You have decided to create a non-destructive testing laboratory. Where to begin? With the purchase of equipment or with the writing of documents? From the appointment of the head and responsible persons or from the name of the laboratory (which is important, author's note)? Or do you need to certify a specialist, and he organizes the creation process? Do you have a certified visual inspection specialist, is this a laboratory? Probably not. And if they just control the performance of certain works within the walls of their own plant, is this a laboratory? If they use special equipment, is that enough to be a laboratory? Accordingly, the question arises - what comes first?
First, it is important to understand where we work. If it is at a hazardous production facility, then there is a mandatory requirement for the presence of a laboratory. If it is any other facility, then you have the right to both create a laboratory and work without it.
Second, who is working? You work at a hazardous production facility, your function is visual control for your own needs. And in this case, you must be certified as qualified personnel. This is a mandatory law for those who work at hazardous production facilities, are engaged in control during the manufacture, construction, installation, operation, reconstruction, repair, technical diagnostics, industrial safety examination of technical devices, buildings and structures.
And even if there is only one person on the staff of the enterprise, he can carry out control, and the conclusion must be approved by the head (not necessarily full-time) and, most importantly, only a certified laboratory issues a conclusion. Hence the mandatory requirement for the creation of a laboratory arises - As soon as a conclusion is issued, there is an obligatory need to create a laboratory, moreover, in accordance with the PB 03-372-00 standard “Certification Rules and Basic Requirements for Non-Destructive Testing Laboratories”. To summarize:
First step- understanding on what objects we will carry out work.
Second step- training and certification of personnel according to PB 03-440-02 exactly for these objects by those types (methods) of control that are specified in the requirements for objects.
Third step– Purchase of equipment - the main equipment must be owned and only high value equipment and auxiliary controls are allowed to be rented.
Fourth step– development of laboratory documents, including control technology.
Fifth step!– certification of the laboratory according to PB 03-372-00.
All requirements for the organization of the laboratory arise from one document - PB 03-372-00 "Certification Rules and Basic Requirements for Non-Destructive Testing Laboratories", where everything is succinctly, qualitatively, in detail and very simply described on 30 pages.
P. S .I will send each participant of the webinar the developed job description of the head of the LNC according to the new professional standard!
Get involved in an active dialogue!
Tatiana Fedorova
OOO ICC Arina
Thank you for the kind words. There is nothing easier than giving advice that you are not supposed to follow. Moreover, it is not necessary to treat my words as the ultimate truth. I may be wrong in my judgments.
Regarding qualification tests, there is also GOST R 15.201-2000. "The system for the development and production of products. PRODUCTS FOR INDUSTRIAL AND TECHNICAL PURPOSE. The procedure for the development and production of products." it says
8.10 qualification tests are carried out according to the program developed by the manufacturer with the participation of the product developer and agreed with the customer (if any). The program specifies:
The number of units of products subjected to testing and verification based on their complexity, cost, reliability and other factors necessary for reliable assessments;
All types of tests corresponding to the periodic tests specified in the TS, as well as other tests and checks to achieve the goal of qualification tests;
Place of testing.
It is allowed not to include in the program of qualification tests the verification of certain requirements of the design documentation, which cannot change during the work on putting into production.
8.11 Qualification tests are organized and ensured by the manufacturer (supplier) of products. Qualification tests are carried out by a commission, which includes representatives of the manufacturer, product developer, developers and suppliers of components and, if necessary, government oversight bodies and other interested parties (for example, insurance organizations, public organizations for the protection of consumer rights, etc.).
Not a word about accreditation. But, because Your products must meet the requirements of the TR, then the commission should have included representatives of Rostekhnadzor.
You can justify the refusal of accreditation by the absence of such a requirement in the ND, but, unfortunately, in market conditions, the customer can make his own requirements even if they are not justified.
Because You will have to be accredited according to the requirements of TR, and they are mandatory, then I think you will not get past Rosaccreditation. I can't say anything about prices.
Because for accreditation, you will have to create a whole package of documents, then it will be quite reasonable to turn to intermediaries.
P.S. I'm still waiting for someone more competent to join our dialogue, but whether it's summer, or something else ... Some time ago, they answered similar questions with an offer of their services, or advice on who to turn to for help.
Can rephrase the question. Who can help in the accreditation of the testing laboratory?
Each ETL, which already has the appropriate certificate of registration with Rostekhnadzor, can safely carry out all the necessary measurements, tests, and checks of electrical devices for compliance with their regulatory and technical documentation. After that, the electrical laboratory has every legal basis to issue a conclusion on the readiness of an object for operation or to eliminate all detected malfunctions.
What is an electrical laboratory?
Now electricity is so “deep” into our lives that we do not appreciate it until such time as it disappears. For high-quality and uninterrupted operation of the electric line, you need to thoroughly know many subtleties. They relate to each of the services of the electrical network. Therefore, periodic monitoring of the entire electrical system should be carried out. It is produced thanks to a special electrical laboratory (ETL).
It checks all devices to which controllers, electricians, dispatch services and control operators have access. More precisely, the electrical laboratory determines the state of all protective devices. With its help, you can also detect such a problem as constant voltage on the equipment case.
The electrical laboratory also performs a scheduled check of control and measuring equipment. Thanks to the normal operation of the devices, you can be confident in the quality supply of electrical energy, in accurate accounting of its losses and consumption.
All the protocols that are drawn up after the relevant tests are carried out are very significant. They are required, for example, when handing over a construction site. They will be able to help carry out a quick replacement of electrical wiring during the reconstruction of the building and, which is very important, ensure the safety of the health of all people in it.
Opening of ETL
How to open an electrical laboratory up to 1kV? This question is asked by many who would like to check the normal functioning of various elements of the power supply, conduct tests and diagnose problems. Today, it can be opened not only by large firms, but also by any organization of a small size.
Each such laboratory provides its services solely on the basis of its license. This means that the main stage is the registration process. Only thanks to the experience and the presence of this license, we can talk about the professionalism and quality of work performed by an employee of such a company.
On the whole territory of Russia, the work of an electrical laboratory is possible after obtaining a special permit "SRO".
But how to open a non-destructive testing laboratory? After all, not every company can issue a license, but only one whose activities are carried out using high-quality serviceable equipment, subject to all existing norms and rules. Specially created registration firms constantly control all these important points.
If an electrical laboratory is opened for the first time, then it is granted a license for only one year. But when renewing the license, the period increases to three years. You should prepare for the fact that collecting all the necessary documents will take you about one month. But, despite this fact, the services of such companies are always in demand. Therefore, you need not to hesitate, but to open your own business in this industry.
Registration process
How to register an electrical laboratory? This issue worries many business leaders who are going to put their construction facility into use, while not performing various contract work. Having your own personal electrical laboratory will save you money and time, but it will require some effort to register it.
Absolutely any legal entity can register ETL. To do this, he needs to collect and submit a certain package of documents to Rostekhnadzor. Then comes the stage of employee training, during which they must thoroughly study their job duties and learn how to accurately perform them. Professional development of employees is carried out once every five years. They must have an appropriate electrical safety certificate, in which the tolerance group is not lower than the fourth and there is a special mark on permission to carry out measuring work in the electrical network.
The number of employees in this structural organization must be at least three people:
- head of ETL;
- his deputy;
- engineer.
In addition, everyone is required to undergo a medical examination.
To register an ETL, you will need to buy special protective equipment: helmets, masks and dielectric gloves. They must be tested with high voltage, as evidenced by a quality certificate.
The head of the electrical laboratory needs to collect the relevant documents about the personnel working for him:
- a copy of the diploma;
- original certificate of advanced training;
- a copy of the electrical safety certificate.
To register with Rostekhnadzor, you will need the following:
- certificate of creation of ETL;
- a document on the establishment of a person responsible for the electrical economy;
- confirmation of the appointment of the head of the ETL;
- certificate of the establishment of a commission to test knowledge and skills;
- ensuring safe working conditions and working condition of measuring instruments;
- responsible for the serviceability of "PPE";
- a document confirming the admission of a specialist to perform work.
Also, it is necessary to create technological instructions:
- for all employees of the electrical laboratory,
- on labor protection.
To this entire list, you will also need to attach the following papers: a copy of documents certifying that you are a legal entity, a seal, a sample of your signature and the application for registration itself. It is worth remembering that each copy of the documents must be certified by the blue ETL seal.
The term for consideration of the application is one month. After that, you will be able to receive your registration or the documents will be returned to you for revision (the presence of errors, the absence of any documents, etc.).
ETL promotion
How can I check the certificate of registration of an electrolaboratory? This is done by filing an application with Rostekhnadzor.
Many production managers are faced with the question of how to promote their electrical laboratory? To do this, you can place ads on your own website or third-party Internet resources. The more people know about it, the more likely it is to get orders.
The engineering center "ProfEnergy" has all the necessary tools for high-quality measurement of insulation resistance, a well-coordinated team of professionals and licenses that give the right to carry out all the necessary tests and measurements. Leaving the choice on the electrical laboratory "ProfEnergy" you choose the reliable and high-quality operation of your equipment!
The creation of a laboratory does not require special knowledge in the field of medicine from the founder, it is more important to know the algorithm and legal conditions for the creation and functioning of an institution as a business organization.
This business plan for a medical laboratory with calculations is a document for practical guidance in setting up an institution and can be used in negotiations with investors and other interested parties.
The opening of the laboratory involves the solution of the following social and entrepreneurial tasks:
- Meeting the needs of citizens in conducting diagnostic medical research.
- Creation of new jobs for qualified medical personnel.
- Replenishment of the budget with tax revenues from a highly profitable enterprise.
- Extraction of profit.
The project implementation costs are financed by a bank loan of 1,470,000 rubles at a rate of 14% per annum.
The total estimated cost of the project is 1,470,000 rubles with a life cycle of 2 years.
During the investment period, the bank will be paid interest in the amount of 94,500.12 rubles. Their payment begins from the 1st month, which allows us to simplify the methods for calculating cash flows and discounting the loan used in this business plan.
Under such conditions of financing and the estimated forecast of receipt of income from the functioning of the laboratory for analysis, the payback period of the project will be:
- From the beginning of practical activities under the project - no later than 4 months.
- Taking into account discounting – no later than 2 years.
Over the life cycle, the overall economic effect will reach 21,459,843.65 rubles.
Description of the object
In modern medicine, diagnosis is one of the main factors in the successful treatment of patients. Unfortunately, testing services are not always readily available due to the overburdening of existing medical laboratories. That is why the creation of a modern laboratory for analysis is, first of all, a socially significant project that allows reducing the overall burden on institutions operating in this field of activity.
The provision of laboratory analysis services is an extremely complex activity in terms of administration, both at the initial stage of the project and during the operation of the institution. The creation of a laboratory requires a lot of approvals, compliance with the standards and procedures provided for by domestic legislation.
The selection of personnel is of paramount importance for the normal functioning of the laboratory. They must not only be highly qualified, but also be ready for continuous professional development, which is due to the high frequency of updating the technologies used in laboratory activities, equipment and the very content of work in this area.
It is important to take into account that, according to statistics, over 70% of patients applying to medical laboratories are women. This fact must always be kept in mind when planning the premises of the laboratory, arranging their interior and selecting personnel.
Market analysis
Russia in the issue of creating a network of private medical laboratories, improving their equipment is in line with global trends. All new institutions are emerging and successfully functioning in the country, which are mastering the most complex tests and comprehensive medical research.
Conventionally, the domestic market of medical diagnostic services is classified into two categories:
- Instrumental laboratories specializing in functional (visual) diagnostics (70% of the market).
- Laboratories specializing in the analysis of biomaterials. They perform cytological (microscopic), hematological, biochemical, molecular genetic, immunological and microbiological studies.
Medical diagnostics as a business is one of the three leading areas in the development of Russian private medicine. In dentistry, it occupies 60% of the market, gynecology - 20%, in the general structure of medical services - 10%. Experts estimate the annual growth of participants in the laboratory services market at 170 institutions. To date, there are over 11.5 thousand medical laboratories in the country operating in various areas, although there are only about 1 thousand private ones. However, they carry out about 70% of research conducted on a paid basis.
The rate of growth in the number of private laboratories is ambiguously reflected in economic statistics. According to some experts, the annual growth is 10%, which is slightly higher than the global average of 7%. According to others, our market adds 15% every year, and in large cities - up to 30%.
In this service sector, 2 main trends are fixed: centralization and automation of ongoing research. This is manifested in the expansion of the range of ongoing research, the development of innovative technologies for analytical and laboratory work, and the improvement of the overall culture of patient care. Analysis laboratories are increasingly introducing into their practice remote methods of interaction with medical institutions, based on the use of modern means of communication and data transmission technologies.
According to the results of the assessment of such indicators as the total population of the country, the demand for medical laboratory services, the existing trends in the market, the demand for increasing their number is 10-15% per year.
Object characteristic
A medical laboratory is an institution that conducts medical tests and research commissioned by the main consumers of these services: citizens and medical institutions.
The implementation of the laboratory creation plan includes the following main activities:
- Administrative and legal registration of business: obtaining a license, permits for its conduct from the State Fire Supervision Service, SES and other competent authorities.
- Selection of premises and bringing it into line with the requirements of the SES.
- Purchase of equipment and materials.
- Purchase of equipment.
- Installation of laboratory equipment and necessary communications.
- Selection and training of personnel for the laboratory.
- Organization of advertising and marketing activities.
In this segment of the business, 2 forms of its organization are most common: the creation of a laboratory or a treatment room.
The second format is simpler and more economical. And the creation of a laboratory for analysis will create a business that can be developed for decades. Of course, such an institution will require much more investment than a treatment room.
Room selection
The premises for the medical laboratory must be selected, guided by the requirements of the SES. From the point of view of work comfort and business demand, the best option is a room with an area of at least 100 square meters. m, located near public transport stops in places with high traffic. A mandatory requirement is the presence of a separate entrance and bathroom. Indoors, it is necessary to make the wiring of the plumbing system and be sure to install a telephone.
Today, medical laboratories operate in two main profiles:
- PCR studies (polymerase chain reaction) aimed at detecting DNA.
- Carrying out enzyme immunoassay (IFL), which allows to establish the presence of antibodies to specific proteins or their pathogens.
In terms of costs, these types of laboratories are practically equivalent, although they differ in the distribution of expenditure items for the purchase of equipment. In addition, in the second case, more funds will be spent on the premises, because there are very strict PTB requirements for performing PCR.
Purchase of equipment
Medical laboratory equipment is not in short supply today. There are many types of domestic and imported equipment on the market in the widest range of prices. Our equipment and materials are practically not inferior in quality to imported ones, since the vast majority are produced under licenses, but their cost is 20-30% lower. It should be borne in mind that the price of reagents for the laboratory exceeds the cost of test tubes and other laboratory glassware.
The cost of opening a treatment room is significantly lower and may not exceed 450-600 thousand rubles. Such an object pays off in no more than one and a half to two years.
On average, the implementation of a project to open a medical laboratory can take from two to three weeks to six months. Basically, it depends on the quality of staff training.
Recruitment
This stage of work is one of the most important in the project, because it affects not only the time spent on the implementation of the business idea, but also the success of the facility.
For the qualitative organization of the activities of the laboratory, this business plan provides for the establishment of three doctors, two nurses working in shifts, and a cashier-administrator on the staff of the institution. Recruitment of personnel is carried out on a competitive basis in compliance with the established requirements for the qualification of specialists for this type of activity.
Couriers who are not included in the staff of the institution and perform work under a contract may also be involved in the work of the laboratory.
Marketing and Advertising
In order to promote the laboratory services on the market, throughout the entire period of its operation, the following is carried out:
- Advertising activities in kindergartens, schools, residential areas.
- Distribution of leaflets and booklets in medical institutions.
- Advertising in local media, including radio and television.
- Printing and distribution of business cards.
- Development of a website with online registration services for the provision of laboratory services.
Technical and economic characteristics of equipment
For a medical laboratory, the main types of equipment are:
- Medical microscope.
- Leukocyte formula counters.
- Thermal cyclers and analyzers.
- Thermostats air, water and dry air.
- Shakers and centrifuges.
- Water distillers.
- Scales, thermostats and dispensers.
- Magnetic mixers and vortexes.
- Special equipment for PCR.
- Lighting equipment.
- Ionometers and pH meters, etc.
Depending on the prevailing profile of the laboratory, this list may change qualitatively and quantitatively.
Financial plan
The sales forecast for laboratory services in this business plan is calculated based on data for 2016, namely:
- Service demand analysis.
- Analysis of the provision of services in the market.
- Conclusions about the balance of the services market.
When compiling the forecast, the lowest profitability indicator of the enterprise at the initial stage of the project implementation was used.
This forecast is based on information about the average prices for medical laboratory services in the country.
| no./p. | Name of service | average price (in rubles) |
| 1 | Plasma clotting time | 500 |
| Research levels and products | ||
| 2 | Paracoagulation | 800 |
| 3 | Procalcitonin | 2 700 |
| 4 | fibrinogen | 380 |
| 5 | fibrinolytic activity | 585 |
| 6 | Coagulogram | 1 100 |
| 7 | Investigation of braids (acid-base state) | 445 |
| 8 | Electrolyte research | 445 |
| 9 | Measurement of thromboplastin/prothrombin time in blood or plasma | 370 |
| 10 | Measurement of thrombin time in blood | 445 |
| 11 | Hematocrit assessment | 135 |
Based on these data, for the billing period, the medical laboratory will provide services in the following volumes:
| Period | Type of service | Number of services per month | Price | Revenue (in rubles) |
| 1-12 months (investment period) | Comprehensive research | 4,000 units | 350 | 1 400 000 |
| 1-12 month (investment period) |
Outsourcing | 350 units | 550 | 192 500 |
| 13 mts (period of operation) | Comprehensive research | 4 400 units | 400 | 1 760 000 |
| 14-24 mts (period of operation) | Outsourcing | 615 units | 600 | 369 000 |
The total cost of the project will be:
Thus, the object will reach the break-even point no later than 4 months after the start of operations. During this period, the company will receive a profit in the amount of 1,052,094.33 rubles. After the end of the lending period, it will increase to 1,722,426.67 rubles.
The total gross profit of the project is 39,880,500 rubles.
conclusions
An example of this business plan for a medical laboratory clearly demonstrates that this business is in demand in society and extremely profitable. Its profitability is determined by the objective conditions of the country's economic and social development. The level of competition in this market allows us to consider the medical laboratory as a promising business in which all investments are quickly paid off and which is not subject to critical risks.
The complexity of business administration will require high responsibility, perseverance and dedication from the founder. The algorithm for opening a medical laboratory requires careful study and calculation of all the components recommended in this document.
