Based on the main goal, the audit tasks are determined:
- The audit shall determine the operation and effectiveness of the quality management system. Those. During the audit, it is determined to what extent the quality system has been implemented in the organization, whether it works, and whether the quality system helps achieve results in the organization’s core activities.
- The audit should provide information about the effectiveness of the quality system - i.e. the audit should show whether the quality system works exactly as a system, or whether only individual elements of this system work, and all other requirements are fulfilled only formally, or are not fulfilled at all.
- It is necessary to determine the level of compliance with QMS standards and procedures - i.e. an audit shows how close to the rules established in the quality system procedures the work in the organization is carried out and whether there are differences between real work and what is established in the quality system documentation.
- The next task will be to check the quality of the work - i.e. During the audit, the compliance of the work results with the requirements established in contracts or technical specifications can be verified.
- The audit should make it possible to assess the impact of changes in the organization on the quality management system - the organization never stands still, any changes occur in any organization. These changes, to varying degrees, may affect the quality system. An audit of the quality system can show how these changes affected the quality system, whether changes are occurring in the quality system that are adequate to the changes in the organization.
The main result that an audit should lead to is the identification of opportunities for improvement in the organization's performance. Therefore, in any audit, objective evidence that auditors discover during the audit is essential. Such evidence can only be obtained if the audit criteria and rules for assessing nonconformities are clear and do not allow for different interpretations.
Audit participants
An audit is a process that always involves many participants. Depending on what tasks are solved by the participants in this process, several main roles can be distinguished.
As a rule, regardless of whether it is an external or internal audit, the following roles of audit participants exist:
- Audit Client – ISO 19011:2011 defines an audit client as the organization or person commissioning the audit. The audit client is the party most interested in conducting it and obtaining audit results. The audit customer is usually the management of the organization being audited. In the case when an internal audit is carried out, the management of the organization is interested in the auditors objectively and accurately assessing the performance of the quality system and providing data on all inconsistencies in the work and opportunities to optimize the work. In the case when an external audit is carried out, the management of the organization is interested in ensuring that the quality system is recognized as meeting the requirements and this is documented (by issuing a certificate - in the case of a certification audit, or concluding a contract - in the case of an external audit). potential customer products, works or services of the organization).
- Auditors are persons competent to conduct an audit (ISO 19011:2011). The quality and effectiveness of the audit largely depends on the qualifications and training of auditors. In this regard, special attention is paid to the qualifications of auditors. General requirements to the qualifications of auditors are presented in the ISO 19011:2011 standard. Typically they apply to professional auditors, working in certification bodies. The organization can set the requirements for the qualifications of internal auditors itself, but this does not mean that any employee of the organization can be appointed as an auditor. In order for an employee of an organization to effectively and efficiently conduct internal audits, he must be trained in the methods and techniques of conducting audits, know the requirements of the quality system, know how the organization’s quality system works and have a good understanding of the subject area of activity that he will audit.
- Technical Experts- these are the persons who provide auditors with specialized knowledge or experience. During the audit, issues may arise for which the knowledge and qualifications of auditors are not sufficient. In such cases, technical experts may be involved in the audit. The involvement of technical experts is possible both during internal and external audits. In the case of internal audit, technical experts can be employees of departments who perform work similar to the one being audited, but they do not have to review their own work or the work of their department. For example, if an organization has two design departments, then a specialist from one department can act as a technical expert when auditing the second department and vice versa. In the case of external audit, technical experts are engaged by external auditors from third parties.
- Inspected party. The audited party is the employees of the audited organization. In the case of both internal and external audits, the audited party can be any employee of the organization, including the management of the organization and internal auditors.
Quality management systems audit status
An audit of quality management systems refers to types of audits that are not regulated by federal or international legislation. Accordingly, there are no mandatory legislative provisions to determine the procedure and rules for auditing quality systems, determining requirements for auditors and required reporting. This is due to the fact that certification of quality systems belongs to the voluntary field of certification and all work related to the construction and implementation of a quality system is a voluntary initiative of the organization. Accordingly, for organizations engaged in auditing quality systems there is no need to obtain licenses or other permitting documents to carry out this activity. To conduct internal audits, such documents are especially not required.
There are three types of quality audit: product quality audit, process quality audit, quality system audit.
1) Product quality audit - quantitative assessment of compliance with established product quality indicators. A product audit can be carried out on its own and focus on one or more types of products. This type of audit is focused on the consumer (conducted from his point of view). It may be carried out by at least one auditor, but may require a large group of auditors. Product audit can be performed:
from the middle, i.e. within the enterprise, when the results are reviewed technological process, when each product is considered as an input material for the next process (or internal consumer);
from the outside, while the product audit can be carried out either at the materials supplier, or at the customer, or with the participation of the end consumer.
2) Process quality audit - analysis of process elements, assessment of its completeness and possible effectiveness. During the audit of the entire process, a certain time is allocated to the product audit. Such an audit is aimed at the results that are obtained as a result of the process. A significant and important part of the quality system audit is devoted to this type of audit. Independent process audit is the most common and convenient, one that brings the fastest and best results. The reason is that the supplier is more likely to accept the need for changes in a specific process than to deal with deep control system problems that affect the outcome of the system audit.
Process audit:
- - less broad than a system audit;
- - as usual, it is aimed at one or more specific processes of production;
- - requires less planning than a system audit;
- - can be very useful in improving the process being considered;
- - less formal than a system audit;
- - can be completed in a time from one hour to two days.
This type of audit verifies compliance with standards, methods, procedures, or other requirements.
3) Quality system audit is a documented activity that is carried out to obtain objective evidence that the elements of the quality system that are applied meet it, that it is developed, documented and effectively used in accordance with specific requirements. A system audit is aimed at the entire quality assurance system as a result of management activities, and thus includes a process audit. So, this is the most time-consuming type of audit. As usual, it lasts from two to five days. It is carried out in order to find out, on the basis of objective evidence, how the quality management system and plans of the organization are implemented and whether they meet the set of requirements placed on them.
A quality audit is an integral part of the implementation of a quality system at an enterprise and a prerequisite for certification of this system. According to ISO 9000: 2000 standards, audits determine the extent to which the requirements for the quality management system are met. Audit materials serve to assess the effectiveness of the quality management system and identify opportunities for its improvement.
The purpose of a quality audit is to verify the effectiveness of management programs implemented by management. Conducting a quality audit provides management with evidence-based feedback, enabling them to make informed decisions.
Quality audit defined as systematic and independent test and assessing the conformity of quality assurance activities and their results with planned activities, the effectiveness of their implementation and the achievement of their objectives.
When talking about a quality audit, we must keep in mind that there are three types: quality audit, process quality audit, quality system audit.
Product quality audit- quantitative assessment of compliance with established product quality indicators. A product audit can be carried out on its own and focus on one or more types of products. This type of audit is focused on the consumer (conducted from his point of view). It may be carried out by at least one auditor, but may require a large group of auditors. Product audit can be performed:
From the middle, that is, inside the enterprise, when the results of the technological process are considered, when each product is considered as an input material for the next process (or internal consumer);
Externally, in this case, a product audit can be carried out either at the materials supplier, or at the customer, or with the participation of the end consumer.
Process quality audit- analysis of the elements of the process, assessment of its completeness, the correctness of the choice of conditions and possible effectiveness. During the audit of the entire process, a certain amount of time is devoted to product audit. Such an audit focuses on the results obtained at the output of the process. A significant and important part of the quality system audit is devoted to this type of audit. Independent process audit is the most common and convenient, bringing quick and fruitful results. The reason is that the supplier is more likely to accept the need for changes in a specific process than to deal with the deep control system problems that emerge as a result of a system audit.
Process audit:
Less broad than system audit;
Typically aimed at one or more specific processes in the production of a product;
Requires less planning than a system audit; can be very useful in improving the process under consideration
Less formal than a system audit;
Can be completed in one hour to two days.
This type of audit certifies compliance with standards, methods,
procedures or other requirements.
Quality system audit- documented activities carried out to obtain verified and assessed objective evidence that the elements of the quality system that are applied are consistent with it, that it is developed, documented and used effectively in accordance with specific requirements. A system audit is aimed at the entire quality assurance system as a result of management activities, and thus includes a process audit. So, this is the most time-consuming type of audit. It usually lasts from two to five days. It is carried out in order to find out, on the basis of objective evidence, whether the quality management system and plans of the organization are being implemented and whether they comply with the set of requirements presented to them.
There are various types audit.
First party audit (internal audit) is an audit that is carried out for its own purposes by the organization itself or on its behalf and can be the basis for the organization’s self-declaration of compliance.
Second party audit (external audit) is an audit that is carried out by the organization’s consumers or other persons on their behalf.
Third party audit (external audit) is an audit conducted by third-party independent audit organizations. Such organizations are usually accredited, provide certification or registration of compliance with requirements, e.g. ISO requirements 9001.
Responsibilities and requirements for planning and conducting the audit, reporting and recording findings should be defined in a documented procedure. An audit can be carried out individually or by a team of auditors.
As a result of the QMS verified by the auditor, a list of non-conformities is compiled, which represents: 1) non-compliance with selected standards from the ISO 9000 series; 2) potential inconsistencies (when a number of activities are on the verge of inconsistency). Evidence of non-compliance can be obtained by the auditor from interviews, verified documentation, observation of activities and conditions in the area being verified. After the audit, an audit report is drawn up.
It is also necessary to note the special role of internal audit.
Internal audit is highest form management control of the enterprise's quality management system. The results of internal audits provide the basis for input to management review and enable an organization to declare its compliance with ISO 9000. Therefore, the important question is how to properly plan, organize and conduct audits, and then analyze their results.
Internal audits can be built according to system-wide ISO 9000 elements or by structural divisions. In the first case, compliance with documentation requirements at all levels is checked and corresponds to a specific element. In the second, all elements of the quality system inherent in a particular department are subject to verification. It should be noted that in practice, more than half of the causes of inconsistencies are in the area of interaction between structural units.
The results of the analysis are used by the quality service and other departments in the development of current and long-term plans, programs to improve the quality of products and services. All these points are mandatory for the functioning and development of the QMS. However, in conditions of only a formal approach to their use, they will bring little benefit, and sometimes they can do harm.
The potential of the QMS is very large. It allows you to constantly form new elements in the organization’s activities, increase its level of development and look into the future with more confidence, contributing to the success of the enterprise.
Introduction
Quality audit quality audit ) - systematic independent verification to determine the compliance of activities and results in the field of quality with planned activities, as well as the effectiveness of the implementation of activities and their suitability for achieving the set goals.
The ISO 9000 series of standards consider quality auditing as a form of quality assurance. However, in domestic regulatory documents the term “quality audit” is replaced by the term “quality check”. In our opinion, such a substitution cannot be considered justified, since a quality audit is only one type of quality control.
A distinctive feature of a quality audit is its purely analytical nature. In addition, it is this term that makes it possible to overcome psychological barrier, associated with the prevailing idea in the country of inspection as an activity, the inevitable consequence of which should be the identification of those responsible for violations of established requirements and the determination of punishment for them. It is also important that the term “quality audit” is generally recognized among specialists around the world involved in quality assurance issues. It is characteristic that the term “auditor”, in contrast to the term “quality audit”, has already been established in Russian regulatory documentation in quality and does not cause any misunderstandings.
Quality audit activities should be distinguished from quality assurance activities such as quality control, quality supervision and quality inspection.
Quality control is an activity that involves taking measurements, examining, testing or evaluating one or more characteristics (for the purpose of calibration) of objects and comparing the results obtained with established requirements to determine whether compliance has been achieved for each of these characteristics.
Supervision of quality-activity to continuously monitor and audit the condition of the facility to ensure that established requirements are being met. Quality supervision activities carried out within the framework of a specific task are usually called quality inspection .
1. Types and purposes of audits
1.1 Internal audit
Internal audit of the quality system is intended to provide enterprise management with objective and timely information on the degree of compliance of activities in the quality system and its results established requirements. The main goal of internal audit should be to prevent a decrease in the effectiveness and efficiency of the quality system operating at the enterprise.
The effectiveness of internal audit of the quality system at an enterprise largely depends on its organization.
Organizing an internal audit of a quality system is the streamlining of the work of the internal audit service and departments of the enterprise in order to maintain the functioning of the quality system in accordance with established requirements.
The internal audit of the quality system is intended to regularly check how well the activities within the quality system and the results of these activities are consistent with the planned activities. Internal audit promptly brings to the attention of the enterprise management objective, fact-based information about the state of the quality system. In this regard, internal audit plays a key role in maintaining the enterprise’s quality system at the required level.
The objects of internal audit of the quality system are its elements mediated in the activities of the enterprise divisions in the implementation of planned activities, i.e., the requirements of the quality system documentation.
The internal audit of the quality system is based on a number of organizational principles, the main ones of which should be considered uniformity, consistency, documentation, diligence, regularity, independence and openness.
The principle of uniformity means that the audit is carried out according to a procedure officially established by the management of the enterprise in order to ensure its orderliness, unambiguity and comparability.
The principle of consistency implies that planning and conducting specific audits of various elements (functions, works) of the quality system should be carried out taking into account their established structural relationship.
The principle of documentation assumes that each audit is documented in a certain way to ensure the safety and comparability of information about the actual state of the audited object.
The precautionary principle establishes that each audit is planned, and the personnel of the audited unit are notified in advance of the purpose, time and methods of conducting the audit, in order to be fully prepared and to eliminate the possibility of personnel evading the provision of all required data.
The principle of regularity determines that audits are carried out at certain intervals so that all elements of the quality system and divisions of the enterprise are the subject of constant analysis and evaluation by the management of the enterprise.
The principle of independence means that those conducting the audit should not be directly responsible for the work being audited and should not depend on the head of the audited unit, which eliminates the possibility of bias in the audit results.
The principle of openness implies that the results of audits should be open, which ensures the “transparency” of the quality system for its users, consumers and external auditors.
From a methodological point of view, it is advisable to create an internal audit service at the initial stage of implementing ISO standards, when the enterprise is just beginning to implement the provisions of the standards, and not after completion of this work. The creation of an internal audit service is evidence that the management of the enterprise understands the importance of quality audit and that such a service meets the interests of the enterprise.
The internal audit service of the quality system is staffed by two or more employees of the enterprise with higher education and at least two years of experience practical work in the field of quality, having undergone special training in the relevant educational institutions or on training courses organized at the enterprise. The functions, responsibilities, powers and rights of auditors are established in their job description.
At enterprises where the creation of an internal audit service for the quality system as a separate structural unit difficult, the audit of the quality system can be carried out by temporary groups specially formed for this purpose. In this case, the duties of auditors are assigned (without exemption from their main work) to specialists from the enterprise departments most closely associated with the development and operation of the quality system (quality assurance, standardization, metrology departments). These specialists are allowed to perform the duties of auditors only after they have received appropriate training, practical training and certification.
The quality audit service not only conducts an audit of all divisions of the enterprise involved in work on the quality system, but is itself the object of such an audit. The management of the enterprise from time to time must receive information on the work of this service and evaluate it from the standpoint of the requirements for the quality audit of the quality system operating at the enterprise.
Required condition efficient work service is the presence of appropriate organizational and methodological documents. Special attention is devoted to the development of methodological documents with the aim of:
Ensure methodological unity in the approaches, interpretations and assessments of auditors,
Ensure the work of auditors when conducting surveys, recording observation results, drawing up reports,
Reduce time wasted during the audit (it should be noted here that the lack of time practically does not allow even fairly experienced auditors to fully examine the audited object.
When forming methodological support for the activities of auditors, suitable rules and methodological procedures, but developed outside the enterprise, can be used. Along with documents, the methodological support includes various kinds of reminders and methodological manuals, facilitating the work of experts.
In all cases, the organizational procedure for conducting internal audits of the quality system provides for the following main stages:
Audit planning,
Preparation of the audit,
Carrying out an audit
Analysis and synthesis of audit results,
Development of corrective actions,
Monitoring the implementation of corrective actions.
1.2 External audit
External audit is carried out by organizations external to the enterprise - the customer of the product or, for example, a certification body. In this case, when the audit is carried out by the customer of the product, it is called a second party audit
The following forms of second party audit are practiced:
Full audit for compliance with a specific standard,
Partial audit relating to any aspect of the enterprise’s activities,
An auxiliary audit carried out by the customer in the presence of several applicants for a contract,
Audit of compliance with contract requirements.
An external audit conducted by an organization independent of the enterprise and the customer is called a third-party audit. This type audit is used for certification.
Of the types of quality audit considered, the highest degree of confirmation is provided by a third-party audit, which is determined by its scale, depth and higher qualifications of the specialists conducting it.
From time to time, inconsistencies may arise in an enterprise's quality system. They can be identified using objective evidence collected during an audit. But what exactly is a quality audit?
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The effectiveness of the quality management system can be determined through a specific audit. This determines whether the quality system is working in the company or whether it needs improvement.
That is, we are talking about conducting an audit. What nuances accompany this process? What is a quality audit?
Important points
The most important tasks of the quality system include internal quality inspection and consideration of the results obtained. Such a check is a manifestation of the control function, and, in essence, represents.
At the same time, the system of control over the main results includes an audit of finances, inventories and quality. But the first two options relate to the sphere of economic management.
Quality audit is carried out in three areas. The following may be checked:
| Product or service | The quality of the inspected object is assessed. Analyzes the compliance of quality with consumer requests, technological and control documentation, and technical specifics |
| Production processes | The quality of production processes is checked for compliance with regulations, instructions, and production specifics |
| Quality system | An extensive assessment of the effectiveness of the entire quality system is carried out |
Basic terms
A quality audit refers to a documented process of acquiring audit evidence for use in an objective assessment of the level of implementation of agreed audit criteria.
Approximately this definition is given in the “Guidelines for Auditing Management Systems” -.
Several important clarifications can be added to this definition:
| Audit is a systematic procedure | Therefore, it should be carried out at scheduled intervals. In this case, the frequency of internal audit is determined by the organization itself. External audit is regulated by the customer or certification body |
| The concept of independence means | That auditors are impartial about the results of the audit. That is, inspectors should not receive any benefit from the results |
| Quality audit is a documented procedure | Consequently, all audit processes must be accompanied by documentation |
| The audit is carried out according to the agreed audit criteria | External standards (for example, ISO 9001:2008) or internal ones (regulations, work plans, procedures, etc.) are used as such criteria. |
Participants in a quality audit, regardless of its type, are:
| Customer | The person or organization that initiated the audit. This is, as usual, the management of the audited entity. But potential partners or government agencies may act as such |
| Auditor | A person competent to carry out the audit. The external auditor must be duly qualified to meet ISO 19011:2011 standards. The competence of the internal auditor is determined by the organization itself based on verification of appropriate knowledge |
| Technical Expert | A person who provides the auditor with experience or specific knowledge. If the auditor does not have sufficient knowledge to verify certain aspects due to the specificity of the issue, then an appropriate technical expert is involved |
| Inspected party | Others may include employees of the organization, including management, as well as internal auditors |
Purpose of the procedure
A quality audit is required to create a holistic picture of the operation of the quality system at the enterprise for a specified time interval.
The purpose of such a check is to collect “observations” that make it possible to detect inconsistencies in products, production processes or quality system.
The fundamental objectives of a quality audit are:
- establishing the effectiveness of the Quality Management System;
- obtaining information about the effectiveness of the QMS;
- determining the degree of compliance with standard requirements (ISO 9000) and QMS procedures;
- checking product quality;
- assessing the impact of modifications on the QMS;
- determining the potential for improving the QMS.
That is, the main purpose of the procedure is to find necessary information, which will allow you to objectively evaluate the quality system, products and processes for inconsistencies.
A quality audit is the most appropriate tool for assessing the actual state of activity.
Legal regulation
Quality audit is not regulated at the federal or international level. Immutable legal norms regulating the procedure and rules of such an audit are simply not provided.
This is due to the voluntary nature of quality system certification. Therefore, entities conducting independent quality audits do not require special licenses or other permitting documentation to carry out activities of this kind.
Moreover, such documents are not needed for internal auditors. But the absence of legal regulations does not mean that no rules are provided.
The audit of quality management systems is regulated by special standards.
An example of such is the international standard ISO 19011:2011 “Guidelines...”. It can be used both for external and internal audits. Also separate rules are developed by certification bodies.
Auditors who are accredited by the certification system are required to comply with them. For internal audit, an enterprise can independently develop requirements for performing a quality audit.
Features of quality control
When performing a quality audit, the auditor uses a checklist. But the personal experience of the inspector and his qualification level are of main importance.
The auditor's checklist is a special “questionnaire”. It forms the main theses of the questions. During a quality audit, a survey is considered one of the essential methods, and the effectiveness of the audit depends on the responses received.
But conducting a conversation based on standard questions leads to formalistic execution and the risk of an uncritical attitude.
Therefore, when preparing a checklist, the auditor establishes only the areas in which information is required, and the questions themselves can be used as needed.
Based on audit practice, it can be noted that:
| The wording of questions for conversation should be clear and precise | Questions must be targeted and avoid ambiguous answers. |
| Avoid closed questions | Which ones can be answered “yes/no”, since answers of this kind are not informative |
| It is not advisable to have questions | With a catch |
| Any hints about personal characteristics | Not acceptable in questions |
| Questions about technical details | Should concern only the scope of the audit and no more |
| Good questions force the respondent to use their own knowledge | And not standard information already available to the auditor |
| Questions are not dogma | And instructions for action |
Regarding qualifications and personal experience, then the auditor must clearly understand the objectives of the audit, the concept of the audit, the area of potential communication partners, and the list of influencing factors.
The auditor's ability to communicate plays a decisive role in the performance of a quality audit. He must be able to conduct a conversation and in the process obtain the necessary information.
That is, the direction of the audit is determined by the special knowledge of the auditor, and the conduct of the process depends on personal qualities auditor and his communication skills.
Who is in charge of the procedure?
During an internal audit, the quality system manager supervises the procedure. In preparation for the audit procedure, the management of the enterprise, together with the head of the audit, agrees on the verification processes, the examined elements of the quality system and organizational units.
The subject and scope of the audit is established by the management of the enterprise, based on information needs. The standards and regulations with which the quality system must be compared must be specified.
An external quality audit is carried out at the request of the customer to confirm quality assurance and compliance with legal standards regarding quality.
It can be carried out at the insistence of the body that certified the quality system. Special requirements for product reliability are established by law. To verify compliance, an audit is initiated by executive authorities.
The result of the survey should be the provision of an audit report from independent specialists. The external audit may be led by the customer of the product or an organization representing the interests of the customer.
Moreover, the initiative may well come from both sides at once. The procedure for conducting and paying for the audit is specified in the contract.
Procedure
The quality audit process consists of three main stages:
- Preliminary study of the documentary base.
- On-site inspection.
- Preparation of the final report.
When examining the documentary base, system documentation related to ensuring proper quality is studied in full. The results of previous audits are analyzed.
Moreover special meaning is given to revealed deviations, corrective actions and the degree of their implementation.
The on-site inspection consists of a general survey of quality assurance measures based on individual documents and a full audit according to a selective scheme.
Typically an on-site inspection consists of:
| Introductory conversation with staff | The tasks and purposes of the audit are explained. Also at this stage, elements for detailed analysis are identified. |
| Conversations with individual employees | The conversation takes place at the workplace. In this case, objects for selective checking are installed. Questions are selected based on a checklist using explanatory questions. It is important that the auditor, during the conversation, state the interviewee’s answer in his own words, which eliminates the possibility of misinterpretation of the answer |
| Random checks | At this stage, information obtained through conversations and document research is verified. |
| Closing conversation | In the process, the main results of the inspection are formulated with arguments for the assessment of deviations. Such a conversation becomes the basis for drawing up a deviation report |
The lack of early findings makes sense. The assessment is made only upon completion of the on-site inspection, and during the final conversation, explanations are formulated for the detected deviations from the standards.
A spot check is a consequence of a survey. The auditor determines the extent and existence of appropriate rules and regulations, as well as the level of compliance with them.
In addition to documents, another element related to the quality criterion, For example:
- batch of material.;
- specific drawing;
- measuring instrument used in production.
When preparing the report, it is necessary to display all stages of the audit. The report describes the detected deviations, how to eliminate them and the recommended date for the next audit.
Attached to the report are a checklist, a list of deviations and audit protocols. It is important for the auditor to distinguish between “systematic” and “random” deviations.
IN controversial situation Sampling should be expanded and further research conducted. Deviations that seriously affect quality assurance are significant.
Minor deviations need to be mentioned in the report only if they cannot be eliminated directly on site together with.
As for documentary support of the entire audit process, the following are developed before the procedure begins:
- inspection plan;
- audit program;
- checklist of questions.
During the audit process the following is prepared:
- protocols of audit conversations;
- deviation protocols;
- audit report.
Regarding the quality management system
A quality management system is a system established by an organization to implement policies and achieve designated quality objectives.
QMS is a set of comprehensive measures that are aimed at managing the quality of products or services. A QMS audit involves obtaining documentary evidence of the degree of compliance with certain standards.
The result of such an audit is the discovery of the reasons that led to the occurrence of inconsistencies in the QMS. When auditing a quality management system, it is determined:
Emerging problems
The ISO 9000 series of standards consider quality auditing as a form of quality control. But domestic regulatory terminology often synonymizes the terms “quality audit” and “quality control”.
This shows a certain unreasonableness, since a quality audit is only one of the types of quality control. Distinctive feature quality audit in its purely analytical nature.
Its purpose is not to identify violators of established requirements and determine penalties for them. The purpose of a quality audit is solely to find significant inconsistencies and deviations.
Quality audit should be distinguished from the concepts of quality control, quality inspection and quality supervision.
During quality control, measurements, examinations, inspections, and assessments of the characteristics of objects are carried out to compare the results with established requirements for compliance.
Quality supervision involves continuous monitoring of compliance with certain requirements. Quality inspection is an activity that involves the supervision of quality within a specific task.
Production quality control check
The general definition of quality control implies the sum of measures that ensure a stable level of quality of the product or service provided.
In a narrower interpretation, this is a comparison of the actual characteristics of the product with the specified ones. In this case, the degree of compliance or non-compliance is determined.
During production quality control checks, planned and systematic production activity, implemented for the purpose of guaranteed confirmation of manufactured products to established standards.
As a result, the ability of the applied quality control to fulfill the tasks assigned to it is stated.
Internal Audit Quality Assurance Program
The commitment to continuous improvement of the quality of internal audit is confirmed by the existence of the Quality Assurance and Improvement Program (QIP).
It includes checking for compliance with each of the International professional standards internal audit.
The presence of the PGPC allows auditors, at the end of the audit, to use the wording “in accordance with International Standards ...” when preparing the audit report.
The presence of the PGPK provides confidence to stakeholders that the audit is carried out using cost-effective, high-quality and effective methods.
For the auditor himself, the PGPC is important in that it allows him to determine the compliance of his activities with International Standards.
The PGP also includes activities to familiarize audit participants with an overview of activities related to internal audit.
This helps to expand the understanding of the importance of internal audit, its main functions and impact on the activities of the audited entity.
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