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Certification Report: Um (U (P) )

This document provides a certification report for a reference material. It details the quality standards and manufacturing processes used to ensure homogeneity, stability, and quality control of the material. Analytical methods were validated and uncertainties were determined using statistical principles.

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0% found this document useful (0 votes)
15 views1 page

Certification Report: Um (U (P) )

This document provides a certification report for a reference material. It details the quality standards and manufacturing processes used to ensure homogeneity, stability, and quality control of the material. Analytical methods were validated and uncertainties were determined using statistical principles.

Uploaded by

AlexS
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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CERTIFICATION REPORT

1. Quality Documentation: This certificate is designed in accordance with ISO Guide 31 (Reference Materials - Contents
of Certificates and Labels) and ISO Guide 35 (Reference Materials – General and Statistical Principles for Certification).

2. Quality Standards:
ISO Guide 34 - General Requirements for the Competence of
Reference Material Producers ACLASS Certificate Number AR-1463
AR-1463

ISO/IEC 17025:2005 - General Requirements for the Competence of


Testing and Calibration Laboratories ACLASS Certificate Number AT-1339
AT-1339

ISO 9001:2008 Quality Management System - Requirements


Eagle Registrations Certificate Number 3774

3. Intended Use: The product covered by this certificate is designed for calibration or for use in quality control procedures
for the specified chemical compounds listed on the reverse side. This product can be used for quantification and/or
identification. This product can also be used as a reference material to validate analytical procedures, subject to the
conditions under Section 11. If dilution is required, use only Class A glassware and diluent compatible with all certified
analytes in this preparation. All solutions should be thoroughly mixed prior to use.

4. Raw Materials: Reference standards are prepared from the highest quality starting materials with defined purities. All
analytes and solvents are obtained from pre-qualified vendors and then analyzed or evaluated prior to use.

5. Manufacturing: All balances are calibrated daily using an in-house procedure with weights that are compared annually
to master weights and traceable to NIST. The balances are also calibrated annually by an ISO/IEC 17025 accredited
calibration laboratory. Please refer to the NIST test number listed on the front of this certificate. Class A glassware
is used in the manufacture and quality control of all standards and calibrated using an in-house procedure. Good
Laboratory Practices have been used throughout the preparation of this CRM.

6. Homogeneity Assessment: Homogeneity of the finished product is assessed by analyzing sample batches or by other
methods consistent with the intended use of the product and by procedures that comply with the appropriate Quality
System requirements, and ISO Guide 35.

7. Stability Assessment: The manufacturer guarantees the stability of this solution through the expiration date stated on
the label, when handled and stored according to the conditions stated on the label. To ensure a uniform solution, mix
the contents of the sealed container thoroughly prior to use. Care should be taken not to contaminate the contents of the
original container.

8. Analytical Quality Control: Products are tested by validated analytical methods specified in the manufacturer’s quality
system.

9. Uncertainty Statistics and Confidence Limits: The uncertainty values as stated on the face of this certificate have
been determined using the EURACHEM/CITAC Guide (Quantifying Uncertainty in Analytical Measurement). We have
evaluated both Type A (based on a series of observations) and Type B (manufacturers specifications and calibration
data) factors and report a combined expanded uncertainty equal to the positive square root of the total variance of
the uncertainty of the components using the following formula: um = (u(P))2 + (u(m))2 + (u(V))2 . The expanded
uncertainty, U, assumes a normal distribution and a coverage factor of k=2 is chosen using approximately a 95%
confidence level. Laboratories accredited to ISO/IEC 17025 and ISO Guide 34 are required to estimate uncertainty
budgets associated with the measurements they make. However, for analysis, the certified value should be used as the
actual value.

10. Warranties: The manufacturer warrants that its products shall conform to the description of such products as provided
in its catalog or on the specific product label. This warranty is exclusive, and the manufacturer makes no other warranty,
express or implied, including any implied warranty of merchantability or fitness for any particular purpose.

11. Legal Notice and Limit of Liability: This product is for routine laboratory analysis and research purposes only. Due
to the hazardous nature, only trained personnel should handle this product. The company’s liability will be limited to
replacement of product or refund of purchase price. Notice of claims must be made within thirty (30) days from date of
delivery.

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