ACLASS Application for ISO/IEC 17025 Accreditation

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ANSI-ASQ National Accreditation Board
APPLICATION FOR ISO/IEC 17025 ACCREDITATION
Please complete this application electronically.
Organization Name:
(As to be officially listed on certificate and scope of accreditation. Separate application required for each accreditation location.)
Accreditation Location:
(As to be officially listed on certificate and scope of accreditation.)
Mailing Address:
(If different from Accreditation Location.)
Website Address:
Authorized Representative Name:
Contact to be listed on Scope of Accreditation (if different from above):
Telephone:
Facsimile:
Email:
Note: Please supply an email address that is checked daily. ACLASS uses email to communicate when reports have been
uploaded, invoicing, and changes to requirements.
Accounting Contact:
Telephone:
Email:
Note: Even if this contact is the same as above, please complete to ensure ACLASS has the appropriate individual for invoicing.
Legal Status:
Government Body
Corporation – Not for Profit
Staff Size: Managerial:
Application for (check one):
Application for Scope of:
Corporation, Proprietorship, LLC
Other
Technical:
Initial Accreditation
Calibration
Testing
Renewal of Accreditation
Scope Expansion
Calibration and Testing
Does the organization perform customer of field (i.e., on-site) calibrations or tests?
Does the organization maintain multiple laboratory sites?
Yes
Yes
No
No
Note: If yes, please contact ACLASS directly for guidance and requirements for multi-site organizations.
Testing Labs Only:
Does the organization perform in-house calibrations?
Yes
No
If the organization performs in-house calibrations, list the devices or attach a list:
Calibration Labs Only:
Does the organization perform in-house calibrations to disseminate traceability to other in-house
standards?
Yes
No
If yes, will any of these standards be done only in house (i.e., not listed on the scope of accreditation?
Yes
No
If yes, please complete ACLASS-FQS form 71, Off-Scope Calibration Tracking (available at
www.aclasscorp.com) and submit with this application.
Does the organization intend to meet requirements of ANSI/NCSL Z540-1?
ACLASS Form 4
ISO/IEC 17025 Application
Page 1 of 10
Yes
No
March 14, 2014
Does the organization intend to meet requirements of ANSI/NCSL Z540.3?
Has the organization ever been accredited to ISO/IEC 17025?
Yes
Yes
No
No
Note: If previously or currently accredited to ISO/IEC 17025, please attach copies of certificate, scope and previous reports
issued by organization’s accreditation body. The process cannot begin until these reports are received.
If yes, has the organization’s accreditation been suspended in the past 12 months?
Yes
No
List recent proficiency testing (PT) activities or provide plan for PT:
Attach Draft Scope of Accreditation: Guidance for preparation of the draft Scope for ISO/IEC 17025
Accreditation is provided as Appendix B of this application. Your draft scope of accreditation must be completed
and submitted for ACLASS to better serve you. Please be advised that failure to submit a draft scope of
accreditation prior to the assessment may result in your assessment being delayed.
Authorization
My organization has submitted payment for the non-refundable application fee. We understand that ACLASS will
invoice us for other accreditation activities when they are performed, and that all invoices are due net 30 days.
We understand that ACLASS will use its best efforts to schedule accreditation services on dates agreeable to us and
that when we agree to specific dates ACLASS will confirm the dates in writing. We understand that if we cancel
confirmed dates within 30 days prior to the first confirmed date, ACLASS will charge us 50% of the daily fee for
each cancelled date. We further understand that there may be additional charges for review of corrective action
and/or a follow-up visit for any nonconformance.
We certify that we have read and agree to comply with the applicable requirements and ACLASS Document 3,
including use of the accreditation symbol. We certify that we have read and agree to the Responsibilities and
Obligations of the Customer in Appendix A of this application. We agree to cooperate fully and supply to ACLASS
all information and documentation needed before, during, and after the accreditation process. We further agree to
allow the release of PT/ILC reports directly to ACLASS from providers of such services, as applicable. We attest
that our organization is a legally identifiable entity and maintains the appropriate resources to supply services under
ISO/IEC 17025 requirements.
I am authorized by my organization to apply to ACLASS for accreditation. I am further authorized to agree that my
organization will pay ACLASS for any charges billed, net 30 days, for services leading to accreditation rendered at
the request of my organization.
Authorized Representative Signature
ACLASS Form 4
Date:
ISO/IEC 17025 Application
Page 2 of 10
March 14, 2014
ACLASS Preparation of Draft Scope of Accreditation
Calibration Laboratories Only
The following information must accompany the Application for Accreditation to assist in preparation of the Scope
of Accreditation (please use the attached scope template table below or obtain the relevant scope template from the
ACLASS website and fill in the relevant information):
1.
Listing of types of measurement and test equipment (M&TE) calibrated by the applicant laboratory.
2.
Range identification for each calibration line item, grouped by a Calibration and Measurement Capability
(CMC) distinct from other ranges.
3.
Identification of methods used to perform the calibrations defined. These may be laboratory-specific, but
whenever possible they should be based on internationally accepted calibration procedures.
4.
Uncertainty (CMC) budgets, determinations, and procedure for preparing them.
5.
Identification of the relevant reference standards and accessories used in the calibration procedure for each line
item.
6.
Identify with an asterisk or other notation those calibrations and measurement parameters that are performed off
the accredited laboratory premises (on-site calibrations). The assessor(s) will observe a sampling of on-site
calibrations during the assessment.
7.
Check all of the following that are applicable to your laboratory:
In-house calibration only
Commercial calibration
On-site (field) calibration
Mobile calibration
Calibration and Measurement Capability: ACLASS requires the CMCs be expressed as an expanded uncertainty
which is obtained by the following formula: U = kuc(y) where
U = expanded uncertainty
k = coverage factor
uc(y) = combined standard uncertainty of measurement process for y
In line with current international practice and National Institute of Standards and Technology (NIST) policy, the
coverage factor of k = 2 (level of confidence of approximately 95 percent) will satisfy the majority of situations
encountered in calibration work. Values of k other than 2 should only be used for specific applications dictated by
established and documented practices. Some guidance documents for determination of uncertainty are:
 ANSI/NCSL Z540-2-1997, American National Standard for Expressing Uncertainty-U.S. Guide to the
Expression of Uncertainty in Measurement - http://www.ncsli.org/
 NIST Technical Note 1297, 1994 Edition, Guidelines for Evaluating and Expressing the Uncertainty of
NIST Measurement Results, Taylor & Kuyatt - https://srmors.nist.gov/referencelinks/references/TN1297.pdf
 NISTIR 6919 – Recommended Guide for Determining and Reporting Uncertainties for Balances and Scales
- http://www.aclasscorp.com/documents/industry-guidance-documents.aspx
ACLASS requires scopes of accreditation to meet NIST SP 811, Guide for the Use of the International System of
Units (SI), where available. This NIST 811 Guide has been prepared by the National Institute of Standards and
Technology (NIST) to assist those who may have need of such assistance, in the use of the SI in their work,
including the reporting of results of measurements. NIST SP 811 can be accessed on the ACLASS website at
http://www.aclasscorp.com/documents/industry-guidance-documents.aspx
The table will be used to develop the draft Scope of Accreditation for your laboratory. A list of suggested
measurement areas/parameters follows the table. All measurement capabilities/uncertainties will be reviewed and
validated by the technical assessors prior to and during the assessment visit.
ACLASS Form 4
ISO/IEC 17025 Application
Page 3 of 10
March 14, 2014
Draft Scope of Accreditation - Calibration
Please complete the following table by typing and submitting electronically in Microsoft Word to allow for future
modifications. For examples of accredited laboratory scopes, visit www.aclasscorp.com and click on “Search
Accredited Organizations.”
Parameter/
Equipment
ACLASS Form 4
Range
Calibration and
Measurement
Capability
[Expressed as
Uncertainty(+)]
ISO/IEC 17025 Application
Page 4 of 10
Reference
Standard or
Equipment
Method(s)
March 14, 2014
Calibration/Measurement Areas and Parameters
Instructions: The following are examples of parameters within each calibration area. Check the calibration
parameters for which your laboratory is seeking accreditation. If you do not see your parameter, check “other” and
specify in the space provided. This document is used in conjunction with the draft scope of accreditation above.
Dimensional
Angularity
Gage blocks
Hand tools (mics, calipers)
Step gages
Measuring wires
Laser frequency/wavelength
UMM/bench micrometers
Roundness
Surface texture
Optical reference planes
OD cylindrical diameter
ID cylindrical diameter
CMMs
Threaded product
Height gages
Surface plates
Radius gages
Indicators, LVDT
Microscopes
Video/optical measuring machines
Other-specify:
Mechanical
Air speed
Flow rate (air or liquid)
Hydrometers
Mass
Volume
Force
Density
Ultrasonic reference block
Ultrasonic transducer
Vibration
Torque
Pressure/vacuum
Hardness testers
Acoustics
Scales and balances
Pipettes
Other-specify:
Thermodynamic
Humidity
Thermometry
Other-specify:
IR thermometry
Thermocouples/pyrometer indicators
Electromagnetic - DC/Low Frequency
DC voltage
AC voltage
DC current
AC current
Resistance
Capacitance
Inductance
Voltage/current converters (to 1 Mhz)
Current transformers
High voltage resistors
LF power/energy
magnetic
mixed dividers
phase meters
power-frequency
DMMs
pulse waveform
Resistance dividers
Oscilloscopes
Voltage transformers
Calibrators
RTD/thermocouples
Other-specify:
Electromagnetic - RF/Microwave
RF power
Attenuation
Phase
Amplitude modulation
Harmonics
Electromagnetic field strength
HF capacitance
Reflection
Transmission
SWR
Other-specify:
Time and Frequency
Frequency/time (source/measure)
Other-specify:
Time dissemination
Ionizing Radiation
Dosimetry
Radioactive sources
Other-specify:
Chemical Quantities
PH
Conductivity
Refractometry
Viscosity
Optical Radiation
Laser power energy
Photometric
UV radiometric-standard detectors
Other-specify:
ACLASS Form 4
Frequency modulation
Distortion
HF inductance
Q-standards
Timers and stopwatches
Other-specify:
Radiometric
Spectrophotometric
Wavelength
UV radiometric-standard source
Attenuation
ISO/IEC 17025 Application
Page 5 of 10
March 14, 2014
Preparation of Draft Scope of Accreditation
Testing Laboratories Only
The following information must accompany the Application for Accreditation to assist in preparation of the Scope
of Accreditation. Using the format on the following page, provide the following information:
1.
Reference to the general field of testing covered under the scope (e.g., Biological, Chemical, Medical,
Mechanical testing).
2.
Identification of the group of products, materials, or items tested, including any relevant matrices.
3.
Identification of the specific tests or types of tests performed.
4.
Identification of the specification, standard (method), or technique used. These may be laboratory-specific but,
whenever possible, they should be based on internationally accepted test procedures.
5.
Other information as applicable such as detection limit, range, type of equipment used, etc. The key equipment
or technology designation is always included here. Limits and ranges are typically not included unless the
applicant lab desires to market particularly sensitive capabilities.
6.
ACLASS requires scopes of accreditation to meet NIST SP 811 Guide for the Use of the International System
of Units (SI), where available. NIST 811 Guide was prepared by the National Institute of Standards and
Technology for those who need assistance in the use of the SI in their work, including the reporting of results of
measurements. NIST SP 811 can be accessed at www.aclasscorp.com/documents/industry-guidancedocuments.aspx.
The table following will be used to develop the draft Scope of Accreditation for your laboratory. A list of suggested
test areas follows the table. Please check all that apply to your laboratory.
ACLASS Form 4
ISO/IEC 17025 Application
Page 6 of 10
March 14, 2014
Draft Scope of Accreditation - Testing
Please complete the following table by typing and submitting electronically in Microsoft Word to allow for future
modifications. For examples of accredited laboratory scopes, visit www.aclasscorp.com and click on “Search
Accredited Organizations.”
Field of Test
Items, Materials, Specific Tests or
or Products
Properties
Tested
Measured
Specification,
Standard
Method, or
Technique Used
Key Equipment
or Technology*
*As applicable
ACLASS Form 4
ISO/IEC 17025 Application
Page 7 of 10
March 14, 2014
Testing Areas and Parameters
Instructions: The following are examples of parameters within each testing area. Check those testing parameters for
which your laboratory is seeking accreditation. If you do not see your parameter, check “other” and specify in the
space provided. This document is used in conjunction with the draft scope of accreditation above.
Accoustics and vibration
Biological/microbiological
Pharmaceutical/nutraceutical
Biotechnology/biochemical
Chemical
Animal drug testing
Fasteners
Metals
Inorganics/organics
Other-specify:
Paint
Fertilizers
Solvents
Coal
Construction materials
Dimensional inspection/measurement
Electrical
Environmental
Air
Environmental lead
Bioassay
Underground storage
Other-specify:
Asbestos
Water
Radon
Solid/hazardous wastes
Mechanical
Fasteners and metals
Plastics
Windows and doors
Other-specify:
Paint
Rubber
Paper
Non-destructive
Optical/photometric/radiometric:
Ionizing radiation
Thermal
Other-specify:
Multi-disciplinary
Information technology
Forensic
Health/hygiene
ACLASS Form 4
Medical/veterinary
Occupational
Food/beverage
ISO/IEC 17025 Application
Page 8 of 10
March 14, 2014
Appendix A
Responsibilities and Obligations of the Customer
By signing the application, the customer hereby requests ACLASS to perform ISO/IEC 17025 accreditation
activities pursuant to the application submitted to ACLASS by the customer (“Accreditation Activities”). ACLASS
shall perform the Accreditation Activities in accordance with ACLASS’s current Accreditation System. ACLASS
shall make available to the customer at the customer’s request the documents comprising ACLASS’s ISO/IEC
17025 Accreditation System.
ACLASS shall determine in its sole discretion whether the customer meets ACLASS requirements for accreditation
to the applicable requirements as set forth in ACLASS’s ISO/IEC 17025 Accreditation System (“Accreditation
Criteria”). In the event ACLASS determines that the customer meets the Accreditation Criteria, ACLASS shall
deliver to the customer ACLASS’s Certificate and Scope of Accreditation, which shall include a copy of the
accreditation symbol. The Certificate and Scope of Accreditation shall be deemed evidence of the customer’s status
as accredited pursuant to ACLASS’s Accreditation Criteria.
ACLASS shall have the right to carry out surveillance and reassessment pursuant to ACLASS’s ISO/IEC 17025
Accreditation System to verify the customer’s continuous compliance to the Accreditation Criteria.
The customer shall conform to the following:
a.
Maintain impartiality and integrity for all services provided under their scope of accreditation.
b.
Commit to meeting the requirements of ACLASS’s Accreditation Criteria including adapting to changes in the
requirements for accreditation.
c.
Take such actions as necessary to allow ACLASS to perform the Accreditation Activities, including providing
for the examination of documentation and the assessment of all areas, records, and personnel for the purposes of
assessment, surveillance, reassessment, resolution of complaints, and access to relevant documents that provide
insight into the level of independence and impartiality from any related body.
d.
Record and address complaints, report complaints to ACLASS, and otherwise continuously comply with all
relevant provisions of the Accreditation Criteria and claim accreditation only in respect of requirements and
scope for which the customer has been granted accreditation (ACLASS certificate and scope of accreditation do
not cover subcontracted calibrations).
e.
Notify ACLASS within 30 days of changes to customer’s laboratory management system or changes
significantly affecting customer (such as a change of ownership, change of location, change in key personnel
including top management, main policies, resources, or change in equipment or if analysis of a complaint or
other information indicates that customer no longer complies with the Accreditation Criteria) (“Change”).
f.
Allow ACLASS to conduct surveillance and/or reassessment of the customer in the event of a Change.
g.
Not expose assessors or others representing ACLASS to unsafe working conditions or environments, and
provide all assessors and others appropriate protective equipment.
h.
Arrange witnessing of services performed at the request of ACLASS, including allowing third parties selected
by ACLASS to witness ACLASS’ assessments.
i.
Not use its accreditation in a manner that may bring ACLASS into disrepute.
j.
Pay ACLASS for the Accreditation Activities as set in ACLASS’ procedures.
The ACLASS logo is a registered trademark solely owned by ACLASS. As long as the customer maintains its status
as accredited by ACLASS pursuant to ACLASS’s Accreditation Criteria, the customer shall have the non-exclusive
and non-transferable right to use the Certificate and Scope of Accreditation and the accreditation symbol (except as
provided for in the paragraph directly below) in the customer’s advertising, and marketing materials and campaigns,
certificates, and reports. In no event shall the customer use the Certificate and Scope of Accreditation and the
accreditation symbol (or a confusingly similar certificate and scope of accreditation or symbol) in a misleading or
unauthorized manner, including but not limited to representing that the Certificate and Scope of Accreditation and
the accreditation symbol exemplifies a product, service, or performance conformity certification; using the
ACLASS Form 4
ISO/IEC 17025 Application
Page 9 of 10
March 14, 2014
Certificate and Scope of Accreditation or the accreditation symbol in connection with requirements or activities not
approved by ACLASS; or otherwise acting to bring ACLASS or the accreditation symbol in disrepute.
If ACLASS expresses any concern with respect to the use of the Certificate and Scope of Accreditation or the
accreditation symbol as being inconsistent with or impermissible under this Application or ACLASS’s ISO/IEC
17025 Accreditation System, (“Improper Use”), ACLASS may ask the customer to cease and desist the Improper
Use, and it shall be deemed to be a condition to the customer’s continued accreditation that such Improper Use be
immediately discontinued. In addition, in the event of such Improper Use or in the event ACLASS determines that
the customer is not complying with any obligation of the customer under this Agreement or the Accreditation
System, ACLASS shall have the right upon written notice to the customer to (a) suspend its Accreditation Activities
until the customer complies with its obligation, (b) determine that the customer is no longer entitled to identify itself
as accredited by ACLASS and to require the customer (temporarily or permanently) to cease using in any manner
the Certificate and Scope of Accreditation (and to return such Certificate and Scope of Accreditation), the
accreditation symbol and/or accreditation mark, (c) refuse to issue a Certificate and Scope of Accreditation to the
customer, (d) require corrective action, (e) publish the customer’s transgression, or (f) take other legal action. In the
event ACLASS takes any of the foregoing actions, ACLASS shall not be required to reimburse any amount to the
customer.
ACLASS and its assessor shall perform the Accreditation Activities in a workmanlike manner consistent with
ACLASS’s current Accreditation System. The warranty set forth in this section is the sole and exclusive warranty of
ACLASS under this application and the services contemplated to be provided herein and no other express or implied
warranties exist, including but not limited to any warranty of merchantability and any warranty of fitness for a
particular purpose. The customer acknowledges that ACLASS does not warrant and has no liability or responsibility
for (and such liability and responsibility belongs solely to customer) the laboratory and safety of any product or
service produced, manufactured, delivered, sold or otherwise distributed by customer.
ACLASS and the customer are independent parties and nothing set forth in this Application creates a joint venture,
partnership or other concerted activity.
If, in ACLASS’s sole discretion, an assignment and/or activity by the customer effects a Change to the customer’s
management system under this Application and/or changes made by ACLASS to the Accreditation Criteria, the
customer shall cooperate and take the actions necessary to allow the assignment to occur based on a reassessment
and/or surveillance visit or such other activity as ACLASS reasonably deems necessary.
These Responsibilities and Obligations of the Customer shall be governed by, and construed and enforced in
accordance with, the laws of the State of Wisconsin. Any dispute under this Application shall be resolved pursuant
to the appeals procedure adopted by ACLASS from time to time. In the event the customer makes any claim that a
dispute is not subject to the appeals process or has not been adjudicated pursuant to the rules provided therein, the
customer shall not have the right to bring any action with respect thereto before a court of law or equity, but shall
only have the right to seek a determination from one arbitrator pursuant to the rules of the American Arbitration
Association as to whether such dispute was subject to the appeals process or was adjudicated pursuant to the rules
provided therein. Such arbitration shall be conducted in the State of Wisconsin, and each party shall bear its own
expense for such arbitration.
ACLASS Form 4
ISO/IEC 17025 Application
Page 10 of 10
March 14, 2014
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