Steps to Accreditation
Accreditation Process Explained
Laboratory Accreditation Bureau provides the best possible accreditation services for your laboratory. L-A-B will provide personal service every step of the way to assure you fully understand what it takes to become accredited. Listed below is a summary of the steps necessary to obtain ISO / IEC 17025 accreditation from Laboratory Accreditation Bureau. You may contact L-A-B at anytime to discuss further and determine if any special circumstances may apply. Additionally, L-A-B provides a Client Instruction Manual which details the entire accreditation process. You may also view a brief 8 minute video overview of the "get a quote function" and sign up for a free 5 part video course on ISO/IEC 17025 here.
- Activities Prior to Assessment
- To Start the Accreditation Process
- Traceability and Measurement Uncertainty
- Internal Audits and Management Review
- Preparing the Scope of Accreditation
- Relationship Between L-A-B and Laboratory
- Surveillance and Reassessment
- Accreditation Date and Surveillance Schedule
- Expanding the Scope of Accreditation
- Decreasing Scope of Accreditation
- Termination or Suspension of Accreditation
- Accreditation of Laboratories that have been Suspended or Withdrawn
- Complaints Received About Accredited Laboratories
- ISO / IEC 17025 Guidance Document
First step is to contact L-A-B Sales and Customer Service to determine the best way to handle your accreditation.
Application for Accreditation Quote
The laboratory should start by completing our free on line application for accreditation located on our website. L-A-B will provide an estimate of the cost for the accreditation based on the submitted information. It is completely free to receive an estimate for accreditation costs.
Accreditation costs are based on the required time to technically evaluate the tests or calibrations defined on the Scope Preparation Matrix(s), the specific major field classification of the testing or calibrations from the scope, and the number of locations to be accredited.
The fee structure for the L-A-B accreditation is as follows:
Application Fee - Covers the cost of reviewing documents submitted by the client and assigning/coordinating the assessor assigned to the client. Only billed after client agrees to go forward with accreditation.
Annual Fee - Covers the cost of maintaining the credentials, staff, relative committee participation and maintenance of the L-A-B website. The accreditation is valid for three years; renewable based on the successful completion of a re-assessment. Annual fees are based off of the number of major field technologies and laboratory locations.
Preparation / Report Fee - Covers the cost of L-A-B staff and Assessors or Technical Experts to review the relevant documents. This fee also covers the time needed to complete the concluding report.
Assessment Mandays - Are the charge per day for the on-site assessor time during all of your visits.
Travel Expenses - Are charged to the client as occurred over and above the L-A-B fees. L-A-B makes every effort to reduce the travel costs of Assessors by utilizing local assessors where available and to keep the travel and living costs to a minimum.
Activities Prior to Assessment
The laboratory is required to own the most recent copy of ISO / IEC 17025 and must maintain a management system that complies with all applicable requirements of this standard. Prior to the initial assessment the laboratory must have completed at least one full 17025 Internal Audit and Management Review. If required, laboratories must also complete there Best Measurement Capability per L-A-B Policy 001 and performed satisfactorily in one approved PT / ILC under there proposed scope of accreditation per L-A-B Policy 002.
- Best Measurement Capability
- Satisfactorily completed one PT / ILC
- Own the most recent copy of ISO/IEC 17025
- Completed at least one internal audit
- Completed at least one Management Review
To Start the Accreditation Process
The laboratory must sign the estimate for accreditation and pay the initial charges.
Laboratory Assessors are assigned based on their qualifications and technical competence as compared with the laboratories scope of accreditation to be assessed. 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.
Policy 002 - Proficiency Testing
Laboratories that wish to become accredited and maintain their accreditation are responsible for participating in a proficiency testing, inter laboratory 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, inter laboratory 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 L-A-B 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 on-site 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 on-site 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 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. Some laboratories may also be required to create uncertainty budgets and have these for the assessor to review during your assessment or surveillance visit. Please see details in Policy 001.
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
The laboratory is required to prepare a "Proposed Scope of Accreditation" as a part of its initial application application process. The Scope of Accreditation is a formal document issued by L-A-B to accredited laboratories. The Scope is the expression of calibration parameters, testing technologies, ranges, parameters, uncertainties for which accreditation has been granted. The L-A-B assessment process assures the technical competence of all parameters listed on the scope of accreditation. Read more about completing the scope of accreditation.
A preassessment is an opportunity for the laboratory to have their quality system and technical activities evaluated by an Assessor prior to the actual initial visit. This is an opportunity to point out areas of the quality system that may need improvement prior to the full assessment process. L-A-B recommends that laboratories utilize a pre-assessment to evaluate their preparedness for the accreditation process. Typically the same assessor that is assigned for the initial assessment will perform the preassessment in a one day onsite visit. If clients desire, they may request and contract for a more lengthy pre-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.
L-A-B fully understands the need for and role of a consultant utilized 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.
Upon the completion of the initial assessment a technically competent individual 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 accreditation requirements. After granting of the accreditation L-A-B will send a Certification of Accreditation along with an approved Scope of Accreditation to the laboratory.
Surveillance and Full Reassessment
Form 214 - Surveillance Flow Chart
Form 205.5 - Assessment Matrix
Surveillance visits are conducted annually. These assessments are shortened versions of the initial assessment and typically cover half of the quality system and scope. Every three years a complete reassessment is conducted.
The laboratory is required to comply with the requirements of ISO / IEC 17025 and L-A-B and maintain technical competence for the items listed on their scope of accreditation. Annual surveillance assessment visits are performed for two years, the third year a full ISO / IEC 17025 assessment is performed to assure compliance with all requirements. The laboratory must also perform in the appropriate proficiency testing and inter laboratory comparison programs with satisfactory participation.
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 exceptions may be made regarding dates for conduct of surveillance visits and re-assessment visits with the approval of L-A-B. 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.
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.
Expanding the Scope of Accreditation
SOP 215 - Scope Modification
If a laboratory wishes to expand its scope of accreditation to include additional tests or calibrations, the laboratory must submit, in writing, a request for the proposed expansion. This request must include a copy of the Proposed Scope with the changes identified, 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:
If the tests are similar to the ones that the laboratory is currently accredited to perform, the submitted information will 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.
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 on site assessment visit must be scheduled. The assessment visit will 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
The laboratory may reduce their scope of accreditation voluntarily at anytime by a formal request in writing. The scope may also be reduced by L-A-B due to technical issues relating to any scope item.
SOP 210 - Transfer of Accreditation
L-A-B makes it easy to transfer your existing ISO / IEC 17025 accreditation. Laboratories who are currently accredited by an ILAC MRA signatory accreditation body may qualify for L-A-B's transfer program. This program is designed for currently accredited laboratories who are in good standing with their current accreditation but may be looking for a fresh opportunity with their ISO / IEC 17025 accreditation.
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 will be notified of the reasons for such actions. The laboratory will 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.
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.
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.
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
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equipment, facilities, working environment or other resources that would impact the validity of data, or the laboratory's ability to perform accredited tests/calibrations
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.
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.
ISO / IEC 17025 Guidance Document
L-A-B offers a free ISO / IEC 17025 guidance document available upon request that provides additional explanation and L-A-B interpretations of each element of 17025.
To obtain a free copy of this document please contact our sales and customer service department at sales@l-a-b.com or call toll free 1-877-ISO-LABS.
Please make sure that you have reviewed understand ALL procedures and policies prior to scheduling an on-site visit for assessment.