ISO Lead Auditor Trainings

3.1 ISO 9001: 2015 Quality Management System (QMS) Lead Auditor Course

The ISO 9001:2015 Lead Auditor course provides professionals with the knowledge and skills
necessary to audit a Quality Management System (QMS) based on the ISO 9001:2015 standard.
The course emphasizes audit planning, conducting audits, reporting, and following up on non conformities to improve quality practices within organizations.

Course Contents

Clause 1: Scope

• Defines the scope of the ISO 9001:2015 standard.
• Describes the requirements for a quality management system (QMS) that an organization must meet to consistently provide products and services that meet customer and regulatory
  requirements.
• Applies to organizations of all sizes and types, regardless of the products or services they
  provide.

Clause 2: Normative References

• This clause references the standards and documents essential for understanding and
  implementing ISO 9001. The only normative reference in ISO 9001:2015 is ISO 9000:2015, which outlines the fundamentals and vocabulary of quality management.

Clause 3: Terms and Definitions

• Defines key terms used throughout the ISO 9001:2015 standard, such as:
  • Quality: Degree to which a set of inherent characteristics fulfill requirements.
  • Quality Management System (QMS): A system to establish policies and objectives to
    achieve customer satisfaction.

Clause 4: Context of the Organisation

• 4.1 Understanding the organization and its context: The organization must determine external and internal issues that may affect its ability to achieve the intended outcomes of the QMS.
• 4.2 Understanding the needs and expectations of interested parties: Identifies relevant
  stakeholders (such as customers, suppliers, regulatory bodies) and their requirements or
  expectations related to quality.
• 4.3 Determining the scope of the QMS: Defines the boundaries and applicability of the QMS in
  relation to the organization’s context and the requirements of stakeholders.
• 4.4 Quality management system and its boundaries: The organization must establish,
  implement, and maintain a QMS based on the scope identified.

Clause 5: Leadership

• 5.1 Leadership and commitment: Top management must demonstrate leadership by ensuring
  the QMS is aligned with the organisation’s strategic direction and objectives, and that the
  quality policy is integrated into the organisation’s processes.
• 5.2 Quality policy: Top management is responsible for establishing, implementing, and
  maintaining a quality policy that includes a commitment to meet customer and regulatory
  requirements, and to continually improve the QMS.
• 5.3 Organizational roles, responsibilities, and authorities: Top management must assign clear roles, responsibilities, and authorities for managing and maintaining the QMS.

 Clause 6: Planning

• 6.1 Actions to address risks and opportunities: The organization must assess risks and
  opportunities that could affect the QMS’s ability to achieve its intended outcomes. The
  organisation must take actions to address these risks and opportunities.
• 6.2 Quality objectives and planning to achieve them: The organisation must establish
  measurable quality objectives that are consistent with the quality policy. These objectives
  should be at relevant functions, levels, and processes.
• 6.3 Planning of changes: When changes are required, the organisation must ensure they are planned in a way that does not negatively affect the QMS.

 Clause 7: Support

• 7.1 Resources: The organization must determine and provide necessary resources (human
  resources, infrastructure, environment for operation, monitoring and measuring resources,
  knowledge, etc.) to establish, implement, maintain, and improve the QMS.
• 7.2 Competence: Ensure that people are competent based on education, training, skills, and
  experience to perform work that affects product/service quality.
• 7.3 Awareness: Ensure employees are aware of the relevance and importance of their roles in achieving quality objectives and the impact of their actions on the QMS.
• 7.4 Communication: Establish processes for internal and external communication related to the QMS, ensuring that relevant information is communicated effectively.
• 7.5 Documented information: The organization must control documented information required by the QMS, including the creation, review, update, and control of documents and records.

Clause 8: Operation

• 8.1 Operational planning and control: The organization must plan, implement, and control the
  processes required to meet quality objectives, product/service requirements, and ensure
  effective performance.
• 8.2 Requirements for products and services: The organization must ensure that customer
  requirements are defined, understood, and met.
  • 8.2.1 Customer communication: Effective communication with customers regarding
    their requirements, feedback, complaints, etc.
  • 8.2.2 Determining the requirements for products and services: Ensuring
    product/service requirements are clearly defined, and legal and regulatory
    requirements are met.
• 8.3 Design and development of products and services: The organization must establish
  processes for the design and development of products/services to ensure they meet customer
  requirements.
  • 8.3.1 Design and development planning: Planning activities related to design and
    development.
  • 8.3.2 Design and development inputs: Identifying requirements needed to design and
    develop the product.
  • 8.3.3 Design and development controls: Managing the design and development process
    to ensure conformity to requirements.
  • 8.3.4 Design and development outputs: Final design and development results must
    meet the input requirements.
  • 8.3.5 Design and development changes: Managing changes to the design and
    development process.
• 8.4 Control of externally provided processes, products, and services: The organization must
  ensure that externally provided products, services, and processes (suppliers, contractors, etc.)
  conform to specified requirements.
  • 8.4.1 General: Establishing criteria for selecting, evaluating, and monitoring suppliers.
  • 8.4.2 Type and extent of control: Determining the level of control to be applied to
    external providers based on the risk associated with the product/service.
• 8.5 Production and service provision: The organization must ensure that operations are
  planned, controlled, and carried out under controlled conditions.
  • 8.5.1 Control of production and service provision: Ensuring that product/service is
    produced in accordance with requirements.
  • 8.5.2 Identification and traceability: Ensuring the identity of the product/service is
    maintained, especially when traceability is required.
  • 8.5.3 Property belonging to customers or external providers: Managing customer or
    external provider property.
  • 8.5.4 Preservation: Ensuring the product is preserved during processing, handling,
    storage, and delivery.
• 8.6 Release of products and services: The organization must establish processes to ensure
  products/services are verified before release.
• 8.7 Control of nonconforming outputs: The organization must identify and manage
  nonconforming products/services and take corrective actions.

 Clause 9: Performance Evaluation

• 9.1 Monitoring, measurement, analysis, and evaluation: The organization must monitor,
  measure, analyze, and evaluate the performance of the QMS to ensure its effectiveness.
  • 9.1.1 General: Monitoring and measuring the effectiveness of processes and the ability
    to meet customer satisfaction.
  • 9.1.2 Customer satisfaction: Gathering and analyzing data on customer satisfaction to
    evaluate whether customer requirements are met.
• 9.2 Internal audit: The organization must conduct internal audits at planned intervals to assess whether the QMS conforms to the standard and is effectively implemented and maintained.
• 9.3 Management review: Top management must conduct periodic reviews of the QMS to
  ensure its continuing suitability, adequacy, and effectiveness, and align it with the strategic
  direction of the organisation.

Clause 10: Improvement

• 10.1 Nonconformity and corrective action: The organization must identify nonconformities,
  take corrective actions to eliminate the causes, and ensure they don’t recur.
• 10.2 Continual improvement: The organization must continually improve the QMS by making
  systematic efforts to enhance performance, ensuring ongoing compliance and customer
  satisfaction.

Your Benefits:

• Builds expertise in auditing ISO 9001 Quality Management Systems.
• Increases career prospects as a lead auditor or quality manager.
• Helps identify gaps in quality practices and suggest improvements.
• Ensures organisations comply with ISO 9001 standards, enhancing product quality.

 Importance:

• ISO 9001 certification demonstrates an organisation’s commitment to quality
  management.
• ISO 9001 auditors play a critical role in identifying areas for improvement in
  product/service quality.