“We want to implement a QMS!” – more and more often such statements are coming from customers. This request is a balm for the soul of a quality expert, contrary to the chronic ones: “You need a certificate - the customer demands it - how much does it cost - what is the deadline?”
There are two fundamentally different approaches to the “implementation” of a management system. At the same time, everyone has the same goal - development, profit.
The second way, conditionally formal: “You need a certificate.” How to do it: open a search, find the cheapest certification offer, call. The certificate will be issued within an hour. Let us warn you right away - this technique will not work.
Therefore, below we will talk about implementation according to this plan:
- Where to start implementing a QMS
- Implementation steps:
1. Analysis
2. Development
3. Adaptation
4. Training
5. Certification
6. Development - Conclusion, conclusions
Where to start implementing a QMS
If the customer says that he wants to “implement first” and then get certified, it won’t work. Because “implementation of a quality management system” is not one-time, but a time-consuming, step-by-step, results-based process of building and improving a quality management system. It aims to develop the organization as a whole.
Let's look at how the process happens step by step.
Steps to implement a QMS
1. Analysis existing quality management system.
It is impossible for an enterprise to operate without a QMS. Most likely, what exists is not called “QMS”.
The ideal situation for implementation is when the development of a QMS “matures” from within, when the driving force is the desire of process participants to increase efficiency and quality of work. This fertile soil remains to be plowed with the right tools and sown with the right crops - to systematize processes, apply experience and knowledge of already proven management systems.
An imperfect situation is when there is nothing. When there are three people on staff, three hundred under GPC contracts, the customer demands a certificate, the military representative threatens to come with an inspection, and you need to resolve urgent production issues.
Here, in the context of implementation, there are two options for analyzing the quality management system:
- – checking the current management system for availability and compliance with the requirements of the required standard: “pass or fail.”
If there is no QMS at all, the summary will be: “There is no system, it needs to be developed.”
If it exists, but is not formulated or formulated incorrectly: “Yes: according to the standard it will pass/fail because….; you need to do this: 1) ...; 2)…; 3)...".
As a rule, such an audit is cheaper, or even free. For example, we practice this type of cooperation - preliminary diagnostics of the customer’s quality management system before concluding development contracts. You can learn more about this.
- An external audit is the same as a diagnostic audit, but in the end it is a whole system of audit reports with detailed comments on identified inconsistencies. This option is usually ordered by companies that have a working quality management system, but need an outside opinion about its quality and compliance.
We analyzed it, got conclusions: what is there, what is not, what is needed, what is unnecessary, we move on.
2. Development based on the current situation of the QMS itself, which meets the requirements of the standard. If you don’t have your own full-time competent specialist, it’s up to consulting.
Let's clarify right away! When there is your expert(s) is the best option! See point 4 below about training.
The main task of a competent specialist (your own or a hired one) is translate requirements from the language of the standard, written at a high level of abstraction, into the understandable language of a specific enterprise.
Let us allow ourselves an allegory. Imagine that you came to New Zealand with the legendary James Cook to establish trade relations with the aborigines, but, due to a lack of understanding of the traditional cultural way of life of the counterparty, you were uncompromisingly eaten with the best intentions.
We will decipher who is Cook here and who are the natives later. Let's say that New Zealand means profitable contracts, and the “best intentions” are the requirements of the standards. According to legend, Cook did not have any competent translators.
Let's return to the QMS. The next tasks of development experts are to reverse engineer, optimize, improve, and document. It is important to understand that the customer’s desire: “We pay you, and you develop everything for us” is impossible. The maximum that is possible is that templates for reporting forms and recommendations can be provided, but this will still need to be adapted. A quality management system is not needed by experts. You need it, so development involves joint with collaboration.
3. Adaptation recommendations from experts at the enterprise. This means that the responsible persons will not just sign the acceptance certificate for the package of developed documents, but subtract them for reality and reliability.
4. Training employees.
There was a case in our work when a teacher came for training, drew a management system on the board with a marker, developed together with the management team, and the next day the head of the quality department quit. Why? Because “doing nothing” is no longer good. A quality management system is something that should work. Even if there is an impression that this is just a “tuning” of the company’s image, the time will come when the QMS will become a support, a vital pillar of the organization, and not a “keychain” with the keys to profitable contracts.
And then about motivation - any manager understands that this is “our everything.” This is how the Great Patriotic War was won: with the right motivation and despite the powerfully paid for A enemy campaigns. Returning to the QMS: it can be built through the command decision of the leader, but support and develop– only on the basis of personal interest of employees. Starting from the manager, ending with the cleaning lady. Otherwise, it turns out that the quality management system is on its own, and the enterprise is on its own.
Therefore, the dialogue between the quality management department and management often does not work. The manager delegates quality management, not allowing it to grow out of his area of competence - from the centralized system management of the enterprise as a whole. It turns out that internal auditors demand something from department heads, but they are ignored until certification is urgently required.
5. QMS certification to meet the required standard.
Simply put, it’s like passing an exam on knowledge of a subject in two stages: tell the theory (documentary audit) and confirm it in practice (on-site audit). If you pass, you receive a certificate, if not, you can retake it. And an adequate examiner will always help and advise: it is in his interests that the graduate has knowledge, and not standard forms on hand. Like the Hippocratic oath “...Whatever house I enter, I will enter there for the benefit of the sick...”
Standard certification scheme:
- Documentary audit:
- providing the necessary documentation to the certification body;
- analysis of documentation by the certification body, drawing up comments and recommendations for their elimination;
- adjustment of documentation, the quality management system itself by the customer.
- On-site audit:
- the auditor evaluates the QMS “on the spot”, makes comments on inconsistencies, and recommendations for their elimination. Transfers them to the customer;
- fixing problems;
- issuance of a certificate.
By submitting an application for certification, an enterprise receives not a “piece of paper” certificate, but a ready-made plan for improving and developing the QMS.
6. Development of QMS.
It was said earlier that implementation is set of measures according to the quality management system within the company. Let us repeat: practice persistently confirms that theory does not work. Our article, which calls for building a QMS from the inside, will most likely evoke a noble response in the soul of every quality specialist. But all the difficulties and problems will begin at the “doing” stage. The so-called “psychological factor” of implementation comes into force.
The management's task is to move this issue forward. Involving third-party experts for implementation is one of the tools.
They will help with:
a) “translation” on legislative updates, adaptation of new requirements of QMS standards;
b) training employees (sometimes this implies a qualitative formatting of the way of thinking, attitude towards quality management in general);
c) optimization, systematization in order to free up resources and get rid of ballast;
c) scheduled inspections, recertification, which involve constant diagnostics of compliance, monitoring of improvements.
Conclusion
(or what does Cook and the Great Patriotic War have to do with it)
Today, there are as many myths and legends on the issue of QMS as there are regarding the eaten Englishman Cook (eaten, or maybe not eaten, by the way, not in New Zealand, but in Hawaii).
For example, that “QMS is coming to us from the West as an advanced practice in efficient production.” Few people know that in the early eighties, senior positions in ISO were occupied by officials from Gosstandart, and when developing the ISO 9000 standard, its developers largely relied on quality management standards in our defense industry (especially in terms of documenting processes, decision making, developing process metrics, management changes).
“The reality is that ISO 9000 grew out of the Soviet military-industrial complex. It was the QMS that allowed us to launch a satellite, forge both a rocket sword and a nuclear shield.”. (With) And before that - to win the Great Victory.
Who, if not us, will introduce, develop, and enrich domestic management systems with methods and technologies for the rational use of resources?
In the story of James Cook, we are the natives who will digest any ISO standard with its fashionable Anglicisms and produce an inevitably effective result.
With respect to you and all domestic standardization,
ISU experts
After studying this chapter, university students and graduates should:
know
- – motivational reasons for implementing a QMS;
- – problems that organizations face during the transition period, and areas of preparatory work before launching the process of developing and implementing a QMS;
- – sequence and content of work at the stages of development and implementation of the QMS;
- – initial data required for the development and implementation of the QMS;
- – the creation of what new functional entities in the organization will be required to ensure the functionality of the QMS;
- – criteria for the completion of the QMS implementation project and its readiness for certification;
be able to
- – develop organizational and planning documents for the creation and implementation of the QMS, including: development order; distribution of powers and responsibilities between leading specialists in the processes necessary for the QMS; a step-by-step schedule for the implementation of all stages of development and implementation work;
- – be able to understand the main reasons for the low effectiveness of the QMS at many domestic enterprises and counteract them with corrective measures;
own
- – skills in assigning relevant QMS documents to different levels of management;
- – skills in organizing functional and information interaction between coordinating bodies and other QMS participants.
General procedure for the development and implementation of a QMS
What is a quality management system (QMS)? This is a procedure for managing an enterprise in market conditions in which the coordinated activities of all its employees and departments are carried out, aimed at ensuring the quality of products or services that meet consumer expectations. Each organization has its own QMS model. It can be created either on the basis of the individual experience of the manager, or on the basis of known standards. However, in reality, all models differ from each other in the degree of commitment of the organization's management and personnel to quality and in what true value guidelines they are guided by regarding the fulfillment of obligations undertaken to the consumer. The “correct” entrepreneur understands that the consumer is the main figure for him. He is interested in developing relationships with him in the direction of obtaining mutual benefits. The consumer is the source of life-giving force for entrepreneurship and therefore requires special treatment. The fight for the consumer requires the entrepreneur to make systematic changes in the activities of his organization. Even if the entrepreneur’s products fully meet the standards, but are not in demand by the consumer, this means that the enterprise in its current state is threatened with loss of work and forced closure.
Unfortunately, reality presents us with a large number of examples when the main reason for consumer dissatisfaction with suppliers of goods and services is not only the inability, but also the reluctance on the part of the entrepreneur to satisfy customer requirements. The client goes to another supplier, with whom the relationship is also not the best. But this order of things cannot last long for an unscrupulous entrepreneur.
If management, neglecting the interests of its consumers (the state of “manufacturer’s dictate”), intends to maintain its presence in the market in the future, it will have to radically change the activities of its enterprise by moving from the current state (“manufacturer’s dictate”) to a new one (“consumer’s dictate”) through the development and implementation of a more progressive management model. Schematically, this transition process and the main problems that the organization will have to solve during the transition period look approximately as shown in Fig. 7.1.
GOST R ISO 9001–2008 is an example of a management model on the basis of which effective regulation of relations between consumer and supplier can be achieved. This model is ideal for an organization that truly:
“a) needs to demonstrate its ability to always supply products that meet customer requirements and relevant regulatory requirements;
b) aims to increase customer satisfaction through the effective application of the QMS, including processes for its continuous improvement and ensuring compliance with customer requirements and mandatory requirements." Here in quotation marks is the formulation of those two goals, the achievement of which at the very top of the organization is prescribed by clause 1.1 of the GOST R standard ISO 9001-2008.
The uniqueness of the standard lies in the fact that it does not offer any absolute quality criteria for each individual type of product or service. This would be impossible due to the fact that quality is the ability of a product or service to satisfy consumer needs, and these needs are infinitely diverse.
The standard specifies only the methodology for the creation and operation of a QMS, which should ensure a high level of quality of products or services and thereby guarantee a high degree of customer satisfaction. A formalized presentation of management processes in accordance with the requirements of the standard allows us to recognize the imperfection of their flow, the lack of necessary connections, identify unnecessary management operations, and, consequently, optimize the organization’s management system.
The QMS, built in accordance with the requirements of the standard, is the basis for the introduction of further modern approaches to the management of organizations.
To initiate any change, the organization's leadership and all staff must believe that they can do better. Today, with supply exceeding demand, no organization can afford to stand still. When employees are satisfied with the level of quality of their work, they stop improving. The organization falls into stagnation. How can we bring about a radical change in the consciousness of the organization's employees? Command methods and slogans are not suitable here. This turnaround will not happen suddenly or as a result of some productivity program. It is important to make the process of improving performance part of the organization's management system, an integral part of the entire life of the organization, the way of thinking and the way of behavior of all its personnel. Then the organization will systematically do what the consumer needs: minimize losses and costs, ensure the lowest possible cost, regulate pricing policy, ensure profitability, and always have consumers.
Rice. 7.1.
The performance improvement process is acceptable for organizations of any form of ownership and type of activity. It has become a sound management practice that, if followed, will help change management practices and the face of an organization.
The successful implementation of the performance improvement process primarily depends on the support and participation of the very first manager. Therefore, before deciding whether to make this process part of the management "culture" in the organization, the manager must require real input from key links in the management environment. The manager should not talk about the quality of the work of a separate group led by a senior manager, but about the work of the entire organization. Leaders must understand that this is a cross-functional process of performance improvement that will ensure greater productivity from each individual. The first leader, together with other executives who support him, will have to create a team of like-minded people who can become a driving force for change.
In Fig. Figure 7.2 shows the initial activities through which this team will have to achieve:
- – understanding of the quality policy by all personnel and their agreement with the objectives of this policy;
- – involvement of employees at all levels, who form the basis of the organization, in the movement for quality;
- – organizing the planned implementation of the requirements of GOST R ISO 9001-2008 in the QMS.
Rice. 7.2.
The development and implementation of a QMS taking into account the requirements of GOST R ISO 9001–2008 is a set of measures, the implementation of which creates conditions for improving the activities of both ordinary employees and managers of the organization. QMS allows you to focus on those aspects of activity that are paid attention to, as a rule, only when control over them is lost or when consumer dissatisfaction reaches a critical level.
This system will help the organization's staff to view change as a necessary way of life.
In table 7.1 presents a sequential diagram of the organization’s work to implement the requirements of GOST R ISO 9001–2008 into its QMS. It is assumed that the current QMS is initially far from meeting these requirements. This work scheme has been tested by many years of application by various organizations with good results.
Table 7.1
Sequential scheme of work for the development and implementation of a QMS taking into account the requirements of GOST R ISO 9001–2008
|
Names of stages (duration) |
Expected results |
|
|
Stage 1. Organization of QMS design (1–3 months) |
1.1. Preliminary analysis of the existing management system |
Initial data for developing a QMS |
|
1.2. Determining the scope of application of the QMS, making decisions on its development and implementation |
Assessing the ISO 9001 requirements applicable to the organization's activities |
|
|
1.3. Determining the list of processes required by the QMS, forming a group for the development and implementation of the QMS and appointing its leader |
Order on the organization of work on the development and implementation of a QMS |
|
|
1.4. Preparation of a draft work schedule for the development and implementation of a QMS |
Approved work schedule for the development and implementation of the QMS |
|
|
1.5. Conducting training for company personnel (top management, middle management, internal auditors, QMS developers) |
Approved plans and programs for personnel training. Conducting training as planned |
|
|
1.6. Distribution of responsibilities and powers in the QMS |
Matrix of management responsibility and interaction between departments |
|
|
1.7. Developing statements of the organization's quality policy and goals |
Documented statements of quality policy and objectives |
|
|
Proposals for adjusting the organizational structure and job descriptions |
||
|
Stage 2 Development and implementation of QMS documentation (4–6 months) |
2.1. Analysis of applicable regulatory and technical documents, work and control instructions, forms, etc.; identification of non-compliance with the requirements of GOST R ISO 9001-2008 |
Proposals for the types of documents required for planning and implementing QMS processes and their management |
|
2.2. Determining the structure and composition of QMS documentation |
Agreed and approved initial data for the development of QMS documentation |
|
|
2.3. Preparation of a detailed schedule for the development, coordination and approval of QMS documentation |
Schedule for the development of QMS documentation (addition to the work schedule) |
|
|
2.4. Development, based on approved initial data, of draft “quality manuals” and documented procedures to the extent necessary for QMS certification |
First editions of the “quality manual” and documented procedures |
|
|
2.5. Correction of identified inconsistencies in documents of the types “specification”, “methodology”, “work instructions”, “drawing”, “record”, etc. |
First editions of documents on planning and implementation of QMS processes and their management |
|
|
Familiarization of performers with documents and their study |
||
|
2.7. Practical testing of all QMS documentation in the workplace |
Proposals for corrective actions and their implementation |
|
|
Stage 3 Preparation of the QMS for certification (2–3 months) |
3.1. Training of specialists appointed to conduct internal audit of the QMS (with the involvement of external auditors) |
Trained auditors |
|
3.2. Preliminary internal audit of the QMS |
Assessment of compliance of the actions performed with the requirements of the QMS documentation |
|
|
3.3. Development of corrective measures to eliminate inconsistencies identified during the preliminary audit |
An updated set of QMS documentation. Approved documentation |
|
|
3.4. Assessment of the degree of readiness of the QMS for certification |
Positive assessment of the level of readiness of personnel and documentation |
|
|
3.5. Filling out an application for certification and the necessary supporting documents |
Working contact with the selected QMS certification body |
The work of developing and implementing a QMS is quite labor-intensive. As a rule, such work at an enterprise is carried out with the participation of an external consultant. It is important to ensure that the consultant has sufficient competence. In general, depending on the size of the organization, the duration of such work can range from 7 to 12 months. At the same time, the total labor intensity for a consultant can reach 50–60 man-days, while for enterprise employees this figure can be an order of magnitude greater. Neglecting the services of an external consultant sometimes results in an organization roughly doubling the total work period.
Certification of the QMS for compliance with the requirements of GOST R ISO 9001–2008 is carried out after completion of all work listed in table. 7.1, under a separate agreement with an accredited QMS certification body. The certification body is obliged to conduct a certification audit in accordance with the rules of the certification system in which this body is accredited.
In the modern world, the number of companies using ISO 9000 standards increases every year, giving organizations huge competitive advantages. The responsibility and level of competence of management is a prerequisite for the development of a quality management system (QMS).
Management must understand that the implementation of a QMS will bring significant benefits to the organization, will allow it to acquire additional advantages in the market and will lead to a reduction in risks. It is necessary to compare the expected result from the development of the QMS and the upcoming costs. To do this, the organization’s specialists must have in-depth training provided by the relevant training centers.
Initially, the project is agreed upon with management. It is also important that all levels of management of the organization participate in the implementation of the QMS, since significant staff resistance to new ideas is possible.
There are many programs and methodological recommendations for the implementation of QMS (recommendations from the management of the ISO committee, recommendations from domestic specialists). At the same time, all the above documents contain the following parameters of the quality management system: time restrictions, resources, uniqueness and complexity.
When creating an organization's quality management system, the following three stages can be distinguished:
1. Making a decision to create a QMS.
2. Development of a QMS
3. Implementation and maintenance of the QMS
Let's consider these stages in more detail. The development of a QMS begins with an information meeting. The meeting discusses the role and importance of quality management and ensuring the successful operation of the enterprise. Basic rights and obligations, responsibility of management, as well as management personnel. The need for the organization to adopt the recommendations of MS ISO 9000 on the creation of a QMS. Functions and structure of the QMS and the procedure for creating, verifying and certifying the QMS.
In fact, the first stage “Making a decision to create a QMS” includes two substages:
a) Organization of work to create a QMS based on ISO 9000 standards. Appointment of those responsible for the development of the QMS, training of participants, and attraction of external consultants. Drawing up requirements and recommendations for the QMS. Providing workers with the necessary resources.
b) Defining strategies and goals for implementing standards. Providing action models to achieve set goals.
The second stage, “Development of a quality management system,” begins with an analysis of the current situation and the development of a schedule for creating a QMS, which includes the following main works: developing a quality policy, developing a program and conducting personnel training, determining the composition of structural units that are part of the QMS. Creation of a system project, development of a QMS structural diagram. Development of regulatory documentation for the QMS, development of a quality manual. Experimental operation of the system.
External consultants or organizations specializing in this can be involved in the development of a QMS. The development of a QMS begins with analysis, production processes, creation of products and their presentation in the form of an initial list. The list of processes determines the functional structure of the QMS, as well as the composition of the services that perform these processes. The structural diagram of the QMS is based on the structural diagram of the enterprise. The management core of the QMS is the quality service. Quality management processes should be linked to the structure diagram. For each process, a structural unit should be indicated. The need to describe processes is to identify and eliminate possible inconsistencies in the organization of quality work. When developing a QMS, the main thing is to determine the composition and state of technical and regulatory documents.
Thus, the second stage of creating an organization’s QMS includes such substages as:
a. Drawing up a detailed project plan (organizational self-assessment). Drawing up a more detailed plan for the QMS project and deadlines.
b. Defining documentation and planning document structure. The requirements are determined by GOST R ISO 9001 standards.
c. Implementation of the process approach. The composition and type of process system depends on the size of the organization, its type of activity, products and services, scope of application and level of development of the QMS.
d. Developing a plan to resolve the non-conformity. The action of the resource is determined, responsibility and schedule are established, QMS documentation is prepared and approved.
The implementation of the third stage - “Implementation and maintenance of the developed quality management system” - is carried out by management and the quality service. At this stage, the quality service is formalized and this structure is integrated into the organizational structure of the enterprise. Work is carried out with personnel: meetings, gatherings in order to convey the basic principles of the organization’s work, taking into account quality requirements. In addition to information support at the stage of implementation of the quality management system, personnel are trained and employees are familiarized with the format of working with QMS documentation.
Based on the results of implementation and to maintain the developed QMS up to date, internal and external audits are carried out, continuous analysis is carried out in order to ensure continuous improvement of the organization’s business processes, its efficiency and effectiveness.
Thus, we can say that the third stage of creating an organization’s QMS consists of the following substages:
a. Implementation of QMS. Implementation of a quality management service, receipt of documentation by performers, notification of all employees about new requirements, personnel training.
b. Audit and analysis. Carried out after the QMS starts operating. The audit aims to verify compliance with the requirements of GOST R ISO 9001.
Stage 1. Management decision.
The manager must decide to start the project, notify company employees, and also create the prerequisites for the rapid implementation of all other stages. It is also necessary to formulate the goals of building a QMS, highlight at the top level the QMS processes that need to be controlled, and the criteria for assessing their quality. Subsequently, the goals of the QMS must be recorded in a document called “Quality Policy,” which also describes the principles for achieving them. This document is fundamental in the system of regulatory documentation of the company's QMS.
Stage 2. Staff training.
For further successful operation of the QMS, company personnel must study the theory of quality management, ISO 9000 series standards, master the theory of the process approach, as well as the basic requirements for the implementation of the QMS. Training in using the system can be carried out either with the help of consultants or independently if the company has an employee who has experience in setting up a QMS.
Stage 3. Formation of a QMS implementation program.
The implementation of a QMS should be considered as a complex and lengthy project (lasting up to one and a half to two years).
Therefore, it is necessary to draw up a QMS implementation program, which should include:
- - description of implementation stages;
- - a list of those responsible for each stage of the project. As a rule, they are selected from among top managers, as well as specialists who best know the specifics of their departments;
- - budget for QMS implementation. It includes both the costs of certification and payment for the services of consultants if they are involved, as well as the cost of further training of personnel and the cost of distracting management from their main work to conduct the project. When setting up a QMS, you can do it yourself, but distracting top management from their main work, as well as training your own specialists of the required level, can cost more than the services of a consulting company;
- - procedure for assessing the implementation of the QMS. The criteria by which management will be able to determine whether the goals set at the beginning of the project have been achieved are indicated.
After drawing up the program, you can begin directly setting up the QMS.
Principles of building a QMS.
When building a QMS, you must be guided by the following principles of quality management, formulated in the ISO 9000 standard. Customer focus.
Organizations depend on their customers and must understand their current and future needs, meet their requirements and strive to exceed their expectations.
Leader leadership. Leaders ensure unity of purpose and direction for the organization. They should create and maintain an internal environment in which employees can be fully involved in solving the organization's problems.
Employee involvement. Employees at all levels form the backbone of the organization, and their full involvement in the company's work enables the company to benefit from their abilities.
Process approach. The desired result is achieved more effectively when activities and associated resources are managed as a process. Systematic approach to management. Identifying, understanding and managing interrelated processes as a system contributes to the effectiveness and efficiency of the organization in achieving its goals.
Continuous improvement. Continuous improvement of the organization as a whole should be considered as its constant goal.
Fact-based decision making. Effective decisions are based on the analysis of data and information.
Mutually beneficial relationships with suppliers. An organization and its suppliers are interdependent, and mutually beneficial relationships enhance the ability of both parties to create value.
Stage 4. Description and optimization of business processes.
The basis of the quality management system is the process approach. First of all, it is necessary to describe those business processes, the management of which is considered most important for the QMS. The description is carried out using specialized computer tools based on information obtained during interviews with performers, etc.
The described business processes must be optimized, that is, eliminate all inconsistencies with the requirements of the standard and duplicate processes, as well as develop new processes in accordance with the rules of the standard.
Most often, companies lack the “Customer Satisfaction Assessment” process, which is necessary according to the standard.
Therefore, it is necessary to develop a system of indicators, as well as the procedures necessary to implement and monitor this process.
Stage 5. Development of regulatory documentation for the QMS.
At this stage, normative documents, regulations and procedures are formed to ensure the operation of the quality management system. The basis for them is usually a set of documents already existing at the enterprise, which is modified and supplemented in accordance with the requirements of the standard.
First, based on the Quality Policy, a document called the Quality Manual is prepared. It contains the main provisions regulating activities within the QMS: delimitation of areas of responsibility, requirements for the quality service, description of quality assurance procedures, procedure for maintaining QMS document flow, description of the complaint handling procedure, etc.
The next level of documents is called “System-Wide Documented Procedures”. According to the ISO 9001 standard, six procedures should be carried out:
- - document management;
- - data (records) management;
- - QMS audit management;
- - management of products that do not meet standards (the process of identifying defects and the procedure for their disposal);
- - management of measures to correct nonconformities;
- - management of measures to prevent the occurrence of inconsistencies.
Documents at the next level describe the rules for effectively planning, implementing and managing processes. Such documents include work methods, job descriptions of employees, process flow charts.
The basis of the “pyramid” of documents is data confirming that the requirements of the QMS are implemented in practice. These are reports on work done, entries in transaction logs, etc., that is, the documentary basis of the daily work of employees.
When drawing up regulatory documentation, it is necessary to take into account the requirement of the ISO 9001 standard on the competence of personnel performing work within the framework of the QMS. This means that regulatory documents must describe the process of employee access to regulatory documentation, as well as requirements for personnel competence (level of knowledge, work experience), a program for raising the level of employees if necessary, a system of employee motivation, etc.
It should be noted that the effective use of a large number of regulatory elements of the QMS requires the presence of electronic document management systems in the organization.
Stage 6. QMS testing and internal audit.
After the development of all regulatory documents, trial operation of the quality management system begins. You can launch processes within the new system gradually, for example, first introduce control of the procurement process, then production, etc.
Trial operation is accompanied by an internal audit and special procedures to verify the operation of the QMS. At the beginning of operation, they are carried out frequently (perhaps once a week), then less often (once a month or even a quarter).
For the purposes of internal audit, it is necessary to record quantitative quality indicators, for example, defect rate, customer satisfaction rate, return rate, etc., to which to strive. To determine the value of such indicators, similar indicators of industry leaders are usually used.
The internal audit should identify inconsistencies between current work and the requirements of the standard. These deviations must be recorded. Then, based on the results of the audit, adjustments are made to the work of employees, as well as regulatory documentation in order to avoid deviations in the future. All this work should also be documented in the appropriate QMS procedures.
Stage 7. Obtaining a certificate.
In order to certify a QMS, it is necessary to submit an application to the certification body. Initially, a number of documents should be submitted to the certification body:
- - application for certification;
- - all documents on the QMS (“Quality Policy”, “Quality Manual”;
- - diagram of the company’s organizational structure, documented procedures and other developed QMS documents);
- - list of the main consumers and suppliers of the enterprise.
Specialists of the certification body carry out an examination of the submitted documents within a month. The examination may include a visit by representatives of the certification body to the enterprise to check the quality system in action. Based on the results of the inspection, a protocol is drawn up in which all inconsistencies between the QMS and the requirements of ISO 9001 are recorded. Usually, based on the results of the first stage of the inspection, more than a hundred inconsistencies are found, and the enterprise’s task is to eliminate them as quickly as possible and prove this to the certification body. As a rule, these operations take 1-4 months.
After this, the actual certification is carried out. If all significant inconsistencies are eliminated, the company is issued a certificate (it takes about a month to complete). The certification body conducts repeated (surveillance) audits of the QMS at a certain frequency. They confirm that the company has not only implemented a quality management system, but is also constantly improving it. The cost of such an audit is approximately one third of the cost of primary certification.
According to GOST R ISO9000-2008 definition Quality Management System- This " management system for directing and controlling an organization with regard to quality».
It represents the totality of the organizational structure, distribution of powers and responsibilities, methods, procedures and resources necessary to establish, maintain and improve product quality.
Objectives of the quality management system
All quality management systems (QMS), despite the characteristics of organizations, are aimed at achieving the following fundamental goals:
Increased customer satisfaction;
Improving quality and: productivity;
Cost reduction;
Increasing competitiveness;
Improving the production climate;
Meeting environmental safety requirements.
Stages of development and implementation of QMS
The approach to the development and implementation of a quality system includes several stages:
1. establishing needs and expectations consumers and other interested parties;
2. development of policies and goals organizations in the field of quality;
3. establishing processes and responsibilities necessary to achieve quality objectives;
4. identification of necessary resources and provision them to achieve quality objectives;
5. development of methods to measure the effectiveness and efficiency of each process;
6. application of data these measurements to determine the effectiveness and efficiency of each process;
7. determination of funds necessary to prevent nonconformities and eliminate their causes;
8. process development and application continuous improvement of the quality system.
General provisions for QMS development
Regardless of the conditions in which the QMS is created, this process usually includes:
Development of a general management system;
- “product systems” of management companies;
Systems for non-contractual conditions.
« Product system» QM is a subsystem of the organization’s overall QMS that ensures the quality of a specific (homogeneous) type of product supplied under contracts (according to ISO 9000). For products manufactured by an organization regardless of any terms of the contract, it is sufficient to carry out quality management within the framework of the general QMS subsystem.
Development and implementation of a QMS requires certain costs, however, world practice shows that all resource investments in the quality management system should be considered not as costs, but as investments. This is due to the fact that activities to improve and ensure product quality within the framework of the quality management system are of an entrepreneurial and innovative nature, therefore it is necessary to more deeply substantiate (for example, business planning) the feasibility of this type of investment and its effectiveness.
The development of the QMS should involve almost all divisions and services of the enterprise, as well as consulting, research and other specialized external organizations. At the same time, it is important to clearly define their tasks, functions, rights and responsibilities.
General leadership All work related to the creation of a QMS is carried out by senior managers, and primarily by the head (general director) of the organization.