Information about the technical service

Registration number:		
Date of assessment:		
Assessor:		

General

These requirements reflect the content of standard EN ISO/IEC 17021-1:2015 as well as approval relevant requirements (ARR) of the KBA to technical services (TS) as far as they are relevant for an office assessment. Parts of the requirements of the standard and Designation rules are only presented in a separated questionnaire for monitoring audit activities.

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

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 17021-1:2015. Some of the requirements of the standard have been shortened. The text of the standard is binding.
Terms like “certification”, “certificate“, etc. refer to an attestation of compliance with ARR. 

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 are relevant (if applicable, additionally to the standard). For the BVA procedures, only these requirements have to be commented and evaluated.

The following codes shall be used for findings:

	iO	- 	no problems
	P	-	best practice 
	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 data)

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 of the KBA 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 ISO/IEC 17021-1:2015
-	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)
BVA	Designation based on full accreditation
(Benennung auf Basis einer vollständigen Akkreditierung)
CoP	Conformity of Production (product and system related)
E	Evaluation
IS-CoP	Information system Conformity of Production
KBA	Kraftfahrt-Bundesamt
MS	Management system
QM	Quality management
TS	Technical Service

Further applicable documents

Checklist for the assessment of audit procedures (A-2.8)

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	
5 General Requirements		
5.1 Legal and contractual matters	
Legal entity, legally enforceable agreement.	5.1.1	1.2
2.0.1			

ZVA	1	
A legally enforceable agreement with the client exists allowing the attendance of KBA staff in audits.	5.1.2	2.0.1	x		

Z*A	2	
The TS shall be responsible for the work carried out at its designated sites and for its decisions relating to certification.	5.1.3	2.3.1	x		

Z*A	3	
The accreditation of the TS (BVA) in the designated scope is still valid and complies with the designation rules		2.2.2
2.4.2	x		

Z*A	135	
5.2 Management of impartiality	
The TS guarantees the impartiality of its conformity assessment activities and does not allow commercial, financial or other pressures to compromise impartiality.	5.2.1	2.1.1

ZVA	4	
A commitment of the top level to impartiality exists.	5.2.2	2.1.2			

ZVA	5	
A process exists for the ongoing identification and analysis of conflicts of interests (risk analysis).	5.2.3	2.1.1
2.1.3
5.4			

ZVA	6	
The risk assessment process shall include identification of and consultation with appropriate interested parties (balanced with no single interest predominating).	5.2.3	2.1.1
2.1.3
2.1.5			

ZVA	7	
The TS shall not certify another TS for its quality management system.	5.2.4				

ZVA	8	
Neither the TS nor any related to it body offer or provide management system consultancy.	5.2.5	2.1.5
2.3.3			

ZVA	9	
Neither the TS nor any related to it body offer or provide internal audit to its certified clients.	5.2.6	2.1.5
2.3.4			

ZVA	10	
Impartiality of internal and external personnel is guaranteed. The TS requires from internal and external personnel to reveal any conflict of interests.	5.2.12	2.1.5	x		

Z*A	11	
The TS reacts adequately on threats to its impartiality.	5.2.13	2.1.1			

ZVA	12	
5.3 Liability and financing	
Liability and financing
-	Evaluation of finance and sources of income
-	Risk analysis
-	Adequate arrangements (e.g. insurance or reserves)	5.3.1	2.0.2
5.4	x		

Z*A	13	
The TS shall demonstrate that commercial, financial or other pressures do not compromise its impartiality.	5.3.2	2.1.3			

ZVA	14	
6 Structural requirements (6)		
6.1 Organizational structure and top management	
Organizational structure, duties, responsibilities and authorities for all certification personnel and all committees are clearly defined and documented (if applicable, also towards higher organizational units).	6.1.1	1.3
1.5
5.1	x		

Z*A	15	
All branches within the meaning of the KBA Designation rules are reported to the KBA.		1.5	x		

Z*A	16	
The person responsible for ARR and the contact person for the KBA are nominated and competent. They communicate effectively		2.0.3	x		

Z*A	17	
Certification activities are structured and managed so as to safeguard impartiality.	6.1.2	2.1.1			
ZVA	18	
Formal rules exist on the appointment, terms of reference and operation of any committees involved in the certification activities.	6.1.4	5.1	x		

Z*A	19	
6.2 Operational control	
The TS has a process for the effective control of certification activities (including ARR) based on a risk analysis.	6.2.1	5.4
	x		

Z*A	20	
The TS has appropriate processes to control activities, processes, competence of personnel, lines of control, etc..	6.2.2		x		

Z*A	21	
7 Resource requirements		
7.1 Competence of personnel	
The TS has processes to ensure that personnel have appropriate knowledge, abilities and skills relevant to MS, ARR and geographic areas in which they operate.	7.1.1	1.3
4.0.1	x		

Z*D	22	
The required competence, competence criteria and means of demonstrating competence are defined, documented and implemented for all personnel (Designation rules, Annex 3).	7.1.2	4.0.1	x		

Z*D	23	
The TS has a documented process for the initial and ongoing evaluation of competence and performance of all personnel applying the defined competence criteria 
(designation rules, Annex 3).	7.1.3	4.0.1	x		

Z*D	24	
The TS has access to the necessary technical expertise and applies it.	7.1.4	3.0.6			

ZVD	25	
Representatives of the TS regularly take part in the exchange of experience as well as in KBA trainings and workshops. An evaluation takes place in the TS. (Designation rules, Annex 3)			x		

Z*D	26	
The personnel know the relevant stipulations of the type approval department and applies them.			x		

Z*D	27	
7.2 Personnel involved in the certification activities	
The TS has access to a sufficient number of personnel, which is competent for managing audit programs and other certification activities.
The minimum requirements for personnel according to the Designation rules, Annex 3 are met.	7.2.1	3.0.2
3.0.4
3.0.6	x		

Z*D	28	
Duties, responsibilities and authorities are made clear to each person concerned.	7.2.3	2.1.43.0.2	x		

Z*D	29	
The TS has defined processes for
•	Selection, training, formal authorization and monitoring of auditors
•	Selecting and briefing of technical experts.	7.2.4	3.0.2
4.0.1	x		

Z*D	30	
The TS has a process to achieve and demonstrate effective auditing.	7.2.5	3.0.2	x		

Z*D	31	
The TS ensures that auditors and technical experts (including external) know audit processes, certification requirements (in particular regarding ARR and technical regulatory acts), and other relevant requirements. Access to an up-to-date set of relevant documents is organized.	7.2.6	3.0.2
4.2.2	x		

Z*D	32	
For the entire personnel involved in certification activities, the TS identifies training needs and offers respective trainings (including ARR). 
ARR auditors are specifically (internally) trained at least once per year regarding ARR or rather take part in an exchange of experience regarding ARR.	7.2.7	3.0.2	x		

Z*D	33	
Auditors for ARR have a valid proof of a KBA-approved ARR-training within not more than the previous 60 months.		3.0.2	x		

Z*D	34	
Decisions taking committees understand the applicable standard and certification requirements (including ARR). They are competent to evaluate the audit processes and recommendations of the audit team. Decision taking persons are authorized as ARR auditors (alternatively the statement of the Veto-person must be accepted). Competence has been demonstrated.	7.2.8	3.0.2	x		

Z*D	35	
There is a documented process for monitoring and measuring competence and performance of all persons involved in certification activities (especially auditors). Procedures include:
-	On-site evaluation (including ARR scope)
-	Review of audit documentation
-	Feedback from clients and from the market.
Related training needs are identified.
The frequency of on-site-evaluations of auditors is based on all available information and a risk analysis.	7.2.9
7.2.10	2.1.43.0.2	x		

Z*D	36	
7.3 Use of individual external auditors and external technical experts	
A written commitment is required from each external auditor or technical expert where they commit to confidentiality, impartiality and information to the TS about all existing or previous links with organisations for which contracts may be awarded. 	7.3	2.1.2
2.1.3
3.0.1	x		

Z*D	37	
7.4 Personnel records	
The TS has up-to-date personnel records (including ARR).	7.4	2.1.4	x		

Z*D	38	
7.5 Outsourcing of certification activities	
ARR activities are subcontracted only in exceptional cases and with the prior consent for the individual case of the KBA. 		3.1.1
3.1.5
4.3	x		

Z*A	39	
A legally enforceable agreement exists with each body that provides outsourced services on the performance of the services, confidentiality and prevention of conflicts of interest.	7.5.1	2.1.2
3.1.2			

ZVA	40	
Decisions of certification are not outsourced.	7.5.2	2.3.5			
ZVA	41	
The TS takes responsibility for all outsourced activities and for compliance of subcontractors with the requirements of EN ISO/IEC 17021-1.	7.5.3	3.1.4	x		

Z*A	42	
A process is installed for the approval and monitoring of all bodies that provide outsourced services.	7.5.4	3.1.3
3.1.6			

ZVA	43	
8 Information requirements	
8.1 Public information	
The TS maintains and makes public, without request, accessible information according to 8.1.1 in all geographical areas in which it operates.
The TS provides information according to 8.1.2 on request.
Note:
The information should, but not has to, explain the specific of each certification scope (including ARR). The specific of the ARR certification process has to be explained in adequate form at least upon request.	8.1.1
8.1.2	2.1.6
4.3.1
4.3.2	x		

Z*A	44	
The information provided to clients and market including advertisement is accurate and not misleading.	8.1.3		x		

Z*A	45	
In public
-	It is not given the impression that a not-designated issue 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
-	The correct perception of the KBA type-approval procedure is ensured.		2.1.6	x		

Z*A	46	
Logo and certificate as well as other references to the designation are used according to the KBA Designation rules.			x		

Z*A	47	
In external communication, there is a clear differentiation between accreditation and designation.			x		

Z*A	48	
Processes are installed ensuring that the KBA (Dresden) is informed in accordance with the Designation rules in due time, in particular regarding:
-	Granting, suspending, reducing, withdrawing of ARR Attestations
-	Insufficient fulfilment of ARR by the client
-	Changes that have consequences for the designation
-	Planned changes and modifications with reference to the basic accreditation/designation
-	Designations and relevant inquiries from other approval authorities or market surveillance authorities (reply with copy to the KBA)
-	Administrative offences and criminal proceedings initiated
-	Activities under the designation, including cross-border activities (on request)
-	The inventory of procedures under KBA designation at least annually on 30 June and 31 December.		1.6
2.1.7
2.4.2
4.0.3
4.1.1
4.1.34.1.4	x		

Z*A	49	
8.2 Certification Documents	
The TS provides certification documents to the client which contain information according to 8.2.2.	8.2.2	4.3.2			

ZVC	50	
A potentially issued attestation about fulfilment of ARR includes:
-	Information according to Designation rules, Annex 2
-	A clear description of the scope regarding approval objects.			x		

Z*C	51	
Only approval objects (groups of approval objects) which have been audited are listed in the Attestation and the Report on CoP.			x		

Z*C	52	
8.3 Reference to certification and use of marks	
Rules exist governing certification marks that it authorizes certified clients to use. The certification marks are unique and traceable.	8.3.1	4.3.3	x		

ZVA	53	
The use of marks of the TS by clients on laboratory test, calibration or inspection reports or certificates is not permitted.	8.3.2	4.3.3			

ZVA	54	
Permissible statements with regard to a certified management system on packaging and information accompanying products (not on type or identification plates) are specified.	8.3.3	4.3.3	x		

Z*A	55	
Legally enforceable arrangements exist ensuring the fulfilment of the requirements according to 8.3.4 by the client.	8.3.4	4.3.3	x		

Z*A	56	
8.4 Confidentiality 	
All information about clients will be treated confidentially. Legally enforceable agreements exist to ensure the confidentiality of information.	8.4.1	2.1.2
3.0.1
4.3.4	x		

Z*A	57	
The TS informs the client in advance about the information it intends to place in the public domain.	8.4.2	4.3.4	x		

ZVA	58	
Information about certified clients is not disclosed to a third party without the written consent of the client, except this is required in EN ISO/IEC 17021-1 or the Designation rules.	8.4.3	3.0.1
4.3.4	x		

Z*A	59	
When the TS is required by law or authorized by contractual arrangements to release confidential information, the client concerned shall (unless prohibited by law) be notified of the information provided.	8.4.4	3.0.1
4.3.4	x		

Z*A	60	
The TS has and uses processes, equipment and facilities that ensure the secure handling of confidential information.	8.4.7	4.3.4			

ZVA	61	
8.5 Information exchange between a certification body and its clients	
The TS provides information about the procedures according to 8.5.1 to the customer in an up-to-date form.	8.5.1	4.0.2
4.3.5			

ZVA	62	
Clients get due notice of any changes to the requirements of the TS. The certification body shall verify that each certified client complies with the new requirements. 	8.5.2	4.0.2
4.3.5	x		

Z*A	63	
The client will be informed about rights and duties of an approval holder and of the KBA. He will be informed that they are valid independently of certification.		4.3.5	x		

Z*A	64	
The client will be informed that the KBA is authorized to request for audit reports, quality records and other documents relevant for the type approval procedure.		4.3.4
4.3.5	x		

Z*A	65	
The TS has legally enforceable arrangements to ensure that the certified client informs the TS, without delay, of matters that may affect the certification. 	8.5.3	3.0.5
4.0.2
4.3.4
4.3.5	x		

ZVA	66	
9 Process requirements	
9.1 Pre-certification activities	
During the application stage, the TS requires all necessary information according to 9.1.1. and about possibly existing approval objects (if applicable whose application is intended).	9.1.1	3.0.5
4.4.1	x		

Z*C	67	
Prior to the audit, the TS reviews the application in accordance with 9.1.2 and ARR.
If the application is declined, the reasons shall be documented and made clear to the client.	9.1.2	4.4.1	x		

Z*C	68	
The necessary competence (including ARR) of the audit team and of decision taking persons is determined.		4.4.1
4.4.2	x		

Z*C	69	
An audit program according to 9.1.3.2 exists for the full certification cycle. It considers, based on a risk analysis, the specifics of the client and ARR. All (groups of) approval objects, which have to be audited, are covered.	9.1.3	4.4.1
	x		

Z*C	70	
Surveillance audits are conducted at least once a calendar year (except years with re-audits). The first surveillance audit following initial certification is realized not later than 12 months from the certification decision date.	9.1.3				

ZVC	71	
If other certifications are to be taken into account, sufficient evidence for fulfilment of the requirements of EN ISO IEC 17021-1 and ARR shall be obtained and retained (i.e. corrective actions concerning previous non-conformities). Adjustments to the existing audit program shall be justified and recorded.
ARR attestations and particular information out of these procedures are accepted only from such TSs which are designated by the KBA.	9.1.3	4.0.44.4.1	x		

Z*C	72	
Where the client operates in shifts, several shifts are audited if this is necessary to cover all relevant activities (including ARR).	9.1.3	4.4.1	x		

Z*C	73	
The procedure for the determination of audit time is documented. A complete and effective audit is guaranteed under consideration Designation rules, Annex 2 and standards.
The audit time and its justification are recorded.	9.1.4	4.4.1	x		

Z*C	74	
The Report on CoP will be completed at least during one certification period; all relevant areas/processes, all relevant sites and groups of approval objects (if possible all approval objects) are included.			x		

Z*C	75	
9.2 Planning audits	
Audit objectives, scope and criteria are defined by the TS.
When planning and implementing certification measures, the Designation rules, Annex 2, are observed.	9.2.1	4.4.2	x		

Z*C	76	
The note to 9.2.1.2. is not seen as relevant in ARR audits for requirements arising from the KBA type approval procedure.		2.1.9	x		

Z*C	77	
The audit scope describes the extent and boundaries of the audit. Where the initial or re-certification process consists of more than one audit, the totality of audits is consistent with the scope in the certification document.	9.2.1	4.4.2	x		

Z*C	78	
A process for selecting and appointing a competent audit team exists.
The competence regarding ARR is sufficiently given (min. 1 ARR auditor).	9.2.2	4.4.2	x		

Z*C	79	
An audit plan is established for each audit. 
The audit plan includes at least the requirements of the standard and the ARR aspects for departments/ processes to be audited	9.2.3	4.4.2	x		

Z*C	80	
The audit must be based on the result of an analysis of the risks relating to
-	Critical or approval relevant product and system properties
-	Process parameters
-	Fulfilment of specific requirements of legal act, approval, ARR
The audit must be planned process-oriented as well as specifically for the company and the approval objects.			x		

Z*C	81	
Additionally, to the systematic evaluation of the QM system, the audit on the client’s premises covers at least for the chosen samples the check if approval data (not only such data which relates directly to the product) are up-to-date.
It includes also the assessment if applicable legislative documents are 
up-to-date and available.			x		

Z*C	82	
The tasks given to the audit team are clearly defined and are communicated to the client.	9.2.3	4.4.2			

ZVC	83	
The audit plan and information on the audit team are agreed upon, early in advance, with the client.	9.2.4	4.4.2			

ZVC	84	
9.3 Initial certification	
The initial certification audit will be conducted in two stages. The stage 1 audit is planned and performed according to the standard. It considers also the readiness for ARR. Stage 1 audit findings are documented and communicated to the client.	9.3.1	4.4.3	x		

Z*C	85	
The stage 2 audits take place at the site(s) of the client and include at least aspects as given in the standard and ARR.	9.3.1	4.4.3	x		

Z*C	86	
In the audit report, all information and audit evidence gathered during the stage 1 and stage 2 audits (including ARR) are analysed to review the findings and agree on conclusions.	9.3.1	4.4.8	x		

Z*C	87	
9.4 Conducting audits	
The TS has a process for conducting on-site audits. This process includes an opening meeting at the beginning of the audit and a final meeting at the end of the audit.	9.4.1	4.4.4			

ZVC	88	
ARR-audits are generally carried out at the client’s site.		4.4.4	x		

Z*C	89	
Audits made by electronic means or at virtual sites are carried out by auditors with appropriate competence.	9.4.1				

ZVC	90	
Communication during the audit	9.4.3				

ZVC	91	
Evidences of adequate sampling and verification of information are recorded.	9.4.4		x		

Z*C	92	
Audit findings are recorded and reported in an adequate way. Nonconformities are not recorded as opportunity for improvement. They are described and discussed with the client. A time frame for their processing is agreed. The client is given the opportunity to ask questions and clarify differences of opinion.
The classification of the ARR findings is made according to the specifications given in the Designation rules, Annex 2.	9.4.5
9.4.6
9.4.7	4.1.1
4.4.8	x		

Z*C	93	
A written report is provided for each audit. It meets the requirements of 9.4.8.2 and 9.4.8.3. 
Subsequent changes shall be clearly identified, and replaced reports shall refer to the original report.
The audit report contains statements about the fulfilment of ARR. The Report on CoP is (possibly as enclosure) part 
of the audit report.	9.4.8	4.0.5
4.0.6
4.4.8	x		

Z*C	94	
The Report on CoP is comprehensive, pursuable and significant.		4.0.5	x		

Z*C	95	
The Report on CoP is internally checked and immediately sent to the KBA (Dresden).		4.1.1	x		

Z*C	96	
The quality of Reports on CoP is regularly analysed.			x		

Z*C	97	
The TS requires from the client to analyse the cause of non-conformities and to describe corrections and corrective actions to eliminate detected non-conformities within a defined time.
Usually, a member of the audit team reviews the cause analysis, corrections and corrective actions submitted by the client and verifies their effectiveness (for ARR by an ARR auditor of the team). The results are recorded. The client is informed of the results.	9.4.9
9.4.10		x		

Z*C	98	
9.5 Certification decision	
The (re-) certification decision is made only by persons different from those who carried out the audit.
Persons making the certification decision shall have appropriate competence for the scope (Designation rules, Annex 3). 
The requirements of 9.5.1.2 are met (link between the decision maker and the TS).	9.5.1	3.0.3
4.4.5	x		

ZVC	99	
Prior to making a decision, the TS confirms that the following requirements are met (also regarding ARR):
-	The information is sufficient with respect to the certification requirements and the scope for certification.
-	All major non-conformities are settled (see also Designation rules).
-	The action plan for minor non-conformities has been reviewed and accepted.
The certification decision including any relevant information is recorded.	9.5.2
9.5.3	4.4.5
	x		

Z*C	100	
The decision about the initial certification is based on the standard (9.5.3.1) and on the Report on CoP.	9.5.3	4.4.5	x		

Z*C	101	
9.6 Maintaining certification	
The certification will be maintained if the audit team leader recommends this.
In case of any major non-conformity or other situation that may lead to suspension or withdrawal of certification, competent personnel that has not been involved in auditing evaluates whether certification can be maintained. 	9.6.1	4.4.5
4.4.6			

ZVC	102	
Competent personnel of the TS monitor its surveillance activities (including reporting by auditors) (also regarding ARR).	9.6.1		x		

Z*C	103	
The TS regularly monitors all relevant areas and activities covered by the MS. Changes made by the customer are taken into account.
Surveillance activities include on-site auditing and cover at least the issues 
as given in the standard and ARR, in particular:
-	Obligation to inform the KBA
-	Up-to-dateness of approval documentation
-	Conformity checks
-	Fulfilment of approval relevant obligations.	9.6.2	4.4.6	x		

Z*C	104	
If there have been significant changes (e.g. regarding ARR), for recertification a stage 1 audit is planned and carried out.	9.6.3		x		

Z*C	105	
On-site audits are planned and carried out for re-certification. They are addressed to evaluation of:
-	Effectiveness of the MS
-	Commitment to maintain the effectiveness and improvement of the MS
-	Effectiveness of the MS with regard to achieving the client’s policy and objectives
-	Fulfilment of ARR
The performance of the MS over the most recent certification cycle will be considered.	9.6.3	4.4.6	x		

Z*C	106	
Major non-conformities are settled prior to expiration of certification.	9.6.3				

ZVC	107	
There are policy and documented procedure(s) for carrying out audits for special reasons.	9.6.4				

ZVC	108	
There are policy and documented procedure(s) for suspension, withdrawal and reduction of certification.	9.6.5		x		

Z*C	109	
9.7 Appeals 	
A documented process exists to receive, evaluate, and make decisions on appeals.	9.7.1	4.4.7	x		

Z*C	110	
9.8 Complaints	
The TS is responsible for all decisions in the complaints-handling process.	9.8.1				
Z*C	132	
There are no discriminatory actions against the complainant in the entire complaints-handling process.	9.8.2				

Z*C	133	
If a justified complaint relates to a certified client,
-	It will be passed on to him within a reasonable time
-	The investigation of the complaint includes the effectiveness of the certified MS	9.8.3
9.8.4	4.0.2	x		

Z*C	111	
A documented process exists to receive, evaluate, and make decisions on complaints.	9.8.5
9.8.6
9.8.7
9.8.10
9.8.11	4.0.2
4.0.7	x		

Z*C	112	
The decision will be made by, or reviewed and approved by, individual(s) not previously involved in the subject of the complaint.	9.8.9				

Z*C	134	
9.9 Client records	
Records on all certification activities are maintained for all clients (including ARR).	9.9.1	4.4.8	x		

Z*C	113	
Confidentiality of records is ensured with regard to storage as well as transport, transmission, transfer (loss, unauthorized access, integrity).	9.9.3		x		

Z*C	114	
10 Management system requirements for certification bodies	
The TS shall establish, document, implement and maintain a management system that is capable of supporting 
and demonstrating the consistent achievement of the requirements of 
EN ISO/IEC 17021-1 and the Designation rules.	10.2.1	1.7
5.2	x		

Z*B	115	
The top management
-	Has established and documented policies and objectives for its activities,
-	Ensures that those policies and the ARR, especially the requirements of the Designation rules, are understood, implemented and maintained in the entire TS,
-	Provides evidence of its commitment to the development and implementation of the MS in accordance with the standard and the Designation rules.	10.2.1	1.7	x		

Z*B	116	
The top management assigns responsibility and authority to ensure that
-	Necessary processes and procedures are established, implemented, and maintained,
-	All activities are carried out with the greatest possible professional diligence,
-	Reports on the performance of the MS and any need for improvement are given.	10.2.1	1.3
4.2.1	x		

Z*B	117	
All applicable requirements of the standard and the Designation rules are addressed either in a manual or in associated documents.	10.2.2	1.9
5.2
5.3	x		

Z*B	118	
The processes are updated according to the current ARR. All available sources of information are used for this purpose (pull principle). The transparency and repeatability of the procedures have been demonstrated.		4.0.1
4.2.2
5.2	x		

Z*B	119	
Procedures to control internal and external documents that relate to the fulfilment of the standard and the Designation rules are established and used.
Regarding ARR, e.g. such documents are concerned as for:
-	Designation procedure
-	Type approval procedure
-	Information towards and from the KBA
-	Approval relevant EU, UN and national regulatory acts.	10.2.3	4.2.2	x		

Z*B	120	
Procedures for controlling records related to the fulfilment of the standard and the Designation rules are established and used.	10.2.4	4.1.2	x		

Z*B	121	
Procedures to review the MS are established and used regarding
-	Continuing suitability
-	Adequacy
-	Effectiveness
in relation to the fulfilment of requirements of the standard and of ARR.
All processes (including ARR specifics) are regularly subjected to risk analysis. Any residual risk is documented, minimized and evaluated by the top management.	10.2.5	4.1.2
5.4
5.5	x		

Z*B	122	
Information, comments and complaints from the KBA are included in the self-assessment and improvement process.		4.1.2
5.5	x		

Z*B	123	
At least once every 12 months the fulfilment of the obligations of the Designation rules, compliance with ARR and the quality of the Reports on CoP are evaluated by the top management.		5.7	x		

Z*B	124	
The outputs from the management review include decisions and actions related to:
-	Improvement of the effectiveness of the MS and its processes
-	Improvement of the certification services
-	Resource needs
-	Revisions of the policy and objectives.	10.2.5	5.5
5.7			

Z*B	125	
The procedures for internal audits are established and used for verification that
-	The requirements of the standard and the Designation rules are fulfilled
-	The MS is effectively implemented and maintained.
Internal auditors are qualified and competent. 
An adequate audit programme is planned.	10.2.6	5.6	x		

Z*B	126	
Procedures for detecting and handling of non-conformities in the own system are introduced and applied. Appropriate corrections and corrective actions are implemented. Causes of deficiencies in the implementation of ARR will be identified and remedied together with the KBA.	10.2.7	4.1.2
4.1.5	x		

Z*B	127	
The quality of audits and Reports on CoP is regularly evaluated. The results of the IS-CoP are used for this purpose.		4.1.2	x		

Z*B	128	
Reports of findings and recommendations from the last review have been sufficiently processed.		4.1.2	x		

Z*B	129	
The exchange of experiences and other information given by the KBA are analysed for prevention of non-conformities. 			x		

Z*B	130	
11 Miscellaneous	Z*S	131