Accreditation procedure
Management Manual (extract)
8.1. General provisions
8.1.1. This Order specifies the procedure for accreditation of conformity assessment bodies (hereinafter - CABs). 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 accreditation.
8.1.2. NAAU shall provide interested parties with information concerning:
a) lists of documents, which determined the requirements of accreditation for CABs;
b) cost of accreditation works;
c) a procedure of complaints and appeals processing;
d) lists of the accredited CABs;
e) other documents concerning the accreditation process.
This information is maintained in actual condition, and is accessible on NAAU web-site.
8.1.3. Accreditation of CABs, according to the determined accreditation scope, can be carried out according to the requirements of such normative documents:
a) testing and calibrating laboratory - ÄÑÒÓ ²SO/²EC 17025-2006;
b) certification body for products, processes and services - ÄÑÒÓ EN 45011-2001;
c) certification body for management systems - ISO/IEC 17021:2006;
d) certification body for persons - ISO/IEC 17024:2003;
e) inspection body - ÄÑÒÓ ISO/IEC 17020-2001.
During accreditation NAAU follows recommendations of international (ILAC and IAF) and regional (EA) accreditation organizations.
8.1.4. NAAU can assess the CAB compliance with additional requirements in relevant sectors of economy.
8.1.5. In the case of CAB-applicant refusal to pay money and/or to make agreement for accreditation works in definite terms, NAAU has a right to annul an application and to cease subsequent accreditation works.
8.1.6. In the case of organizational changes in the accredited CAB and separation of a part of the CAB as an independent legal entity, accreditation of the newly established CAB is conducted excluding the stage of document review. In the case of positive decision according assessment on-site results the CAB is granted a new accreditation.
8.2. Accreditation procedure
8.2.1. Submission of the CAB application for accreditation or extending accreditation
NAAU gives the list and the forms of documents necessary for accreditation or information concerning placement of it in mass media according to the procedure “Preparation and rendering of informational services” (P-08.08.04).
The applicant submits an application for accreditation or extending accreditation to NAAU according to the form “Application for the CAB accreditation” (F-08.00.02) and a set of documents according to the form “List of documents enclosed to the application” (F-08.xx.03). Provided that the applicant intends to be accredited in compliance with several standards, according to the p.8.1.3, it should submit separate applications.
NAAU registers the application, analyzes its accuracy and completeness according to the procedure “Reception, incoming inspection, registration of application” (P-08.08.03).
8.2.2. Review of document set enclosed to the application
NAAU checks completeness of materials added to the application according to the procedure “Review of document set enclosed to the application” (P-08.08.05). In case of wrong filling of the application or insufficiency of given information in documents the applicant has to update the given set of documents. Documents update period shall not exceed 120 days. If the update period exceeds 120 days the application is annulled.
According to the consent of the parties, NAAU can conduct a preliminary assessment of the applicant to determine his readiness for assessment according to the procedure “Carrying out of preliminary assessment” (P-08.XX.10). Maximum number of preliminary assessments may be two. During preliminary assessment an assessor shall avoid any kind of consultancy.
8.2.3. Forming an assessment team and informing the applicant
The accreditation body appoints an assessment team (hereinafter- team), which will carry out the assessment of the applicant. If necessary, experts can be included in the team according to the procedure “Forming an assessment team and informing the applicant” (P-08.08.07). If the CAB applies to NAAU for the first time, the assessment team consists at least of two persons.
The applicant is informed about membership of the assessment team beforehand according to the procedure “Forming assessment team and informing applicant” (P-08.08.07).
Drawing up, checking up and signing of a Contract is carried out according to the procedure “The order of work with contracts” (P-08.08.06).
NAAU draws up and submits the assessment program to the appointed team (F-08.xx.07).
8.2.4. Review of supplied records and documents
The appointed assessment team analyses given records and documents according to the procedures “Review of documents and records supplied by the applicant-laboratory” (P-08.01.09) and “Review of documents and records supplied by the applicant (certification/ inspection body)” (P-08.03.11).
The outcomes of review are sent to the applicant.
In case of positive results, accreditation works proceed and the on-site assessment of the applicant is conducted.
In case of negative results, the documents are sent back to the applicant for updating. Document update period shall not exceed 3 months. After updating the applicant sends the documents for repeated review according to a new Contract. If updating period exceeds 3 months the application is canceled.
8.2.5. Drawing up the assessment program and informing the applicant
NAAU draws up the assessment program (F-08.xx.26). NAAU informs the applicant, who shall inform NAAU in written form about agreement (or disagreement) with the program.
The Chairman of NAAU or Deputy Chairman of NAAU approves the coordinated assessment program.
8.2.6. On-site assessment
The assessment team follows the assessment program and conducts an assessment on site according to the procedures “Carrying out on-site assessment of laboratory” (P-08.01.14) and “Carrying out on-site assessment of certification /inspection body y” (P-08.03.15).
On-site assessment of the applicant consists of such main stages:
- preliminary meeting with the applicant management;
- gathering objective evidences concerning the compliance of the applicant with the requirements for accreditation;
- analysis of collected findings and determination conformity (nonconformity) of the applicant to the requirements for accreditation;
- final meeting with the applicant management concluding discussion of assessment results, drawing up and signing the meeting protocol defining a term of elimination of the revealed nonconformities;
If the CAB has subsidiaries, the central office and all subsidiaries are to be assessed during the first accreditation.
8.2.7. Analysis of findings, drawing up assessment reports and statement
The assessment team gathers all findings during the assessment and analyses them according to the procedures “Carrying out 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 outcome analysis the lead assessor draws up an assessment statement including recommendations concerning accreditation or refusal thereof using the form “On-site assessment statement” (F-08.xx.28). The assessment statement together with the necessary document set is sent to NAAU. Thus the CAB in a term of three months must implement correcting actions to resolve nonconformities and give proper information to NAAU. In case if the CAB in a term of three months did not give to NAAU proper information an application may be annulled.
In case of necessity NAAU can conduct complete or partial reassessment, having informed the applicant in advance.
8.2.8. Evaluation of accreditation work results, giving recommendations and decision making on accreditation of the CAB
In case of necessity NAAU can make the request to Technical Accreditation Committee (TAC) for consideration of assessment results (necessity can be in case of different interpretations etc)
For giving recommendations concerning granting accreditation, a relevant sub-committee of TAC appoints a specialist in a proper sphere, who is a member of this sub-committee to carry out such work. This specialist shall obligatory fill in “Declaration on confidentiality” (F-08.00.32). Evaluation of assessment results is carried out in the office of NAAU, and the representative of sub-committee has access to the accreditation file. Recommendation concerning granting accreditation is giving according to the form F-08.00.14. If accreditation scope of the CAB is in the competence of several subcommittees, then representatives of all subcommittees are appointed to carry out such activity.
The Chairman of NAAU makes a decision concerning granting accreditation according to the form “Decision on accreditation of the CAB” (F-08.00.30) on receipt of the assessment statement, document set and recommendation of TAC. The Deputy Chairman, the management system manager, a chief of corresponding department and a responsible executor are involved in the process of decision-making.
In case of making decision about granting accreditation of the CAB, NAAU issues an accreditation certificate with period of validity to three years, and all information about the CAB is registered according to the instruction “Preparation of accreditation certificate and its recording in the Register” (IH-08.08.02), after that the CAB gets the accreditation certificate. NAAU and the CAB conclude Contract (F-08.xx.27), which contains rights and responsibilities of the accredited CAB and NAAU.
The certificate of accreditation is issued in Ukrainian. After writing the CAB demand, an accreditation certificate duplicate can be additionally issued in a foreign language (English or Russian). The accreditation certificate in a foreign language can be issued both simultaneously with granting accreditation, and during its validation. The term of validation of a duplicate in a foreign language equals the term of validation of the accreditation certificate, issued in Ukrainian, and is issued after the same number.
Provided that accreditation is refused, the notification, where all reasons for accreditation refusal are indicated, shall be sent (given) to the applicant in written form.
8.3. Surveillance after the accredited CAB
NAAU carries out planned surveillances of the accredited CABs according to the procedures “Organization and carrying out surveillance of the accredited laboratory” (P-08.01.12) and “Organization and carrying out of surveillance of the accredited certification/inspection bodies” (P-08.03.13). The terms of conducting planned surveillance on-site assessments are determined by Agreement between NAAU and the CAB (F-08.xx.27) and are usually 12 and 24 months from the date of issue of accreditation certificate.
During the surveillance on-site assessment the central office and one or several branch offices are to be assessed but in such a way to cover all branches within the accreditation validity period.
For carrying out the surveillance NAAU appoints an assessor (assessment team). The CAB is informed about the assessment team membership.
In case of obtaining valid information about nonconformance of the accredited CAB with the accreditation requirements, NAAU carries out an unplanned surveillance.
The number of unplanned surveillances of the CAB does not influence on the number and periodicity of the planned surveillances.
In case of revealing evidences for nonconformity with the accreditation requirements during surveillance the assessor to have a right to demand of the CAB to implement corrective actions.
The maximum term of non-conformities removal after the surveillance is 1 month after assessment on site end.
According to the results of the surveillance on-site assessment, an assessor draws up report according to the form determined by NAAU. The statement of surveillance on-site assessment shall contain recommendation on possibility of further CAB activity or necessity of suspension or withdrawal of the accreditation. A maximum term on which action of accreditation can be suspended is one year, whereupon accreditation is withdrew.
8.4. Extending or reducing accreditation
If the CAB applies to an extension of the accreditation scope NAAU takes relevant measures to assess the competence of the CAB.
NAAU has a right to reduce the scope of accreditation on CAB’s request or if the CAB regularly violates the accreditation requirements and does not meet the requirements for the competence in this part of the scope of accreditation. These processes are described in the procedures “Reducing accreditation of the CAB” (P-08.00.17) and “Extending accreditation of the CAB” (P-08.00.18).
8.5. Suspending or withdrawing accreditation
In case of CAB’s voluntary request, violation of the Contract between NAAU and the CAB (F-08.xx.27) or non-compliance of this order, according to the procedure “Suspending or withdrawing of the accreditation certificate” (P-08.00.20) NAAU:
- suspends accreditation;
- withdraws accreditation.
The Chairman of NAAU or the Deputy Chairman of NAAU makes a decision on suspension or withdrawal of accreditation on basis of the surveillance results.
The decision on suspension or withdrawal of accreditation is drawn up according to the form established by NAAU (F-08.00.31) and is directed to the CAB and other interested parties.
In case of suspension of accreditation, the CAB must develop corrective actions to eliminate the revealed nonconformities. The decision on suspension is taken, if the CAB can eliminate revealed nonconformities on term that does not exceed 30 days. Otherwise accreditation will be withdrawn. After implementation of corrective actions by the CAB, NAAU assess their performance and, in case of positive results, makes decision on renewal of accreditation.
In case of withdrawal of accreditation the CAB is marked in the register such as the CAB with invalid accreditation. After decision-making on suspension of accreditation, it is prohibited for the CAB to carry out its activity refering to the national accreditation mark.
In case of withdrawal of accreditation the CAB is obliged to return the accreditation certificate to NAAU.
8.6 Order of alteration relevant to accreditation granted to the CAB
Order of alteration in accreditation granted to the CAB is carried out according to the procedure “The order of alteration relevant to CAB accreditation” (P-08.00.02).
8.7 Order of conducting of reassessment of the CAB
With the purpose of conducting of reassessment the CAB must submit complete set of documents on paper and electronic media in a term, not later than 6 months to ending of accreditation validation.
Procedure of reassessment of laboratories is performed according to the procedure “Conducting of reassessment of laboratory” (P-08.01.08), certification and inspection bodies - according to the procedure of “Conducting of reassessment of certification and inspection bodies” (P-08.03.16).