ISO 9001:2015 (QMS) Lead Auditor Course

1. Introduction to ISO 9001 and QMS Scope, objectives, and benefits of implementing a Quality Management System.

2. Quality Management Principles & Key Terminologies Customer focus, leadership, engagement of people, process approach, improvement, evidence‑based decision making, and relationship management.

3. ISO 9001:2015 Clauses and Requirements Detailed review of clauses 4–10, including context, leadership, planning, support, operation, performance evaluation, and improvement.

4. Risk‑Based Thinking and Process Approach in QMS Identifying risks and opportunities, applying the process approach, and embedding continual improvement.

5. Legal, Regulatory, and Customer Requirements Understanding compliance obligations, contractual requirements, and customer expectations.

6. Roles, Responsibilities, and Leadership in QMS Responsibilities of top management, auditors, and quality teams in maintaining QMS effectiveness.

7. Audit Principles and Techniques (ISO 19011 Guidelines) Audit types, principles, ethics, and auditor competence requirements.

8. Audit Planning, Preparation, and Checklist Development Creating audit programs, defining scope, preparing checklists, and allocating resources.

9. Conducting On‑Site and Remote Audits Opening meetings, evidence collection, interviews, observations, and remote audit techniques.

10. Audit Reporting, Nonconformity Management, & Follow‑Up Writing audit reports, documenting findings, managing nonconformities, and verifying corrective actions.

• Builds competence in auditing ISO 9001:2015 Quality Management Systems

• Enhances compliance with ISO 9001 and ISO 19011 auditing standards

• Strengthens skills in risk‑based thinking, audit planning, and reporting

• Provides tools for documentation, corrective actions, and continual improvement

• Offers recognized certification to support careers in quality auditing, compliance, and consultancy

• Quality managers and compliance officers

• Internal and external auditors

• Consultants specializing in QMS frameworks

• Individuals progressing from ISO 9001:2015 Internal Auditor (QMIA‑515) or equivalent qualifications

• Assessment Type: Written exam + audit simulation + project

• Format: MCQs, essay‑style questions, applied audit scenarios, and project submission

• Total Questions: 100 theory + 1 audit simulation + 1 project submission

• Passing Score: 70%

• Duration: 6–7 days (45–50 hours total)

• Certification: ISO 9001:2015 (QMS) Lead Auditor (QMLA)

To deliver this Qualification, HiQual UK Approved ATPs must demonstrate the capability to deliver, assess, and internally quality assure qualifications in line with recognised regulatory principles and the expectations of the Regulated Qualifications Framework (RQF).

Approved centres must operate effective systems to ensure the validity, reliability, fairness, consistency, and security of assessment.

1. Centre Recognition and Legal Compliance

Centres must be formally recognised by HiQual UK prior to the delivery or assessment of any qualification. To maintain recognition, centres must: Be a legally constituted organisation operating in compliance with applicable legislation and regulatory requirements. Demonstrate effective governance, management oversight, and clear lines of accountability. Comply with all HiQual UK policies, procedures, and conditions of centre recognition. Notify HiQual UK promptly of any material changes that may affect delivery, assessment, or internal quality assurance arrangements.

2. Resources, Facilities, and Learning Environment

Centres must ensure that sufficient and appropriate resources are in place to support learning and assessment. This includes: Learning environments appropriate to the mode of delivery, including classrooms and, where applicable, specialist or practical facilities. Access to learning and assessment resources that enable learners to meet qualification outcomes. Secure systems for managing learner data, assessment records, and certification claims. Arrangements that support equality of access and reasonable adjustments for learners where required.

3. Staff Competence and Occupational Expertise

Centres must ensure that all staff involved in delivery, assessment, and internal quality assurance are competent and suitably qualified. Centres must: Appoint tutors with appropriate subject knowledge, teaching competence, and relevant occupational or professional experience. Ensure assessors are trained and competent in applying HiQual UK assessment requirements and standards. Appoint a qualified Internal Quality Assurer (IQA) responsible for monitoring assessment practice and decisions. Maintain records of staff qualifications, experience, training, and continuing professional development (CPD).

4. Assessment Practice and Internal Quality Assurance (IQA)

Centres must operate robust internal quality assurance systems to ensure assessment integrity. Centres must: Ensure assessment is valid, fit for purpose, and conducted in line with HiQual UK requirements. Implement effective IQA procedures to monitor assessor performance and confirm the consistency of assessment decisions. Maintain accurate, complete, and auditable records of learner registration, assessment evidence, and outcomes. Carry out regular internal reviews and standardisation activities to support continuous improvement.

5. Integrity, Risk Management, and Malpractice

Centres must take appropriate measures to protect the integrity of assessment. Centres must: Maintain policies and procedures for the prevention, identification, and management of malpractice and maladministration. Ensure secure handling, storage, and retention of assessment materials and learner evidence. Report any suspected or confirmed malpractice to HiQual UK in accordance with published procedures.

6. Health, Safety, Safeguarding, and Learner Protection

Centres must provide a safe, inclusive, and supportive learning environment. Centres must: Comply with applicable health and safety and safeguarding legislation. Conduct risk assessments for learning activities, particularly where practical or technical work is involved. Maintain procedures to safeguard learner welfare and wellbeing.

7. Learner Information, Support, and Fair Treatment

Centres must ensure learners are informed, supported, and treated fairly. Centres must: Provide clear and accurate information on programme requirements, assessment methods, and certification. Ensure learners receive timely and constructive feedback on assessment outcomes. Operate transparent complaints and appeals procedures aligned with HiQual UK requirements. Manage learner information securely in compliance with data protection legislation.