Audit

An audit is a systematic, independent, and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which defined requirements are fulfilled. In quality management, audits are used for the structured assessment of management systems, processes, or products against defined criteria. An audit is not an operational control instrument, but rather an evaluation and insight-generating instrument.

Systemic Classification of Audits in Quality Management

Audits are an integral part of quality management and support the evaluation of the effectiveness of regulations, processes, and systems within quality assurance. They provide structured feedback regarding the degree to which defined requirements are fulfilled.

Within a quality management system according to ISO 9001, audits are a central element for verifying conformity and effectiveness of the quality management system.

Objectives and Basic Logic of Audits

The objective of an audit is the objective determination of whether defined requirements are being fulfilled and whether the underlying regulations are suitable for achieving the intended objectives.

The fundamental audit logic is based on:

• defined audit criteria
• systematic collection of information
• objective evaluation of evidence
• traceable documentation of results

Audits provide insights into conformity, deviations, and opportunities for improvement without prescribing specific actions themselves.

Types of Audits

Depending on the object of assessment and the objective, different types of audits are distinguished:

• System audit: Evaluation of management systems, e.g. quality management systems
• Process audit: Assessment of the effectiveness of individual processes
• Product audit: Examination of products or services against defined requirements

These audit types differ in focus but follow the same methodological principles.

Internal and External Audits

Audits can also be differentiated according to their organizational origin:

• Internal audits: conducted by the organization itself
• External audits: conducted by independent external bodies or customers

Internal audits primarily serve self-assessment and system improvement, while external audits are often used for formal conformity assessment.

Distinction Between Audits, Inspections, and Testing

An audit must be clearly distinguished from inspections or testing activities. Inspections evaluate specific results or product characteristics, whereas audits assess the systematic fulfillment of requirements at the system or process level.

Audits are therefore retrospective and analytical in nature, rather than operationally controlling.

Role of Audits in Industrial Manufacturing

In manufacturing industries, audits are used for the structured evaluation of complex process landscapes and management systems. They support transparency regarding regulatory conformity and system effectiveness throughout the value chain.

The impact of audits can be seen on several levels:

• Organization: evaluation of system conformity
• Management: objective basis for decision-making
• Processes: identification of structural weaknesses
• Culture: promotion of regulatory awareness and systems thinking

Normative Classification

ISO 9001 requires internal audits to assess the effectiveness of the quality management system. Additional standards such as ISO 19011 provide guidelines for conducting audits without changing the fundamental character of the audit as an evaluation instrument.

Distinction from Methods, Tools, and Software

An audit is a methodological approach and not a software solution. Audit software supports planning, documentation, and evaluation, but does not replace methodological or professional assessment.

FAQ – Frequently Asked Questions About Audits

What is the purpose of an audit?

The purpose of an audit is the objective evaluation of whether defined requirements are fulfilled.

Is an audit a form of control?

No. An audit is a systematic evaluation instrument and not an operational control mechanism.

Are audits mandatory?

Internal audits are part of quality management systems according to ISO 9001, but they are not legally required.

Who conducts audits?

Audits are conducted by qualified and independent individuals.

Do audits directly result in actions?

Audits identify deviations and findings that may form the basis for actions, but they do not define those actions themselves.

Further Internal Content

• Quality Management – Fundamentals (only in German)
• Action Management in Quality Management (only in German)
• Audit Management in the Context of CAQ Software