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Reinforcement of Quality Behavior Internal Audit Activities

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Competence of internal auditors

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Objectives-process-results

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ISO 9001:2008

Internal Audit
The Value Added of ISO 9001 Internal Audit

The Value added of Internal Audits

ISO 9001

The internal audit is a real and effective measurement of all processes of quality management system. Is an accurate picture of company's strengths, weakness and results. Audit decisions are based on audits finding, on operations results and on audit evidences. Focus on conformity, on prevention and on continual improvement. Effective management review process, better value added and people involvement. Those are the benefits that can be achieved with the ISO 9001:2008 Internal Audit.

1. The reinforcement of quality behavior

The internal audit is one of the most powerful tools for the implementation, maintenance and improvement of ISO 9001:2008 system. Every process of the system is audited by independent and qualified internal auditor and the results are reported to the top management for actions focused on prevention and continual improvement. Internal audit is defined by ISO 19011 standard as systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled. In several businesses, day-to-day supervision of employees is simply impractical or can be made on higher cost that will decreases organization's competitiveness. Well-organized and planned internal audits help companies to meet customers expectations with greater consistency. Internal audit empowers employee confidence by reducing their supervision and by enabling a quality behavior in performing their work. The internal auditors provide reliable picture of company's processes and results to top management. The internal audit reinforces the discipline, liberates employees working in the audited areas and enables their involvement in the continual improvement process.

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2. Internal Audit Activities

The internal audit is a process with six activities (Figure 1): 2.1 Initiating the internal audit Establish an internal audit program and schedule, and allocate the internal auditors. Define the objectives and scope for each internal audit (by process, by procedures, by departments and by ISO 9001:2008 elements). Communicate the audit program and schedule to the responsible of audited areas and processes. 2.2 Conducting document review The purpose of document review is to evaluate the conformity of procedures and described process to the ISO 9001:2008 requirements. The purpose is also to verify document's cohesion to the real practices used in day-today activities. The latest versions of controlled documents are to verify. The preparation of audit questions is important factor in this stage for effective internal audit. 2.3 Preparing the internal audit The purpose of this activity is to prepare the internal audit schedule, to consolidate internal audit team, to prepare the work documents, audit samples, audit check-list and audit questionnaire. 2.4 Conducting on-site internal audit On-site internal audit involves: Opening meeting Communication during the audit Roles of guides and observers Gathering and verifying information Generate audit findings Preparing audit conclusions Closing meeting The open communication with the auditee for the acknowledgement of non-conformities is recommended for effective and transparent internal audit. 2.5 Internal Audit Report The internal chef auditor prepares and approves the internal audit report. The report is the summary of the audit results and audit decisions, indicating the status of the audited process of the ISO 9001 system. The internal audit report includes the non-conformities found during the audit and the request for preventive and corrective actions. 2.6

PRINCIPLES OF AUDITING Ethical conduct Exact presentation Professional care Independence Evidence-based approach
Completing the Audit and Follow-up

The internal audit results are communicated to the top management. The requested corrective and preventive actions are transmitted to the process managers and they shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes.

Initiation Review Preparation On-site audit Audit report Audit completion

Figure 1: Internal Audit activities The internal audit results combined with the customer satisfaction results and analysis of other relevant data are powerful enablers for the company management to take actions on quality goals, business results and strategy. The areas for improvements and innovation are determined and are based on the reliable data and audit finding. The management review analyzes the audit results, decides improvement actions and follows up on the implementation. The decided actions are focused on improvement of human competence, process effectiveness, prevention of problems, and on continual improvement of customer satisfaction and the quality of products and services.
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3. Competence of internal auditors

An effective internal audit needs knowledgeable and skilled internal auditors. Existing or new internal auditors must be trained on: 1) The requirements and processes of ISO 9001:2008 standard; 2) The internal audit activities according to the ISO 19011 standard. The internal auditors competence is based on knowledge, education, personal attributes, training and working experience. The generic knowledge of internal auditors involves good quality behavior, quality management and communication skills. The specific skills of internal auditors involve the knowledge of their organization, processes, product and services. The personal attributes of internal auditors involve: ethics, open mind, observance, perceptivity, versatility, tenacity, decisiveness and self-reliance. Education, internal audit training and experience complete the profile of the competent internal auditor.

5. The value-added of internal audits

The internal audits contribute to maintain conformity to the ISO 9001:2008 standard, to improve the maturity of quality management system, to ensure fulfillment of product requirements and to improve customer satisfaction. In fact is the only tool that ensures that all processes of quality management system are effective, capable and connected. The external audit conducted by registrar is limited to standard compliance and to product requirements.

Conformity Maturity Efficiency

4. Objectives - Process - Results

The process approach of the new ISO 9001:2008 standard require to focus on delivered results and desired outcomes. Some processes are well documented, another have only flowchart description. This requires an objective-process-results approach for auditing that differs from the traditional documentation-record based approach. To audit effectively the processes with complete, with little or without documentation, the internal auditor must follow the process flow: the input, the process activities and the results. The internal auditor must be focused on the objectives, on the criteria for process control and should review the data and results from different sources to produce reliable audit report. The most important questions are: Are the quality objectives met? Are the customers requirements met? Have the processes the capability to meet customer, product and standard requirements? Are the taken actions effective? Do we have opportunities to do better? Figure 2: The value-added of internal audits The internal audit can improve the process efficiency, with the subsequent or immediate improvement actions on inefficient process found during the audit. If internal audit is focused on continual improvement, is a value added tool and can consider: redefinition of quality objectives, set-up of improvement goals, preventive actions, reallocation of resources, reduction of non-quality cost, improvement of customer satisfaction and product innovation. The internal audit can improve directly the operational profits of organization. The review of the internal audit results is one of the best continual improvement tools for the top management. The management review is a generator of corrective, preventive and improvement actions and decisions focused on improvement of process efficiency and on achievement of desired goals and results.

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