An internal audit assesses an organization's quality management system and overall performance to ensure compliance. It evaluates the effectiveness of policies and identifies opportunities for improvement. Principles of auditing include ethical conduct, fair presentation, professional care, independence, and an evidence-based approach. Auditors should prepare thoroughly, follow audit principles, build rapport, and focus on driving improvement rather than fault-finding. Common audit types are system audits of the quality management system and process audits of specific operations. Internal audit checklists help determine compliance and identify areas for corrective action.
An internal audit assesses an organization's quality management system and overall performance to ensure compliance. It evaluates the effectiveness of policies and identifies opportunities for improvement. Principles of auditing include ethical conduct, fair presentation, professional care, independence, and an evidence-based approach. Auditors should prepare thoroughly, follow audit principles, build rapport, and focus on driving improvement rather than fault-finding. Common audit types are system audits of the quality management system and process audits of specific operations. Internal audit checklists help determine compliance and identify areas for corrective action.
An internal audit assesses an organization's quality management system and overall performance to ensure compliance. It evaluates the effectiveness of policies and identifies opportunities for improvement. Principles of auditing include ethical conduct, fair presentation, professional care, independence, and an evidence-based approach. Auditors should prepare thoroughly, follow audit principles, build rapport, and focus on driving improvement rather than fault-finding. Common audit types are system audits of the quality management system and process audits of specific operations. Internal audit checklists help determine compliance and identify areas for corrective action.
An internal audit assesses an organization's quality management system and overall performance to ensure compliance. It evaluates the effectiveness of policies and identifies opportunities for improvement. Principles of auditing include ethical conduct, fair presentation, professional care, independence, and an evidence-based approach. Auditors should prepare thoroughly, follow audit principles, build rapport, and focus on driving improvement rather than fault-finding. Common audit types are system audits of the quality management system and process audits of specific operations. Internal audit checklists help determine compliance and identify areas for corrective action.
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INTERNAL AUDIT company’s management policies and
policies whilst providing suitable objective
What is an Internal Audit? The purpose of information that your company can act upon an internal audit is to assess the to continually improve its performance. effectiveness of your organization’s quality management system and your organization's Adherence to the following principles are overall performance. Your internal audits considered to be a prerequisite for ensuring demonstrate compliance with your ‘planned that the conclusions derived from the audit arrangements’, e.g. the Quality Management are accurate, objective and sufficient. It also System (QMS) and how its' processes are allows auditors working independently from implemented and maintained. one another to reach similar conclusions when auditing in similar circumstances. Why perform Internal Audits? The following principles relate to auditors. 1. Ensuring compliance to the 1. Ethical conduct: Trust, integrity, requirements of internal and industry confidentiality and discretion are standards & regulations, and customer essential to auditing requirements 2. Fair presentation: Audit findings, 2. To determine the effectiveness of the conclusions and reports reflect truthfully implemented system in meeting specified and accurately the audit activities objectives (quality, environmental, 3. Professional care: Auditors must financial) exercise care in accordance with the 3. To explore opportunities for importance of the task they perform; improvement 4. Independence: Auditors must be 4. To meet statutory and regulatory independent of the activity being audited requirements and be objective 5. To provide feedback to Top 5. Evidence-based approach: Evidence Management must be verifiable and be based on samples of the information available. The auditor should avoid: Selection of Auditors 1. Finding guilty parties or specifying that a particular person made a mistake; Competence level may be measured by 2. Seeing problems universally; training, participation in previous audits and 3. Producing an evasive report; experience in conducting audits. Auditors 4. Applying unnecessary technical may be external or internal personnel; terms; however, they should be in a position to be 5. Lauding their own work. The report impartial and objective. should have a natural and straightforward tone. When internal personnel are selected to perform an audit, a mechanism needs to be Principles of Internal Auditing established to ensure objectivity, for Auditing relies on a number of principles instance, a representative from another whose intent is to make the audit become an department may be selected to do the audit. effective and reliable tool that supports your Audits are demanding and require various forms of expertise. The size of the audit simply good audit practice. Putting these team will vary pending the size of the sections into a worksheet format gives organization, size and type of operations and auditors a guide to follow, to ensure the the scope of the audit. relevant links are audited.
The Human Aspect of Auditing
Preparing for the Audit Good auditors realize very early on that they Before the audit, prepare thoroughly! are dealing with personalities as much as Spending time in preparation will make you processes, systems, and papers. Whilst the much more effective during the audit - you intent of the audit is a serious one, often will become a better auditor. Auditors light humor, politeness and diplomacy are should not skip this step as it provides much the best ways to build rapport. It is vital to needed value to the audit. Taking the time to note that every effort is made to reassure prepare and organize actually saves time those being audited that the audit’s primary during the audit. function is to drive improvement, not to name and shame. You should have an up-to-date audit schedule and a well-defined audit plan for If you are new to auditing, acknowledge this each process. Be sure to communicate the fact, be open and honest. It is also important audit schedule to all parties involved as well to explain to the auditees that they are free as to Top Management as this will help to express their views during the audit. reinforce your mandate. Remember that you, the auditor, are also there to learn. Gather together all the relevant documented information that relates to the process you Always discuss the issues you have will be auditing. Look at process metrics, identified with the auditees and always work instructions, turtle diagrams, process provide guidance on what is expected in maps and flowcharts, etc. If applicable, terms rectifying any non-conformances or collect and review any control plans and closing out observations you raised. Let the failure mode effects analysis work sheets auditees know they are welcome to read too. Review these thoroughly and highlight your notes and findings; the audit is not a the aspects that you plan to audit. Using the secret – except the SPOT AUDIT. documented information ensures they become audit records. Try not to be drawn into arguments concerning your observations. It is never Your organization’s documented appropriate to directly name people in the information may not cover all of the audit report as this may lead to requirements that may be relevant to the defensiveness which is ultimately counter- process. If certain information is not productive. available, it may become your first audit finding, not bad for the pre-audit review! Types of Internal Audit Internal audits are commonly referred to as Certain information and linkages should be ‘first-party audits’ and are conducted by an audited. Some are required and some are organization to determine compliance to a set of requirements which might arise from An internal audit checklist will help you to standards like ISO 9001:2015, as well as determine the extent to which your customer or regulatory requirements. organization’s quality management system conforms to the requirements by There are common methods of internal determining whether those requirements auditing that may be used to determine have been effectively implemented and compliance: maintained. The templates will help you to 1. System Audits assess the status of your existing 2. Process Audits management system and identify process 3. Product Audits weakness to allow a targeted approach to prioritizing corrective action to drive improvement. System Audits The internal audit checklist is just one of the The system audits are best undertaken using many tools which are available from the the internal audit checklist. This type of auditor’s toolbox that helps to ensure each audit focuses on the organization’s quality internal audit addresses the necessary management system as a whole, and requirements. It stands as a reference point compares the planning activities and broad before, during and after the audit process system requirements to ensure that each and if developed for a specific audit and clause or requirement has been used correctly will provide the following implemented. benefits:
Process Audits 1. Checklists can be used as a reference
for planning future audits 2. Checklists can be provided to the The process audit is an in-depth analysis auditee prior to the audit which verifies that the processes comprising 3. Checklists can provide a means of the management system are performing and communication producing in accordance with desired 4. A completed checklist provides outcomes. The process audit also identifies evidence the audit was performed any opportunities for improvement and 5. Ensures the audit is conducted possible corrective actions. Process audits systematically and consistently are used to concentrate on any special, 6. Ensures a consistent audit approach vulnerable, new or high-risk processes. 7. Actively supports the organization’s audit process Product Audits 8. Provides a repository for notes collected during the audit process The product audit may be a series of audits, 9. Ensures uniformity in the at appropriate stages of design, production performance of different auditors and delivery to verify conformity to any 10. Provides reference to objective specified product requirements, such as evidence dimensions, functionality, packaging and 11. Audit checklists provide assistance labelling, at a defined frequency. to the audit process The internal audit checklist comprises tables of the certifiable (‘shall’) requirements, from Use an Internal Audit Checklist Section 4.0 to Section 10.0 of ISO activities and processes with what the 9001:2015, each requirement is phrased as a standard requires. At the end of this activity question. you will have a list of activities and processes that comply and ones that do not A Gap Analysis comply. The latter list now becomes the The gap analysis will likely be your first target of your implementation plan. ISO 9001:2015 audit. The gap analysis checklist highlights the new requirements Preparing the Audit Report contained in ISO 9001:2015 but it not A good summary report is the output which intended to cover all of the requirements is the value of the audit. It deserves an from ISO 9001:2015 comprehensively. appropriate amount of attention and effort. As you moved through the audit, you should The unique knowledge obtained about the have noted the issues and observations you status of your existing quality management saw. These should have been marked clearly system will be a key driver of the so you are now able to quickly review and subsequent implementation approach. capture them as you write the report. Armed with this knowledge, it allows you to establish accurate budgets, timelines and These findings and conclusions should be expectations which are proportional to the formally documented as part of the summary state of your current management system report. Too often, the audit report only when directly compared to the requirements recites back facts and data the managers of the standards. already know. The value is in identifying issues and opportunities they do not know! Your organization may already have in place This summary should be reviewed first with an ISO 9001:2008 compliant quality the lead auditor, then the Process Owner and management system or you might be Management Team. Make final revisions running an uncertified system. If this is the and file the audit report and all supporting case, you will want to determine how audit materials and notes. closely your system conforms to the requirements ISO 9001:2015. Gather the whole audit package together, in an organized manner. The rest of the work The results of a gap analysis exercise will instructions, flowcharts, notes and relevant help to determine the differences, or gaps, papers should be gathered into the audit between your existing management system package as supporting records. All findings and the new requirements. Not only will the should also be documented on your analysis template help you to identify the corrective action forms. The audit summary gaps, it will also allow you to recommend and the corrective action forms should be how those gaps should be filled. attached to the audit package, which now becomes the audit record. Only the summary The gap analysis output also provides a report and corrective actions need be given valuable baseline for the implementation to the process owner. process as a whole and for measuring progress. Try to understand each business process in the context of each of the requirements by comparing different Elementary Audit Questions 20. How are quality objectives determined? These basic audit questions will help guide 21. Is there a clear link between the the audit in the right direction since the policies and objectives? answers they provide often unlock the doors 22. How is progress towards objectives to information the auditor requires in order measured and communicated? to accurately assess the particulars of a 23. Has the number of customer process. complaints changed over time? 24. What tools are used to identify the causes of complaints? Consider these common audit questions: 25. How are improvement efforts and 1. What are your responsibilities? successes communicated to employees? 2. How do you know how to carry them Getting the Most from the Audit Schedule out? The audit schedule is divided up to reflect 3. What kind of training is given to new each section of ISO 9001 You should employees? determine which of these sections are of 4. How is the effectiveness of training greatest relevance to your business; in other evaluated? words, which processes, should there be 5. Are training records maintained? problems, will affect your customers the 6. What are the objectives of your most. These are the processes that your processes? company must make certain remain stable 7. What is the quality policy and where and consistent. You might wish to schedule is it found? these key processes for additional audits, 8. Which documents do you use and are perhaps two or even three times per year. they correct? 9. What outputs does your process create? The audit schedule provides the following 10. How are your records maintained? benefits: 11. How do you ensure that products 1. Provides a visual plan of the audit meet the stated requirements? programme 12. Is customer satisfaction data 2. Demonstrates coverage of the whole analyzed? standard 13. How do you ensure that products 3. Provide current status of the audit meet the stated requirements? programme 14. What happens when changes are 4. Promotes awareness made to product requirements? 15. What are the Other types of Audit responsibilities/authorities for dealing Certification Audit with non-conformances Surveillance Audit 16. Are there trends in non-conforming Is a Certified Auditor "required" to do an products and what's being done about it? internal audit or can the company do the 17. Is the non-conformance procedure internal audit themselves? linked to the corrective action process? 18. Are employees made aware of the You do not need a 'Certified Auditor' to quality policy and objectives? undertake internal quality audits of your 19. Are policies and objectives available management system and its processes. and relevant? Internal Auditors can be people from within your organization who possesses the necessary competence and impartiality to undertake internal audits in order to ensure effective operation of your organization's processes. The Internal Auditors often report to the Quality Manager.