Internal Quality Auditor Training Program

[Audio] Good afternoon everyone, and welcome to today's presentation on the Internal Quality Auditor Training Program of EU ISO 13485:2016. Through this program, our goal is to provide everyone with the knowledge and resources to become an effective auditor in their respective industry. Please be aware that this training program is only applicable to those industries that are compliant with the EU ISO 13485:2016 standard. We look forward to a successful session today..

[Audio] This slide covers the Internal Quality Auditor Training Program of EU ISO 13485:2016. We will look into the ISO 13485 Quality Management System and product regulatory requirements, auditing techniques, identification of non-conformities and report preparation, and personal test- an open book examination. This will help build the capacity of quality system auditing and ensure compliance with regulatory requirements..

[Audio] I will be introducing you to the Training Program of EU ISO 13485:2016. Quality is the degree to which a set of characteristics fulfil the requirements. Such characteristics can either be qualitative or quantitative, physical, functional or behavioural or a distinguishing feature that can be inherent or assigned. The requirement for achieving Quality may be stated, implied or obligatory and can refer to many different aspects such as safety, reliability, conformance and durability. The ISO 13485 Quality Management System, or QMS, is an internationally recognized standard that defines requirements of quality management system applicable to organisations providing medical devices. EU ISO 13485:2016 sets out the requirements for implementation and maintenance of a Quality Management system and achieves regulatory compliance. I am sure that with the introduction of this Training Program, you will be able to gain the necessary knowledge and skills to become an Internal Quality Auditor for EU ISO 13485:2016..

[Audio] Good morning everyone, today we are discussing the Quality Management System. A Quality Management System can be defined as a set of coordinated activities to direct and control an organization in order to continually improve the effectiveness and efficiency of its performance. This diagram illustrates the various aspects of QMS as well as the interactions between the various components. It shows the importance of customer and regulatory authorities at both the input and output level, as well as the relationship between the various value-adding activities and process interactions. We will be discussing each of these components in further detail throughout the course of our training program. Thank you..

[Audio] We will begin with the ISO 13485, which is the Quality Management System for Medical Devices. Then, we will discuss the ISO/TS 16949 for the Automotive Industry, the AS 9100 for the Aerospace Industry, the ISO 14001 for Environmental Management, the ISO 27001 for Information Management Security, and OSHAS 18001 for Occupational Health and Safety Management System. Lastly, we'll cover the ISO 9001, the General Quality Management System. Let's get started!.

[Audio] As part of this Internal Quality Auditor Training Program for EU ISO 13485:2016, we will be discussing ISO 13485. This standard is a process standard, not a product standard. Its primary objective is to facilitate harmonised medical device regulatory requirements for Quality Management Systems. It is also a stand alone standard that is based on ISO 9001..

[Audio] The purpose of the Internal Quality Auditor Training Program of EU ISO 13485:2016 is to help establish, document, and maintain a quality management system that focuses on designing, developing, purchasing, producing, installing, and servicing medical devices and related services. A well-documented, implemented, and maintained quality management system or QMS is essential to demonstrate the capability to provide medical devices and related services that meet both customer expectations and regulatory requirements. Organizations must also evaluate how well the customer expectations, and regulatory requirements are met..

[Audio] In this slide, we will be discussing why it is important for organizations to have a fully documented, implemented, and effectively maintained quality management system. This quality management system will ensure that three important requirements are met: that customers needs and expectations are met consistently, that products are developed and manufactured at an effective cost, and that organizations have access to the global market..

[Audio] The Internal Quality Auditor Training Program of EU ISO 13485:2016 is designed to help organizations understand and apply quality management systems and regulations in order to ensure their products and services meet the requirements of the standard. Quality management systems are necessary to achieve and maintain compliance with EU ISO 13485:2016. During the program, attendees will acquire knowledge of the concepts, principles and requirements of a quality management system, as well as how to apply them in their organization's operations..

[Audio] We will be discussing the Internal Quality Auditor Training Program for EU ISO 13485:2016. Adherence to the regulations of ISO 13485:2016 is paramount to ensure a successful implementation of the Quality Management System. This includes requirements for general roles, risk-based process control, changes to the QMS process, evaluation of impacts, quality agreements for outsourced processes, and validation and revalidation of the computer software used in the QMS. Additionally, the quality manual should include explanations for exclusions and non-applicability, a medical device file, and controls for documents and records with a corresponding retention period..

[Audio] I'd like to talk to you about the Internal Quality Auditor Training Program of EU ISO 13485:2016. This program covers two distinct aspects - firstly, Management Responsibility, which includes Management Commitment, Customer Focus, Quality Policy, Quality Planning and Objectives, Responsibility and Authority, Communications and finally Management Review. Secondly, we have Resource Management, which covers the provision of resources for an effective QMS and customer/regulatory requirements, Human Resources for Competency and Training, Infrastructure and Work Environment, and finally Contamination Control..

[Audio] We'll now discuss the Internal Quality Auditor Training Program of the EU ISO 13485:2016 Quality and Regulatory Training. This program focuses on the core elements of ISO 13485:2016, as well as their respective Quality Management System requirements. These requirements involve Planning of Product Realization, Product Realization, Customer-Related Processes, Design and Development, Purchasing, Supplier Evaluation and Re-evaluation, Purchase and Inspection, Production and Service Provisioning, and Control of Monitoring and Measuring Devices. We'll be examining each topic in depth, with the goal of gaining an understanding of why they are necessary for successful Quality Management System management. Let us dive into the Internal Quality Auditor Training Program and begin our productive discussion..

[Audio] We'll now review the Monitoring and Measurements for the Internal Quality Auditor Training Program of the EU ISO 13485:2016. This includes Feedback, Customer satisfaction, Complaint handling, Reporting to Regulatory authorities, Internal audits, Monitoring & Measurement of Processes and Products, as well as Control of Non-conforming Products before and after delivery, and Rework. Additionally, Analysis of Data and Improvement, Audit results, PMS, MRM, Analysis data, CAPA, Corrective action and Preventive action are all part of the Quality process. This concludes our Monitoring and Measurements review..

[Audio] The Internal Quality Auditor training program of the EU ISO 13485:2016 focuses on the importance of Quality Policies. Quality Policies are statements or documents issued by top management in an organisation which reflect the organisation's commitment to providing quality products and services. These policies are based on the vision and mission of the organisation and are essential components of any ISO standard. Quality Policies must include the organisation's commitment to meeting customer requirements, continually improving their Quality Management System, establishing and reviewing Quality Objectives, and communicating Quality Policies throughout the organisation..

[Audio] I am going to talk to you about Quality Objectives and how they are related to the EU ISO 13485:2016 Quality and Regulatory Training Program. Quality Objectives are the measurable steps towards achieving organization’s quality policy, either determined while establishing Quality Management System or reviewed and agreed during management review meetings. Top management must ensure that the quality objectives, including those needed to meet applicable regulatory requirements and product requirements are established and should have relevance at all levels of the company, meaning that each employee should understand how their job supports meeting the Quality Objectives. To ensure that employees understand their role in the organization, SMART objectives should be designed, meaning Specific, Measurable, Achievable, Relevant and Time-based. So, let's get started..

[Audio] As can be seen on this slide, medical device manufacturers wanting to place their products in various markets must adhere to the regulatory requirements of those countries. An overview of the regulatory requirements of the five founding members of the IMDRF, or GTHF, is shown. Manufacturers must keep up to date with the necessary certifications to guarantee their products meet all regulatory requirements. This is for the month of March 2023..

[Audio] We are going to learn about the regulatory controls of five IMDRF founding members. The European Union's compliance label is the CE Mark and requires ISO 13485, while in the United States it is the 510k/PMA backed by the QSR 21 CFR part 820, and Australia requires an ARTG number with ISO 13485 and MDSAP. Canada requires a device license certified by the CMDR with MDSAP, Japan requires a Shounin approval with both MDSAP and QS Standard for medical devices, and India has an Indian certification with ISO 13485 and ICMED 13485, effective from January 2018. Let's review each of these terms in more detail..

[Audio] We are here to discuss the Internal Quality Auditor Training Program of EU ISO 13485:2016. This program is designed to help us learn and understand the quality and regulatory standards. Learning is an interactive process, so we must be open to new ideas from our peers and colleagues. Everyone present is a valuable asset and we are all committed to the success of this program. We must have a "show me" attitude and acknowledge any ideas and thoughts in order to work together successfully. Silence does not mean non-involvement, and inauditing techniques, it is essential that we all understand and learn from each other. Let's get to work and have a fruitful session..

[Audio] Today, I will explain what is Quality Audit and Audit Evidence. Quality 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. Audit Evidence is a record, statement of facts or other information which are relevant to the audit criteria and are verifiable. It must be based on actual observation, uninfluenced by emotions or prejudice, quantitative or qualitative, stated or documented and meaningful data..

[Audio] This Internal Quality Auditor Training Program of EU ISO 13485:2016 will explore the multitude of components that make up the quality and regulatory system. We'll review the Quality Manual and associated policies, procedures, and requirements. Additionally, we'll look into the distinct roles of the auditor, auditee, and any audit findings. Lastly, we'll consider nonconformities, corrective actions, and preventive actions to stave off causes. I'm eager to assist you in navigating the program and to impart my knowledge so that you can put it to use in your daily work..

[Audio] Concerning types of audits, Internal Audits involve a company evaluating its own products or services, External Audits are when a customer evaluates the supplier and Third-Party Auditing is when an independent organisation reviews the company and its services. The EU ISO 13485:2016 Internal Quality Auditor Training Program provides an opportunity to gain a deeper understanding of these different types of audits..

[Audio] We are discussing the EU ISO 13485:2016 Internal Quality Auditor Training Program, designed to allow organizations to audit their own systems and find any weaknesses or strengths against the necessary requirements. This process involves looking into internal policies, regulations and standards to ensure a safe and efficient system. Audits allow organizations to assess their own performance and take necessary steps to improve where needed..

[Audio] Welcome everyone, this slide is dedicated to the Internal Quality Auditor Training Program of EU ISO 13485:2016. Here we are going to talk about the purpose and benefits of an Internal Audit. The purpose of an Internal Audit is to collect audit evidence in order to check the effectiveness of Quality Management Systems implementation and maintenance in an organization. The Internal Audits are useful for many reasons. They are a powerful tool for continual improvement, serve as a control mechanism used by management and guarantee that non-compliance is detected before external entities do. Internal Audits also ensure compliance with applicable regulatory requirements. Thank you for being here..

[Audio] Topic of discussion is Internal Quality Auditor Training Program of EU ISO 13485:2016. We will be covering two objectives. First objective focuses on preparing for an internal audit. This includes understanding tasks that need to be accomplished prior to an audit, who is conducting the audit and what standards or criteria must be met. Second objective covers performance of an internal audit. This includes understanding how to document results of the audit and what actions need to be taken post audit. Exciting to begin!.

[Audio] We are going to look at the important topic of internal quality auditor training program of EU ISO 13485:2016. Planning an internal audit program, which is normally completed by the management representative, needs to consider how much work is involved and the date, time and duration of the audit. The internal auditors need to be selected and specific tasks assigned to them. It is also important to ensure the availability of the auditors and the Auditee, as well as their preparation. This topic is of great importance and we will explore it further..

[Audio] We are discussing the Internal Quality Auditor Training Program of EU ISO 13485:2016. Breaking down the preparation of internal audits, we will look at factors such as independence of the activity being audited, audit duration, geographical location, technical knowledge required, language familiarity and acceptability. Methodology for the preparation of checklists, composed of bullet points and questions, will also be discussed. Audit frequency, covering results of previous audits, changes to the QMS, any serious concerns and any specific customer requirements, will also be part of our conversation. Looking forward to discussing these important topics..

[Audio] Good morning everyone. Today, I will be talking about the importance of checklists when it comes to auditing. Checklists are useful because they provide a systematic and comprehensive approach to audit. This helps to ensure objectivity and accuracy of the results. The use of checklists also allows audits to be completed in a timely manner and provides evidence of the audit coverage. Checklists can also be used as a guide and memory jogger, to collect and collate notes during the audit, and to help prepare the audit report and reduce the risk of losing important information. All these benefits make checklists a valuable tool when conducting an audit. Thank you..

[Audio] Describing the scope of the internal audit and identifying the factors that contribute to an audit's success are key elements of the Internal Quality Auditor Training Program of EU ISO 13485: 2016. It is essential to confirm that all relevant parties have been informed of the program, explain any requirements and criteria, and review relevant records. Observations of the process must be done to ensure that the required standards are met. It is important to remember not to review personnel, disciplinary, finance, or HR records that are not related to the audit scope. Moving forward with the Internal Quality Auditor Training Program of EU ISO 13485: 2016 is essential..

[Audio] We are now discussing the Conducting the Internal Audit – Sample Selection section of the Internal Quality Auditor Training Program of EU ISO 13485:2016. To conduct an internal audit, the auditor must choose a random sample that covers the scope and time parameters of the audit. The auditor should choose a minimum of 3 to 5 samples. The aim of the audit is to determine the existence, operation, and effectiveness of the quality system. In order to gather evidence, the auditor can use different techniques such as discussion with people, verification of the facilities and environment, verification of documents and records, and observation of work in progress. If necessary, a product audit can also be conducted. It is important to remember to take notes during the audit process..

[Audio] Good morning everyone. Today, I'd like to talk about the Internal Quality Auditor Training Program of EU ISO 13485:2016. Auditing techniques are the crux of this program, and can be accomplished through discussion with people, verification of facilities and the environment, documents and records, observation of the work-in-progress, and product audit. It is also important to look out for evidence collecting information. We should observe how the people react to our questions, if they know their jobs, if they are organised, if they are aware of their procedures, and if they act quickly on nonconformity. However, we must avoid taking a policeman attitude. It is also important to trace forward and backward, take spot checks and samples of products and documents, and make written notes on the facts gathered. We must also take a look at the general housekeeping and condition of the equipment. Thank you..

[Audio] Fact finding is an essential element while conducting an audit and quality auditors must possess the qualities of six honest servants - what, why, when, how, where, and who. To properly audit, however, requires one more servant - “show me”. This seventh servant will use questioning techniques to reveal hidden facts. For a succinct description of the traits auditors should possess, look no further than Rudyard Kipling’s poem “Six Honest Men.”.

[Audio] I will be discussing the different types of questions to ask when auditing. With the EU ISO 13485:2016, it is important for auditors to be able to ask the right questions in order to get the necessary information. In this presentation, I will focus on open and closed questions. Open questions are those which cannot be answered with a simple yes or no, such as “Can you please tell me what you do?” Open probes are essential to ensure that the responder has to give detailed information. Closed questions on the other hand, yield a simple yes or no answer, such as “Are you responsible for this?”, and should only be used sparingly. A neutral tone should be used and the aim should be to obtain factual evidence in a polite, yet professional, manner. I hope this brief discussion has provided you with the tools to ask the right questions during your audits..

[Audio] Topic of discussion is Internal Quality Auditor Training Program of EU ISO 13485:2016. Combining seven servants with “else” or “if” is essential when interrogating an auditee. Examples of this include “What if?”, “Who else?” and “Suppose....then what?”. When the auditee cannot provide the necessary information, gently ask “I do not understand. Could you explain that again, please?”. Silence is key after a brief answer. Remain silent for a moment to motivate the auditee to provide more information. Let's discuss how to apply this in our daily activities..

[Audio] Good morning everyone! Today, we will focus on Internal Quality Auditor Training Program of EU ISO 13485:2016. It is an important part of Quality and Regulatory Training. This training program is helpful in ensuring the quality of a product by identifying any discrepancies. We will look at written notes and document numbers and dates for audit criteria. We will also identify documents, materials, operators, jobs, tools, instruments, fixtures, records, personnel, customers and others. Moreover, statements made and all relevant factors pertaining to the sample are to be noted in order to determine non-conformance. We will further hone our auditing skills and discuss notes, document numbers and dates, identifiers, statements and non-conformance determination. So, let's get started!.

[Audio] We now look at the different types of reporting which may be required as part of an Internal Audit. Oral reporting is conducted at the time of the closing meeting and allows the team to get an immediate assessment of the findings. Written reports should be concise, complete, clear, correct and appropriate in tone. This concludes our discussion on the types of reporting required for an Internal Audit..

[Audio] Non-conformities occur when a product fails to meet audit criteria. Identification requires a non-conformity triangle of requirement failure, evidence and all three criteria existing. If any one or two criteria is absent, then it's an observation. If all three criteria exist, but make no impact on Quality Management System requirements or Product Conformity, it is still regarded as an observation. This explanation of non-conformity and its identification should make the concept clear..

[Audio] Non-conformance reports are a formal way to document any discrepancies found in a quality system audit. They should include the department or function being audited, the date and clause number of the ISO 13485, as well as the names of the auditee and auditor. The report should also include details of the non-conformance and any corrective or preventive actions taken. The signatures of both the auditee and the auditor should be included. An example of a non-conformance report is the one provided in the slide. This contains the information mentioned, plus additional details such as the non-conformance category and any comments or corrective or preventive actions. By understanding the purpose and contents of a non-conformance report, one can ensure that audits are compliant with EU ISO 13485:2016..

[Audio] Conduct a cause analysis to understand why the non-conformance has occurred. Take action based on the objective evidence. Also, take action for the other items that might have similarly affected the scenario. Ensure that the non-conformance does not repeat and set a target date for corrective actions implementation. Close the meeting..

[Audio] Audit findings should be used to inform planning of the next audit, and it is important to assess the sufficiency and effectiveness of corrective actions to ensure any problems have been properly addressed. An audit report should be issued once the audit is complete. For the management of the audit process, the audit team should continually focus on fact finding rather than fault finding. Adopting a systematic approach is key and the team should never lose sight of the final product to be audited. They should also gain an understanding of the auditee's interpretation of events and offer help where needed. Additionally, clear audit objectives should be defined and communicated effectively. Lastly, the team should look for the root cause of any problems and ensure that corrective and preventive measures are followed up..

[Audio] This examination paper has three sections. Section A consists of 8 questions with a maximum of 1 mark each. The questions require you to select the best choice out of four given options. You are only allowed to provide one answer for each question and if your option is not clear, you will receive zero marks. Section B has 2 questions with a maximum of 3 marks each. The answers to these questions should be written on the sheet provided in the examination and should be brief. Section C consists of 2 questions with 8 marks each. These questions are based on audit situations and the answers should be provided in the form of a nonconformity report (NCR). This is an open book examination and you are permitted to refer to any material during the 40 minutes allotted. The pass mark for the examination is 80% (24 marks) and you must also attain at least 50% in each of the three sections..

[Audio] A table is presented regarding the Internal Quality Audit of ABC Company. Noteworthy are the columns: Department, Internal Quality Audit number, Nonconformity number, ISO 13485 Clause Number, NC Category, Nonconformity Details, Auditee Name and Signature, Auditor Signature, and Corrective and Preventive Actions..

[Audio] Assessment for this EU ISO 13485:2016 Internal Quality Auditor Training Program is set to take 40 minutes to complete with a passing marks of 80%. Links to access the assessment will be provided shortly..

[Audio] I have discussed the 8 most important aspects of the EU ISO 13485:2016 Internal Quality Auditor Training Program of a company providing Quality and Regulatory Training, including Picture 8, Picture 10, Picture 13 and Picture 19, which are all essential components of the program. I hope this presentation has been of great help in understanding the subject matter. I appreciate your time and thank you for your attention..