently provide medical devices and related services meeting customer and applicable regulatory requirements. It certifies the management system of the organization, not individual products.

4How does the structure of ISO 13485:2016 differ from most other modern ISO management system standards such as ISO 9001:2015?

A.It is not based on the Annex SL high-level structure; it retains a clause structure aligned with the ISO 9001:2008 process model

B.It follows the Annex SL high-level structure exactly like ISO 9001:2015

C.It has no clause structure and is written as a continuous narrative

D.It is structured around the chapters of the EU Medical Device Regulation

Explanation: Unlike ISO 9001:2015, ISO 13485:2016 deliberately does not use the Annex SL high-level structure. It retains the eight-clause structure and process model based on ISO 9001:2008, with requirements in Clauses 4 through 8.

5Which clauses of ISO 13485:2016 contain the certifiable requirements for a Medical Devices Quality Management System?

A.Clauses 4 through 8

B.Clauses 1 through 3

C.Clauses 9 and 10

D.Only Clause 7

Explanation: Clauses 1–3 cover scope, normative references, and terms and definitions. The auditable requirements are in Clause 4 (Quality management system), Clause 5 (Management responsibility), Clause 6 (Resource management), Clause 7 (Product realization), and Clause 8 (Measurement, analysis and improvement).

6Which requirement does ISO 13485:2016 retain that ISO 9001:2015 removed as a separate clause?

A.Preventive action

B.Management review

C.Internal audit

D.Control of documented information

Explanation: ISO 13485:2016 retains a separate preventive action requirement (Clause 8.5.3) to eliminate causes of potential nonconformities. ISO 9001:2015 folded prevention into risk-based thinking and removed the standalone preventive action clause.

7Which statement best captures the intent of ISO 13485:2016 compared with ISO 9001:2015?

A.ISO 13485 focuses on maintaining the effectiveness of the QMS and meeting regulatory requirements, rather than emphasizing continual improvement and customer satisfaction

B.ISO 13485 is essentially ISO 9001 with medical device examples added

C.ISO 13485 exists only to help organizations win government supply contracts

D.ISO 13485 replaces the need for product-level regulatory approval in all markets

Explanation: ISO 13485:2016 requires the organization to maintain the effectiveness of the QMS and emphasizes meeting regulatory requirements. ISO 9001:2015, by contrast, emphasizes continual improvement and enhancing customer satisfaction, which is not the primary driver in the medical device regulatory context.

8According to ISO 13485:2016 Clause 4.1, how must an organization approach the control of its quality management system processes?

A.Apply a risk-based approach to the control of the appropriate processes needed for the QMS

B.Apply identical, uniform controls to every process regardless of risk

C.Delegate all process control decisions to the certification body

D.Control only the processes that directly touch manufacturing

Explanation: Clause 4.1.2 of ISO 13485:2016 requires the organization to apply a risk-based approach to the control of the appropriate processes needed for the QMS. The rigor of control is proportionate to the risk each process presents to product conformity and patient safety.

9Which ISO standard provides the framework for the application of risk management to medical devices throughout their life-cycle?

A.ISO 14971

B.ISO 15223-1

C.ISO 19011

D.IEC 62366-1

Explanation: ISO 14971 (current edition ISO 14971:2019) specifies the process for manufacturers to identify hazards, estimate and evaluate risks, control risks, and monitor the effectiveness of risk controls for medical devices. ISO 13485:2016 references risk management aligned with this framework.

10In the vocabulary used by ISO 13485 and ISO 14971, how is 'risk' defined?

A.The combination of the probability of occurrence of harm and the severity of that harm

B.The financial loss an organization suffers from a product recall

C.The probability that a regulator will issue a warning letter

D.The severity of harm alone, regardless of likelihood

Explanation: Risk is defined as the combination of the probability of occurrence of harm and the severity of that harm. Both dimensions must be considered together when estimating and evaluating risk for a medical device.

About the PECB ISO 13485 Foundation Exam

Entry-level certification validating knowledge of Medical Devices Quality Management Systems (MDQMS) based on ISO 13485:2016, covering fundamental QMS and risk management concepts, regulatory frameworks (EU MDR/IVDR, FDA QMSR, MDSAP), and the standard's requirement Clauses 4 through 8 including design controls, sterile device requirements, traceability, and CAPA.

Assessment

Two competency domains: Domain 1, fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS); Domain 2, MDQMS requirements based on ISO 13485:2016 Clauses 4-8. PECB does not publish a per-domain question split for this exam.

Time Limit

60 minutes

Passing Score

70%

Exam Fee

Included with PECB training course (exam and certificate fees included in course price; one free retake within 12 months). Standalone: US$500 Foundation exam plus US$200 certificate application fee (PECB)

PECB ISO 13485 Foundation Exam Content Outline

Foundational concepts (Day 1 of the official course)

Domain 1: Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)

QMS concepts, process approach and PDCA, ISO 13485:2016 scope and structure, ISO 14971 risk management, key device definitions, and regulatory frameworks (EU MDR/IVDR, FDA QMSR, MDSAP)

MDQMS requirements (Day 2 of the official course)

Domain 2: Medical Devices Quality Management System (MDQMS) requirements

ISO 13485:2016 Clauses 4–8: QMS documentation and the medical device file, management responsibility, resources and work environment, product realization including design controls, purchasing, validation, sterilization and traceability, and measurement, analysis and improvement including complaint handling and CAPA

How to Pass the PECB ISO 13485 Foundation Exam

What You Need to Know

Passing score: 70%
Assessment: Two competency domains: Domain 1, fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS); Domain 2, MDQMS requirements based on ISO 13485:2016 Clauses 4-8. PECB does not publish a per-domain question split for this exam.
Time limit: 60 minutes
Exam fee: Included with PECB training course (exam and certificate fees included in course price; one free retake within 12 months). Standalone: US$500 Foundation exam plus US$200 certificate application fee

Keys to Passing

Complete 500+ practice questions
Score 80%+ consistently before scheduling
Focus on highest-weighted sections
Use our AI tutor for tough concepts

PECB ISO 13485 Foundation Study Tips from Top Performers

1Memorize the ISO 13485:2016 clause map: 4 QMS, 5 Management responsibility, 6 Resource management, 7 Product realization, 8 Measurement, analysis and improvement — and that it is NOT the Annex SL structure

2Know what makes ISO 13485 different from ISO 9001:2015: regulatory purpose, retained preventive action (8.5.3), more mandatory documented procedures, and maintaining QMS effectiveness rather than continual improvement

3Master key definitions: medical device, sterile medical device, implantable medical device (30-day rule), advisory notice, and risk (probability × severity of harm)

4Learn the design control chain in Clause 7.3: planning, inputs, outputs, review, verification (outputs meet inputs), validation (product meets intended use on representative product), transfer, changes, and design files

5Focus on device-specific requirements examiners probe: sterilization batch records, sterile barrier system validation, implantable traceability, rework controls, and concession only when regulatory requirements are met

6Connect the standard to regulators: EU MDR 2017/745, IVDR 2017/746, FDA QMSR (21 CFR Part 820 incorporating ISO 13485:2016, effective February 2, 2026), and MDSAP's five participating authorities

Frequently Asked Questions

What is the PECB ISO 13485 Foundation exam format?

The official PECB ISO 13485 Foundation exam consists of 40 multiple-choice questions completed in 60 minutes. Foundation exams are closed-book, delivered online (proctored) or paper-based through PECB partners, and the passing score is 70%. Each official PECB multiple-choice question offers three options with one correct answer.

What topics are covered on the PECB ISO 13485 Foundation exam?

The exam covers two competency domains: Domain 1, fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS); and Domain 2, Medical Devices Quality Management System requirements based on ISO 13485:2016 Clauses 4 through 8. PECB does not publish a per-domain question split for this exam.

What is ISO 13485?

ISO 13485:2016, 'Medical devices — Quality management systems — Requirements for regulatory purposes', is the international standard for quality management systems of organizations involved in one or more stages of the medical device life-cycle. It supports regulatory compliance worldwide and is incorporated by reference into the U.S. FDA Quality Management System Regulation effective February 2, 2026.

Are there prerequisites for taking the PECB ISO 13485 Foundation exam?

PECB lists no education or experience prerequisites, and the Foundation credential requires no professional experience or audit experience. Completing the PECB ISO 13485 Foundation training course (2 days, 14 CPD credits, available as classroom, live online, eLearning, or self-study) is itself a stated certificate requirement, alongside passing the exam and signing the PECB Code of Ethics.

How much does the PECB ISO 13485 Foundation exam cost?

Certificate and examination fees are included in the price of the PECB training course, and candidates who fail can retake the exam once for free within 12 months, so the total depends on the partner and delivery format chosen. PECB separately publishes a US$500 Foundation exam fee and a US$200 certificate application fee for candidates buying the exam on its own.

Is this practice test the official PECB exam?

No. OpenExamPrep provides free English multiple-choice practice questions as an independent study aid. It is not affiliated with PECB, does not replace official training materials, and is not the live certificate exam. The official exam uses 40 three-option questions in 60 minutes; this bank uses 100 four-option questions with no time limit, so it is a knowledge study aid rather than a simulation of the exam format.

100+ Free PECB ISO 13485 Foundation Practice Questions

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