Quality Management Systems Certification Body

About Us

The certification body for quality management systems (QMS CB) was created as part of the State Institution "Center for Pharmaceutical Product Safety" under the Ministry of Health of the Republic of Uzbekistan based on the order of the Minister of Health No. 360 dated November 25, 2024. The activities are regulated by the Regulation on the procedure for certification of management systems, approved by Appendix No. 4 to the Resolution of the Cabinet of Ministers No. 502 dated August 14, 2024.

The QMS CB conducts independent and objective assessment of quality management systems of pharmaceutical industry organizations. Certification is carried out for quality management systems of medical devices according to the national standard O'zMSt ISO 13485:2025, identical to the international standard ISO 13485:2016.

Our mission: To conduct professional and objective evaluation of quality management systems of organizations in the pharmaceutical sector for compliance with the national standard O'zMSt ISO 13485:2025, which is identical to the international standard ISO 13485:2016.

The body is headed by Shadibekov Kozimbek Bakhtiyarovich, under whose leadership processes were developed that guarantee transparency and impartiality.

Personnel composition

The QMS CB is staffed with qualified specialists who possess competencies and experience in conducting certification of quality management systems according to the ISO 13485 standard. The specialists are certified in accordance with the Cabinet of Ministers Resolution No. 177 dated March 30, 2024.

Certification and audit processes

The processes include:

1. Submitting an application via the website: https://www.uzpharm-control.uz or email: farmkomitet@ssv.uz .
2. Development of an audit program and plan taking into account the scope and objectives of certification.
3. Analysis of quality management system documentation.
4. On-site audit to assess compliance with ISO 13485.
5. Preparation of a report based on the audit results.

Supervisory inspections are conducted annually, recertification – every 3 years. The cost of certification is available upon request via the website or email. Full procedures are posted in Uzbek, Russian and English and are provided in open access to all interested parties in all regions where the certification body operates.

Decision making processes

Decisions related to certification processes, including issuance, refusal, confirmation, renewal, suspension, or cancellation of a certificate, as well as expansion or reduction of the certification scope, are made based on the analysis of documentation and on-site audits.

Competence and Independence of Decision-Makers Individuals making certification decisions (the head of the Certification Body (QMS CB) and authorized personnel) possess verified competence in assessing quality management systems and knowledge of the requirements of O‘zMSt ISO 13485:2025 and O‘z DSt ISO/IEC 17021-1:2019 standards. Decisions are made independently—auditors who conducted the audit do not participate in the certification decision for that client.

Application Receipt and Analysis

• Applications are received by a Category 1 specialist.
• The analysis of the application and documents is conducted within 3 working days by a Category 1 specialist and the QMS CB head, including an assessment of the sufficiency of information, the QMS CB competence, the absence of conflicts of interest, and the feasibility of conducting an audit.
• A decision or a reasoned refusal is sent to the applicant within 1 working day via email or an information system.
• Grounds for refusal: incomplete documentation, inaccurate information, lack of QMS CB competence in the relevant field, or an unresolvable conflict of interest.

Certification Contract Upon a positive decision, a legally binding certification contract is concluded, defining the rights and obligations of the parties, the certification scope, audit conditions, certificate usage, and the procedure for notifying about changes. Financial matters are regulated by the contract and are not grounds for refusing certification if technical compliance with the standard is confirmed.

Conducting Audits

• Audits are conducted by at least two employees, excluding the one who received the application, who possess the required competence and have no conflict of interest with the client.
• Documentation analysis (Stage 1) — up to 15 working days; on-site audit (Stage 2) — up to 20 working days.

Audit Reports Reports include: identification of the QMS CB and the client, audit type and objectives, audit criteria and scope, audit team composition, dates and locations, audit findings (conformities and nonconformities classified as major or minor), conclusions on the effectiveness of the quality management system, and audit team recommendations regarding certification.

Information Analysis and Decision-Making Before making a certification decision, the following are analyzed:

• Sufficiency of information provided by the audit team;
• Effectiveness of the client’s resolution of all major nonconformities (verified through documentation or, if necessary, on-site);
• The client’s action plan to address minor nonconformities (effectiveness is verified during subsequent surveillance audits);
• Audit team recommendations. All decisions are documented with justifications.

Decision on Certificate Issuance The decision to issue a certificate is made by the QMS CB head based on:

• Reports from Stage 1 and Stage 2 audits;
• Confirmation of the resolution of all major nonconformities within 6 months after Stage 2 (if this period is exceeded, a repeat Stage 2 audit is conducted);
• An approved action plan for addressing minor nonconformities. The certificate is issued within 3 working days, registered in the State Register, and is valid for 3 years.

Grounds for Refusal to Issue a Certificate

• Failure to resolve major nonconformities within 6 months after Stage 2 audit.
• The quality management system does not meet the requirements of O‘zMSt ISO 13485:2025.
• Insufficient evidence of conformity obtained during the audit. Note: Financial matters (payment for services) are regulated by the contract. Late payment is not a basis for refusing to issue a certificate if technical compliance is confirmed but may lead to the suspension of audits until financial obligations are settled.

Certificate Confirmation The certificate is confirmed annually through inspection control (surveillance audits), which include checks of internal audits, management reviews, resolution of previously identified nonconformities, the effectiveness of the quality management system, and the use of conformity marks.

Recertification At the end of the 3-year certification cycle, a recertification audit is conducted to confirm the ongoing conformity and effectiveness of the quality management system.

Expansion and Reduction of Certification Scope

• Expansion of the scope is carried out upon the client’s request after analyzing the application and conducting an additional audit of new activities, products, or production sites.
• Reduction of the scope is implemented if the client cannot ensure compliance with the standard in certain areas of activity. The client must immediately update all promotional materials.

Certificate Suspension Suspension is initiated by the QMS CB, the Technical Regulation Agency, or a court in cases of:

• Persistent or significant nonconformity of the quality management system with standard requirements;
• Failure to provide access for audits;
• Justified complaints against the client;
• Voluntary request by the client. Reinstatement: Upon resolution of the reasons for suspension and confirmation of the effectiveness of measures taken, the QMS CB decides to reinstate the certificate. The maximum suspension period is 6 months, after which the certificate is canceled.

Certificate Cancellation Cancellation is initiated by the QMS CB, the Technical Regulation Agency, or a court in cases of:

• Failure to resolve suspension reasons within 6 months;
• Gross violations of standard requirements or certificate usage conditions;
• Unauthorized use of the certificate or conformity marks;
• Changes in certification conditions that prevent maintaining compliance;
• Liquidation of the organization. Decisions are communicated to the client within 3 working days. Canceled certificates are returned to the Agency for exclusion from the State Register.

Appealing Decisions QMS CB decisions can be appealed in accordance with the QMS CB appeal review procedure, through the Appeal Council of the Technical Regulation Agency, or via judicial proceedings.

Certification documents

Certificates contain:

• Name and address of the customer (including all production sites).
• Date of issue, extension/reduction or renewal (not earlier than the decision on certification).
• Validity period or recertification date .
• Unique identification number.
• Standard (ISO 13485, with version indication).
• Scope of certification (type of work, products, services).
• Name, address and sign of the QMS CB.
• When revising a certificate - means of distinguishing it from outdated versions.

Certificates are issued through the information system and registered in the State Register.

Types of management systems and certification schemes

Certification is carried out for quality management systems of medical devices according to ISO 13485.

SCHEME

management system certification

Steps		Items		Events		Execution deadlines
Stage 1		Applicant		Generates a set of documents for certification of management systems. Submits an application to a certification body for certification of management systems.		At the applicant's request
Stage 2		Certification body		1. The completeness of the submitted documents and information in the application is checked as follows:
				a) reviews the application and analyzes the information provided;		Within 3 working days
				b) makes a decision on accepting an application for certification;		Within 3 working days
				c) returns documents if they are incomplete.		Within 1 working day
				2. In case the application for certification is accepted, starting from the date of its acceptance, a certification agreement is concluded between the QMS Certification Body and the applicant.		Within 3 working days
				3. Forms a group of auditors.		Within 10 working days
				4. Prepares a report on the results of the first stage audit.		Within 15 working days
				5. Prepares a report on the results of the second stage of the audit.		Within 20 working days
				6. If non-compliance of management systems with the requirements of regulatory legal acts and regulatory documents in the field of technical regulation is identified, a non-compliance report is drawn up, which is submitted to the applicant together with a report on the identified non-compliances. results of the audit of the management system.		Within 1 working day
				7. In the event of failure to provide information and supporting documents on the elimination of non-conformities within the established timeframes, the certification body shall send the applicant a notice of termination of certification work.		Within 3 working days
				8. If the results of the supervisory audit are positive, a decision is made to approve the certificate of conformity and a certificate of conformity is issued.		Within 3 working days
Stage 3		Applicant		If any non-conformities are identified during the production assessment process, the non-conformity is eliminated and the information is transferred to the certification body with supporting documents.		No more than 25 working days
Stage 4		Certification body		In cases where non-conformities identified during the analysis of the management system documentation or the audit of the management system are not eliminated within the timeframes specified in the relevant reports, the QMS Certification Body makes a decision to refuse to issue a certificate of conformity.		Within 1 working day

 

Right to use the name and certification mark or logo

Organizations that have received a certificate of conformity are permitted to use the name of the certification body and/or the conformity mark (if any) exclusively within the scope of the certification and only in relation to the certified management system.

It is not permitted to use the logo of the certification body, its name or conformity mark:

– in laboratory test reports;

– in calibration protocols;

- in the acts or results of inspection control issued by the organization or its contractors; misleading

– in its own certificates, documents or advertising materials that could mislead about the nature or scope of certification.

A certified customer has the right to use references to its certification status only in accordance with the established rules of the certification body. These rules include:           

precise identification of the certified customer (name/trademark);

indication of the type of certified management system (e.g. QMS, EMS) and the standard applied;

identification of the certification body that issued the certificate.

Rules :

• The sign or logo is agreed upon with the QMS Certification Body.
• May not be placed on products, packaging, accompanying information or otherwise in any manner that could be construed as a certification of a product, service or process.
• Do not use the certification document in a misleading manner.
• Misleading statements are prohibited.
• Termination of use upon suspension/revocation of certificate.
• Updating materials when the certification area changes.
• Do not imply that the certificate applies to activities outside its scope.
• Do not use the certificate in a way that negatively affects the reputation of the certification body.

The QMS CB monitors the use of the mark or logo, requiring corrective action, suspension or revocation of the certificate in case of violations.

Processes for handling requests, complaints and appeals

Filing complaints and appeals:

• • Via the website: https://www.uzpharm-control.uz
  • By email: farmkomitet@ssv.uz
  • In person at the office of the QMS CB at the State Institution "Center for Pharmaceutical Product Safety".

Complaint handling:

• • Registered and reviewed within 30 calendar days.
  • Confirmation of receipt and a report on the results will be sent to the applicant.

Processing appeals:

• • Review within 2 weeks.
  • Decisions are made by independent employees who were not involved in the audit.
  • Notifications of progress and results are sent to the applicant.

Confidentiality and impartiality:

• • Information about complaints and appeals is confidential.
  • Decisions are made objectively, without discrimination.

Appeal:

• • If you disagree with the decision of the QMS Certification Body, an appeal is submitted to the Appeals Council of the Agency for Technical Regulation.

Access to information:

• • Upon request, information on regions of activity, certificate status, name and address of certified customers, regulatory documents and scope of application of certificates is provided.

 

Privacy Policy

QMS Certification Body ensures confidentiality of information:

• Employees sign non-disclosure agreements and are held liable for violations (reprimand, suspension, dismissal).
• Employees and subcontractors sign legally binding non-disclosure agreements.
• Confidential information is disclosed only with the consent of the customer or by law (with notification of the customer).
• Information from external sources (e.g. complaints) is considered confidential.
• The documents are stored in a secure cabinet, access is subject to the manager’s permission.
• The removal of documents is possible only with the permission of the manager, a request from the National Certification Body, law enforcement agencies or in arbitration.
• Damages resulting from breaches of confidentiality shall be compensated to the customer.

Before publishing certification information, the QMS Certification Body informs the client in advance about the content of the information that will be made publicly available.

All information provided by the QMS Certification Body to clients or distributed to the market (including advertising) must be accurate and not misleading.

Impartiality policy

QMS Certification Body ensures impartiality in the certification of management systems:

• Independence: Absence of influence from applicants, consumers, commercial or other pressures.
• Objectivity: Decisions are based on verified evidence of compliance.
• Risk Management: Regularly identify and manage conflicts of interest.
• Prohibition of consultations: QMS Certification Body does not provide consulting services that pose a threat to impartiality.
• Confidentiality: The staff maintains confidentiality and does not disclose data to third parties.
• Equal Treatment: Non-discriminatory approach to all applicants.
• Employee Commitments: Signing declarations of impartiality and disclosing potential conflicts of interest.

Exchange of information with customers

Certification Information

The quality management system certification body (QMS CB) at the State Institution "Center for Pharmaceutical Product Safety" provides:

Description of certification processes:

• • Application submission, initial and surveillance audits, recertification .
  • The procedure for issuing, refusing, confirming, expanding/narrowing the scope of certification, suspending or revoking a certificate.

Regulatory requirements: Compliance with the standards specified in O'z DSt ISO/IEC 17021-1:2019.

Cost : Information on the costs of application, initial certification and subsequent certification.

Requirements for customers:

• • Compliance with certification requirements.
  • Providing access to documentation, processes, areas, records and personnel for audits.
  • If necessary, the presence of observers (e.g. accreditation auditors).

Rights and Responsibilities: Documents governing the use of certification status in information materials.

Complaints and appeals:

• • Submission via https://www.uzpharm-control.uz , email: farmkomitet@ssv.uz or in person.
  • Complaints are considered within 30 days, appeals within 2 weeks.
  • The decisions are appealed to the Appeals Council of the Agency for Technical Regulation.

Change Notifications

Changes from the QMS CB side:

• • Customers are promptly notified of changes in certification requirements.
  • Compliance with the new requirements is being checked.

Changes from the customer:

• • The Customer is obliged to immediately inform the QMS CB about changes:
  • Legal, commercial, organizational status or ownership.
  • Management, key personnel, contact details, location.
  • Areas of activity or significant changes in the management system.
  • The QMS CB is taking measures to assess compliance with the new conditions.

Online certificate verification

After certification, the status of certificates (organization name, address, standard, and scope of certification) is available through the following links: the State Register of enterprises certified for quality management systems — https://sifat.standart.uz/uz, and the official global database of accredited certificates IAF CertSearch — https://www.iafcertsearch.org/.

Contact information

• Address: 100002, Tashkent, st. Ozod, K. Umarov passage, 16.
• Phone: +998 71 203-01-01.
• Email: farmkomitet@ssv.uz
• Website: https://www.uzpharm-control.uz

Note: Information is current at the time of publication and is updated as necessary.