• Laboratory accreditation

Accreditation and monitoring procedure (Stages of accreditation, decision-making on accreditation, monitoring)

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Decision of the national accreditation body of Ukraine on granting accreditation

 

If the national accreditation body of Ukraine establishes that the relevant conformity assessment body is competent to carry out conformity assessment activities defined in the application, the national accreditation body of Ukraine shall take a decision on its accreditation or expansion of the scope of its accreditation. In case of decision on accreditation of a conformity assessment body, it shall be issued an accreditation certificate and granted the right to use the national accreditation mark. The term of validity of the accreditation certificate is five years. The description and rules of application of the national accreditation mark shall be established by the central executive body ensuring the formation of state policy in the sphere of economic development.

In case of a decision to refuse accreditation or refusal to extend the scope of accreditation, the applicant is given (sent) a written notification of such refusal, which specifies its grounds.

Decision on accreditation, denial of accreditation, expansion and limitation of the scope of accreditation, temporary suspension and renewal and revocation of accreditation certificate is made by the head of the national accreditation body of Ukraine, or in his absence – by the person who replaces him.

If the head of the national accreditation body of Ukraine or the person substituting him/her for the time of absence, took (took) part in the assessment of the conformity assessment body, the decision specified in part eight of this Article, on the basis of such assessment shall be made by one of the deputy heads of the national accreditation body of Ukraine, who did not take part in the relevant assessment.

 

The preparation is carried out sequentially, in stages
Submission of an application by a conformity assessment body (applicant) for accreditation or extension of its accreditation scope
Provision by the applicant of information and documentation required for accreditation
Appointment of the accreditation audit team
Drawing up the accreditation work program and informing the applicant about it
Analyzing the information and documentation provided
Conducting an on-site assessment of the applicant
Analysis of the collected materials and preparation of an assessment report with recommendations on accreditation of the applicant (extension of the scope of its accreditation) or refusal to accredit the applicant (refusal to extend the scope of its accreditation)
Decision-making on accreditation of the applicant (extension of the scope of its accreditation) or refusal to accredit the applicant (refusal to extend the scope of its accreditation)
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Accreditation and Monitoring Procedure

Accreditation is the official process of confirming an organization’s compliance with established criteria and standards in the field of conformity assessment, certification, laboratory testing, and other regulated sectors. It serves as proof of an organization’s competence and compliance with international and national requirements.

The accreditation process consists of several key stages, including application submission, document analysis, audit, decision-making, and subsequent monitoring of the accredited organization’s activities.

Stages of Accreditation

Accreditation follows a structured procedure that includes the following steps:

1. Submission of an Accreditation Application

An organization seeking accreditation must submit an application to the relevant accreditation body. The application should include:

  • The organization’s name and registration details.
  • The scope of accreditation (industry, standards, methodologies).
  • Information on personnel qualifications and technical capabilities.
  • Details of the quality management system.

A set of supporting documents confirming compliance with accreditation requirements must accompany the application.

2. Document Analysis

At this stage, the accreditation body reviews the submitted documents to ensure compliance with standards. The key focus areas include:

  • Quality management policies and procedures.
  • Personnel competence and experience.
  • Testing, certification, or conformity assessment methodologies and protocols.
  • Compliance with legal and regulatory requirements.

If deficiencies are found in the documentation, the organization receives recommendations for corrective actions.

3. Conducting the Audit

Once the documentation is approved, the accreditation body conducts an on-site audit of the organization. The audit process evaluates:

  • Actual compliance with the declared quality management system.
  • Practical implementation of documented procedures.
  • Compliance with accreditation standards.
  • Personnel qualifications, training, and expertise.
  • The state of technical infrastructure and the adequacy of equipment for accreditation requirements.

Following the audit, a report is generated highlighting any non-conformities and necessary corrective actions.

4. Corrective Actions for Non-Conformities

If any violations or deviations from standards are identified during the audit, the organization is given a deadline to implement corrective measures. After the necessary adjustments are made, the accreditation body may conduct a follow-up audit or request additional documentation to confirm compliance.

5. Decision on Accreditation

Once all evaluations are complete and any non-conformities are addressed, the accreditation body makes a final decision on granting accreditation. If the outcome is positive, the organization receives an accreditation certificate, confirming its competence in the declared field.

If the organization fails to meet the requirements, accreditation may be denied, or a limited timeframe may be provided for re-evaluation.

Monitoring of an Accredited Organization

After obtaining accreditation, the organization must maintain compliance with established requirements and undergo regular assessments. The monitoring process includes the following elements:

1. Conducting Surveillance Audits

Periodic audits are carried out to verify:

  • Continued compliance with the standards under which accreditation was granted.
  • Updates to methodologies and documentation in line with regulatory changes.
  • Ongoing personnel competence and training.
  • The effectiveness of the quality management system.

If non-conformities are identified during an audit, the organization must rectify them within a specified timeframe.

2. Internal Control by the Accredited Organization

Accredited organizations are required to conduct internal audits, identify potential risks, and continuously improve their quality management system.

3. Re-Accreditation

At the end of the accreditation validity period, the organization must undergo a re-evaluation process. This includes updating documentation, confirming compliance, and passing another audit.

Accreditation is a comprehensive process that confirms an organization’s compliance with international standards. It involves application submission, document review, auditing, corrective action implementation, and decision-making. Once accredited, organizations must undergo regular monitoring to ensure continued compliance and maintain their accreditation status.

Adhering to all accreditation stages and continuously improving quality management systems enables organizations to uphold their status, build client trust, and achieve long-term success in the industry.