• Gubarev Andrey Viktorovich, Candidate of Science, Associate Professor
• Sharapova Alexandra Sergeevna, student
• Ryazan State Radio Engineering University

• ISO 9001
• AUDITOR
• INTERNAL AUDIT
• QUALITY MANAGEMENT SYSTEM

The article is devoted to the organization and conduct of internal audits of the quality management system. The main stages of internal audit, duties and responsibilities of the persons conducting the audit are considered.

• Improvement of the quality system based on internal audits
• Implementation of 14 principles of E. Deming in the pipe industry

The presence of a quality management system (QMS) at the enterprise indicates a high level of its organization and functioning. One of the QMS procedures is the internal audit procedure.

Internal audit is one of the ways to control the activities of individual divisions of organizations. The main task of internal audit is to ensure the efficiency of the organization's departments and processes in accordance with the requirements of the QMS documentation, as well as to protect the interests of the owners.

Internal audits at the enterprise are divided into:

1. Scheduled audits;
2. Unscheduled audits.

Scheduled audits are carried out in accordance with the objectives and terms established in the "Program for conducting internal audits", which is approved by the CEO.

Unscheduled audits are carried out at the initiative of senior management, process owners, and heads of individual departments. The objectives of the unscheduled audit are agreed with the initiator. The program of the event (including terms) is coordinated with the heads of the participating subdivisions.

Internal audits are conducted by the internal audit team. The audit team consists of a senior auditor, auditor (s). Also, during the internal audit, a trainee auditor may be present.

The internal audit team is formed from the company's specialists.

Employees are allowed to check the compliance of QMS processes with the requirements of ISO 9001 (GOST R ISO 9001):

1. Passed specialized training (external) on the course "Internal audits of the QMS", having the appropriate knowledge and experience in the field of the audited object - when switching to the new version of the standard;
2. Passed internal training on the current version of the standard by an employee who has a valid certificate in the course "Internal audits of the QMS", as well as participating in the internal audit for at least four months.

Internal audits of the QMS are carried out by persons independent of the audited:

1. Heads of functional structures;
2. Activities (processes).

Preparation for conducting an internal audit includes:

1. Development of the "Program for conducting internal audit", which is sent to the audited units at least 10 days before the start of the audit. The "Internal Audit Program" should contain information on:
   • the object of verification;
   • areas of audit, including the definition of organizational and functional units and processes to be audited;
   • criteria;
   • goals;
   • the list of the audit team;
   • the date of the inspection.
2. Conducting a preliminary analysis of the QMS documents describing and regulating the activities of this QMS / SPP / official's process within the enterprise;
3. Development of a questionnaire (optional). The audit questionnaire records the questions that the auditor should receive an answer to. The answer to the question is recorded in the corresponding column of the document.

The introductory meeting confirms the audit plan in the audited unit, and summarizes the audit actions.

To collect data during the audit, the following methods are used:

• interviewing (carried out on the basis of the audit questionnaire);
• study of QMS documents; observation of actual activities and conditions.

The identified nonconformities should be identified in accordance with the requirements of the standards, other documents that can be referred to during the verification process, and documented in the Audit Report. The Report specifies the scope of the check (complete or incomplete), assesses the compliance of the process with the established requirements (complete, incomplete). In the event of incomplete compliance, the senior auditor indicates the need to develop corrective actions, making the necessary entry in the Report (The process complies with the requirements of the QMS, with the exception of the identified inconsistencies. For the identified inconsistencies, the Process Owner should develop corrective actions by "___" _______ 20__).

At the final meeting, the results of internal audits are summed up, the Audit Report is provided, the validity of the inconsistencies recorded in it is confirmed, and the date of submission of the Plan to eliminate the identified inconsistencies is indicated.

Based on the Audit Report provided by the senior auditor, the process owner, within the specified timeframe, is obliged to:

1. Establish the cause of the identified inconsistencies;
2. Develop corrective / preventive actions;

Verification of the implementation of the corrective / preventive actions taken is carried out by re-verification by the group of auditors who participated in the previous audit, 30 days after the implementation of the planned action specified in the corresponding Nonconformity Remediation Plan.

Evaluation of the effectiveness of the corrective / preventive actions taken is carried out by a group of auditors during the next audit.

The owner of the QMS process is responsible for preparing the QMS process and the process team for audit; development of corrective actions based on identified inconsistencies; implementation of planned corrective / preventive actions.

The senior auditor is responsible for:

1. Development of the "Program for conducting internal audits";
2. Organization of QMS audits at the enterprise;
3. Audit;
4. Registration of revealed inconsistencies;
5. Organizing and conducting a repeated audit aimed at checking the effectiveness of the corrective / preventive actions taken;
6. Preparation of a report on the conduct of internal audits.

The auditor is responsible for:

1. Preparation for the audit;
2. Audit;
3. Preparation and submission to the senior auditor of the "Audit Report";
4. Providing copies of the "Audit Report" to the owners of the QMS processes.

Thus, we have considered one of the options for organizing the procedure "Internal audits" at the enterprise.

List of references

1. GOST R ISO 9001-2015 Quality management system. Requirements. entered 28.09.2015. M .: Standartinform, 2015.77 p.
2. GOST R ISO 19011-2012 Guidelines for auditing management systems. entered 19.07.2012. M .: Standartinform, 2013.42 p.
3. Gubarev A.V., Nazarova D.I ..) - 2016 T. 1.No. 57.P. 95-98.

After studying this chapter, students and graduates of universities should:

know

• - special methods and organizational foundations of the internal audit process;
• - forms of working documents required for planning and implementation of the internal audit process;
• - the main mistakes made when planning internal audits;
• - the technique of constructing conversations with the audited personnel;
• - the types of questions that may arise in the auditor's practice and how they are applied;
• - rules for the application of audit criteria;

be able to

• - interpret regulatory requirements and QMS terminology;
• - to apply in practice the five main methods of audit (survey, observation, analysis, assessment, proof);
• - formulate various types of questions for the auditees in order to gain knowledge about the audited object for subsequent comparison with the audit criteria;
• - distinguish corrective actions from the correction of inconsistencies identified during internal audit;

own

• - the use of professional terminology;
• - skills in preparing working documents for planning and the results of internal audit;
• - skills in proving nonconformities;
• - skills in assessing the effectiveness of the application of corrective actions in order to eliminate the causes of nonconformities.

Organization of the internal audit process

Internal audit of the QMS is one of the key processes of the QMS. According to experts, if such QMS processes as internal audit, corrective and preventive actions and management by top management are debugged and operate in accordance with the requirements of GOST R ISO 9001-2008, then all other QMS processes will not only work, but also improve every year.

Requirements for conducting internal audits are formulated in and. 8.2.2 GOST R ISO 9001-2008:

“The organization shall conduct internal audits (checks) at planned intervals to determine that the quality management system:

a) complies with the planned activities (clause 7.1 of GOST R ISO 9001-2008), the requirements of this standard and the requirements for the quality management system developed by the organization;

b) is effectively implemented and maintained.

The audit program should be planned taking into account the status and importance of the processes and areas to be audited, as well as the results of previous audits. Criteria, scope, frequency and methods of audits should be defined. The selection of auditors and the conduct of audits should ensure the objectivity and impartiality of the audit process. Auditors do not have to check their own work.

A documented procedure should be established to define the responsibilities and requirements for planning and conducting audits, maintaining records and reporting results.

Records of audits and their results must be maintained (Clause 4.2.4 of GOST R ISO 9001-2008).

The management responsible for the audited areas of activity shall ensure that all necessary corrections and corrective actions are taken without undue delay to eliminate the detected nonconformities and their causes. Follow-up actions should include verification of the actions taken and a report on the results of verification (Clause 8.5.2 of GOST R ISO 9001-2008).

Note. See ISO 19011 for guidance. "

The above requirement gives a very definite idea of \u200b\u200bhow the process of internal audits in the QMS should be organized.

The QMS audit, which is analytical in nature, should be carried out on the basis of the recommendations of GOST R ISO 19011-2003 "Guidelines for the audit of quality management systems and / or environmental management systems". As a rule, many employees of the enterprise are involved in this work, primarily auditors, audited personnel, managers of different levels. The internal audit procedure must be documented without fail, records of the results of audits must be maintained. To implement the internal audit process, it is necessary to implement the following functions:

• - planning audits;
• - preparation of the audit;
• - documenting audit results;
• - exercising control over the elimination of inconsistencies.

In addition, in order to organize effective management of audit processes, it is necessary:

• - carry out training and professional development of internal auditors;
• - ensure the use of the results of internal audits for the analysis of the QMS by the management;
• - to measure and analyze the audit process itself;
• - improve the internal audit process.

The main value of internal audit is that it promptly brings to the attention of the organization's management objective, fact-based information about any deviations of the QMS from the requirements and directions for improving the organization's activities.

In this regard, internal audit plays a key role in maintaining and improving the performance of the system. From a methodological point of view, it is advisable to create an internal audit service already at the initial stage of implementation of ISO standards, when an enterprise is just starting to implement the provisions of the standards, and not after the completion of these works.

The internal audit service is staffed by two or more employees of the company with higher education and at least two years of practical work experience in the field of quality management, who have undergone special training in the relevant educational institutions or courses. The attitude of the company's management towards internal audit indicates the degree of its interest in the company's success.

When auditing the QMS, auditors communicate with the personnel of the audited departments. In the practice of such communication, they need to strictly adhere to those business terms and definitions related to audit, which are given in GOST R ISO 19011-2003 and GOST R ISO 9000-2008.

The use of generally accepted terminology excludes possible differences in the interpretation of the actions and conclusions of the auditors by the auditor and the audited party. The following are only those basic audit concepts that are used in the text of the subsequent paragraphs of this chapter. If you need to expand your knowledge in this area, you should refer directly to the texts of GOST R ISO 19011-2003 and GOST R ISO 9000-2008.

So, in the future we will use the following terms from these regulatory documents.

Audit (verification) - a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which agreed audit criteria have been met.

Auditor - a person with the competence to conduct an audit (check).

Audit team - one or more auditors conducting the audit (check)

Audit evidence (checks) - records, statements of fact or other information related to audit criteria (verification) that can be cross-checked.

Conclusions (observations) - the result of the assessment of the collected evidence against the audit criteria. Audit findings can indicate compliance or non-compliance with audit criteria, or opportunities for improvement.

Audit conclusions - the audit output provided by the audit team after reviewing the audit objectives and all of its findings.

Audit plan - a description of the activities and arrangements for the audit.

Audit program - a set of one or more audits planned for a specific period of time and aimed at achieving a specific goal.

Audit criteria - a set of policies, procedures or requirements that are applied by reference. Audit criteria are used as a basis for comparing audit evidence.

Quality Management System - a management system for the direction and control of the organization in relation to quality.

Inconsistency - non-fulfillment of requirements.

Conformity - fulfillment of requirements.

Correction - the action taken to correct the detected nonconformity.

Corrective action - the action taken to eliminate the cause of the detected nonconformity or other undesirable situation.

It is important to distinguish between correction and corrective action. As a result of the correction, the revealed discrepancy itself is eliminated, while as a result of the corrective action, the cause of the discrepancy is eliminated. After the performed correction, the discrepancy can be repeated again, and after the corrective action, the recurrence of the discrepancy is excluded forever. However, we often encounter such a situation when, at the time of the current check, the observations are not enough to unambiguously establish the cause of the discrepancies. In such cases, it is necessary to limit ourselves to correction, and the auditor recommends to the audited party to continue monitoring the area of \u200b\u200bwork where non-compliance with requirements periodically occurs.

The generally accepted procedure for planning, preparing and conducting internal audits, which determines who, what, how and when does the audit, is as follows.

• 1. Internal audits (inspections) are carried out according to the audit criteria established for the types of activities of departments and services on the basis of:
  • - the requirements of GOST R ISO 9001-2008 and additional corporate requirements established in the documents of CM K;
  • - goals and objectives of the company's quality policy.
• 2. The following are subject to internal checks:
  • - scope of SM K;
  • - completeness and accuracy of reflecting the requirements of GOST R ISO 9001-2008 in the QMS documents;
  • - the degree of conformity of product quality to customer requirements and mandatory requirements;
  • - the actual activities of departments and services to fulfill the requirements of the QMS documents and ensure the effectiveness of the QMS processes.
• 3. QMS checks are based on the requirements contained in the quality manual and other QMS documents developed in accordance with GOST R ISO 9001-2008 and other additional (in-house) requirements.
• 4. When conducting internal audits, the following tasks are solved:
  • - checking the compliance of the documented QMS procedures with the requirements of GOST R ISO 9001-2008 and additional (in-house) requirements;
  • - verification of the conformity of product quality to the technical requirements established for it;
  • - checking the compliance of the activities of the departments with the requirements of the QMS documents;
  • - checking the implementation of the planned corrective actions and assessing their effectiveness;
  • - assessment of the degree of achievement of the objectives set out in the quality policy, including the quality of products and production processes;
  • - assistance in improving the QMS;
  • - collecting information on all aspects of the QMS at all levels and transferring to management the information that shows where corrective or preventive actions to improve are required;
  • - verification of compliance with the requirements for the working environment, order at the workplace and safety requirements.
• 5. Responsibility for the content of the internal audit procedure, the organization of work in accordance with its requirements, for the qualified identification of discrepancies in the objects of internal audits is borne by a representative of the quality management (QMS PR).

The responsibility for the performance of individual works on internal audits is borne by the auditors who are the executors of these works.

6. The organizational basis for conducting inspections (audits) of the QMS is the annual program. In addition to internal audits, the annual program may include prospective audits by external bodies (certification or inspection audits by a third party, audits by other supervisory authorities, including the customer, if such audits are available in the practice of the enterprise).

The draft annual program of internal audits is developed by the quality management service in accordance with Form 1 (Appendix 1 to paragraph 8.1).

The inspection program is approved by the PR for the QMS before the start of the planned year. Once approved, he communicates the annual program to the concerned departments and officials.

The execution of the program is controlled by the PR according to the QMS.

• 7. On the basis of the approved PR program for QMS, no later than two weeks before the start of the check, for each item or for a set of items of the program, appoints an auditor or an audit group from among the quality management staff with the involvement, if necessary, of specialists from departments who are users of the results of the work of the audited department ... Auditors are appointed from a pool of competent professionals who have received specific audit training. For the appointed auditors, the PR for the QMS determines the audit task. In the presence of special circumstances requiring operational measures, the QMS PR may appoint an unscheduled inspection, for example, in the following cases:
  • - detection of nonconformities of products and services identified by internal control and (or) the customer;
  • - preparation of the QMS for certification or inspection control (if necessary);
  • - the need for an additional check established by the management but the results of the analysis of the functioning of the QMS.
• 8. Having received the audit task, the auditor or the audit team leader draws up an audit plan, including, at the discretion of the QMS PR, checking one or more points of the annual program for a specific period of time. The plan is developed in the form (Appendix 2 to paragraph 8.1) and approved by the PR for the QMS.
• 9. When preparing for the audit in accordance with the approved plan, the auditor is obliged to submit working documents, which include:
  • - forms of questionnaires for audit in accordance with Form 3 (Appendix 3 to paragraph 8.1);
  • - blanks of non-conformity accounting cards according to Form 5 (Appendix 5 to paragraph 8.1);
  • - forms for registration of audit evidence in any form.
• 10. During preparation, the auditor should:
  • - familiarize yourself with the audit plan;
  • - to study the audited subdivision, having familiarized with the nature of the work performed, the official duties of the audited employees;
  • - according to the organizational structure diagram, determine the relationship of the audited division with other divisions of the enterprise;
  • - review the procedures and work instructions required for the audit;
  • - prepare questionnaires, forms of non-conformity accounting cards, forms of an audit report in accordance with Form 6 (Appendix 6 to paragraph 8.1);
  • - agree with the head of the audited department on the date, time, route of the audit.
• 11. The head of the audited subdivision is responsible for:
  • - timely informing the staff about the tasks and scope of the check;
  • - preparation of all the necessary means for the successful conduct of the audit;
  • - providing, upon request of auditors, access to equipment and necessary materials;
  • - open interaction with auditors in order to satisfactorily address audit tasks.
• 12. In the process of conducting an internal audit, auditors collect information at the audited areas through observations, interviews and examination of documents. At the same time, the collected information is formalized in the form of audit evidence on the actual state of work.
• 13. At the audited sites, auditors carry out their activities in accordance with the audit plan in the presence of a representative of the unit.
• 14. The auditor should be able to record each discrepancy revealed by the audit in the nonconformity record card and bring it to the attention of the head of the audited department immediately after the audit is completed.

The head of the audited unit (service) confirms his agreement with the revealed discrepancy with his personal signature in the non-compliance record card. The auditor hands over copies of the accounting cards of all inconsistencies drawn up during the audit to the head of the audited department.

In case of disagreement of the head of the audited unit with the conclusions of the auditors, he must submit his motivated objections to the PR for the QMS in writing.

15. After the completion of the audit, the auditors draw up a report on the results of the audit in accordance with Form 6 (Appendix 6 to paragraph 8.1). The report is accompanied by non-conformity cards and checklists completed during the audit.

The internal audit report is coordinated by the head of the QMS service, and approved by the PR but the QMS.

The original report, along with all inspection materials, is stored in the quality management service. A copy of the approved report is sent to the representative of the QMS management.

16. On the basis of the report on the conducted internal audit, the detected discrepancy is corrected and, if necessary, corrective measures are developed in accordance with the requirements of the documented procedure in accordance with clause 8.5.2 of the requirements of GOST R ISO 9001 - 2008.

Responsibility for the timely adoption of decisions to correct the detected inconsistencies or to develop corrective measures in connection with the identified inconsistencies rests with the head of the audited subdivision.

17. The auditors monitor the timeliness of the implementation of the proposed adjustments or corrective actions and verify their effectiveness.

If the results of corrective actions are positive, the auditor or the head of the auditor group who carried out the control signs on the nonconformity record card to close the nonconformity (the signature of the head of the auditors' group is indicated in the form).

• 18. In case of unsatisfactory results of corrective actions, the quality management service plans and takes the necessary actions for subsequent inspections.
• 19. Based on the results of the audit, the auditor can prepare recommendations or proposals for improving the activities of the audited unit, which, after agreement with the head of this unit, are included in the improvement plan in accordance with Form 4 (Appendix 4 to paragraph 8.1).
• 20. Based on the results of internal audits, the PR for the QMS reports to the head of the enterprise summary annual information for analysis, assessment of the state of the QMS and making decisions on its improvement.

The results of the analysis with the assessment of the state of the QMS and the decisions taken by the head of the enterprise are recorded. The records are kept and kept by the quality management service. All internal audit records are kept in the order defined in the documented procedure in accordance with clause 4.2.4 of the requirements of GOST RI SO 9001-2008.

• 21. Evaluation of the effectiveness of the process of conducting internal audits of the QMS is carried out by the head of the quality management service on the basis of systematic observations of such process parameters as:
  • - the extent to which the annual audit program has been completed;
  • - the number of identified inconsistencies;
  • - the number of proposals for improving the activities of the divisions;
  • - the number of corrective actions taken;
  • - the number of inconsistencies in the work of internal auditors identified by the certification body of the audits carried out for a certain period of time.

The quantitative results of internal audits for a certain period of time are signed by the PR for the QMS and submitted to management in accordance with Form 7 (Appendix 7 to paragraph 8.1).

22. All work of the quality management service is controlled by the PR for QMS.

The internal audit algorithm is graphically shown in Fig. 8.1.

Of course, each auditor, as he accumulates his own experience of working on internal audits, has the opportunity to improve the proposed procedure and the working forms of documents used, if such a need arises. It is not always necessary to adhere to emerging stereotypes, especially in such a delicate matter as internal audit.

Fig. 8.1.

Appendix 1 to paragraph 8.1. Form 1

Appendix 2 to paragraph 8.1. Form 2

Appendix 3 to paragraph 8.1. Form 3

Appendix 4 to paragraph 8.1. Form 4

Appendix 5 to paragraph 8.1. Form 5

Appendix 6 to paragraph 8.1. Form 6

Appendix 7 to paragraph 8.1. Form 7

Source: "News in detail. Newspaper of the village Novosineglazovsky", February 2013

We are grateful to the OMK Press Center for providing this material.

Produce without surprises

A quality management system (QMS) is necessary in order to purposefully manage quality at the enterprise, so that all products come out the way our customers and consumers want them to be. At the same time, the main task of the system is not to control each branch or tee, but to make sure that there are no errors in the work that can lead to a marriage.

The introduction and certification of management systems has led to the emergence of a completely new category of specialists - auditors. These specialists study and closely monitor how the departments interact during the production process, how the procedures are performed, including the documented ones, how the workflow is carried out. And are there any phenomena in all of this that can lead to a failure of the current quality management system, and therefore lead to the release of low-quality products.

Defining quality ... quality systems

A quality management system is the result of a production activity, such as a part. That is, QMS is a product to which, like any product, certain requirements are imposed and with which certain expectations are associated. And we are fully justified in talking about the quality of the QMS as the degree of satisfaction of these expectations and requirements. But here one problem arises: how to determine how high-quality the quality management system itself is? After all, this is not a tee - you cannot measure it with a caliper and compare it with the numbers that are recorded in the technical requirements. What characteristics does the QMS itself have so that, having studied them, one can say: yes, this system will not fail? Here they are:

* Compliance of the QMS with the requirements of ISO 9001.

* The suitability of the QMS (i.e. the potential ability to deliver the intended results).

* The effectiveness of the QMS (i.e. the degree of actual implementation of the planned).

Any quality management system where these three conditions are met can be called quality. So, the internal audit of the QMS is just a tool for measuring the characteristics of the system, designed to provide data for assessing the quality of the QMS.

It's no secret that wrong actions are always the cause of marriage. In order to avoid them, it is necessary to describe what needs to be done to produce quality products. And then control these actions. Therefore, at the stage of implementation of the QMS, we have developed documents (standards, instructions, regulations), which fix the rules, methods, distribution of responsibilities, powers, algorithms for performing activities.

The most essential are the requirements of ISO 9001. And the internal audit is designed to answer the question: to what extent the implemented quality management system meets the specified requirements. The object of verification will be the QMS documentation, as criteria - the requirements for the system, including the requirements of the ISO 9001 standard.

At the stage of functioning of the system, the result is the achievement of the set goals. This will be the object of verification, and the criteria are the requirements established in the QMS documentation.

Every audit has its own purpose

An important question is who is the customer of the internal audit of the QMS. Here, in general, only two options are possible: either a top manager or a quality management representative. Each of these customers has its own interest, which is determined both by their areas of responsibility and by the decisions they will have to make based on the results of the audit.

Why is senior management introducing internal audit procedures? Why pay for the staff conducting the audit and the time of the staff being audited?

Three main goals can be distinguished:

* Prevention of inconsistencies during external audits of the QMS

Indeed, internal audit allows you to prepare for an external audit. The more deviations and inconsistencies are revealed during the internal audit, the fewer these inconsistencies are left for the external.Where auditors are qualified and conduct a thorough analysis of activities in terms of compliance with internal procedures and the requirements of ISO 9001, the audit already adds value. At least that the organization is successfully passing the certification procedure.

* Prevention of inconsistencies during other checks

All organizations are controlled by someone: Rostekhnadzor, fire supervision, etc. All types of control that we need to go through carry certain risks associated at least with warnings, instructions and fines. The task of any organization is to prevent possible losses (money, image, time). Therefore, here the functions of internal audit are expanded from checking the fulfillment of established procedures to checking all issues related to other types of external control.

* Assessment of compliance with the requirements of internal documented procedures, risk reduction, identification of potential for improvement and implementation of these improvements

The internal auditor, in fact, carries out the transfer of the best practices of some departments to others.

A highly qualified auditor, or external auditor, has a broader outlook, sees other companies, sees which schemes have worked well and which ones actually work. By following the production chain, all sequential activity becomes visible. Specialists are involved in the process audit - internal auditors from consumer processes who know all the weaknesses of the supplier process and can focus on them.

Our auditors

The training of internal auditors is carried out by special training organizations under the certification bodies, as well as consulting organizations. All internal auditors working at our company have undergone such training.

We have 20 internal auditors in total. Some of them stood at the origins of the implementation of the QMS and have about 15 years of experience as an auditor. This is the leading welding engineer Yuri Popkov.

There are auditors who have been helping to assess the quality of the QMS for more than five years. These are leading experts Igor Dyachok, Olesya Fedorova, Irina Prilutskaya, Elena Markina, Andrey Pozdnyakov and others. The composition of the auditors is regularly updated. Many former internal auditors now hold managerial positions: Elena Gulyaeva - head of the test center, Pavel Goncharov - chief welder, Vitaly Zolotukhin - head of the investment department, Olga Redreeva - head of the department for the implementation of lean manufacturing tools, Elena Chastova - head of the planning and controlling department ...

In place of the retired auditors, new ones come - trainees who, for the first time after training, carry out inspections under the supervision of more experienced auditors.

In conclusion, I would like to say a big thank you to all internal auditors of Trubodetal for their contribution to maintaining the quality management system at a decent level.

1. Audit of the quality management system. Types of audits. The main stages of the audit of the QMS. Definitions related to audit in accordance with STB ISO 9000 - 2006.

Definition of quality management audit

Audit (audit) - an independent check in order to express an opinion on reliability. The word "audit" in translation from Latin means "hearing" and is used in world practice to refer to verification.

An audit is understood as any verification of a phenomenon or activity performed by an independent expert (distinguish between operational, technical, environmental and other types of audit). Certain types of audit are close in importance to certification.

Quality audit is a systematic, independent and documented process for obtaining audit evidence and evaluating it objectively in order to determine the extent to which agreed audit criteria have been met (ISO 19011: 2002, Guidelines for auditing quality management systems and / or environmental management systems). According to this definition, it is necessary to give several explanations:

Firstly, audit is a systematic process, therefore, it should be carried out in the organization at a certain, planned frequency. The frequency of the audit will depend on whether the audit is internal or external. If an internal audit is carried out (i.e. the organization checks itself), then the organization sets the frequency of such an audit independently. If an external audit is carried out, then the frequency of such an audit is established by the rules of the certification body or the customer.

Second, independent means that the professionals conducting the audit should not be held accountable for the results of the work they are checking. This independence is provided in different ways. For internal audit, independence is ensured by the selection of auditors from various parts of the organization. For external audit, independence is ensured by the “non-involvement” of auditors in the development and implementation of the quality system in the auditee. External auditors cannot act as consultants on the implementation of the quality management system for the organization, which they will further audit.

Thirdly, an audit is a documented process - all stages of an audit, its procedure, audit requirements and audit results must be documented. Audit evidence can be records, documents or facts of work.

Fourth, the audit must be conducted against agreed audit criteria. The agreed audit criteria are understood as the requirements of regulatory documents (external standards, for example ISO 9001: 2008 or internal standards - procedures, work schemes, regulations, etc.). Thus, any regulatory documents that present the requirements to be verified can act as audit criteria. Consistency of audit criteria is ensured by the acceptance of these criteria by the audit parties. For example, an organization undertakes to comply with the requirements of ISO 9001: 2008, and a certification body undertakes to audit its quality system for compliance with ISO 9001: 2008.

Goals and objectives of the audit

Quality audit is focused on identifying the causes of inconsistencies in the quality system, processes or products (services) of the organization. Hence, the main purpose of the audit arises - to collect objective evidence that will identify inconsistencies in processes, products (services) or a quality system.

Based on the main goal, the audit objectives are also determined:

The audit should determine the operation and effectiveness of the quality management system. Those. during the audit, it is determined how the quality system is implemented in the organization, whether it works, and whether the quality system helps to achieve results in the main activities of the organization.

The audit should provide information on the effectiveness of the quality system - i.e. the audit must show whether the quality system works exactly as a system, or only individual elements work from this system, and all other requirements are met only formally, or not at all.

It is necessary to determine the level of compliance with QMS standards and procedures - i.e. the audit shows how closely the work is done in the organization to the rules established in the quality system procedures and whether there are differences between the actual 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 terms of reference can be checked.

The audit should allow assessing the impact of changes in the organization on the quality management system - the organization never stands still, in any organization there are any changes. These changes can affect the quality system to one degree or another. An audit of the quality system can show how these changes affected the quality system, whether changes in the quality system are taking place that are adequate to the changes in the organization.

The main result that the 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 course of the audit is essential. Such evidence can only be obtained if the audit criteria and rules for assessing nonconformities are clear and not subject to varying interpretations.

Audit participants

Auditing 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: 2002 defines an audit client as the organization or person who ordered the audit. The customer of the audit is the party most interested in conducting it and obtaining the results of the audit. The customer of the audit, as a rule, is the management of the auditee. In the event that an internal audit is carried out, the organization's management is interested in the auditors to objectively and accurately assess the work of the quality system and provide data on all nonconformities in the work and opportunities for optimization of work. In the event that an external audit is carried out, the organization's management is interested in the quality system being recognized as complying with the requirements and this was documented (by issuing a certificate - in the case of a certification audit, or by concluding a contract - in the case of verification by a potential customer of products, works or services of the organization).

Auditors are persons with the competence to conduct an audit (ISO 19011: 2002). 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 for the qualifications of auditors are presented in ISO 19011: 2002. They generally apply to professional auditors working for 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 the organization to effectively and efficiently conduct internal audits, he must be trained in audit methods and techniques, know the requirements of the quality system, know how the organization's quality system works and be well versed in the subject area of \u200b\u200bthe activity that he will be checking.

Technical experts are individuals who provide auditors with specialized knowledge or experience. During the audit, questions may arise, for the verification of which the knowledge and qualifications of auditors is not enough. In such cases, technical experts may be involved in the audit. The involvement of technical experts is possible both for internal and external audits. In the case of internal audit, technical experts can be employees of departments who perform work similar to the audited one, but they do not need to check their 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 in the audit of the second department, and vice versa. In the case of an external audit, technical experts are hired by external auditors from outside organizations.

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 organization's management and internal auditors.

Quality management systems audit status

Quality management system audit refers to the types of audit that are not regulated by federal or international legislation. Accordingly, there are no mandatory legislative norms to determine the procedure and rules for auditing quality systems, determining the requirements for auditors and the necessary reporting. This is due to the fact that certification of quality systems belongs to the voluntary area of \u200b\u200bcertification and all work related to the construction and implementation of a quality system is a voluntary initiative of the organization. Accordingly, for organizations involved in the audit of quality systems there is no need to obtain licenses or other permits to conduct this activity. For conducting internal audits, such documents are all the more not required.

Standardization documents

Metal structures

"TsNIIPSK them. Melnikov "

ORGANIZATION STANDARD

Quality Management System
INTERNAL AUDITS

PLANNING, CARRYING OUT

STO SMK 27-2004

Moscow

2004

CENTRAL ORDER OF LABOR RED BANNER RESEARCH AND DESIGN INSTITUTE OF BUILDING METAL STRUCTURES NAMED AFTER N.P. MELNIKOVA

tsniipsk them. MELNIKOVA (About founded in 1880)

ORGANIZATION STANDARD

Quality Management System

INTERNAL AUDITS

Planning, conducting

STO SMK 27-2004

Foreword

1 DEVELOPED AND INTRODUCED by the Standardization Department of ZAO TsNIIPSK im. Melnikov "

2 ACCEPTED AND PUT INTO ACTION from the date of its approval by the director of ZAO TsNIIPSK im. Melnikov "February 20, 2004.

3 INTRODUCED for the first time

4 Development, coordination, approval, publication (replication), update (change or revision) and cancellation of this standard is carried out by the standardization department of ZAO TsNIIPSK im. Melnikov "

Introduction

This standard is a mandatory documented procedure for a quality management system operating at an institute in accordance with the requirements of the ISO 9000 family of standards, model GOST R ISO 9001-2001.

This standard was developed in the development of the section "Quality manuals" - "Internal audits" in accordance with the requirements of the organization's standards STO SMK 07-2004 "Organization standards. The procedure for the development, construction and execution "and STO SMK 28-2004" Management of documentation and records ".

APPROVED

Director of ZAO TsNIIPSK

them. Melnikov "

V.V. Larionov

"20" 02 2004 r.

STO SMK 22-2004

STANDARDORGANIZATIONS

Introduction date 2004-02-20

1 area of \u200b\u200buse

This International Standard establishes the procedure and sequence of actions when conducting internal audits (inspections) of the quality management system (QMS).

When developing the standard, the requirements of the family of international standards ISO 9000 model 9001: 2000, draft ISO 19011: 2002 and ISO 10011-1 / 2 / 3-93 were taken into account.

This International Standard is intended for use in planning and conducting internal audits at the institute and serves as a guide for specialists performing internal audits and is mandatory for all structural divisions and services of the institute.

2 Normative references

GOST R ISO 10011-1, 2, 3-93 Guidelines for the verification of quality systems.

Part 1. Verification.

Part 2. Qualification criteria for expert auditors

Part 3. Management of the audit program

I SO 19011 (First edition 2002-10-01)

GOST R ISO 9000-2001 Quality management systems. Fundamentals and vocabulary

GOST R ISO 9001-2001 Quality management systems. Requirements

STO SMK 01-2004 Quality Manual

STO SMK 04-2004 Monitoring and measurement of products

STO SMK 07-2004 Organization standards. The order of development, construction and design

STO SMK 28-2004 Documentation and records management.

3 Terms and definitions, abbreviations

The following terms and definitions apply in this HKSA and during internal audits:

3.1 internal audit(verification): A systematic, independent and documented process to determine the conformity of activities and quality results with planned activities, as well as the effectiveness of implementation of activities and their suitability for the stated objectives.

3.2 auditor:A specialist of the institute authorized by the Directorate, having the competence to conduct internal audit.

3.3 audit team leader:A specialist from the internal audit team, appointed by the directorate of the institute, to lead this audit.

3.4 procedure:An established way of carrying out an activity or a process.

The procedure can be documented or undocumented.

3.5 entry:A document containing results achieved or evidence of activities carried out.

3.6 recommendation:A proposal aimed at eliminating the identified inconsistency and / or its causes, which does not impair the functioning of the QMS. Developing activities is desirable but not required.

3.7 deviation:Failure to comply with the established requirement.

3.8 comment:Revealed deviation in the functioning of the QMS, which reduces its effectiveness.

3.9 inconsistency:Revealed deviation, that is, the absence of one or more quality characteristics, points and sub-points of the QMS elements based on quality criteria, or their deviation from the established requirements of the standard.

3.10 observation during quality control:A statement of fact made during the audit and based on objective evidence.

Abbreviations:

QMS - quality management system of the Institute TsNIIPSK named after Melnikov

OPR - a responsible representative of the management of TsNIIPSK them. Melnikov for QMS, Deputy Director

OS - standardization department

GMK - quality management group

RK - quality manual

STO - the standard of the organization TsNIIPSK them. Melnikov

4 General

4.1 Internal audits of the quality management system are carried out with the following objectives:

Evaluating the effectiveness of the functioning of the QMS and identifying opportunities and ways to improve it;

Revealing inconsistencies in the QMS (procedures, processes, products) with the established requirements;

Determination of all the reasons for the identified inconsistencies (main, additional, concomitant);

Checking and evaluating the effectiveness of corrective actions based on the results of previous audits;

Improvements to audited activities in departments.

4.2 The audit of the QMS should be:

Planned and consistent;

Understandable to staff;

Comprehensive and comprehensive, i.e. the audit plan should cover all activities related to the QMS;

Repeated at least once a year, however, this depends on the complexity of the work and the number of inconsistencies found;

Objective and reasonable;

Provided with a reporting system and corrective actions with verification of the implementation of these actions.

4.3 Audits can be carried out both by the personnel of the quality management group of the OS department, and by specially trained employees of the institute.

4.4 The audit team should include specialists who meet the following requirements:

Have a higher education in one of the areas of work;

To be able to communicate with people, establish personal contacts, listen to the interlocutor, control oneself;

Know the documents of the QMS, regulatory documents of the organization, methods of conducting internal audits;

Be able to work with documents, verbally and in writing to express your thoughts.

4.5 In order to constantly improve and improve professional skills in conducting audits, specialists who are included in the formed composition of auditors (order dated January 22, 2001 No. 7) are trained in special courses on QMS, and also independently study the regulatory and methodological documentation on the quality management system.

4.6 The results of the audit are the main input data for the analysis of the QMS by the management.

5 Planning internal audits

5.1 Audit objects

5.1.1 The main objects of internal audits are:

Institute QMS processes;

The quality of work (products);

Functioning of the QMS at the Institute.

5.1.2 The process state audit determines the ability to consistently perform the processes to the specified quality requirements, as well as the validation of the developed processes.

5.1.3 An audit of the quality of work (products) is intended to determine the degree of fulfillment of those quality requirements that are established by agreements (contracts), standards and other regulatory documents that apply to this product.

The audit of the quality of work (product) can be an integral part of the process audit.

5.1.4 When checking the functioning of the QMS, the QMS documentation and the actual fulfillment of the requirements set forth in it are checked.

5.1.5 Checking the QMS documentation is built in the following areas:

The documentation is checked in terms of compliance with the requirements set out in the RK, organization standards - STO (STP) and other documents, as well as in terms of its compliance with the objectives of the Quality Policy;

Procedures for document management are checked for approval, implementation, changes, withdrawal of outdated and canceled documentation;

The quality of the documentation itself is checked in relation to its availability and correctness of the wording of requirements, clarity of presentation, the presence of a complete set of figures, tables, annexes, etc .;

The presence and condition of documentation at workplaces is checked;

Quality records are checked (STO SMK 28-2004).

5.2 Planning audits

5.2.1 Internal audits (checks) are carried out:

In accordance with the plan approved by the institute - scheduled audit;

At the direction of the management of the Institute - an unscheduled audit;

Based on customer requirements;

Before conducting an external audit by a third party for the purpose of QMS certification.

5.2.2 The annual plan for conducting internal audits of the QMS is developed by the standardization department at the beginning of the year (I sq.). The plan is coordinated by the ODA and approved by the director of the institute. The plan form is presented in the annex .

5.2.3 When developing a plan, it is necessary to consider:

The importance and state of the processes;

The degree of fulfillment of the requirements of GOST R ISO 9001-2001 contained in the QMS documents;

Results of the analysis of the state of the QMS;

Results of previously conducted internal audits;

Results of external audits.

5.2.4 The basis for unscheduled audits is:

Appearance (increase in the number) of remarks or complaints in the manufactured products;

Changes in the organizational structure of the institute;

Customer's requirement;

Changes to the QMS documentation;

Changes in economic or social conditions, etc.

6 Sequence of work during internal audit

6.1 The standardization department, in accordance with the plan for conducting internal audits, proposes to the RRO the composition of the team and the leader of the audit team.

Specialists of the audited units are not included in the group members. The size of the audit team must be at least two people.

6.2 The standardization department together with the team leader draw up the Audit Task. The task is approved by the ODA. The Task form is given in the appendix. .

6.3 In accordance with the approved Assignment, the auditor conducts an audit, adhering to the audited sections of the RK and documentation specified in it.

6.4 Based on the results of the check, the auditor fills in the protocols of nonconformities or comments on the identified deviations. The form of the non-conformity protocol and the remarks protocol is given in the annex and respectively.

6.5 The head of the audited department signs the protocols of non-compliance, comments, indicating in them the corrective actions for each specified deviation and the deadline for its implementation.

6.6 Protocols of inconsistencies, remarks are registered in the Protocol Accounting Sheet, the Accounting Sheet is stored in a folder along with the minutes in the OS department. The form of the Sheet of record of protocols of non-compliance, remarks is given in the appendix .

6.7 When conducting the next scheduled or unscheduled inspection in this unit, the auditor analyzes the implementation of corrective actions specified in the non-compliance protocols, comments from previous audits. The auditor and the head of the department complete the registration of the non-compliance protocols, comments from previous audits, filling in the columns on the implementation of corrective actions.

In case of failure to comply with the corrective actions on time, the auditor informs the RRO and the head of the CB, who take appropriate action.

6.8 The audit team leader prepares a report on the audit. The report is approved by the ODA. The report form is given in the appendix. .

The report should contain:

The date of the audit;

Audit objects (processes, quality of work, QMS documentation);

Audit results (list of identified deviations: inconsistencies, remarks, recommendations);

Conclusion on the degree of compliance or non-compliance with the requirements of GOST R ISO 9001-2001, the effectiveness and efficiency of the verified processes;

Suggestions for improvement, if any, were developed as a result of the audit;

Conclusion on the need for a repeated audit.

6.9 Audit reports are reviewed and analyzed by the standardization department.

The results of the analysis of the state of the QMS and proposals for its improvement are considered at a meeting with the director of the institute with the heads of departments.

Based on these results, a section of the annual report "On financial and economic activities" of the management of the institute is formed.

6.10 The materials on the conducted audit (report, assignment, minutes, record sheet) are stored in the standardization department for at least five years.

7 Responsibility

7.1 The responsibility for planning, organizing and finalizing internal audits (inspections) at the institute rests with the head of the standardization department. Control over the conduct of audits, provision of methodological assistance and coordination of the entire audit process is entrusted to the ERP.

7.2 The auditor is responsible for registering and monitoring the implementation of corrective actions to eliminate the inconsistencies and comments identified during audits, as well as for conducting the audit strictly in accordance with the approved assignment.

7.3 The heads of all departments of the institute are responsible for:

For organizing and supporting the audit in your department;

For providing the auditor with all the necessary data, in accordance with the approved assignment;

For a friendly attitude towards auditors and assistance in their work;

Effective and timely implementation of corrective actions.

Appendix A

(required)

The form of the plan for conducting internal audits of the QMS

APPROVED

Director of ZAO TsNIIPSK

them. Melnikov "

V.V. Larionov

"____" ___________ 200__

PLAN
conducting internal audits of the quality management system of the institute for 200 __ year

Name of departments (services)	Activities	Checked items of the standardGOST R ISO 9001-2001	Timing of inspections

Deputy director of the institute,

responsible for the system

quality management Molchanov

Head of the Standardization Department S.I. Bochkova

Appendix B

(required)

Form of assignment for the internal audit of the QMS

APPROVED

Deputy Director of ZAO TsNIIPSK

them. Melnikov ", responsible

for the quality management system

A.A. Molchanov

"____" _________________ 200 __

Assignment for the internal audit of the quality management system

1 Basis for audit ____________________________________________________

(plan, order)

2 Audit Team Leader _______________________________________________

(Full Name)

Beginning standardization department _____________________

Appendix B

(required)

Non-conformance protocol form

NON-CONFORMITY REGISTRATION PROTOCOL No. _____________
COMPANY: ZAO TsNIIPSK im. Melnikov				THE DATE:					HEAD OF THE AUDIT GROUP
				____________			200 BC	signature			initials, surname
PRODUCT TYPE:				STANDARDS: GOST P ISO 9001-2001					AUDITOR:		initials, surname
SUBDIVISION:				ITEM NUMBER:					DEPARTMENT HEAD:
									initials, surname
					critical						uncritical
DESCRIPTION OF NON-CONFORMITY:
AUDITOR:									TERM OF REMOVAL: no more than 3 months
		Signature
						A.A. Molchanov
	signature					initials, surname					_______________ 200 BC
EVALUATION OF THE RESULTS OF CORRECTIVE ACTIONS:
NON-CONFORMITY:			ELIMINATED					REMOVED PARTLY
REMAINED UNRESOLVED:
to be filled in in the case of "REMOVED PARTLY"
AUDITOR:			signature							DATE OF NON-CONFORMITY VERIFICATION _______ 200 BC

Appendix D

(required)

Comment protocol form

REGISTRATION PROTOCOL REMARKS No. _____________
COMPANY: ZAO TsNIIPSK im. Melnikov				THE DATE:				HEAD OF THE AUDIT GROUP
				____________		200 BC	signature			initials, surname
PRODUCT TYPE:				STANDARDS: GOST P ISO 9001-2001				AUDITOR:		initials, surname
SUBDIVISION:				ITEM NUMBER:				DEPARTMENT HEAD:
								initials, surname
DESCRIPTION REMARKS:
AUDITOR:		Signature						TERM OF REMOVAL: no more than 3 months
CORRECTIVE ACTIONS OF THE UNIT:
MANAGEMENT REPRESENTATIVE:					A.A. Molchanov					DESIGNATED EXECUTION DATE:
Protocol number	Number of protocols		Elimination date		Audit Team Leader's Signature
inconsistencies	remarks	inconsistencies	remarks	inconsistencies		remarks
					3 Basis of audit: planned / unscheduled audit 4 Composition of auditors: _______________________________________________________________________ 5 Purpose of the audit: assessing compliance with _________________________________ requirementsGOST R ISO 9001-2001 6 Audit results: _________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________ 8 Conclusion on the conducted audit: ___________________________________________________________________________ ___________________________________________________________________________ 9 Suggestions for improvement: ___________________________________________________________________________ ___________________________________________________________________________ 10 Re-audit: ________________________________________________ Beginning department of standardization __________________________________________________ Audit Team Leader __________________________________________________ Auditors _______________________________________________________________ Change registration sheet Change number Section numbers, paragraphs (subparagraphs) The term for the introduction of the change signature modified replaced new canceled

Keywords: Quality management system, internal audit, planning, work sequence, responsibility