Regulation on Occupational Hygiene Measurement, Test and Analysis Laboratories

Institution: Ministry of Labor and Social Security
Date of Approval: 24.01.2017
Official Gazette Date: 24.01.2017
Official Gazette No: 29958

CHAPTER ONE: Purpose, Scope, Basis and Definitions

Purpose

Article 1 - (1) The purpose of this Regulation is to regulate the procedures and principles regarding the authorization of laboratories performing occupational hygiene measurement, test and analysis related to personal exposures in the working environment and physical, chemical and biological agents in the working environment within the scope of occupational health and safety legislation, as well as the employer's obligations regarding the necessary occupational hygiene measurement, test and analyses to determine the risks to which employees are exposed in the workplace environment.

Scope

Article 2 - (1) This Regulation covers workplaces within the scope of the Occupational Health and Safety Law No. 6331 dated 20/6/2012 and private or public institutions and organizations performing occupational hygiene measurement, test and analysis in these workplaces.

(2) The certification and authorization provisions of this Regulation do not apply to the following institutions:

  • a) Laboratories performing occupational hygiene measurement, test and analysis for internal control purposes for their own workplace and employees.
  • b) Laboratories of the Occupational Health and Safety Research and Development Institute Presidency.

(3) The following activities are outside the scope of this Regulation:

  • a) Occupational hygiene measurement, test and analysis activities carried out by the Turkish Atomic Energy Authority within the framework of its own legislation.
  • b) Measurement, test and analysis activities performed to determine the health status of the employee.
  • c) Measurement, test and analysis activities performed on biological samples taken from the employee.

Basis

Article 3 - (1) This Regulation has been prepared based on Articles 10, 24, 27, 30 and 31 of Law No. 6331 and Article 12 of Law No. 3146 dated 9/1/1985 on the Organization and Duties of the Ministry of Labor and Social Security.

Definitions

Article 4 - (1) In the implementation of this Regulation;

  • a) Accreditation: The evaluation of laboratories, inspection and certification bodies according to nationally and internationally accepted technical criteria, approval of their competence and regular audits,
  • b) Accreditation Body: The Turkish Accreditation Agency (TÜRKAK) or one of the accreditation bodies that have signed mutual recognition agreements with the European Accreditation Association, International Laboratory Accreditation Cooperation and International Accreditation Forum,
  • c) Accreditation standard: The TS EN ISO/IEC 17025 "General Requirements for the Competence of Testing and Calibration Laboratories" standard,
  • ç) Ministry: The Ministry of Labor and Social Security,
  • d) Audit: Any sudden, scheduled or complaint-based on-site and/or workplace environment monitoring conducted by the General Directorate to determine whether a laboratory with a pre-qualification or qualification certificate operates in accordance with the provisions of this Regulation,
  • e) Test personnel: The person authorized by the laboratory who performs occupational hygiene measurement, analysis, test, and sampling operations,
  • f) General Directorate: The General Directorate of Occupational Health and Safety,
  • g) İSG-KATİP: The occupational health and safety registration, tracking and monitoring program used by the General Directorate for recording, tracking and monitoring occupational health and safety services and related work and procedures,
  • ğ) İSGÜM: The Occupational Health and Safety Research and Development Institute Presidency affiliated to the General Directorate,
  • h) Occupational hygiene measurement, test and analysis: The quantitative and qualitative determination of physical agents such as noise, vibration, lighting, non-ionizing radiation; chemical agents such as dust, gas, vapor; and biological agents such as viruses, bacteria, fungi present in the working environment that may adversely affect employees' health,
  • ı) Quality manager: A person graduated from domestic or foreign educational institutions accepted as equivalent by the Higher Education Council, from faculties providing at least four years of undergraduate education such as Engineering, Science, Medicine, Veterinary, Agriculture, Pharmacy, Fisheries, or the Departments of Physics, Chemistry and Biology of the Faculty of Science and Letters, responsible for establishing, implementing, improving the laboratory management system and reporting identified deficiencies and/or nonconformities to management,
  • i) Scope extension: The addition of new parameters to the existing certificate of a laboratory that has obtained a qualification certificate,
  • j) Proficiency test: The organization, execution and evaluation of measurements and analyses performed by laboratories on the same or similar items under predetermined conditions,
  • k) Laboratory: A private or public institution laboratory established to perform occupational hygiene measurement, test and analysis,
  • l) Laboratory top management: The founder(s) or partners of the laboratory published in the Turkish Trade Registry Gazette,
  • m) Laboratory manager: A person graduated from domestic or foreign educational institutions accepted as equivalent by the Higher Education Council, from faculties providing at least four years of undergraduate education such as Engineering, Science, Medicine, Veterinary, Agriculture, Pharmacy, Fisheries, or the Departments of Physics, Chemistry and Biology of the Faculty of Science and Letters, responsible for occupational hygiene measurement, test and analysis results and laboratory management,
  • n) Pre-qualification certificate: The certificate issued by the General Directorate to a laboratory that has applied for accreditation for methods within the scope of occupational hygiene measurement, test and analysis that require accreditation according to this Regulation and has fulfilled other relevant conditions foreseen by the Regulation,
  • o) Parameter: Factors measured, tested and analyzed in the field of occupational hygiene,
  • ö) Reference exposure duration: The specified duration for the limit value of a certain substance,
  • p) On-site inspection: The evaluation and reporting by the General Directorate to determine whether a laboratory applying for a pre-qualification or qualification certificate complies with the provisions of this Regulation,
  • r) Qualification certificate: The certificate issued by the General Directorate to a laboratory that fulfills the provisions of this Regulation,
  • s) Proficiency experiment: A comparison program organized by an independent and impartial legal entity or organization to evaluate the performance of multiple laboratories,
  • ş) International traceability: The property of a measurement result to be related to a specific reference through an unbroken chain of calibrations, each contributing to measurement uncertainty, which is documented,

CHAPTER TWO: Obligations and Rules to be Followed

Employer's obligations regarding occupational hygiene measurement, test and analysis

Article 5 - (1) The employer is obliged to protect employees from harmful effects of substances present, used, generated or processed in any way in the workplace and working environment conditions, and within this framework;

  • a) While conducting and renewing risk assessments to provide a safe working environment, the presence of physical, chemical and biological hazard sources is determined by environmental and personal exposure measurement, test and analysis when necessary.
  • b) To evaluate the effectiveness of control measures taken, environmental and personal exposure measurement, test and analysis are repeated.

(2) The employer shall have occupational hygiene measurement, test and analyses performed or repeated in any of the following cases:

  • a) When there is a change in the workplace environment or the employee's personal exposure due to the nature of the work.
  • b) When deemed necessary by the workplace physician or occupational safety specialist.
  • c) When requested during external audits conducted at the workplace.

(3) The employer is obliged to have occupational hygiene measurement, test and analysis performed by laboratories holding a pre-qualification or qualification certificate.

(4) The employer informs the laboratory personnel coming to the workplace to perform occupational hygiene measurement, test and analysis about the following:

  • a) Health and safety risks that may be encountered in the workplace, protective and preventive measures.
  • b) Persons assigned for first aid, search, rescue, evacuation and fire fighting.

(5) The employer assigns a person knowledgeable about the work to accompany the laboratory personnel during their activities at the workplace.

(6) To obtain accurate results during occupational hygiene measurement, test and analysis, the employer;

  • a) Provides necessary information about the technologies used in the workplace to the test personnel performing occupational hygiene measurement, test or analysis and ensures that the personnel communicate with employees.
  • b) Ensures that occupational hygiene measurement, test and analysis are performed according to the plan prepared by the laboratory.
  • c) Ensures that work continues under normal working conditions and production capacity without any changes to provide real results.
  • ç) Provides laboratories with all kinds of information, documents and records about physical, chemical and biological agents to be measured in the workplace, including safety data sheets.
  • d) Obtains opinions of employees or their representatives regarding occupational hygiene measurement, test and analysis to be performed in the workplace.

(7) The employer keeps printed or electronic records of all occupational hygiene measurement, test, analysis and evaluation results performed under this Regulation at the workplace to be shown upon request during inspections.

(8) The employer stores occupational hygiene measurement, test and analysis records at the workplace in accordance with the periods specified by relevant legislation. For records not specified by legislation, the retention period is 10 years.

Laboratory obligations

Article 6 - (1) Occupational hygiene measurement, test and analyses, except for the exceptions specified in the second paragraph of Article 2 of this Regulation, shall be performed by a laboratory holding a pre-qualification or qualification certificate in this field. The laboratory cannot perform measurement, test and analysis outside the parameters specified in the pre-qualification or qualification certificate.

(2) The laboratory establishes, implements and improves a quality management system in accordance with the accreditation standard for the parameters for which it will obtain authorization.

(3) A laboratory applying for a pre-qualification certificate must have applied to the Accreditation Body for the methods used for one or more of the parameters specified in Annex-1 within the scope of occupational hygiene measurement, test and analysis services it will provide. If it will not perform occupational hygiene measurement, test and analysis for any of the parameters specified in Annex-1, it must have applied to the Accreditation Body for at least one of the methods within the scope of occupational hygiene measurement, test and analysis it will apply.

(4) A laboratory applying for a qualification certificate must be accredited by the Accreditation Body according to the accreditation standard for the methods used for one or more of the parameters specified in Annex-1 within the scope of occupational hygiene measurement, test and analysis services it will provide. If it will not perform occupational hygiene measurement, test or analysis for any of the parameters specified in Annex-1, it must be accredited by the Accreditation Body according to the accreditation standard for at least one of the methods within the scope of occupational hygiene measurement, test and analysis it will apply.

(5) The conditions to be provided by a laboratory measuring parameters that are not required to be accredited according to the fourth paragraph of this article and that is not accredited for these parameters are as follows:

  • a) Documents the quality management system at a level that ensures the accuracy of occupational hygiene measurement, test and analysis results.
  • b) The system documentation is communicated to the relevant test personnel and is understandable, accessible and applicable by this personnel.
  • c) The laboratory top management establishes a procedure for reviewing requests, offers or contracts and ensures their continuity.
  • ç) The laboratory has a policy and procedures for the selection and purchase of necessary services and materials affecting the quality of occupational hygiene measurement, test and analyses. It controls the suitability of the materials received.
  • d) The laboratory top management identifies responsible and authorized persons for inappropriate occupational hygiene measurement, test or analysis operations and takes all necessary measures to prevent recurrence. When an error is detected in reported occupational hygiene measurement, test and analysis results, the laboratory evaluates the significance of the error, withdraws the report if necessary, revises or cancels the report based on the evaluation.
  • e) The laboratory top management establishes a procedure for each test to ensure that only competent and authorized personnel perform the test.
  • f) Test personnel receive basic training related to the devices they use. Trainings are recorded with training certificates provided by another competent institution or internal training given by a person holding such a certificate.
  • g) Test personnel work according to the method used and fulfill all conditions of this method.
  • ğ) All necessary measures are taken to prevent environmental and settlement conditions from adversely affecting test results. If sampling or testing is performed outside the laboratory facilities, environmental conditions that may affect the results are evaluated and recorded.
  • h) Test personnel monitor, control and record environmental conditions as required by methods and procedures or where environmental conditions may affect occupational hygiene measurement, test and analysis results.
  • ı) The laboratory establishes and applies a procedure for determining measurement uncertainty. If measurement uncertainty cannot be calculated due to the nature of the test, at least all uncertainty components are attempted to be identified.
  • i) The laboratory has internal and external quality control procedures to monitor the validity of tests. It regularly uses certified reference materials and/or performs internal quality control using secondary reference materials. The laboratory participates in proficiency tests and inter-laboratory comparison programs.
  • j) The laboratory analyzes quality control data. If it detects that these data are outside predefined criteria, it implements planned measures to correct the problem and prevent incorrect results.

(6) The laboratory uses the devices, equipment and procedures required by the methods included in the pre-qualification or qualification certificate.

(7) The laboratory possesses all devices necessary for the application of the method.

(8) The laboratory determines maintenance and calibration periods of devices according to relevant standards, information provided by the manufacturer, user manuals and usage frequency. It performs maintenance and calibration according to determined periods and keeps records. Devices found to be outside tolerance limits according to calibration certificates are taken out of use.

(9) Calibrations are performed by calibration laboratories with international traceability.

(10) The laboratory is obliged to comply with the following:

  • a) Ensures that personnel performing occupational hygiene measurement, test and analysis at the workplace comply with workplace rules and work instructions.
  • b) Keeps completely confidential the trade secrets of the employer and workplace such as production technologies and raw materials used in the workplace, as well as health surveillance information of employees and personnel information learned or seen during the work.