Rules of accreditation and monitoring

(extract from the Management Manual dated 25.02.2019 No. 261-Я)

8 Rules of accreditation and monitoring

8.1 General provisions

8.1.1. These Provisions determine the procedure of accreditation and surveillance for conformity assessment bodies (hereinafter – accreditation). The accreditation is carried out by NAAU according to the Law of Ukraine “On accreditation of conformity assessment bodies” taking into account the requirements of international and European standards for CAB accreditation.

The procedure applies to all CABs willing to be accredited by NAAU regardless of whether they are already accredited, for example, by other accreditation bodies that are signatories to corresponding EA/ILAC/IAF Agreements, as well as CABs already accredited by NAAU.

8.1.2. NAAU provides interested parties with the information concerning:

a) list of the documents where the accreditation requirements (criteria) for conformity assessment bodies are determined;
b) list and form of documents to submit application for accreditation to NAAU;
c) cost of accreditation works;
d) procedure of processing of complaints and appeals;
e) list of accredited conformity assessment bodies with their scopes of accreditation;
f) other documents concerning accreditation process.

This information is maintained as actual, and is available on the web-site of NAAU.

8.1.3. Accreditation of CABs, according to the declared accreditation scope, can be carried out according to the requirements of such normative documents:

a) testing and calibration laboratories – ДСТУ ІSO/ІEC 17025:2006, ДСТУ ISO/IEC 17025:2017;
b) products, processes and services certification bodies – ДСТУ EN ISO/IEC 17065:2014;
c) management systems certification bodies – ДСТУ EN ІSO/ІEC 17021-1:2015 (and other standards of ISO/IEC 17021 series – ДСТУ ISO/IEC TS 17021-2:2014, ДСТУ ISO/IEC 17021-3:2014, etc.) and additional standards:
- for food management systems certification bodies the requirements of ISO/TS 22003:2013;
- for information safety management systems certification bodies – ДСТУ ISO/IEC 27006:2015,
- for energy management systems certification bodies – ДСТУ ISO 50003:2016.
d) certification bodies of persons – ISO/IEC 17024:2014;
e) inspection bodies – ISO/IEC 17020:2014.
f) medical laboratory – ДСТУ EN ISO 15189:2015;
g) proficiency testing providers – ДСТУ EN ISO/IEC 17043:2017.

During accreditation NAAU follows appropriate recommendations of international (ILAC and IAF) and regional (EA) organizations for accreditation.

8.1.4. NAAU can assess CAB compliance with additional requirements in relevant sectors of economy.

8.1.5 With the purpose of preparation of application documents set for accreditation CAB should send to NAAU the request for accreditation according to the Form F-08.08.01. Registration of requests for accreditation is done according to the Instruction “Order of registration of requests for accreditation of conformity assessment bodies” (IN-08.08.01).

8.1.6 At any point in the application or initial assessment process, if there is evidence of fraudulent behavior, if the CAB provides false information or conceals information, NAAU rejects the application or terminates the assessment process.

8.1.7. In the case of CAB-applicant refusal to pay money and/or to make agreement for accreditation works in defined terms NAAU has a right to cancel an application and to cease subsequent accreditation work.

8.1.8 Situations that make it impossible for NAAU to conduct the on-site assessment of a CAB are the following:

- Circumstances which prevent access of NAAU representatives to CAB’s location or threaten their lives (e.g., flood, earthquake, hostilities, terrorism, fire, emergency or martial law, etc.) and force majeure;
- Absence of CAB personnel at the workplaces (e.g., disease, epidemics, etc.);
- Absence of premises in a CAB or access to it (e.g., due to the completion the rental period, the destruction of buildings, obstruction of access by representatives of a CAB, security or law enforcement authorities, etc.).

The source of information on the occurrence of situations, that prevent conducting the on-site assessment, can be letters from CABs, memos of NAAU workers, official publication of appropriate government authorities.

In case of receiving of such information, NAAU studies relevant circumstances, and decisions are made, namely:

- postponement of the date of on-site assessment (for a term not exceeding 2 years since the last on-site assessment of a CAB);
- suspension of the validity of accreditation certificate in the above mentioned cases is issued for a period not exceeding one year;
- withdrawal of the accreditation certificate.

Suspension or withdrawal of the CAB accreditation certificate or suspension of the part of its accreditation scope is carried out according to the procedure “Suspension or withdrawal of accreditation certificate or suspension of the part of its accreditation scope” (P-08.00.20) and decisions are made on the grounds of the minutes of the meeting of NAAU relevant commission.

8.1.9 Heads of accreditation departments control the timely execution of accreditation works by executors and are responsible for updating the information on the status of work on accreditation (F-01.08.02), which are placed on the NAAU internal network.

8.2 Accreditation procedure

8.2.1 Submission of application by the conformity assessment body (applicant) for accreditation or extension of accreditation scope

NAAU makes public available list and forms of application documents on the web-site of NAAU.

The applicant submits the application for accreditation or extensions of the accreditation scope to NAAU according to the established form “Application for accreditation  of  CAB”     (F-08.00.02) and also set of documents according to “List of documents enclosed to the application” (F-08.xx.03) depending on the type of the CAB. Provided that the applicant intends to be accredited separately on each type of activity according to the p.8.1.3, it should submit separate applications for each type of activity.

Registration of the application for accreditation in NAAU is conducted according to the Procedure “Reception, incoming inspection, registration of application” (P-08.08.03).

The application from the CAB which has the accreditation certificate withdrawn according to the results of surveillance or unplanned assessment is registered not earlier than in a year after NAAU decision making on withdrawing of the accreditation certificate.

8.2.2 Examination of documents and information enclosed to application

Checking completeness of documents enclosed to the application is doing according to the Procedure “Examination of documents and information enclosed to the application” (P-08.08.05). In case of wrong filling of the application or insufficiency of given information and documentation the applicant has to update submitted set of documents. Documents update period shall not exceed 120 days. If the update period exceeds 120 days the application is canceled.

In case of positive results of analysis, accreditation works are proceeded. In case of negative results of analysis, documents are given back to the applicant for a revision.

According to the consent of the parties NAAU can make a preliminary assessment of the applicant to determine his readiness for assessment according to the Procedure “Organization and carrying out of preliminary assessment of laboratories” (P-08.01.10) and “Organization and carrying out of preliminary assessment of certification bodies and inspection bodies” (P-08.03.10). Preliminary assessment continues one day. Only one preliminary assessment of the specific applicant may be performed. During performance of preliminary assessment assessor shall not give any consultant services.

In the course of consideration of a draft scope of accreditation the analysis of resources shall be performed in accordance with clause 7.3 of ISO/IEC 17011. In the event of lack of relevant resources in NAAU (e.g. experts with respective technical knowledge) NAAU may refuse to accredit a CAB.

In the event that the results of consideration of the application establish the non-compliance of the submitted documents with the provisions of the “Evaluation Criteria and Adoption of Conformity Assessment Schemes” (GD-08.08.29), NAAU may refuse to accredit the CAB.

Pending to the decision-making on the results of application consideration (F-08.00.23) the following persons are involved: First deputy chairman on accreditation issues, head of the relevant department on accreditation, head of the relevant division on accreditation and responsible

The following responsibility during the decision-making on the results of application consideration is established:

- Head of the division verifies the correctness of drawing up the protocol and a draft decision;
- Head of the accreditation department is responsible for the correctness of the recommendations and conclusions made by the executor in charge, and the draft decision on the consideration of the application
- First Deputy Chairman on Accreditation is responsible for the final adoption and approval of the decision.

8.2.3 Forming the assessment team and informing the applicant

According to the Procedure “Forming the assessment team and informing the applicant” (P-08.08.07) the assessment team (hereinafter – team), which will carry out the assessment of the applicant, is appointed. Accreditation lead assessors and experts can be included into the team. If CAB applies to NAAU for the first time, the team consists at least of two persons.

The applicant is informed about the members of assessment team beforehand according to the Procedure “Forming of assessment team and informing applicant” P-08.08.07.

In case of involvement of the observers from CAB to the assessment process, in such case CAB shall inform NAAU beforehand. Observers shall sign declaration of confidentiality.

Drawing up, checking up and signing of a contract on accreditation is carried out according to the Procedure “Drawing up of the contract” (P-08.08.06).

The accreditation program is designed and coordinated with the appointed team (F-08.xx.07). in selecting the activities to be assessed, the team leader shall consider the risk associated with the activities, locations and personnel covered by the scope of accreditation.

8.2.4 Carrying out analyses of given information and documents

The appointed assessment team analyzes given information and documents according to the Procedures “Carrying out analyses of information and documents submitted by the applicant-laboratory” (P-08.01.09) and “Carrying out analyses of information and documents submitted by the applicant (certification/inspection body)” (P-08.03.11).

The statement on analysis is sent to the applicant.

In case of positive results of analysis, works proceed and the assessment of the applicant is carried out on site.

In case of negative results of analysis, the documents are sent back to the applicant for updating. Documents update period shall not exceed 90 days. After updating the applicant sends the documents for reconsideration according to the additional Contract. Maximum possible number of repeated document analyses is two ones. If the updating period exceeds 90 days the application is canceled.

In the decision-making on the results of consideration of a Document Review Act (P-08.00.25), the following persons are involved: Head of the Department on Accreditation, Head of the relevant division on accreditation, the first deputy chairman on accreditation, deputy chairman.

The following responsibilities are established when deciding on the results of consideration of an act of analysis of documents:

- the head of the department is responsible for the analysis of the completeness and performance of the program of assessment and content of the reports and documents review acts.
- the head of the accreditation department is responsible for the correctness of the recommendations and conclusions made by the group of accreditation auditors and the draft decision on the analysis of documents;
- The first Deputy-Chairman on Accreditation is responsible for the final adoption and approval of the decision.

If any person from the above list participated in the evaluation of a particular CAB, they are not involved in the decision-making process on this CAB, and the scope of their responsibility in this process rests with the person they are subordinate to.

If the first Deputy Chairman on Accreditation takes part in the evaluation of a particular CAB, his/her responsibility lies with the Deputy Chairman.

8.2.5 Drawing up the assessment plan and informing applicant

The on-site assessment plan (F-08.xx.26) is composed, the plan is to contain the information on accreditation criteria (standards, ILAC/IAF/EA documents, etc.). NAAU informs the applicant, who shall inform NAAU in written form about agreement (or non-agreement) of the plan.

8.2.6 On-site assessment

An assessment on site is carried out according to the assessment program and the Procedures “Laboratory on-site assessment” (P-08.01.14) and “On-site assessment of certification bodies/inspection bodies” (P-08.03.15).

On-site assessment consists of such main stages:

  • preliminary meeting with the management of the applicant;
  • collection of the objective information concerning the compliance of the applicant with the criteria of accreditation;
  • analysis of the collected data and determination of the conformity (nonconformity) of the applicant to the criteria of accreditation;
  • final meeting with the applicant management concerning the discussion of the assessment results, drawing up and signing the protocol of closing meeting defining the terms of elimination of the nonconformities.

If CAB has subsidiaries, during the first accreditation central office and all subsidiaries are to be assessed.

During the CAB’s assessment, a mandatory photo-fixation of the accreditation team during the preliminary and final meetings is conducted. Photo and video fixation can be also performed during on-site assessment. The objects of such fixation may be: the CAB’s location, equipment, separate stages of on-site assessment (opening meeting, final meeting, etc.), monitoring of the CAB’s activities. Before conduction of photo and video fixation, it is necessary to obtain permission of the CAB.

If the on-site assessment can not be carried out in full (for example, the impossibility of a member of the accreditation team to participate in on-site assessment, force majeure, etc.), the team leader agrees with the CAB’s management on additional measures to complete the assessment, which are defined in the minutes of the final meeting.

8.2.7 Analysis of the collected materials, drawing up reports and statement of on-site assessment

The appointed assessment team collects objective evidence to confirm the CAB’s competence and carries out analysis of that documents according to the Procedures “Carrying out the on-site assessment of laboratory” (P-08.01.14) and “Carrying out the on-site assessment of certification/inspection bodies” (P-08.03.15).

According to the results of the analysis the assessment team leader draws up the on-site assessment statement including recommendations concerning accreditation or refusal thereof using the Form “On-site assessment statement” (F-08.00.28). The statement together with the necessary document package is sent to NAAU. Thus CAB in a term of 90 days must implement correcting actions for the removal of the discovered non-conformities and give the proper information to NAAU. In case if CAB in a term of 90 days did not give to NAAU proper information an application is cancelled.

In case of necessity NAAU can carry out complete or partial repeated assessment on site, having informed the applicant in advance. Maximum possible number of repeated on-site assessment of applicant is two. If the reason for the re-assessment is the existence of doubts as to the reliability of the data received, such assessment is carried out at the expense of the NAAU.

8.2.8 Evaluation of the accreditation work results, giving recommendations and decision making

In case of necessity NAAU can make the request to TSCA for discussion and consideration of results of accreditation activities (necessity can be in case of different interpretations etc)

Responsible TSCA gives candidacy specialists in the relevant sphere, who are the members of this TSCA in order to make analysis and give recommendations. This specialist shall obligatory fill in ‘Declaration on confidentiality’ (F-08.00.32). Evaluation of the accreditation work results is carried out in the office of NAAU, and the representative of TSCA has access to all accreditation documents. Recommendation concerning accreditation is formed according to the form F-08.00.14. If accreditation scope of CAB is in the competence of several subcommittees, then representatives of several subcommittees can be involved to such activity.

The Chairman of NAAU makes decision (F-08.00.30, F-08.00.31, F-08.00.36, F-08.00.47, F-08.00.50, F-08.00.51, F-08.00.52, F-08.00.56) after receiving the act of on-site assessment, the whole set of documents and, if necessary, recommendation of TSCA. Prior to the adoption of the decision, the first deputy-chairman for accreditation, the head of the accreditation department, the head of the relevant department are involved.

The following responsibility was established when making the above decisions:

- the head of the department is responsible for analyzing the completeness and implementation of the program and the assessment plan, analyzing the content of the reports and acts of on-site assessment, checking the revealed non-compliances and performing corrective actions, checking the availability of all necessary documents for the accreditation process, the correctness of accreditation certificate and accreditation scope;
- the head of the accreditation department is responsible for the correctness of the recommendations and conclusions made by the accreditation assessors team and the draft decision on accreditation;
- the first Deputy-Chairman on accreditation is responsible for verifying the implementation of the accreditation process;
- the Chairman of NAAU, in accordance with the current legislation of Ukraine, is responsible for the final adoption and approval of the decision.

If any person from the above list participated in the evaluation of a particular CAB, they are not involved in the decision-making process on this CAB, and the scope of their responsibility in this process rests with the person they are subordinate to.

If the NAAU Chairman participates in the assessment of a particular CAB, then the scope of his responsibility rests with the first Deputy-Chairman on accreditation.

In case of making decision about accreditation of CAB, NAAU draws up and submits to the CAB an accreditation certificate with a period of validity to five years (accreditation cycle). The date of the accreditation cycle shall begin with at or after the date of the decision for granting accreditation. The accreditation cycle includes the following reassessment.

Registration of the accreditation certificate and all information about CAB are conducted according with the Instruction “Procedure for registration of accreditation certificates of conformity assessment bodies and maintenance of the Register of accredited conformity assessment bodies” (IN-08.08.02).

NAAU and CAB conclude General Agreement (F-08.xx.27), which contains rights and responsibilities of the accredited CAB and NAAU.

The accreditation certificate is issued in the Ukrainian language. Upon the CAB’s written request, the accreditation certificate in a foreign language (English or Russian) can be additionally issued according to the Instruction “The order of issuance of accreditation certificates of a CAB in English/Russian” (IN-08.08.03). The accreditation certificate in a foreign language can be given out both simultaneously with the accreditation certificate, and also during its validation. The term of validation of the accreditation certificate in a foreign language corresponds to the term of validation of the accreditation certificate, given out in the Ukrainian language, and is given out under the same registration number. NAAU doesn’t carry out translation of accreditation scope into foreign languages.

Provided that the accreditation is denied, the notification, where all reasons for the accreditation dismissal are indicated, shall be sent (issued) to the applicant in written form.

The person in charge in the registry sector sends to the CAB one copy of the act on the on-site assessment (F-08.0X.28), the Accreditation Decision (F-08.00.30), the Accreditation Certificate with the scope, one copy of the General Agreement between NAAU and the CAB.

8.3 Carrying out surveillance and unplanned assessments of accredited CABs

NAAU carries out planned surveillance and unplanned assessments of the accredited CAB according to the Procedures “Organization and carrying out surveillance and unplanned assessments of accredited laboratories” (P-08.01.12) and “Organization and carrying out surveillance and unplanned assessments of accredited certification and inspection bodies” (P-08.03.13). The terms of conducting the planned surveillance is according to the «NAAU Policy on surveillance and unplanned assessment of conformity assessment bodies accredited by NAAU» (GD-08.00.16) and approved monitoring plans by means of conduction surveillance for each quarter.

During surveillance central office and selected branches/sites are to be assessed but in such a way that the accreditation cycle covers all branches/sites.

For carrying out of surveillance NAAU appoints an assessment team and the applicant is informed about it.

In case requests of central executive authorities or demands of state supervising and law enforcement bodies are received regarding the necessity to consider revealed gross violations in CAB activities as stated in NAAU general document List of possible gross violations committed by accredited conformity assessment body (GD-08.00.35), NAAU reviews and analyses these materials and may make a decision without conducting an extra-ordinary on-site assessment provided that the aforementioned requests are supported by a sufficient amount of materials on gross violations facts necessary for review and decision-making.

In case requests of central executive authorities or demands of state supervising and law enforcement bodies are received regarding conducting extra-ordinary assessment of accredited CAB activities, due to the identified facts or information about committed gross violations according to the General Document of NAAU “List of possible gross violations committed by accredited conformity assessment body” (GD-08.00.35), that need additional on-site assessment, NAAU conducts monitoring by means of extraordinary assessment, as defined by the Procedure “Organization and carrying out of monitoring by means of conducting an extraordinary assessment” (P-08.00.19).

The number of extraordinary assessments of the CAB does not influence on the number and frequency of the scheduled assessments for the purpose of surveillance of the accredited CAB’s.

In case of ascertainment of facts of nonconformity to the accreditation criteria during the surveillance the assessor can demand implementation of corrective actions from CAB.

The maximum term of non-conformities removal after the surveillance is 1 month after assessment on site.

According to the results of surveillance, assessor draws up a report. The report shall contain recommendation about the possibility of the further activity of CAB or about the necessity of suspension or withdrawal of the CAB accreditation certificate or part its accreditation scope.

For the CABs, that are designated in the field of technical regulations, at the beginning of each year, information is collected on the following indicators:

-    number of performed conformity assessment activities (with the determination of the conformity assessment procedure);
-    number of withdrawn and suspended certificates;
-    number of personnel involved in conformity assessment activities;
-    established framework for conducting conformity assessment activities;
-    information about complaints and appeals.

Information received from the CAB is used by the accreditation departments for the certification and inspection bodies to plan the next monitoring by means of surveillance.

8.4 Extending or reducing accreditation scope

If CAB applies to extend the accreditation scope NAAU takes relevant measures to assess the competence of CAB according to the Procedure “Extending of accreditation scope of CAB” (P-08.00.18).

NAAU has a right to reduce the accreditation scope or if a CAB requests or violates accreditation requirements and does not meet the requirements for the competence in certain part of the accreditation scope. These processes are described in the Procedure “Reducing accreditation scope of CAB” (P-08.00.17).

The reason for limiting part of the scope of accreditation is the established facts of non-compliance of the CAB with the requirements of accreditation or the absence of a sustainable experience of the CAB in the area of accreditation in accordance with the general document of NAAU “Criteria for the sustainable experience of CAB” GD-08.00.19.

If CAB wishes to merge the works on extension of its accreditation scope with works on monitoring through surveillance by NAAU, for the timely preparation of NAAU CAB shall apply for extension of the accreditation scope to NAAU not later than three months before the start of work on surveillance. Otherwise, work on extension of its accreditation scope of CAB will be held at the next on-site assessment after the surveillance.

8.5 Suspending or withdrawing of CAB accreditation certificate or suspending part of its accreditation scope 

Suspending or withdrawing of CAB accreditation certificate or suspending part of its accreditation scope is conducted according to the Procedure “Suspending or withdrawing of CAB accreditation certificate or suspending part of its accreditation scope” (P-08.00.20).

In case of detection of gross violations made by CAB, decision to suspend CAB accreditation certificate or suspend part of its accreditation scope is valid no more than one year period.

In case of statement from accredited CAB to suspend CAB accreditation certificate or suspend part of its accreditation scope, decision operates not more than one year.

If the validity of the accreditation certificate is not renewed during the term indicated in a decision, then it is withdrawn. In case the part of an accreditation scope is not restored during period stated in the decision, the accreditation scope is reduced in in the part that was suspended. In case of withdrawal of accreditation certificate on other reasons than violations of requirements of law or standards, CAB may apply for accreditation by the procedure of initial accreditation,

After decision is made to suspend the CAB accreditation certificate or part of its scope, CAB is forbidden to perform works in the field of its activity with reference to the national sign of accreditation or ILAC MRA or IAF MLA combined mark and accreditation by NAAU.

Renewal of the CAB accreditation certificate or a part of its accreditation scope after its suspension is performed according to the Procedure “Suspending or withdrawing CAB accreditation certificate or part of its accreditation scope” (P- 08.00.20).

Withdrawal of the accreditation certificate is made at the same terms that suspension, if detected violations cannot be eliminated for the certain time interval or CAB did not take in time measures concerning non-admission of breach of Agreement with NAAU, and also if CAB fully stops its activity or stops activity in the accreditation scope.

Renewal of the accreditation certificate in case of withdrawal is impossible.

8.6 Order of alteration concerning accreditation granted to CABs

Order of alteration concerning accreditation granted to CABs is carried out according to the Procedure “Order of confirmation of conformity with requirements of accreditation in case of changes in accredited CAB and in accreditation scope” (P-08.00.02).

8.7 Order of conducting of CAB re-accreditation

Re-accreditation is conducted every five years.

With the purpose of conducting of re-accreditation CAB must give complete set of documents on paper and electronic media in a term, not later than 6 months to ending of the accreditation certificate validation.

If CAB did not appeal to NAAU with an application for re-accreditation within the specified period, procedure of assessment must be performed in accordance with the requirements of initial assessment.

In case of submitting an application for re-accreditation by CAB that had the withdrawn accreditation certificate the CAB must give additionally documented corrective actions about elimination of reasons on the basis of what the certificate was withdrawn.

Procedure of re-accreditation of laboratories is conducted according to the Procedure “Conducting of re-accreditation of laboratory (P-08.01.08), certification and inspection bodies – according to the Procedure of “Organization and conducting of re-accreditation of certification and inspection bodies (P-08.03.16).