DIN EN ISO/IEC 17021:2011
Name and address of CAB:
Case number:
Date of assessment:
For / Initial AccreditationReaccreditationExtension of AccreditationSurveillance of AccreditationFollow-up on-site assessmentWitness audit
and / Initial AccreditationReaccreditationExtension of AccreditationSurveillance of AccreditationFollow-up on-site assessmentWitness audit
CAB with several locations: / Yes / No
(Name)/Address:
(Name)/Address:
(Name)/Address:
(Name)/Address:
Assessed area
(technical fields of DAkkS, certification fields, sector-specific requirements, directives/modules)
Details of the assessor
Lead assessor / System assessor (SA) / Assessor (A) / Technical expert / Observer
Name
Institution
Telephone / Fax / /
Detailed information on the assessed area[1)]
5 / General requirements / Appraisal[2])5.1 / Legal and contractual matters / S[3) ] / 1 / 2 / 3
SA[4)] / Legal entity • certification agreement (contract) between headquarters of the certification body or a branch and the customer •
(headquarters or branches) • sole responsibility for certification decisions
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[5)]
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5.2 / Management of impartiality / S / 1 / 2 / 3
SA+A / Commitment to impartiality • (publicly accessible) • identification of possible conflicts of interest (including those arising from its related bodies) also comprising actions to correct/minimize them, exclusion of certification of other certification bodies for management
systems, exclusion of consultancy on management systems within the same legal person • exclusion of audits (less than two years) • exclusion of outsourcing audits to a management system consultancy organization • neutral marketing of the certification body’s
operations • independence of auditors relating to consultancy and to personnel, in general relating to conflicts of interest • independence of personnel (internal and external) from commercial, financial and other pressures • submission of required documents
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5.3 / Liability and financing / S / 1 / 2 / 3
SA / Adequate arrangements to cover liability claims • risk assessment • annual evidence of financial stability towards the committee
for safeguarding impartiality
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6 / Structural requirements
6.1 / Organizational structure and top management / S / 1 / 2 / 3
SA
If SA not on-site:
A / Legal entity:
Reg. no. / at:
Third party liability insurance including compensation for personal injury, property damage and other risks
(insurance company and insurance policy no.):
Management:
Deputy:
Quality manager:
Deputy:
SA+A / Submission of one or several organisational chart(s) • list of committees with the correspondent terms of reference and member lists (including the required details) • required details relating to 5.2 if the certification body is part of a major organization • appointment
of the top management • determination of responsibilities and authorities of the respective functions • details on sites (rule for the accreditation of certification with several sites)
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6.2 / Committee for safeguarding impartiality / S / 1 / 2 / 3
SA / Tasks, duties, composition, identification of members including the relevant information • terms of reference • minutes of the last
meeting (at least the constituent meeting)
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7 / Resource requirements
7.1 / Competence of management and personnel / S / 1 / 2 / 3
SA+A / Determination of required competence for management, auditing, certifying and administration personnel (see annex A of ISO 17021; documented and proof of efficient consideration process, e.g. annex B and C of ISO 17021) • access to knowledge and expertise for the technical and geographic scope
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7.2 / Personnel involved in the certification activities / S / 1 / 2 / 3
SA+A / Employment of personnel with sufficient competence (within the own organization) • availability of auditors (internal/external) to cover the scope • determination and clarification of duties, responsibilities, authorities, procedures and planning • performance of training activities including the identification of training needs • first approval of auditors • regular exchange of experience • use of competent auditors/technical experts • competence relating to the decision on certification • monitoring and appraisal of performance of the
personnel involved (depending on their relevance) • monitoring of auditors (see annex D of ISO 17021)
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7.3 / Use of individual external auditors and external technical experts / S / 1 / 2 / 3
SA+A / Written agreement • commitment to use and comply with applicable policies and procedures • confidentiality • independence from
the client to be audited
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7.4 / Personnel records / S / 1 / 2 / 3
SA+A / Records relating to qualifications, training, experience, affiliations, professional status, competence and any relevant consultancy services (technical, administrative and external personnel)
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7.5 / Outsourcing / S / 1 / 2 / 3
SA / Rules for a possible outsourcing of certification activities • contract provision regarding confidentiality and conflicts of interest (body and personnel) • exclusion to outsource the decision on certification • assumption of responsibility • records on assigned auditors / experts
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8 / Information requirements
8.1 / Publicly accessible information / S / 1 / 2 / 3
SA / Publicly accessible information on certification procedure • confirmation of the validity of a granted certification • publicly accessible information about certifications granted, suspended or withdrawn
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8.2 / Certification documents / S / 1 / 2 / 3
SA+A / Certification documents with the required contents
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8.3 / Directory of certified clients / S / 1 / 2 / 3
SA+A / Publicly accessible register of valid certifications with required information
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8.4 / Reference to certification and use of marks / S / 1 / 2 / 3
SA / Rule for the use of marks • use of marks not on products, product packaging and the like, also not on test reports, calibration certificates or inspection reports • control of ownership
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8.5 / Confidentiality / S / 1 / 2 / 3
SA / Confidentiality at all levels and structures as well as included persons • equipment and facilities that ensure the secure handling
of confidential information • rules to pass on confidential information
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8.6 / Information exchange between a certification body and its clients / S / 1 / 2 / 3
SA / Information of the certification body to the client • information on essential changes
(by the client to the certification body and vice versa)
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9 / Process requirements
9.1 / General requirements / S / 1 / 2 / 3
SA+A / Audit programme with a two-stage initial audit (e.g. annex E and annex F of ISO 17021)• surveillance audits in the first and second years, and a recertification audit in the third year (3-year cycle) • audit times for individual and multisite cases • qualification of auditors and audit team • audit process according to ISO 19011 • audit plan (see annex F of ISO 17021) • selection of audit team and definition of duties • determination of audit duration • sampling (multi-site) • communication of duties, members of audit team and audit schedule retraceability •on-site audit (general, initial meeting, communication during audit, guides and observers, sampling and verification of information, audit feedback, results, final meeting) • audit report • cause analysis of non-conformities • implementation of corrective actions • additional audits • certification decision • action previous to certification decision
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9.2 / Initial audit and certification / S / 1 / 2 / 3
SA+A / Contract review (approval/ denial) • rights and duties of both parties • general terms and conditions (or equivalent) • audit times for individual and multi-site cases • qualification of auditors and audit team • audit process according to ISO 19011 • audit plan • sampling • traceability • reporting • corrective actions • decision (separation between audit, review / decision) • notice
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9.3 / Surveillance activities / S / 1 / 2 / 3
SA+A / Audit times for individual and multi-site cases • qualification of auditors and audit team • audit process according to ISO 19011 • audit plan • sampling • traceability • reporting • corrective actions • information from previous audits • decision (separation between audit, review / decision) • notice
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9.4 / Recertification / S / 1 / 2 / 3
SA+A / Audit times for individual and multi-site cases • qualification of auditors and audit team • audit process according to ISO 19011 •
sampling • traceability • reporting • corrective actions • information from previous audits • decision (separation between audit,
review / decision) • notice
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9.5 / Special audits / S / 1 / 2 / 3
SA / Procedure and criteria to perform special audits:for extension to the scope and short-notice audits
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9.6 / Suspending, withdrawing or reducing the scope of certification / S / 1 / 2 / 3
SA+A / Procedure to suspend, withdraw or reduce the scope of certification • criteria
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9.7 / Appeals / S / 1 / 2 / 3
SA / Procedure of the appeals-handling
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9.8 / Complaints / S / 1 / 2 / 3
SA / Procedure of the complaints-handling
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9.9 / Records of applicants and clients / S / 1 / 2 / 3
SA+A / Procedure for retaining records • completeness • traceability • legibility • retention time • security and protection
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10 / Management system requirements for certification bodies
10.1 / Options
SA / Option 1: Management system requirements in accordance with ISO 9001
Option 2: General management system requirements
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10.3 / General management system requirements / S / 1 / 2 / 3
SA / • Establishment, documentation, implementationandmaintenance ofa management system(MS) to support and demonstrate the consistent achievement of the requirements of this International Standardand evidence of itscommitmentby the certification body's top management(TM) • documentedpolicies and objectives foractivities of the TM • ensuringofunderstanding, implementation of and
maintaining the policies at all levels of thecertification body's organization by the TM
• Appointmentof a member of managementirrespective of other responsibilities by the TMwith responsibility and authority making sure that processes and procedures needed for the management system are established, implemented and maintained• reporting to the TM on the performance of the MS and any need for improvement• documentation of all applicable requirements of this InternationalStandardin a manual or in associated documentsand its accessibility to all relevantpersonnel
• procedures to control the documents (internal and external)definingcontrols needed for theadequacy, review, update, changes,
reapproval, revisionstatus, availability, legibility andidentifiability • identifiabilityanddistribution of documents of external originand obsolete documents where required
• Establishing procedures fortaking preventive actions to eliminate the causes ofpotential nonconformities as well as definition of requirements for preventive actions for identification of potential nonconformities and theircauses; the actionneeded; determining and implementing the actionneeded; recording the results of actions taken and reviewing the effectiveness of the preventiveactions taken
SA
If SA not on-site:
A / •Management review:Procedures to review theMS at planned intervals- at least once a year MS to ensureits suitability, adequacy and effectiveness incl. the stated policies and objectives related to thefulfilment of this International Standard • input to the management review shall includeinformation related to internal and external audits, fulfilment of this InternationalStandard,impartiality,preventive and corrective actions,follow-up actions from previous managementreviews, objectives, effects of changes of the MS,appeals and complaints •outputs from the management reviewincl. decisions and actions related to improvement of the effectiveness of the MS and its processes, improvement of the certification services and resource needs
• Interne Audits: Planned audit programme – at least once every 12 months -taking into consideration the importance of the processes and the results of previous audits, if applicable reduced frequency of internal audits if the effectiveness ofthe MS is proven • Ensuring: the competence of audit personnel,that auditors do not audit their own work, the information of the personnel responsible for the area audited of the outcome of the audit, timely and appropriate manner of the actions resulting from internal audits andidentification of any opportunities for improvement
SA+A / • Control of records regarding. identification, storage, protection, retrieval, retention time and disposition (for a period consistent with itscontractual and legal obligations)
• Procedures for identification and management of nonconformities with requirements for identifying, determining the causes andcorrecting nonconformities • determining and implementing the corrective actions needed as well as recording the results and its effectiveness
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Use of the accreditation symbol / S / 1 / 2 / 3
SA / Compliance with the rule 71 SD 0 011 on the use of the symbol in certificates, business letters, offers, website,
other documentsand advertising media. (Not applicable for assessments for initial accreditation)
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If SA not on-site:
A
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Is the certification body notified for the assessed scope for EU directives / modules or is notification requested?
Yes / No
Fullfilment of additional requirements for notification according to relevant directives / modules
(taking into account EA 2/17, Decision No 768/2008/EC)
Yes / No / Not applicable
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Remarks:
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Information about activities of the certification body abroad / SA
Countries for which the certificates have been issued by the certification body directly from the German office of the certification body:
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Locations (“critical locations”), within and outside Germany, from which certification activities against ISO/IEC 17021
(IAF GD 3:2003) are conducted in the accredited area or area to be accredited (name and exact address):
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Fulfilment of imposed conditions and implementation of the corrective actions from the previous
assessment
Yes / No / Not applicable
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Remarks:
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Witness audits in the context of this assessment
(Submission of the results and evaluation as attachments to the report or later submission to the case manager)
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Assessor:
Certification schemes:
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Recommendations for accepting further areas of certification
As applied / Not applicable
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Remarks:
Communication during the assessment
Languages of communication:
/ Name of the persons, independent of the client, having the knowledge of the local language:
Remarksto the communication (interviews with staff, evaluation of records in the local language etc.)
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Summary, remarks and improvement potential
Appropriateness of personnel and other resources • fulfilment of additional requirements • overall impression with respect to the certification body’s particularities, strengths and areas requiring improvement, appraisal of the appropriateness and effectiveness of the quality system
including potential for improvement • final evaluation
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No. of non-conformities / Non critical: / To be rectified until:
Critical:
Reductions:
Focus for the following assessment based on the construction of the standard text:
Recommended date of the next assessment:
Recommendation on accreditation by the assessor:[6]) [7)] / Yes / No
Place / Date: / Signature:
Report reviewed by the customer manager:
Place / Date: / Signature:
Name in print: / Stamp
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[1)] This report follows the format of the standard text of DIN EN ISO/IEC 17021:2011
in the parts relevant for the accreditation of certification bodies for management systems.
[2]2)Grading of the compliance with the requirements of each clause:
1no non-conformity
2non critical non-conformity
3critical non-conformity
[3) ]3)S = Focus for the subsequent assessment visit
[4)]Responsibility for the evaluation of the standard point by the system assessor (SA) and/or technical assessor/technical expert (A). In each assessment, the responsible assessor provides an evaluation.
[5)]Comment and explanations to implement the particular standard requirement, where appropriate stating
the objective evidence and reviewed documents
[6])The applicant was informed on the preliminary result of the assessment in the closing meeting.
[7)]Subject to the adequate correction of the findings.