flexible scope of accreditation
Details of the conformity assessment body (CAB)
Name:
File number:
Case number / Phase
Date of assessment:
For/to: / Initial AccreditationReaccreditationExtension of AccreditationSurveillance of AccreditationSurveillance and Extension of AccreditationFollow-up on-site assessment
CAB with several locations: / Yes / No
Name / Address of assessed locations:
Details of the assessor
Name:
Status[1] : / TE / TA / SA
Statement to the flexible scope of accreditation:
The testing, calibration or examination areas and categories of the flexible scope correspond to the draft agreed upon before the assessment or the currently valid annex to the accreditation certificate.
Yes, please selectcurrent valid annex to the certificatecurrent draft of the annex to the certificate continues to apply.
No, please selectcurrent valid annex to the certificatecurrent draft of the annex to the certificate will be submitted with marked changes with this report/checklist to the DAkkS.
The laboratory maintains at the time of the assessment a current list of all testing, calibration or examination methods covered by accreditation. (including an identification of the last changes):
Yes, Date of issue of the list:
No, (a corresponding non-conformity will be set in a non-conformity-report and in the partial assessment report).
Since the last assessment were introduced and applied within the scope of accreditation:
Standard testing methods or their equivalent (category I).
Modified, new introduced or developed testing methods (category II).
Different versions of the standards or/and equivalent testing or calibration methods (category III).
In addition to the report for testing or calibration laboratories according to ISO/IEC 17025 and for medical laboratories according to ISO 15189 this checklist references the detailed requirements to the laboratories, which have applied for a flexible scope of accreditation or which are already accredited with a flexible scope of application. This checklist contains the additional requirements, only - not any pure reference to the accreditation standard itself.
This checklist/this report does NOT repeat the objective evidence (OE) and reviewed documents (RD), text passages and explanation of non-conformities listed or given in the partial assessment report according to ISO/IEC 17025 or ISO 15189. The responsible assessor may, however, list further documents and add explanatory text. Non-conformities arising from the application of this checklist have to be documented in the partial assessment report/ checklist.
Note: The italic, bold, and blue formatted passages refer to the requirements of ISO 15189. /No.[2] / Implementation of the requirements in relation to the flexible scope of accreditation / ful-filled / not fulfilled / Notes (optional)[3] /
4.1
4.1 / Are organizational regulations and responsibilities for the modification, revision and development of testing methods/examination procedures documented as well as their implementation and validation?
→ not applicable for category III
4.2.1
4.2.1 / Are the laboratory’s procedures for the introduction of newly developed, modified and/or revised testing or calibration methods/examination procedures considered and documented by the management system as required?
4.2.2
4.2.3 / Is the implementation of newly developed, modified and/or current testing or calibration methods/examination procedures taken into account in the quality policy?
4.3
4.3 / Are documents from external sources completely recorded by the documentation control system? Has the laboratory established procedures to regulate documents in regard of change (in case of publication of new standards)?
4.4
4.4 / Is the information which standard and which edition needs to be used unmistakably passed from the inquiry-acceptance to the laboratory’s technical personnel?
4.13.1 - 4.13.2
4.13 / Are modifications and updates of testing or calibration methods/examination procedures or development activities, including all underlying validation and verification results and other relevant data completely recorded?
4.14.1 - 4.14.4
4.14 / Is the process for the acceptance of newly developed, modified and/or revised testing and calibration methods/examination procedures considered in the audit program?
4.15.1 - 4.15.2
4.15 / Does the management review take into account the process of introduction of newly developed, modified and/or revised testing or calibration methods/ examination procedures?
(Suitability and effectiveness of the management system with regard to the control of the flexible scope of accreditation including evaluation of the regulation for approval of newly developed, modified and/or current testing and calibration methods/examination procedures as well as the competence of authorized personnel)
5.2.1 -5.2.5
5.1 / Is the personnel within the context of flexible scope of accreditation authorized and sufficient competent to develop newly or modified testing methods/ examination procedures as well as having a sound technical understanding of the testing methods/examination procedures and the techniques used?
(among others qualification, job descriptions, education)
→ not applicable for category III
5.4.1 - 5.4.6
5.5 / Are verified and/or validated testing methods/examination procedures applied within the limits specified in the flexible scope of accreditation?
→ not applicable for category III
5.9
5.6 / Is the development, evaluation, validation and authorization of newly developed, modified and/or current testing or calibrating methods/examination procedures verified on a regular basis by using appropriate quality assurance activities?
(Results of the internal or external quality assurance have to be considered among others. Records of these examination activities must be available to the DAkkS.)
[4]
Place / Date / Assessor
75 FB 032_e / Rev. 1.0 / 25.10.2017 / Date of issue: / Page 1 of 3
[1] Status in the assessment team: TE=Technical expert; TA=Technical Assessor; SA=System Assessor
[2] For the check of the individual standard clauses the assessors mentioned in the partial assessment report are responsible.
[3] Here can be referenced to the appropriate section of the partial assessment report.
[4] This report/checklist has been electronically compiled by on and is valid without signature.