Quality Audit

A quality audit is the systematic assessment that an organisation's quality management system is applied as defined and delivers the intended results. It may be carried out as a first-, second- or third-party audit; the party determines what the output will be.

The aim is to verify that the quality system works on the shop floor rather than on paper, and to surface areas for improvement.

• Organisations establishing and maintaining a management system
• Companies preparing before certification
• Buyers assessing their supplier's quality system
• Businesses experiencing a decline in quality performance
• Senior management required to present assurance to the board

The criteria are the quality management system standard applied (ISO 9001 and its sector derivatives), the organisation's own procedures, customer requirements and applicable legislation.

• Deployment of the quality policy and objectives
• Process definitions and process ownership
• Documented information and records management
• Design and development control (where applicable)
• Purchasing and external-supplier control
• Control of production and service provision
• Suitability of monitoring and measuring resources
• Control of nonconforming output
• Customer satisfaction and complaint management
• Internal audit and management review
• The effectiveness of corrective actions
• Evidence of continual improvement

• ISO 9001
• ISO 19011
• IATF 16949
• AS9100
• ISO 13485

1. 1Defining the Scope and CriteriaWhat is to be audited and against which criteria is set out in writing: a customer code of conduct, a specification, a standard or a checklist.
2. 2Preliminary Information GatheringThe size and activity of the party to be audited, its audit history and any open nonconformities are reviewed.
3. 3Audit PlanThe audit date, team and timetable are prepared; the areas to be visited and the roles to be interviewed are planned.
4. 4Opening MeetingThe purpose, scope, method and reporting format of the audit are explained; the principles of confidentiality and impartiality are confirmed.
5. 5On-site AuditProduction or service areas are walked, records are examined and workers are interviewed. Findings are recorded on the spot.
6. 6Classification of FindingsDeterminations are graded according to the classification of the scheme in use (critical / major / minor / observation).
7. 7Closing MeetingThe findings are presented to management, their justification is explained and the expectation for corrective action is set out.
8. 8Report and Follow-upThe audit report is issued; a corrective action plan is obtained and its close-out is followed up. Where necessary a follow-up audit is carried out.

Findings are classified as a nonconformity (major/minor) or an opportunity for improvement, each resting on objective evidence. Widespread findings showing that a system requirement is not met at all, or that effectiveness has broken down, fall into the major category.

• Details of the audit body, the auditor and the auditee
• Date, duration and scope of the audit
• Criteria or checklist applied
• Areas and processes audited
• Findings and their classification
• Evidence and photographs supporting the findings
• Scoring or rating, where the scheme requires it
• Corrective action plan and close-out status

This audit documents the situation observed at the time of the audit and within the scope audited. Auditing is sampling-based: the records examined and the areas visited are selected to represent the whole, but this does not mean that every record was checked. The report is neither a guarantee nor a certificate, and it does not relieve the auditee of its responsibility.

Accreditation differs with the type of audit. Third-party audits underpinning management system certification are carried out under ISO/IEC 17021-1 and those underpinning product certification under ISO/IEC 17065; these scopes are subject to accreditation. First- and second-party audits, and audits governed by a scheme owner's own rules (such as SMETA or amfori BSCI), do not fall within accredited certification; they are conducted following the ISO 19011 guidance and produce a report. EUROLAB holds internationally recognised accreditation under ISO/IEC 17021-1 and ISO/IEC 17065, granted by accreditation bodies that are signatories to the IAF multilateral recognition arrangement; which audits can be offered within accredited scope is confirmed in writing at the quotation stage.

• Supplier Audit
• Factory Audit
• Process Audit
• Product Audit
• Compliance Audit
• Technical Audit
• Supply Chain Audit