How Many SOPs Does a Private Doctor Need: 9 Documents for a Gynecology Practice

You search for a "ready-made SOP package for a medical office" and find either a universal three-document template that clearly does not cover everything you actually do, or a set of twenty binders, half of which deal with procedures your office does not perform at all.

Both options mean money spent in the wrong place. A package that is too short leaves a real risk unaddressed: during an inspection—or worse, after an incident—you discover that the very process you perform every day is not documented anywhere. A package that is too long wastes budget and time on documents about sterilizing equipment you do not even have or maintaining a refrigerator temperature log when you do not store vaccines.

Many people are also concerned about the new healthcare cleaning rules approved by Ministry of Health Order No. 725 and whether they already need to urgently adjust their operations to comply with this order.

Short answer: the new rules should not mistakenly be treated as already governing day-to-day cleaning. The order has been published and is in force, but the Rules themselves take effect two years after martial law is terminated or canceled. This is not a reason to postpone preparation: a private medical office should already review its current SOPs, actual processes, disinfectants, and equipment, and treat the date when the new Rules take effect as a mandatory review trigger.

The main practical mistake is looking for a ready-made "one-size-fits-all package." A physician who only provides consultations and an office that performs invasive procedures, sterilizes reusable instruments, performs ultrasound examinations, and sends biological specimens require different documents. The minimum is determined not by the number of templates, but by the risks and operations actually involved.

We encountered this in practice when a physician registered as an individual entrepreneur (FOP) with a private gynecology office contacted us. What appeared to be a typical consultation-based practice turned out, after a detailed review, to combine six processes with different risk profiles, each requiring its own documentation logic.

In this article, you will learn how we determined the actual minimum for this specific office and the six questions that will help you determine how many SOPs you need.

Do SOPs Need to Be Rewritten Immediately Because of Order No. 725?

In 2026, the Ministry of Health approved new Rules for Cleaning and Disinfection of Surfaces. They regulate the organization of healthcare cleaning, staff training, cleaning equipment, working SOPs, and quality control.

At the same time, the order expressly provides for a delayed effective date for the Rules—two years after martial law is terminated or canceled. Therefore, an existing SOP cannot be declared unlawful merely because it has not yet been revised to comply with Order No. 725. Likewise, future requirements cannot be cited as a current basis for requiring the purchase of new equipment or the replacement of all documents.

The correct approach is to divide the work into two tracks.

First: check whether current practices and documents comply with the requirements currently in force.

Second: create a list of changes that will need to be implemented once the deadline specified by the order is reached.

This preparation provides time to align equipment, training, processing protocols, and records instead of rewriting documents at the last minute.

Worth reading: New Requirements for Licensing Medical Practice: Standard Operating Procedures (SOPs) and Other Important Changes

Who Already Needs Working Procedures Today?

For healthcare facilities, the Licensing Conditions for Medical Practice expressly require locally approved documents, including standard operating procedures. For a physician registered as an individual entrepreneur (FOP), the scope of obligations cannot simply be copied from the structure of a large healthcare facility: the specific sanitary and other rules applicable to each process must be reviewed.

For example, hand hygiene, safe injections, handling of sharps, medical waste, equipment cleaning, and sterilization of reusable instruments are governed by different regulations and manufacturer instructions. If a process takes place in the office, it must be properly organized and clearly documented regardless of whether one person or a large team performs it.

This is why statements such as "three SOPs are enough for an individual entrepreneur" or "everyone needs twenty SOPs" are weak both legally and practically. The actual operating model should be documented first, and only then should the titles and number of documents be determined.

What We Learned from a Private Gynecology Office

In a recent engagement, we worked with the private gynecology office of a physician registered as an individual entrepreneur (FOP). The need was very practical: to obtain the basic minimum set of documents that would allow the office to operate in compliance with requirements without paying for procedures unrelated to its actual activities.

At first glance, ready-made templates could have been used. After reviewing the actual services, however, we found that the office combined several processes with different risk profiles:

• gynecological examinations, colposcopy, and transvaginal ultrasound;
• collection of specimens for Pap tests, microscopy, and bacterial cultures;
• collection of histology specimens after Pipelle biopsy and cervical biopsy;
• injections and vaccination;
• use of reusable instruments sterilized directly in the office;
• reprocessing of the probe, colposcope, and electrosurgical equipment.

One generic document could not safely cover everything. At the same time, there was no reason to create a separate SOP for every tube, instrument, or surface. The solution was to group related activities into several operational blocks.

What Minimum Package Was Developed in Practice

For this operating model, the package was based not on a random list of document titles, but on the full chain of risks:

1. Order approving the documents, responsible persons, and the acknowledgment procedure.
2. Hand hygiene, gloves, and standard precautions.
3. Cleaning and disinfection of rooms and surfaces.
4. Medical waste, sharps, biological fluid spills, and occupational exposures.
5. A single reprocessing cycle for reusable instruments: from safe handling after use through sterilization, storage, and monitoring.
6. Reprocessing of medical equipment subject to different manufacturer restrictions.
7. Safe injections, vaccination, and an anaphylaxis response algorithm.
8. A brief laboratory instruction covering identification, labeling, fixation, storage, and transfer of biological specimens.
9. Instructions on how to approve the package, put it into effect, and determine when it must be reviewed.

This list is not a regulatory template for every medical office. Its value lies in the logic: each document addressed an actual process, while anything not performed in the office was excluded. For example, vaccines were not stored in the office, so a separate permanent refrigerator temperature log was not created. However, requirements for safe injections and emergency preparedness remained necessary.

How to Determine Your Minimum: Six Decisive Questions

The owner of a medical office can perform an initial review independently. To do so, it is enough to answer six questions in sequence:

1. Are reusable instruments used? If so, where and how does the entire cycle of cleaning, packaging, sterilization, and storage take place?
2. Are invasive procedures, injections, or sharps involved? If so, safety rules, waste-handling procedures, and post-exposure actions are required.
3. What equipment comes into contact with skin or mucous membranes? The reprocessing method must comply with the instructions for that specific model.
4. What specimens are sent to a laboratory? Written requirements are needed for labeling, transport medium, temperature, timeframe, and transportation.
5. Are vaccines or other temperature-sensitive products stored? This determines whether a cold chain and temperature monitoring are required.
6. Who actually performs each task? The order, SOP, log, and acknowledgment sheet should not identify different people as responsible for the same task.

If even one answer is unknown, it is too early to buy a ready-made package. First, the actual process must be established or a decision must be made about how it will be organized.

Why the Disinfectant and Equipment Model Change the SOP

The phrase "process according to the instructions" does not by itself make a document operational. A staff member must understand which product to use, at what concentration, for what contact time, on which surface, and with which personal protective equipment. At the same time, an SOP cannot prescribe a regimen that is not included in the current instructions for the product.

This is especially important for equipment that comes into contact with mucous membranes. A product suitable for furniture or floors does not automatically become suitable for a transvaginal probe. Both the current instructions for the disinfectant and manufacturer-confirmed compatibility with the specific medical device are required.

The same logic applies to sterilization. The instrument material, packaging, temperature, and cycle duration must comply with the instructions for both the medical device and the sterilizer. If the material is unknown or the manufacturer does not permit the selected cycle, legally correct SOP wording will not solve the technical problem.

Worth reading: Medical Waste Disposal Agreement: How to Choose a Contractor and What to Check

Laboratory Appendix: A Small Document That Is Often Incomplete

An office that collects several types of biological specimens does not need to turn every test into a large separate SOP. A short instruction or appendix is often sufficient. However, it must cover all specimens that are actually collected.

In our case, the laboratory materials initially related mainly to cytology testing. After clarification, the document was expanded to cover the transfer of histology specimens after Pipelle biopsy, cervical biopsy using biopsy forceps, and a radiofrequency technique. For such specimens, the exact anatomical site, collection method, fixative, time when fixation begins, and number of containers all matter.

The laboratory instruction therefore needs to be checked not only against the laboratory name, but also against the full list of procedures performed in the office. A verbal arrangement with a courier does not replace written specimen requirements.

What to Prepare Before the New Cleaning Rules Take Effect

Order No. 725 does not require immediate replacement of an existing SOP, but it already provides a benchmark for preparation. It is advisable to check whether the documents describe:

• premises, zones, and surfaces that are cleaned or disinfected;
• types of cleaning and the situations in which they are performed;
• cleaning equipment, its labeling, decontamination, and storage;
• cleaning agents and disinfectants actually used;
• responsible persons and the procedure for their training;
• quality control methods and records confirming completion.

This does not mean that all future requirements should be declared effective ahead of schedule. The purpose of a preparatory audit is to identify the gap between the current state and the future model and plan the necessary changes without unnecessary purchases or repeated rewriting of documents.

How to Approve an SOP So It Becomes a Working Document

A signed file in a folder does not mean the SOP has been implemented. For a small medical office, the process can be brief, but it should leave a clear audit trail:

1. Approve the list of documents by an order of the manager or the physician registered as an individual entrepreneur (FOP).
2. Complete the version details, effective date, and identification of responsible persons.
3. Have each person acknowledge the procedures they perform.
4. Provide practical training where a written acknowledgment alone is insufficient: preparing a solution, packaging instruments, monitoring sterilization, and responding to a needlestick injury or anaphylaxis.
5. Maintain only those logs and forms that document actual operations and are included in the package.
6. Keep a controlled copy together with the current instructions for products and equipment and the applicable laboratory requirements.

If the physician operating as an individual entrepreneur is the only person working in the office, there is no need to invent a committee or nonexistent staff members. Responsibility and control can be assigned to the physician. If a nurse, administrator, or cleaner is involved, their functions should be clearly separated.

When the Package Should Be Reviewed

A scheduled annual review is useful, but there is no reason to wait for the calendar date if the process itself has changed. An unscheduled update is required when:

• a new medical service or procedure is introduced;
• a different disinfectant, sterilizer, probe, or other equipment is acquired;
• the laboratory changes the container, transport medium, labeling, or transfer route;
• vaccines or other products not previously kept in the office begin to be stored;
• staff members or the distribution of functions change;
• an incident shows that the procedure does not work;
• a new regulation enters into force or takes effect.

A separate review trigger is the date when Order No. 725 takes effect. It is also necessary to monitor the future entry into force of the new medical device reprocessing rules under Order No. 1212: until then, they should not be described as current requirements, but it is worth assessing in advance whether the existing process is compatible with the future rules.

How We Help Build a Minimum Package Without Unnecessary Documents

What the owner of a medical office needs is not the maximum number of files, but a clear set that reflects the services actually provided and can be followed in daily work.

To do this, we first map the procedures, equipment, instruments, disinfectants, waste, and biological specimen routes. We then review the current documents and manufacturer instructions and determine which processes can be combined and which require a separate procedure. The package includes an approval order, the necessary forms, and a brief instruction on implementation and updates.

This approach avoids purchasing templates that do not match the office's work and prevents a high-risk procedure from being left undocumented simply because it was absent from a standard list. If your office already has SOPs, the work can begin with an audit: compare the documents with actual practices and determine what genuinely needs to be changed.

If you manage a hospital or multidisciplinary clinic, we discussed the general SOP requirements in the article "Mandatory SOPs for Healthcare Facilities".

If you need help today creating a tailored set of SOPs, contact us!