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Requirements of ISO 9001 Internal Audits for Effective Quality Management System in Any Organization
Reason 1: Major Changes to ISO 9001
Major changes have been made to both standards, including many for which documented procedures are unlikely to exist. Consider just four such examples:
· Context of the organisation, where the monitoring and review of information regarding external and internal issues affecting the organisation is an entirely new concept
· Leadership, where the involvement of management is greatly expanded and the need to involve top management in internal audits is a requirement,
· Planning, where the auditing of actions to address risks and opportunities is now a requirement and, consequently, an understanding of the application of these terms is needed, and
· Organisational knowledge, where both the consideration of tangible and intangible assets is needed.
Reason 2: The Requirements of ISO 9001 Internal Audits
The ISO 9001 internal auditor training helps the company employees to qualify as 'Internal Auditor' for Quality Management System based on ISO 9001:2015. An internal auditor helps auditing the effectiveness of implementation of procedures alone fulfil the requirements. The QMS internal auditor requires audit evidence on whether the QMS/EMA conforms to ‘the requirements of this International Standard’.
Reason 3: The Requirements of ISO 9001 Competence
· ISO 9001 describes competence as an appropriate combination of education training or experience.
· Requires the organisation to ‘take actions to acquire the necessary competence’.
· Education and experience alone cannot make someone a competent internal auditor.
Reason 4: to Secure the Benefits of good Auditing Techniques
To thoroughly audit a QMS/EMS, it is necessary that internal auditors mimic the behaviour of CB auditors. External auditors use many sources of information, which will vary depending on the scope and complexity of the audit, and may include the following.
· observations of activities and the surrounding work environment and conditions;
· documents, such as policy, objectives, plans, procedures, standards, instructions, licences and permits, specifications, drawings, contracts and orders;
· records, such as inspection records, minutes of meetings, audit reports, records of monitoring programmes and the results of measurements;
· data summaries, analyses and performance indicators;
· information on the audit sampling programmes and on procedures for the control of sampling and measurement processes;
· reports from other sources, for example, customer feedback, other relevant information from external parties and supplier ratings;
· Computerized databases and web sites.
Reason 5: To Harvest Improvement Suggestions
Internal audits offer convenient and relaxed opportunities for personnel at all levels and functions within the organisation to point out defects in systems and procedures, and to suggest many small improvements (and occasionally a major improvement) to management systems.
By capturing, reviewing and implementing these suggestions, you help ensure the robustness of the QMS/EMS. And every non-conformance avoided represents a real saving of time, money and other resources.