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Steps to Accreditation
Listed below are the steps and Forms necessary to obtain accreditation to
ISO/IEC 17025 from Laboratory Accreditation Bureau, LLC (L-A-B). You
should contact L-A-B first to determine if any special circumstances may
apply.
Contact L-A-B
First step is to contact L-A-B
Sales and Customer Service to
determine the best way to handle your accreditation.
Assessment Procedure Flowchart
Form 11A – Initial Assessment & Reassessment Flow Chart
Form 11B – Accreditation through an Affiliate Flow Chart
Form 214 – Surveillance Assessment Flow Chart
Form
205.5 - Assessment Matrix
The assessment flow is defined in Forms
11A or 214 for direct accreditation thru L-A-B.
Accreditation thru an affiliate is
defined in Form 11B. All policies and procedures
must be understood prior to scheduling an onsite visit for
assessment.
Application Process
Application for Accreditation Quote
The laboratory
should start by completing the Application for Accreditation Quote located
on our website. L-A-B will produce an
estimate of the cost for the accreditation based on the submitted
information.
Costs are based on the number of employees, type of service in-house or
on-site, and the number of tests or calibrations defined on the Scope
Preparation Matrix(s)
Fee Structure
The initial application fee covers the cost of
reviewing documents submitted by the client and assigning/coordinating the
assessor assigned to the client.
The Annual Fee pays the cost of maintaining the credentials, staff, relative
committee participation and maintenance of the L-A-B web. The accreditation
is valid for three years; renewable based on the successful completion of a
re-assessment.
The additional annual fees beyond the first field/site are for each
additional field or site, but not both. A laboratory credentialed for three
fields and two sites would have two additional field/sites applied provided
that both sites are under the identical quality system, not five as perhaps
expected.
Preparation/Report is the cost of L-A-B staff and assessor’s review of the
relevant documents. This takes place prior to the initial or pre-assessment
visit to assure that your documentation indicates that you are ready for
your visit from the assessor. The fee also covers the time needed to
complete the concluding report.
Assessment Day is the charge per day for the assessor during all of your
visits.
L-A-B Program involves an initial assessment followed by a surveillance
visit in each of the next two years and then a full re-assessment.
Assessor expenses are charged to the client over and above the L-A-B fees.
Assessors try to keep the travel and living costs to a minimum
The quote and a copy of Form R 20.4—L-A-B Laboratory Accreditation Agreement
shall be sent to the client for approval and signature.
Activities Prior to Assessment
Prior to the initial assessment
laboratories are required to have completed there Best Measurement
Capability per Policy 001 and performed satisfactorily in one approved
PT / ILC under there proposed scope of accreditation per Policy 002. In addition to the requirements set forth
by L-A-B, the laboratory must maintain a management system that complies
with all applicable requirements of ISO/IEC 17025 General requirements for
the competence of testing and calibration laboratories and completed at
least one internal audit to these requirements. The laboratory is
required to own the most recent copy of ISO/IEC 17025.
To Start the Accreditation Process
The laboratory shall send a check for the
initial charges, a signed copy of Form R 20.4 - L-A-B Laboratory
Accreditation Agreement, and a signed estimate for accreditation.
Assessor Assignment
Laboratory Assessors are assigned based on
their qualifications and technical competence in the testing or fields of
testing to be assessed. With an adequate reason, the laboratory has the
right to ask for another assessor if they object to the original assignment.
L-A-B will allocate an assessor for the laboratory after all activities
prior to the assessment have taken place and all the required documentation
submitted to L-A-B.
Proficiency Testing
Policy 002 -
Proficiency Testing
Laboratories that wish to become accredited
and maintain their accreditation are responsible for participating in a
proficiency testing, interlaboratory comparison or a round robin testing
program that will meet the requirements of the international accreditation
community prior to the initial assessment. At a minimum, the ILC/PT must meet the requirements of ISO Guide
43. Any proficiency test, interlaboratory comparison or round robin (ILC/PT)
that is not conducted by an L-A-B approved provider
must be
approved by L-A-B before conducting the test to have the results accepted as
proof of compliance with the requirement. See Policy 002 for
details of the
requirements. It is critical that you understand this requirement prior to
the accreditation process.
Traceability and Measurement Uncertainty
Policy 001 -
Traceability and Uncertainty of Measurement
The laboratory must follow Policy 001 to
prove their traceability of measurements through all steps
of the calibration chain from NIST (or other national equivalents) down to
their laboratory. Please make sure that you understand the Policies and
Procedures prior to scheduling an onsite visit for assessment.
Best Measurement Capability must be calculated in accordance with Policy
001. The laboratory is required to submit these to L-A-B for evaluation
prior to the onsite assessment visit.
Reporting Uncertainty & Traceability
Policy 001 -
Traceability and Uncertainty of Measurement
Calibration and Dimensional Inspection
laboratories
Laboratories must report their measurement uncertainty on all
calibration and Inspection certificates, unless it can be proven that the
client does not want it reported. Evidence that the client does not want the
calibration uncertainty reported shall be available for an assessor to
review at the time of an assessment. Regardless of whether the client wants
the measurement uncertainty reported, the laboratory shall retain sufficient
information to report the uncertainty.
Testing Laboratories
Laboratories must perform and have available for the assessor a
Needs Assessment, Procedure(s),
and calculated uncertainties for those tests that require to have it
reported. They shall also create uncertainty budgets and have these for the
assessor to review during your assessment or surveillance visit. Please see
details in Policy 001—Traceability.
Internal Audits and Management Review
Prior to the initial assessment, the
laboratory must complete at least one Internal Audit of its
activities that covers their technical competence, compliance with ISO/IEC
17025, and one Management Review that is compliant with the requirements of ISO/IEC 17025.
Preparing the Scope of Accreditation
SOP 216 –
Handling Scopes of Accreditation
Form 28.10 and
Form 28.8 Calibration Labs
Form 28.9 and
Form 28.6 Testing Labs
Form 28.11 and
Form 28.5 Dimensional Inspection Labs
The laboratory must follow L-A-B procedure
SOP 216 when preparing their Proposed Scope(s) of Accreditation according to
the type of laboratory. Calibration Labs use Forms 28.10 and 28.8. Testing
Labs use Forms 28.9 and 28.6. Dimensional Inspection Labs use Forms 28.11
and 28.5.
Calibration and Dimensional Inspection laboratories must calculate and
report their best measurement capability, as defined above.
Optional Pre-Assessment
and Assessment
Form 48B - ISO/IEC17025:2005 Assessor Client Checklist
Pre-Assessment (Optional)
L-A-B recommends that laboratories have a
pre-assessment to evaluate its preparedness for the accreditation process.
The assessor(s) spends one to two days at the laboratory evaluating
the management system, and will point out areas that need improvement prior
to the full assessment process.
The laboratory must complete L-A-B Form 48B and submit this along with
all supporting documentation to L-A-B prior
to scheduling the pre-assessment visit. L-A-B will review the
documentation, and resolve any issues prior to sending the Form 48B and
supporting documents to the assessor for use during the pre-assessment.
At the time of the pre-assessment visit, the quality management system will
be assessed for implementation and compliance with ISO/IEC 17025. In
addition, and time permitting, a sampling of tests / calibrations may be
monitored for competence.
All noted areas of weakness must be addressed by the laboratory prior to the
full assessment visit. It should be understood that the areas found
noncompliant will receive a more thorough investigation in the full on-site
assessment. If clients desire, they may request and contract for a more
lengthy pre-assessment. This is an opportunity to identify areas of
weakness, and correct them before a full assessment is performed.
Full
Assessment
The laboratory must complete L-A-B Form 48B and
submit this along with all supporting documentation to L-A-B prior
to scheduling the full assessment visit. L-A-B will review the
documentation, and resolve any issues prior to sending the Form 48B and
supporting documents to the assessor for use during the full assessment.
At the time of the full assessment visit, the quality management system will
be assessed for implementation and compliance with ISO/IEC 17025. All
equipment and tests / calibrations that wish to be on the scope of
accreditation will be verified for technical competence.
Consultants
L-A-B fully understands the need for and
role of a consultant engaged by the client (s) of L-A-B. Often the client
has need to obtain outside assistance in the development of such items
including, but not limited to, the quality manual, development and
computation of best measurement of uncertainty, and proficiency testing
programs.
L-A-B also understands that the assessment must be of the client, its’
facilities, and its personnel. In no circumstances, may the consultant or
any person not a direct employee of the client speak on behalf of the client
during the assessment. All communication during the assessment must be
between the client and the assessor without interference.
When the consultant has been given the authority to speak on behalf of the
client, generally during the standards’ interpretation or document
development phases, it must be clear to the client that he must abide by the
decisions being made on his behalf. The changes must become part of his
system.
Relationship Between L-A-B and Laboratory
The laboratory
must accommodate L-A-B during the accreditation process to assure that they
are provided with the necessary materials, and appropriately arrange access
to all areas of the laboratory necessary to assess the compliance of the
laboratory. These accommodations extend to surveillance, reassessments and
for purposes of resolving complaints against the laboratory.
An accredited laboratory shall:
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At all times
comply with the provisions of the accreditation program, as defined in
the Accreditation Program Documentation.
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Claim that
it is accredited only for those services for which it has been granted
accreditation and which are carried out in accordance with these
conditions.
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Pay fees
assessed by L-A-B.
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Not use its
accreditation in a way that brings the accreditation body into
disrepute, and not make any statement relevant to its accreditation that
the accreditation body may consider misleading or unauthorized.
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If the
accreditation is suspended or withdrawn, the laboratory shall
discontinue the use of all advertising materials that contain any
reference to L-A-B, and return any certificate of accreditation to
L-A-B.
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Not use its
laboratory accreditation to imply product approval by L-A-B.
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Endeavor to
ensure that no certificate or report, nor any part thereof is used in a
misleading manner.
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Make sure
that its references to its accredited status comply with L-A-B
requirements in all communication media, such as
advertising, brochures or other documents.
Granting or
Denying Accreditation
Upon the completion of the assessment, one or more members of the L-A-B
staff or where necessary a technically competent individual, determined
appropriate by the Operations or Testing Manager will review the
accreditation documentation. The decision to accredit the laboratory
will be made by L-A-B technical staff based on the laboratory’s
compliances with the specific and L-A-B requirements.
L-A-B will then send a Certification of Accreditation along with an
approved Scope of Accreditation to laboratories that are granted
accreditation.
If a laboratory is denied accreditation, L-A-B shall notify the
laboratory of the decision, and provide them with the reasons for
denying accreditation. If the laboratory disagrees with the reasons
given for denial, it may appeal to the Operations Manager of L-A-B, who will initiate
an appeals procedure. Appeal actions must be initiated
within 30 days of the notification to deny accreditation.
Surveillance Assessment of
Laboratories
Form 214 - Surveillance Flow Chart
Form
205.5 - Assessment Matrix
Surveillance visits are conducted annually.
This assessment will cover a portion of the standard and evaluate the
technical competence of the laboratory. Every three years a complete reassessment is
conducted. Special surveillance visits may be scheduled more frequently
should circumstances indicate that a laboratory might not be compliant
with the requirements of the L-A-B program.
Maintaining Accreditation
Accreditation is maintained by surveillance assessments annually for two
years, the third year a full ISO/IEC 17025 assessment is performed, and
satisfactory participation in the appropriate proficiency testing and
interlaboratory comparison programs.
Accreditation Date
and Surveillance Schedule
The date of
accreditation will be the date of the final approval for the granting of
accreditation by L-A-B in accordance with the system requirements for review
and approval of assessment reports and associated materials. The
yearly surveillance visit (years 1 and 2) or re-assessment (year 3) must
take place within thirty days of the last assessment day of the initial
visit, regardless of the date of the accreditation.
Exceptions
If there are extenuating circumstances with the express approval of the
Operations Manager exceptions may be made regarding dates for conduct of
surveillance visits and re-assessment visits. At times, there may be
need to extend the date of accreditation beyond the date shown on the
certificate of accreditation. The same rules apply for the granting of
extensions as are stated previously.
Extending or Expanding the Scope of Accreditation
SOP 215 -
Scope Modification
There are
several circumstances that might require the extension of an accreditation.
In each instance L-A-B technical staff will
review all available documentation, which includes but is not limited to
proficiency testing results, complaint files, and previous assessments,
to determine whether the laboratory’s accreditation may be extended for
a defined period of time.
If a laboratory wishes to expand its scope of accreditation to include
additional tests or fields of testing, the laboratory shall submit, in
writing, a request for the proposed expansion. This shall include a copy
of the Proposed Scope, test/calibration methods, and necessary
uncertainty documentation that supports the expansion requested. L-A-B
technical stall will review the proposed expansion
request and supporting documentation to determine what actions may be
necessary to grant the expansion. The actions may include, but are not
limited to, the following:
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If the tests are similar to the ones that the laboratory is currently
accredited to perform, the submitted information shall be reviewed by
the assessor who performed the most current assessment. Based on the
assessor’s recommendation, L-A-B will decide whether the laboratory can
be granted the expansion, or whether an additional visit is necessary.
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If the laboratory has asked for an expansion into a completely new
field of testing or calibration, or the test/calibration method is not
similar to that for which the laboratory is currently accredited, an
assessment visit shall be scheduled. The assessment visit shall be
limited to the technical assessor(s) capable of assessing the
testing/calibration under consideration. The assessment visit will
normally include only those elements that are necessary to determine the
laboratory’s technical competence with regard to the proposed expansion.
However, if the assessor(s), during the investigation for the expansion,
uncover evidence that indicates a systemic problem may exist, they may
choose to follow the thread until they are assured that a larger problem
does or does not exist.
Decreasing Scope of Accreditation
When a laboratory loses a key person without replacing them, loses the
use of equipment necessary to perform an accredited test without
replacing it, or any other change that may affect the capability of the
laboratory, the laboratory will notify L-A-B immediately. L-A-B will
determine a course of action based on the circumstances. In all
instances the test(s) in question shall be removed from the laboratory’s
scope of accreditation, until such time as the laboratory has proved its
competence. The laboratory may wish to voluntarily decrease its scope
and is free to do so at anytime by notifying L-A-B or the desired
changes.
Other actions may be necessary if the laboratory wishes to have the
removed test method added to their scope of accreditation at a later
date. These actions may include reassessment, review of test methods and
documentation, and/or review of personnel qualifications.
Transfer of Accreditation
SOP 210 - Transfer of Accreditation
L-A-B shall consider each transfer of an accreditation from one
accreditation body to L-A-B. The decision to accept a transfer is based
on the review of the previous accreditation body’s report, and/or
assessment visit. This is based on the time until expiration of the
current accreditation.
If the legal status (e.g. ownership) of an accredited laboratory
changes, the information on the changes that have taken place shall be
forwarded to L-A-B for review. The Operations Manager shall determine
what actions may be necessary to continue the accreditation. These
actions may include, but are not limited to the following:
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Review and approval of changes, with no surveillance.
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The review indicates that the changes could have an effect on the
testing or calibrations; therefore, a surveillance visit is necessary
immediately.
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The review indicates that the changes can be covered at the next
scheduled surveillance visit
Termination or Suspension of Accreditation
SOP 306 - Suspension and Termination of Accreditation
In the event that L-A-B proposes to withdraw or suspend accreditation,
the laboratory shall be notified of the reasons for such actions. The
laboratory shall be given the opportunity to provide evidence that the
reasons for withdrawal or suspension are not warranted. The laboratory
may appeal the decision to withdraw or suspend accreditation following
the Appeals Procedure SOP 203 and as defined in this manual. Appeal
actions must be initiated within 30 days of the notification to withdraw
or suspend accreditation.
When an accreditation is suspended, the laboratory must cease using the
L-A-B logo on its test and calibration reports and certificates, and
notify their clients of the loss of the accredited status. The
laboratory must cease using the L-A-B logo in any way. The laboratory
will also return the Certificate of Accreditation and Approved Scopes
of Accreditation. See SOP 204 Use of Logo for details
Accreditation of Laboratories that have been denied, suspended or
withdrawn
A laboratory who has been denied accreditation or had its accreditation
suspended or withdrawn may apply for and be granted accreditation if the
following requirements are met:
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The laboratory management system must be in full compliance with ISO/IEC
17025, and L-A-B requirements.
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The laboratory can prove its technical competence in the tests or
types of tests for which accreditation is sought.
Disputes and Appeals
SOP 203 - Appeals complaints and Disputes
A laboratory may appeal a L-A-B decision not to grant, suspend, or
terminate accreditation. This appeal must be sent to L-A-B, in writing,
within 30 days of notification of the decision. The appeal will state
the reasons why the laboratory believes it should receive or retain its
accreditation.
Complaints Received About Accredited
Laboratories
When a complaint
is filed against an accredited laboratory, the Operations Manager will determine if the complainant
is valid and will contact the laboratory to seek resolution. If resolution is not
possible with the laboratory, the Operations Manager will
initiate an investigation into the matter. If the investigation or any
other matter indicates that a laboratory no longer complies with the
requirements of this program, L-A-B will initiate an immediate
surveillance assessment.
Notification of Changes
Form 19 - Laboratory Change Request Form
L-A-B must be
notified of any matters that may affect the
laboratory’s capability, scope of accredited activities, or compliance
with the requirements for accreditation including:
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Legal, commercial or organizational status
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Organization and management, e.g. key managerial staff
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Policies or procedures that directly affect the validity of data
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Physical location or premises
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Key personnel, equipment, facilities, working environment or other
resources that would impact the validity of data, or the laboratory’s
ability to perform accredited tests/calibrations
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Authorized signatories
After receiving
notice of changes relating to the accreditation, L-A-B will ensure that the
laboratory carries out the necessary adjustment to its procedures within a
reasonable amount of time. The laboratory should inform L-A-B of the actions that it has taken or
will be taking to adjust its procedures, to ensure that the laboratory
remains compliant with the requirements of accreditation. L-A-B may choose to assess the changes as follows:
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Perform a surveillance visit
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Make a brief visit to the laboratory to assess the impact of the
change
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Perform a full surveillance
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Request further proof of compliance with requirements
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Revise the Scope of Accreditation to reflect the lost of capability
L-A-B will inform its accredited laboratories of changes to the
requirements for accreditation such as:
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Changes to the standards
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Changes to L-A-B policies and procedures
L-A-B will inform the laboratory of the allotted time in which it must
become compliant with the new requirements.
Use of Logo
Policy 012 - Control and Use of Symbol
Accredited laboratories are granted the right to use the L-A-B
symbol on
the test reports and certificates, and calibration certificates, for
those tests and calibrations for which they have been accredited. Tests
that are not accredited shall be identified as such when they appear in
a report that has the L-A-B symbol on it. See Policy 012 - Control and
Use of Symbol for guidance.
Guidance
Guidance Document 002 – ISO/IEC 17025:2005 Laboratory Guidance Document
L-A-B offers a guidance document that may help explain the
requirements of ISO/IEC 17025 item by item.
Please make sure that you have reviewed understand ALL procedures and
policies prior to scheduling an onsite visit for assessment.
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