A quality management system (QMS) is a set of policies, processes and procedures required for planning and execution (production/development/service) in the core business area of an organization. (i.e. areas that can impact the organization's ability to meet customer requirements.) ISO 9001:2008 is an example of a Quality Management System.

The Concept of Quality Management

  • A Quality Management System in its basic concept is quite simple. It seeks to: Recognize the external quality related requirements specified in Licenses to Trade, guidelines, specified customer requirements, and the chosen management system standard(s)
  • Ensure that all requirements have been documented within the management system in the appropriate location in terms of defined specific system requirements
  • Confirm that employees receive applicable training in the quality system requirements
  • Outline performance processes, where applicable, to the quality system requirements
  • Produce records or evidence that system requirements have been met
  • Measure, monitor and report the extent of compliance with these performance procedures
  • Continually monitor and analyze changes to the requirements and confirm that all changes are reflected in changes to the specific requirements when necessary
  • Execute the audit and analyze the system processes and correct them when necessary
  • Include processes that will help continually improve the quality system
  • Conducting internal audit is a vital tool to assess organization’s quality management system. The organization gets information in a planned way by conducting internal audit from a variety of sources.

The purpose of conducting internal audit is to find out the answers to following questions:

  • Is quality management system of the organization conformed to the planning of product realization carried out in the organization?
  • Is the quality management system of the organization conformed to the requirements of ISO 9001:2008 QMS Standard?
  • Is the quality management system of the organization conformed to the quality management system requirements established by the organization?
  • Is the quality management system of the organization effectively implemented and maintained?

An internal audit is a tool to monitor and determine the health of the quality management system of the organization. For an organization, a properly conducted audit is beneficial and we need to conduct value added internal audit that is useful to the organization, auditee department, management representative and top management.

Clause 8.2.2 of ISO 9001:2008 QMS Standard deals with internal audit requirements. As per requirements of ISO 9001:2008 QMS Standard, an organization needs to conduct internal audit at planned intervals. An audit process should include the following aspects:

  • Planning of internal audit – such as planning of audit schedule, assignment of auditors, auditee area, and scope of audit, status and importance of processes, results of previous audits.
  • Examining and reviewing the quality management system documentation of the organization,
  • Examining and reviewing other relevant information of the organization, such as production reports, failure trends, customer complaints, customer survey reports etc.
  • Examining and reviewing the quality management system procedures and processes by visiting the audit area spot, interviewing relevant personnel and looking to relevant processes.
  • Reporting the internal audit results (including corrective action requests from auditors).
  • Verifying corrective actions taken.

An organization should have a documented procedure for conducting internal audit that define and narrate the following aspects:

  1. Audit criteria
  2. Scope of the audit
  3. Frequency of audit
  4. Audit methods
  5. Responsibilities and requirements for planning and conducting internal audit
  6. Relevant audit records (including results of audit) to be established and maintained
  7. Reporting results of the audit.