Information about the technical service  

Registration-No:		
Date of assessment:		
Assessor:		

General

These requirements reflect the content of standards EN ISO/IEC 17025:2017 and EN ISO/IEC 17020:2012, including approval relevant requirements of the KBA to technical services (TS). 

The requirements apply to all locations and activities included in the designation.

EN ISO/IEC 17020:2012 is to be interpreted in the meaning as for technical services category B and D. The term “inspection” is synonymous for “supervision of tests” in this context. The term “test” covers also supervision of tests.

The requirements shall give an objective basis to the assessors for document review and assessment. At the same time, it is written evidence of the degree of compliance with requirements in the technical service. 

Handling

Unless otherwise stated, references given in column “Standard” refer to the respective paragraphs of EN ISO/IEC 17025:2017. Corresponding requirements of EN ISO/IEC 17020:2012 apply, if the technical service is/will be designated in categories B or D.

References given in the column “EU-Checklist Reg. (EU) 2018/858“ refer to numbers given in version 5 of the respective document.

In case of requirements marked in column ARR, approval relevant requirements of the KBA are relevant (if applicable, additionally to the standard/to the Regulation (EU) 2018/858). For the BVA/BTA procedures, only these requirements have to be commented and evaluated.

The following codes shall be used for findings:
	iO	-	no problems
	P	-	positive finding
	V	-	opportunity for improvement 
	N	-	minor non-conformity (with number of the Report of findings)
	H	-	major non-conformity (with number of the Report of findings)
	nb 	- 	not evaluated 
	nz 	- 	not applicable (reasons must be given, if not obvious from other information)

Findings P, V, N, and H shall be commented in the assessment report in a separate list in section “Summary”. Additional comments will be noted by the assessor in italic in column “Information of the TS/Notes by the assessor”.

The 3-digit codes and the numbering in column “E” are used for internal purposes only.

The Lead Assessor is responsible for the whole evaluation. If several assessors perform the assessment, the catalogue of requirements might be split. It must be guaranteed that finally one complete copy is available at the KBA. 

Abbreviations

ARR	Approval relevant requirements
-	Specification of the relevant EN ISO/IEC standards
-	Other requirements, resulting from designation rules 
-	Other requirements of the relevant regulatory acts 
-	Other approval relevant requirements of the KBA
BOA	Designation without accreditation 
(Benennung ohne Akkreditierung)
BTA	Designation with partial accreditation
(Benennung auf einer teilweisen Akkreditierung)
BVA	Designation based on full accreditation
(Benennung auf Basis einer vollständigen Akkreditierung)
E	Evaluation
ISGQ	Information system for quality of test reports 
	(Informationssystem Gutachten- (Prüfbericht-) Qualität)
IST	Type-approval procedure information collection
	(Informationssammlung Typgenehmigungsverfahren)
KBA	Kraftfahrt-Bundesamt
MS	Management system
QM	Quality management
TS	Technical Service

Further applicable documents

Checklist test/inspection procedures (A-2.9)
Checklist virtual testing (A-2.10)

Requirement	Standard	EU-Checklist
Reg. (EU) 2018/858	ARR	Information of the TS/
Notes by the assessor (italic)
(Reference to paragraphs of documents is possible)	E	
4	General requirements	
Impartiality	4.1	2.1.1			

PVA	1	
Independence
As far as this might influence its independence, the TS is independent regarding to designated activities. It is not involved in design, manufacturing, supply, maintenance of the object to be tested. 
(for EN ISO/IEC 17020 – Type A)	4.1.6
(17020)
	2.1.3
2.1.5
2.2.1
2.2.3
2.2.4	x		

P*A	2	
Confidentiality	4.2	2.1.2
3.0.1			

PVA	3	
In public
•	It is not given the impression that a not-designated fact is included in the designation
•	No misleading or unjustified statements are made regarding the designation
•	The reputation of the KBA or of the designation system is not damaged.			x		

P*A	4	
Logo and certificate as well as other references are used according to the designation rules.			x		

P*A	5	
In external communication, there is a clear differentiation between accreditation and designation (within the respective scope).			x		

P*A	6	
The TS carries out to an appropriate extent the activities for which it has been designated		2.1.7	x		P*A	7	
5	Structural requirements	
The TS is a legal entity, or a defined part of a legal entity.	5.1
	1.2
2.0.1
2.2.1	x		

P*A	8	
Liability insurance	5.1.4
(17020)
	2.0.2	x		

P*A	9	
The accreditation of the TS (only BTA/BVA) for the designated scope is still valid and complies with the designation rules.		2.2.2
2.4.2	x		P*A	10	
Management that has overall responsibility for the TS	5.2	2.0.3	x		

P*A	11	
The top management ensures that the ARR, in particular the requirements of the designation rules, are understood, put into practice and maintained within the entire TS.		1.7	x		

P*A	12	
The contact person for the KBA communicates effectively.			x		

P*A	13	
The TS takes the full responsibility for the work carried out in its designated branches.		3.1.2
3.1.4	x		

P*A	14	
Defined and documented scope of the laboratory activities. (branches, test procedure, particularity manufacturer laboratory)
The in-house TS supplies its services only to the manufacturer's company of which it forms part.	5.3	1.5
1.8
2.1.6
2.1.7
2.2.5	x		

P*A	15	
The TS meets the requirements of the standards, and the customers, and regulatory authorities (including designation body) in the whole scope and at all branches and test sites, which are essential for creating test reports in the approval procedure.	5.4	2.1.8
2.1.9	x		

P*A	16	
Definition of organisation, responsibility, authority, interrelationship; appropriate documentation of all processes	5.5	1.5
2.2.3
5.1	x		

P*A	17	
Personnel with appropriate authority and resources	5.6	1.3	x		

P*A	18	
Effective communication to fulfil all requirements (e.g. information, complaints, decisions of the KBA- and internal exchanges of experiences etc.).	5.7	2.2.3
4.0.2	x		

P*A	19	
Obligations regarding information to be given to the KBA are met.
This includes information in due time about
•	Changes that have consequences for the designation
•	Planned changes and modifications with reference to the basic accreditation/designation
•	Designations and relevant requests from approval and market surveillance authorities
•	Initiated administrative offences and criminal proceedings.

Upon request information is provided on activities regarding its designation.		1.6
4.0.3
4.1.1
4.1.3
4.1.4	x		

P*A	20	
The processes regarding the procedure for the examination of MS according to UN-R 155/156/ Regulation (EU) 2022/1426 (stipulations of KBA) and necessary witness audits are defined. The KBA (Dresden) is informed in due time, especially about
•	deadlines
•	reporting on granting and maintenance of certificates of conformity
•	Circumstances which have an effect on the validity of issued certificates of conformity			x		

P*A	79	
The integrity of the MS is maintained when changes to the MS are planned and implemented.	5.7	2.1.4			

PVA	21	
6	Resource requirements	
The TS has available or has access to the necessary personnel, facilities, equipment, system and support services to manage or perform its laboratory activities.	6.1	3.0.4
3.0.6	x		

P*C	22	
Personnel
•	Impartiality
•	Secrecy 
•	Competence
•	Observance of the QM-System	6.2	2.2.4
3.0.1			

PVD	23	
Requirements to the competence of the personnel are sufficiently defined, documented and implemented in accordance with the designation rules, annex 4
•	Management
•	Administrative personnel
•	Authorized signatories
•	Experts, testing personnel.		1.3
3.0.2
4.0.1
	x		

P*D	24	
Processes for
•	Duties, responsibilities and authorisation
•	Selection
•	Training
•	Formal authorisation
•	Maintenance of qualification
•	Monitoring
are established and effective in accordance with the designation rules, annex 4.		2.1.3
2.1.4
3.0.3
4.0.1	x		

P*D	25	
The requirements for employees of TS for auditing MS according to UN-R 155/156/Regulation (EU) 2022/1426 (stipulations of KBA) are sufficiently defined, documented and implemented in the TS, especially with regard to 
-	Duties, responsibilities, authorities
-	Contracts if applicable
-	Selection
-	Training
-	Formal authorization
-	Maintaining qualification (annual participation in a procedure and in an exchange of experience for respective experts) 
-	Monitoring			x		

P*D	80	
There is at least 1 authorized signatory available for each of the designated scopes. 			x		

P*D	26	
Additional requirements for achieving and maintaining the competence of authorized signatories in the area of competence I are met according to the stipulations of KBA.			x		

P*D	81	
Tests will only be carried out at test sites, which are conform to the requirements of EN ISO/
IEC 17025 and the applicable technical/ approval relevant regulatory acts. 
The requirements are documented and implemented, the environmental conditions are recorded (applicable also for external test sites).	6.3	1.5
3.1.3
3.1.6
4.5.1	x		

P*C	27	
Equipment
•	Access
•	Suitability
•	Compliance with the requirements
•	Transport, storage, use
•	Maintenance
•	Calibration
•	Records, …	6.4	3.0.7	x		

P*C	28	
Classification of designated test procedures in category A is (still) justified.		1.5
1.6
3.0.7	x		

P*C	29	
Sufficient legally enforceable agreements with legally independent branches and external test sites exist, which ensure the application of the QM system and of ARR. 		2.1.8
3.1.5	x		

P*C	30	
Documented metrological traceability
•	Process of traceability
•	Acceptance criteria
•	Labelling
•	Action in case of negative results, …	6.5	4.2.7	x		

P*C	31	
Externally provided products and services
•	Requirements
•	Suitability
•	Records
•	If applicable necessary actions, …	6.6	1.5
4.0.4			

PVC	32	
The TS has the necessary access to the documentation of the object to be tested (including Software).
The integrity of the used hardware and software is guaranteed.		3.0.5	x		

P*C	33	
7	Process requirements	
Review of requests, tenders and contracts	7.1				

PVC	34	
There are sufficient contractual arrangements between TS and manufacturer for examination of MS according to UN-R 155/156/ Regulation (EU) 2022/1426 (stipulations of KBA)
-	Access control
-	Information requirements
-	Handling of confidential information
-	Communication channel
-	Use, retention and exchange of documents			x		

P*C	82	
The testing is done in general himself. Only in exceptional justified cases subcontracting in accordance with EN ISO/IEC 17025 is done. The justification shall be documented. 
The TS assess the contractor and the test result with the required competence.		3.1.1
3.1.3
3.1.5
3.1.6	x		

P*C	35	
Selection of methods. 
Changes to the procedure are verified and validated. They are recorded.	7.2				

PVC	36	
Clear and adequate test instructions for the specific conditions at the test site (including external test sites) exist for all designated test procedures. 
(The specification given in the regulatory act might be sufficient in individual cases.)		4.0.1
4.2.2
4.2.6	x		

P*C	37	
Supervising of tests is sufficiently described and ensures the required quality of the test results.		4.0.1
4.5.2	x		

P*C	38	
For the process of auditing MS according to UN-R 155/156/ Regulation (EU) 2022/1426, all requirements (stipulations of KBA) are implemented in the audit process, such as
-	Evaluation of the submitted documents
-	Planning of the audit (audit program, audit time, selection of personnel, pre-audit)
-	Audit execution
-	Audit report (records, classification of findings)
-	Certificate recommendation 
-	Retention requirements			x		

P*C	83	
“Virtual testing” is used only if the designation for virtual test methods has explicitly been granted and a validation released by the KBA is available for the respective test method		1.4
4.0.1
	x		

P*C	39	
The required test conditions are known and fulfilled.		4.0.1
4.2.5	x		

P*C	41	
Test procedures are properly carried out and recorded.		4.0.1
	x		

P*C	42	
The selection of the worst case can be traced in the records of the TS.		4.2.3	x		

P*C	43	
Sampling	7.3	4.2.3
4.5.3	x		

P*C	44	
Handling of test items:
•	Labelling
•	Records
•	Retention period	7.4	4.2.6
4.5.3	x		

P*C	45	
Technical records:
•	Unambiguous
•	Complete
•	Ensure the reproducibility 
of the test	7.5	4.2.4
4.5.4	x		

P*C	46	
The measurement uncertainty is known, optimized and accepted for all test conditions and sites:
•	Is state of the art
•	Will not be taken into consideration for evaluation of test results	7.6	4.2.5	x		

P*C	47	
Ensuring the validity of results	7.7	4.2.1			

PVC	48	
Test data of other laboratories is only used in exceptional justified cases according to the designation rules, annex 6. The justification shall be documented.			x		

P*C	49	
Quality of test results is sufficiently guaranteed (e.g. periodical internal evaluation and risk analysis, round robin tests, comparison tests etc.).		4.2.1	x		

P*C	50	
Reporting of results	7.8	4.0.5			

PVC	51	
Test reports meet the requirements according to the rules of designation, annex 5; KBA specifications and interpretations are observed (e.g. test report templates).		4.0.5	x		

P*C	52	
In any case, test reports are signed by authorized persons, who have carried out or supervised the test. There is an appropriate documentation of the proceeding in the TS.			x		

P*C	53	
Audit reports for examination of MS according to UN-R 155/156/ Regulation (EU) 2022/1426 comply with the requirements of the stipulations of KBA.			x		

P*C	84	
Complaints
documented procedure, publicly available on request	7.9	4.0.2
4.0.7			

PVA	54	
Nonconforming work
•	Records
•	Incorrect test reports are recalled: all affected parties are made aware of possible consequences using the incorrect data
•	Corrective actions	7.10	4.0.6
4.1.2	x		

P*A	55	
The requirements of the KBA for the exchange of test reports and parts thereof are observed.		4.0.6	x		

P*C	56	
ISGQ results and other (internal and external) quality data are evaluated promptly, if necessary corrective actions are derived.			x		

P*C	57	
Control of data and information management	7.11	3.0.5			

PVB	58	
Ensuring the functional security and capability of software configurations and data interfaces.			x		

P*C	85	
Ensuring information security
•	Protection against unauthorized access
•	Manipulation and data loss (data integrity)			x		

P*C	86	
8	Management system requirements	
The management system is
•	Appropriate
•	Efficient
•	Effective
•	Documented	8.1	5.2			

PVB	59	
The management system is capable to meet the ARR at any time at all branches and test sites that are essential for the quality of test reports in the approval procedure.		1.7
5,2	x		

P*B	60	
Management system documentation 	8.2	5.1
5.2
5.3			

PVB	61	
The manual or related documents address all requirements of the designation rules.		1.9	x		

P*B	62	
The processes will be updated according to the latest designation rules and approval relevant requirements; all available sources of information will reasonably be used (obtaining this information is a duty of the TS). The transparency and repeatability of the procedures have been demonstrated.		5.2	x		

P*B	63	
Control of 
•	Management system documents
•	External documents
•	Information to/of the KBA	8.3	5.3	x		

P*B	64	
Control of records	8.4	5.3	x		

P*B	65	
KBA recommendations regarding retention periods are applied.			x		

P*B	66	
Actions to address risks and opportunities	8.5	5.4			

PVA	67	
Analyses of risks and opportunities are performed, and the necessary conclusions are implemented relating to:

•	Impartiality
•	Personnel (qualification and maintenance of competence)
•	Control of approval relevant documents/information/records (IST, information sheets, test data, …)
•	Information management (TS-manufacturer-KBA)
•	Test quality
•	New or modified methods
•	New or modified software/ equipment
•	Virtual testing, …		2.1.1
5.4	x		

P*A	68	
Risk analyses are regularly updated. In case of modified frame conditions, new facts, non-conformities etc., they are updated.		5.4	x		

P*A	69	
Improvement	8.6	5.5			

PVA	70	
Regular active participation in the exchanges of experiences, trainings, and workshops organised by the KBA. Information, hints or complaints provided by the KBA are analysed for improvement. Necessary actions are implemented. 		5.5	x		

P*A	71	
Corrective actions	8.7	4.1.5			

PVA	72	
Reports of findings and opportunities for improvement shown in the last assessment have adequately been processed. Corrective actions are suitable, comprehensive and effective.			x		

P*A	73	
Internal Audits	8.8	5.6			

PVA	74	
Internal audits of the QM system and the test procedures are carried out at appropriate intervals. Fulfilment of ARR is adequately assessed in internal audits (within the complete scope, including external test sites).		3.1.6
5.6	x		

P*A	75	
Management reviews	8.9	5.7			

PVA	76	
At least once every twelve months, the fulfilment of the obligations of the designation rules, the compliance with the approval requirements and the quality of testing is reviewed by the management.		5.7	x		

P*A	77	
9	Miscellaneous	P*S	78