ID-code assessment xxxCONFIDENTIALNaam laboratorium:xxxxx
MODULE DX: REPORT OF THE TECHNICAL ASSESSOR/EXPERT
(NBN ISO/IEC 17025:2005- ISO Guide 34:2009)
"X" provides a unique identification of the reports of the technical assessors / experts. Please indicate the appropriate number based upon the order in the official assessment quotation. Please also complete the reference in the footer section.
File numberType of assessment
ID-code assessment
Date and location of the assessment
Name assessor/expert
EVALUATION OF THE IMPLEMENTATION OF CORRECTIVE ACTIONS TAKEN FOLLOWING THE PREVIOUS ASSESSMENT
Date of the previous assessment:xxxxxx
Type of assessment:Initial/surveillance/renewal/extension assessment
Findings:
Please give a brief summary of the findings in this section. It is not intended to enter into detail here.
ASSESSMENT REPORT
Part 1:GeneralFINDINGS
- MANAGEMENT REQUIREMENTS (CHAPTER 4 OF ISO/IEC 17025:2005and ISO Guide 34:2009)
If required, findings related to chapter 4 of ISO/IEC 17025:2005and ISO Guide 34: 2009 can be included in this section.
For this purpose you can use the template report, as developed forthe lead assessor (BELAC 6-431(17025-guide 34)). Please limit this section only to clauses that have been actually evaluated,since chapter 4 will be globally evaluated by the lead assessor.
- TECHNICAL REQUIREMENTS (CHAPTER5OF ISO/IEC 17025:2005and ISO GUIDE: 2009)
NBN EN ISO/IEC 17025:2005 § 5.1 and ISO Guide 34 § 5.1: General: /
NBN EN ISO/IEC 17025:2005 § 5.2 and ISO Guide 34:2009 §5.2: Personnel
ClauseISO 17025 / Clause
ISO guide 34 / Description / Evaluation
5.2.1 / Production competence
5.2.1 / 5.2.2 / Competence of technical personnel
5.2.2 / 5.2.3 / Education and training : policy, procedures, planning
5.2.3 / 5.2.5 / Supervision
5.2.4 / 5.2.4 / Job descriptions
5.2.5 / 5.2.6 / Registration of qualifications
Main documents subject to evaluation:
Overall description of the findings, including the reference to any detected non-conformities:
NBN EN ISO/IEC 17025:2005 § 5.3 and ISO Guide 34:2009 §5.6: Accommodation and environmental conditions
ClauseISO 17025 / Clause
ISO guide 34 / Description / Evaluation
5.3.1 / 5.6.1 / Appropriateness of the infrastructure (description, provisions) –environmental conditions and risk for contamination
5.3.2 / 5.6.1, 5.6.2 / Monitoring, controlling and recording the environmental conditions
5.3.3 / 5.6.1 / Separation of incomptatible activities
5.3.4 / Control of access
5.3.5 / Housekeeping
5.6.3 / Health, safety and environmental protection
Main documents subject to evaluation:
Overall description of the findings, including the reference to any detected non-conformities:
NBN EN ISO/IEC 17025:2005 § 5.4: Test and calibration methods and method validation
ISO Guide 34 § 5.9: Measurement methods
ISO Guide 34 § 5.11: Data evaluation
ClauseISO 17025 / Clause
ISO Guide 34 / Description / Evaluation
5.4.1 / 5.9.1 / Appropriateness of methods - content of the procedures – instructions for use
5.4.2 / Selection of methods – Standard methods: appropriate for use – information to the customer
5.4.3 / Laboratory-develop methods (planning, implementation)
5.4.4 / 5.9.2 / Non-standard methods – validation
5.4.5. / Validation of methods
5.4.5.1-2 / Type and extend of validation
5.4.5.3 / Range and accuracy of values – being adequate for intended use
5.4.6 / Measurement uncertainty
5.4.6.1 / Determination of measurement uncertainty (calibrations)
5.4.6.2 / Determination of measurement uncertainty (test methods)
5.4.6.3 / Identification of the components of measurement uncertainty
5.4.7 / 5.11.1, 5.11.2 / Control of data
5.9.3 / Sampling
Main documents subject to evaluation:
Overall description of the findings, including the reference to any detected non-conformities:
NBN EN ISO/IEC 17025:2005 § 5.5 and ISO Guide 34 § 5.10: Equipment
ClauseISO 17025 / Clause
ISO Guide 34 / Description / Evaluation
5.5.1 / Availability of adequate equipment
5.5.2 / 5.10.1, 5.10.4 / Specifications and accuracy of equipment – calibration programme
5.5.3 / Instructions for use
5.5.4 / Identification
5.5.5 / Registration of equipment and software
5.5.6 / Procedures and registrations of maintenance
5.5.7 / 5.10.2 / Non-performing equipment
5.5.8 / 5.10.3 / Labeling and calibration condition
5.5.9 / Calibration condition of equipment outside the control of the laboratory
5.5.10 / 5.10.4 / Intermediate checks
5.5.11 / Correct use of correction factors
5.5.12 / Safeguard from adjustments
5.10.5 / Calibration programme to establish appropriate traceability
Main documents subject to evaluation:
Overall description of the findings, including the reference to any detected non-conformities:
NBN EN ISO/IEC 17025:2005 § 5.6 and : Measurement traceability
ISO Guide 34: 2009 § 5.12: Metrological traceability
ClauseISO 17025 / Description / Evaluation
5.6.1 / Principles, program and procedures
5.6.2 / Specific requirements
5.6.2.1 / Calibration: traceability of the calibration towards SI units or alternative approach - participation to an interlaboratory comparison
5.6.2.2 / Test methods: importance of traceability of the measurement in relation to the Total Measurement Uncertainty of the test method. – use of certified reference material and methods when lacking SI traceability.
5.6.3 / Reference standards and materials
5.6.3.1 / Calibration procedure and use of reference standards
5.6.3.2 / Control and traceability of the reference material
5.6.3.3 / Intermediate checks
5.6.3.4 / Transport and storage of reference standards/materials
Clause
ISO Guide 34 / Description / Evaluation
5.12.1 / Documented evidence
5.12.2 / Stated references
5.12.3 / Specific requirements for relative and absolute measurements
5.12.4 / Traceability to the same reference
Main documents subject to evaluation:
Overall description of the findings, including the reference to any detected non-conformities:
NBN EN ISO/IEC 17025:2005 § 5.7: Sampling
ClauseISO 17025 / Description / Evaluation
5.7.1
(see also 5.9.3 of ISO Guide 34) / Procedures for sampling and sampling plans
5.7.2 / Deviations of sampling
5.7.3 / Recording of sampling
Main documents subject to evaluation:
Overall description of the findings, including the reference to any detected non-conformities:
NBN EN ISO/IEC 17025:2005 § 5.8: Handling of test and calibration items
ClauseISO 17025 / Description / Evaluation
5.8.1 / Procedures for reception, handling, protection, storage and disposal
5.8.2 / Identification of the test-/calibration objects - Prevention against confusion
5.8.3 / Registration of deviations
5.8.4 / Procedures and infrastructure for storage, handling and preparation - Protection and integrity of the test-/calibration objects
Main documents subject to evaluation:
Overall description of the findings, including the reference to any detected non-conformities:
NBN EN ISO/IEC 17025:2005 § 5.9: Assuring the quality of test and calibration results
ClauseISO 17025 / Description / Evaluation
5.9.1 / Procedures for the quality control of the tests/calibrations – types of quality control – trend detection- interlaboratory comparisons
5.9.2 / Control of the pre-defined criteria – corrective actions
Main documents subject to evaluation:
Overall description of the findings, including the reference to any detected non-conformities:
NBN EN ISO/IEC 17025:2005 § 5.10: Reporting the results
ClauseISO 17025 / Description / Evaluation
5.10.1 / Procedure of reporting (general requirements)
5.10.2 / Content of the test report and or the calibration certificate
5.10.3 / Special requirements for test reports
5.10.4 / Special requirements for certificates of calibration
5.10.5 / Opinions and interpretations
5.10.6 / Identification of results of subcontractors
5.10.7 / Electronic transmission of results
5.10.8 / Format of the reports/Certificates
5.10.9 / Amendments of the reports
Main documents subject to evaluation:
Overall description of the findings, including the reference to any detected non-conformities:
ISO Guide 34:2009§ 5.3: Subcontractors
ClauseISO Guide 34 / Description / Evaluation
5.3.1 / Selection
5.3.2 / Evidence of competence
5.3.3 / Compliance with Guide 34 and ISO 17025 measurement, testing and calibration
5.3.4 / Records
Main documents subject to evaluation:
Overall description of the findings, including the reference to any detected non-conformities:
ISO Guide 34:2009§ 5.4: Production planning
ClauseISO Guide 34 / Description / Evaluation
5.4.1 / Selection of processes and use of technical standards
5.4.2 / Mechanism for technical support
5.4.3 / Specific procedures and facilities
Main documents subject to evaluation:
Overall description of the findings, including the reference to any detected non-conformities:
ISO Guide 34:2009§ 5.5: Production control
ClauseISO Guide 34 / Description / Evaluation
5.5 / Production control
Main documents subject to evaluation:
Overall description of the findings, including the reference to any detected non-conformities:
ISO Guide 34:2009§ 5.7: Material handling and storage
ClauseISO Guide 34 / Description / Evaluation
5.7.1 / Shielding and separation
5.7.2 / Packing and storage facilities
5.7.3 / Monitoring of the condition of materials during storage
5.7.4 / Packing and marking for transportation
5.7.5 / Labeling of reference materials
5.7.6 / Integrity during production (and delivery)
Main documents subject to evaluation:
Overall description of the findings, including the reference to any detected non-conformities:
ISO Guide 34:2009§ 5.8: Material processing
ClauseISO Guide 34 / Description / Evaluation
5.8 / Material processing
Main documents subject to evaluation:
Overall description of the findings, including the reference to any detected non-conformities:
ISO Guide 34:2009§ 5.13: Assessment of homogeneity
ClauseISO Guide 34 / Description / Evaluation
5.13.1 / Quantification or limits for heterogeneity test, ISO Guide 35
5.13.2 / Design of homogeneity test, ISO Guide 35
5.13.3 / Reporting minimum sample size
Main documents subject to evaluation:
Overall description of the findings, including the reference to any detected non-conformities:
ISO Guide 34:2009§ 5.14: Assessment of stability
ClauseISO Guide 34 / Description / Evaluation
5.14.1 / Establishment of required stability (fit for purpose)
5.14.2 / Testing according to ISO 17025 criteria, design according to ISO Guide 35
5.14.3 / Stability under transport conditions
5.14.4 / Periodic confirmation of stability
5.14.5 / Information on changes shelf-life
Main documents subject to evaluation:
Overall description of the findings, including the reference to any detected non-conformities:
ISO Guide 34:2009§ 5.15: Characterization
ClauseISO Guide 34 / Description / Evaluation
5.15 / Characterization; ISO guide 35
Main documents subject to evaluation:
Overall description of the findings, including the reference to any detected non-conformities:
ISO Guide 34:2009§ 5.16: Assignment of property values and their uncertainties
ClauseISO Guide 34 / Description / Evaluation
5.16.1 / Procedures and statistical principles, expert team, ISO Guide 35
5.16.2 / Method for assigning measurement uncertainty on property values, ISO Guide 35, GUM
Main documents subject to evaluation:
Overall description of the findings, including the reference to any detected non-conformities:
ISO Guide 34:2009§ 5.17: Certificates or documentation for users
ClauseISO Guide 34 / Description / Evaluation
5.16 / Certificates or documentation for users, ISO Guide 31
Main documents subject to evaluation:
Overall description of the findings, including the reference to any detected non-conformities:
ISO Guide 34:2009§ 5.18: Distribution service
ClauseISO Guide 34 / Description / Evaluation
5.18.1 / Conditions for transport and documents for customs clearance
5.18.2 / Records of material sales and distribution
5.18.3 / Guidance and technical support
5.18.4 / Notification in case of changes in assigned value
5.18.5 / Resale through authorized distributors
5.18.6 / Resale by other organizations
Main documents subject to evaluation:
Overall description of the findings, including the reference to any detected non-conformities:
- ADDITIONAL REQUIREMENTS OF BELAC – use of the accreditation symbol – sectoralrequirements
Main documents subject to evaluation:
Overall description of the findings, including the reference to any detected non-conformities:
Part 2:EVALUATION OF SPECIFIC ACTIVITIES OR GROUP OF ACTIVITIES
Witnessed activity / group of activities:
Spoken with:
Evaluation of documents / followed in practice / witnessed on site:
Clauses of ISO/IEC 17025:2005and ISO Guide 34: 2009 subject to evaluation:
ClauseISO 17025 / Clause
ISO guide 34 / Description / Evaluation
§ 4 / § 4 / Management requirements
§ 5.2 / § 5.2 / Personnel
§ 5.3 / § 5.6 / Accommodation and environmental conditions
§ 5.4 / § 5.9, § 5.11 / Test and calibration methods and method validation – Measurement Method – Data evaluation
§ 5.5 / § 5.10 / Equipment
§ 5.6 / § 5.12 / Traceability
§ 5.7 / Sampling
§ 5.8 / Handling of test and calibration items
§ 5.9 / Assuring the quality of test and calibration results
§ 5.10 / Reporting of results
§ 5.3 / Subcontractors
§ 5.4 / Production planning
§ 5.5 / Production control
§ 5.7 / Material handling and storage
§ 5.8 / Material processing
§ 5.13 / Assessment of homogeneity
§ 5.14 / Assessment of stability
§ 5.15 / Characterization
§ 5.16 / Assignment of property values and their uncertainties
§ 5.17 / Certificates or documentation for users
§ 5.18 / Distribution service
Main documents subject to evaluation:
Overall description of the findings, including the reference to any detected non-conformities:
PArt 3:TECHNICAL ANNEX (SCOPE)
Please report in this section your remarks with regard to the scope of accreditation, particularlyconcerning the modifications to be made.
You received an Excel file with a scope proposal: please indicate in this file which activity/group of activities has been subject to evaluation, whether on a documentary basis or in practice. Also indicate your agreement on the formulation of each activity within your sector.
The completed excel file will form the basis for the final scope of accreditation: Please send this file to the lead assessor,together with your assessment report.
conclusiON
With regard to activities already covered by accreditation:
With regard to activities for which an application of extension was submitted:
Additional information:
In this section, any additional information can be added e.g. planned changesin a firm's organizational structure or activities, points of attention for the next assessment,…
When no additional information is to be mentioned, please indicate “not relevant”
DATE: xx/xx/xxxx
BELAC 6-432(17025-Guide 34) Rev 0-2012 Assessment report - module DX: Report technicalassessor/expert (ISO/IEC 17025:2005-ISO Guide 34:2009)
1/8