Speaker 1: Like so many of the sections which make up the ISO 9001-2015 standard, this next section covers a topic which warrants its own course. Internal audit is such a vital part of maintaining a functional and effective quality management system. And although we could go into great detail on the many intricate facets of the internal audit process, we will stick to the specific requirements as stated by the ISO 9001 standard for the purpose of this course. According to ISO 9000, the Fundamentals and Vocabulary Standard, an audit is a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. In other words, making sure that what is happening in practice aligns with policies, processes and procedures. Audits should be carried out to look for areas of improvement and best practice. They should not be adversarial or confrontational. Internal audits should be formal, planned and organized. They are conducted in an impartial and objective manner, following an agreed scope and procedures. Audits are used to gather facts and determine the degree to which requirements are being met. As well as meeting the conformity requirements of ISO 9001, there is a lot of value to be added to an organization by making use of internal audits to gather other valuable information during the audit process. So much can be learned about the overall performance of an organization by simply communicating with people on other issues and ideas. The key is not to simply limit internal audits to conformity issues alone. There is a standard for management systems auditing within the ISO 9001 family, ISO 190011. Organizations contemplating or conducting audits should obtain this invaluable standard. Section 9.2 of the standard states that organizations must conduct internal audits at planned intervals. What does the standard mean by planned intervals? You will notice that there is no actual timeline given. That is because ISO 9001 does not dictate how often an organization is required to audit its own QMS. It's up to the organization to determine how often they will conduct internal audits on its own processes. It is, however, commonly accepted that those intervals be within a 6-month to annual interval, and in fact, if an organization is registered to the ISO 9001 standard, the certifying registrar or certification authority will require a minimum of yearly internal audits as part of its certification acceptance criteria. In order to manage this requirement, organizations can implement an audit schedule, outlining the planned audit intervals, including proposed dates and departments or processes to be audited. The purpose of an internal audit program, or schedule, is to plan the type and number of audits as well as to identify and provide the necessary resources to conduct them. It's also important to note that it is not required to do a complete system audit in one shot. It's perfectly acceptable for the organization to segment or break up the audit process, and plan for particular processes to be audited at specified times, which can be outlined in the audit schedule. Doing this alleviates some of the resources needed as well as the time and disruptions to regular activities. The whole point of the internal audit process is to provide information on whether the quality management system conforms to the organization's own requirements for its quality management system, and that it also conforms to the requirements of the ISO 9001 2015 standard. Now, for the sake of maintaining certification to the ISO 9001 standard, and benefiting from the valuable concepts and frameworks it provides, it's vital that the organization perform internal audits to ensure it is in conformance of the requirements laid out in the standard. This is pretty straightforward, and required as part of the certification process. But most importantly, the organization must ensure it is conforming to the requirements that it has set out for itself. These are the requirements that the organization has painstakingly established in order to produce the products and services it offers to its customers, and is how it maintains a level of customer satisfaction. This is by far the most important set of requirements to maintain conformity to. Without this, the organization does not stand a chance of being successful. Along with management review, internal audit of the organization's quality management system is an essential process for providing confidence in the effective implementation and maintenance of the QMS. Internal audits provide the organization with insights into the adequacy of its processes and documentation, conformance to requirements, how well they are operating, and where improvements are needed most. Is the organization following in practice what they have implemented in process or procedure? Are objectives being achieved? Is there a satisfactory level of customer satisfaction? Are there ongoing efforts to identify continuous improvement opportunities, and are actions being taken to realize these opportunities?