Experiences with the accreditation of the Institute for Medical Research and Occupational Health, Zagreb, Croatia

In order to provide validated high-quality results IMROH has been implementing measures to improve the quality of its performance from the very beginning. This resulted in full readiness for acceptance of a quality management system in line with the (17) standard as the only internationally accepted standard for laboratory quality systems that provides globally accepted testing and calibration reports.

In 2010, IMROH was accredited by HAA for the following scopes: “determination of radioactivity”; “testing of ambient air quality”; and “testing in the scope of ionizing radiation protection”. This accreditation encompassed three laboratories: Radiation Protection Unit, Environmental Hygiene Unit, and the Radiation Dosimetry and Radiobiology Unit. In 2015, IMROH was duly re-accredited, and the second re-accreditation is planned for the end of 2020. Accredited materials, products, types of tests, and methods are listed in the Accreditation Certificate No. 1288, publicly available at the web site of HAA (20).

The quality management system operating at IMROH has the following characteristics:

Laboratory diaries have been replaced by checklists to minimise error (skipping or incorrectly applying required procedures) and to keep a thorough record of all data and samples (aka test items) needed for calculations.

After regular HAA audit in February 2020, IMROH made a successful transition from HRN EN ISO/IEC 17025:2007 to the new 2017 edition of the ISO standard, i.e., HRN EN ISO/IEC 17025:2017. The transition went smoothly, and external auditors found only two nonconformities, the first one dealing with new requirements for monitoring competences and authorisation of personnel and the other one dealing with quality assurance, as the exact dates for calibration were not properly documented.

Documentation did not change, but a new procedure for risk management and related forms were developed, quality policy was improved, and several forms were upgraded.

As required by standard, all three accredited laboratory units assure metrological traceability of their testing results by unbroken and documented chain of calibrations. Each of these calibrations contribute to the overall measurement uncertainty. Measurement uncertainties of methods are evaluated following the principles set out in the HAA document “Evaluation of measurement uncertainty” (21) and guidelines set by European Accreditation Cooperation (22), International Laboratory Accreditation Cooperation (23 and EURACHEM/CITAC (24).

Among the three accredited units, the Environmental Hygiene Unit issues a statement of conformity. It is a binary statement that accepts or rejects measurement results and describes the decision rule that is applied, i.e., how measurement uncertainty is evaluated and accounted for (25).

Quality objectives of the IMROH quality policy are as follows:

A laboratory must clearly define its structure and activities and describe them in its documentation which is compliant with quality policy. Quality policy statement is a strategic document developed by unit management in line with top management quality directive(s). The policy should demonstrate laboratory’s commitment to implementation of the ISO/IEC 17025 standard and to continuous improvement.

Management system documentation includes a set of documents (quality policy, quality manual, procedures, working instructions, regulations, standards, and other normative documents) organised in a so called documentation pyramid. Quality manual is the top tier document, which describes organisation’s quality management system and approaches to achieve quality data. It also specifies the adopted and implemented competence, impartiality, and operational requirements. The new, 2017 version of the HRN EN ISO/IEC 17025 standard does not require a quality manual, but most accredited laboratories worldwide have retained it, including our laboratories at IMROH.

The next, second tier, if we look from the top down, are standard operating procedures (SOPs) – generic instructions for how to perform a specific task, such as personnel management, documentation management, internal auditing, or reporting of results.

The third tier are working instructions – step-by-step instructions that clearly and precisely describe the correct way to perform certain tasks such as specific testing methods or calibration of a specific instrument.

The fourth tier consists of records generated on a day-to-day basis, such as checklists, forms, calibration and analytical results, as well as various other maintenance, testing, and training records.

Finally, the last tier consists of various external documents such as standards, regulations, instructions for instrument use and maintenance, manuals, HAA accreditation documents (26), and other rules.

At IMROH standard operating procedures include:

Regarding test methods, each method has a comprehensive and validated working instruction. If applicable, validation parameters are as follows (for definitions se ref. 27): working range in which the calibration equation applies (linearity of calibration); measuring interval; matrix effects; selectivity; sensitivity; accuracy; precision; repeatability; reproducibility; trueness; limit of detection; limit of quantitation; limit of reporting; ruggedness; and measurement uncertainty.

Validation records also include reports from quality assurance programmes and results of participation in proficiency testing and inter-laboratory comparison schemes. Validation is performed by professional staff in charge of respective methods.

Every year, IMROH participates in more than ten national and international quality assurance programmes for various analytical methods organised by providers like the Joint Research Centre (JRC), International Atomic Energy Agency (IAEA), Institut für Arbeitsschutz der Deutschen Gesetzlichen Unfallversicherung (IFA), Institut national de l’environnement industriel et des risques (INERIS), LGC Group, Ekonerg, and others.

Equipment and measuring instruments are calibrated at appropriate, usually annual intervals. An important part of quality assurance is continuous investment in human resources in order to improve their competencies and level of expertise through international workshops, trainings, and courses).

How is quality assurance implemented in gamma-ray spectrometry at IMROH has been reported in more detail elsewhere (28).

Internal audits verify compliance of laboratory’s performance with the ISO/IEC 17025 requirements and company policies, processes, and procedures. At IMROH internal audits take place 1–2 months before external audits. All internal auditors have been trained for auditing. Over the last 10 years, internal auditors have reported 166 nonconformities (85 related to the management system requirements and 81 to methods and technical requirements) and 81 recommendations (43 related to the management system requirements and 38 to methods and technical requirements). Thirty non-conformities concerned the performance of testing methods, 18 the management of personnel, and 13 quality assurance of results. A large number of non-conformities and recommendations found in management system helped to identify and minimise the risks associated with organisation and impartiality (Table 1).

The first (initial) accreditation audit of IMROH took place in 2010. Between 2010 and 2020, HAA carried out nine external audits and found a total of 22 non-conformities, only three of which concerned system management. It also issued 58 recommendations, 15 of which concerned system management. Most non-conformities and recommendations concerned testing methods (8 and 18, respectively).

Figure 2 compares the non-conformities found by external (HAA) and internal auditors to show how competent, impartial, and strict internal audits are at IMROH. Both auditing teams paid special attention to clause 5.4 of the EN ISO 17025:2017 standard (test and calibration methods and method validation). Internal auditors were also very strict regarding clause 5.9 of the EN ISO 17025:2017 standard (assuring the quality of test and calibration results). The ratio between the total number of non-conformities found by external and internal auditors is 13:100, respectively and clearly shows that internal audits were much more rigorous. Namely, very strict internal audits, designed and conducted much in the same way as external audits, proved to be beneficial in maintaining the high standard and robustness of the quality system at IMROH. Consequently, non-conformities were successfully corrected before external audits.

Figure 2

Figure 3 shows a similar analysis for recommendations given by internal and external auditing teams. The HAA teams preferred to give recommendations rather than nonconformities regarding clause 5.4, which is yet another evidence that internal auditors were much more rigorous.

Figure 3

Generally, the analysis of the non-conformities is useful to assess quality assurance and risk analysis. Over the last ten years, the steady annual decrease in identified nonconformities by either internal or external auditors clearly suggests that the implementation of corrective and preventive actions has been successful. The good agreement between external and internal auditor findings indirectly validates the approach and competence of internal auditors.

In October 2019, the Radiation Protection Unit underwent a two-day external “verification of bodies having competence in the field of environmental radioactivity monitoring in Zagreb, Croatia” carried out by verifiers of the European Commission (Directorate-General for Energy - Directorate D for nuclear energy, safety and ITER) under the Euratom Treaty article 35 (29). This verification covered environmental radioactivity monitoring, radiological surveillance of foodstuffs and nuclear and radiological emergency preparedness.

No non-conformities were found. The verifiers concluded that the environmental radioactivity monitoring programmes in Zagreb complied with the requirements of the Euratom Treaty article 35 and reported that the “facilities needed to carry out continuous monitoring of levels of radioactivity in air, water and soil in Zagreb are adequate (29).

The main purpose of quality assurance is to meet all customer expectations in terms of product quality at an acceptable cost. Quality assurance is therefore primarily focused on preventing any mistakes throughout the process of creating and using a product or service. Prevention involves planning, but successful planning is not possible without up-to-date information on quality costs. Quality management system costs include: administrative costs (accreditation, external audits, etc.); cost of process controls (actions taken for reduction of process, output variability); product quality-related costs (control, detection, prevention); poor quality costs / defect-related costs (failure, non-conformance, deficiencies); and other, hidden quality costs.

These costs are extra, on top of production costs, but ensure the quality end-product.

To minimise possible losses within the quality system it is important to monitor and control these costs.

After the initial high costs of implementing quality management, IMROH saw a steady decrease. In addition, accreditation and higher quality of laboratory activities have a direct impact on productivity and savings, although it is not always tangible. As we mentioned before, Croatian regulations stipulate that only accredited institutions can participate in certain activities and projects, including routine environmental monitoring. Accreditation therefore enabled IMROH to bid and win quite a number of national and international projects.

There are several commercial software tools available for quality cost management (30), but IMROH has developed its own, simple but effective tool based on the concept introduced by Feigenbaum (31), which also includes risk analysis and actions to address risks and opportunities.

At IMROH, financial benefits of accreditation far outweigh the costs. Our accredited units have increased the number of contracts with external clients, the number of analysed samples also, and the number of implemented projects (Table 2).

In Croatia, environmental monitoring of radioactive contamination and air quality is mainly entrusted to scientific institutions. In return, they provide additional value to monitoring results. Instead of having binary approach to measurement results (contaminated/not contaminated, safe/unsafe, above/below specified limits) scientists strive to obtain real numbers, i.e. validated data that allow modelling and prediction of trends. This improves monitoring design and optimisation and facilitates decision-making and planning emergency response if necessary. Similar applies to dosimetric surveillance.

However, validated and internationally recognised data/testing results can be produced only by accredited laboratories. Reliability of test results leads to higher confidence of customers, which increases demand for such services.

The set-up and implementation of a functioning quality system based on the ISO 17025 standard at IMROH required coordination and collaboration of all involved organisational units and all of them demonstrated competence and skills. All personnel was trained to adopt changes that came with the new edition of the ISO 17025 standard. Implementation and maintenance of the quality system and accreditation helped personnel to get in touch with real-world economy and broaden their minds, which has had a lasting positive impact on research studies and academic production.

A functional and validated quality management system facilitates the introduction of other accreditation schemes, such as Good Laboratory Practice – GLP (32), the Federation of European Laboratory Animal Science Association - FELASA accreditation scheme (33) in laboratory animal science (LAS), and ISO 14000 series standards (34), which are often required for applying to various tenders and for various institutional collaborations.

In conclusion, the accredited management system at IMROH significantly improved the performance of the accredited units, and IMROH improved its visibility, customer loyalty, and market position.