AIHA Laboratory Accreditation Programs, LLC
Application for
Laboratory Accreditation
Revised: February 10, 2017
Effective: February 10, 2017
AIHA Laboratory Accreditation Programs, LLC
3141 Fairview Park Drive, Suite 777
Falls Church, VA 22042
Phone: (703) 846-0736 Fax: (703) 207-8558
www.aihaaccreditedlabs.org
Revision14 Effective February 10, 2017 AIHA-LAP, LLC Application for Laboratory Accreditation Page 41 of 41
INSTRUCTIONS
Ensure you are using the most current version of the application and that it aligns with the current AIHA-LAP, LLC Policy Modules. Out-of-date versions of the application will not be accepted.
1. The laboratory must purchase International Standard ISO/IEC 17025:2005, “General Requirements for the Competence of Testing and Calibration Laboratories” and provide evidence of ownership of this document prior to applying for accreditation. See Attachment 6A.1 and Form 9 of this application.
a) For initial laboratories only: Prior to submission of this application, the laboratory must submit Form 9 and/or proof of purchase of the ISO/IEC 17025:2005 standard or other applicable requirements and if necessary, request a copy of the current AIHA-LAP, LLC Site Assessment Checklist.
b) Completion of indicated sections of the Site Assessment Checklist and submission of the completed Checklist with the application is required; see Attachments 6A.2 and 6A.8 of this application.
c) Contact the Manager of Operations for information on accreditation fees.
2. Read all instructions carefully.
a) A complete and concise application will expedite the accreditation process.
b) A complete listing of terms and acronyms is located in Policy Module 9.
3. The laboratory must be familiar with and comply with all relevant AIHA-LAP, LLC Policy Modules and ISO/IEC 17025:2005.
a) The current version of the Policy Modules is available on the AIHA-LAP, LLC web site located at: http://www.aihaaccreditedlabs.org.
b) The AIHA-LAP, LLC Policies are comprised of specific modules, outlining general quality system requirements, program-specific technical requirements, and proficiency testing requirements. The laboratory must comply with all of the policies related to the scope of accreditation being sought prior to initiating the application process.
c) Particular attention must be given to Module 2A and the program-specific policy modules (2B-2F) for the program(s) for which the laboratory is applying.
d) It is strongly recommended that laboratories complete an internal audit using the AIHA-LAP, LLC Site Assessment Checklist in order to determine their compliance to ISO/IEC 17025:2005 and AIHA-LAP, LLC requirements prior to submitting their application.
e) A description of the accreditation process (with timelines) is included in Policy Module 3. Laboratories are expected to become familiar with the accreditation process before submitting an application to AIHA-LAP, LLC. Per Policy 3.1 - Laboratories that fail to complete all the requirements for accreditation for any or all selected FoT(s) within twelve (12) months from the date of receipt of the application by AIHA-LAP, LLC will have their application for the FoT(s) not meeting accreditation requirements removed from consideration. Per Policy 3.12.1, the reaccreditation process is similar to the initial accreditation process, except that the process must be completed before the expiration date of the current accreditation(s) and failure to submit a complete application may result in suspension of accreditation(s).
4. Laboratories must submit the application and attachments, plus a copy of the Quality Manual, electronically. Application materials should be uploaded through AIHA-LAP’s secure site: http://www.aihaaccreditedlabs.org/filetransfers/Pages/default.aspx
Applications will be accepted via email, however please be aware that email size limitations are in place, so large files (5MB and greater) will need to be sent in multiple emails.
a) If you do not receive confirmation of your application submission within two weeks, contact AIHA-LAP, LLC.
b) Compile the completed application and clearly labeled attachments, in chronological order, into a single application package. Some methods of accomplishing this task may be a bookmarked PDF document, a hierarchical folder system, etc. (see “Instructions for Forms 6A – 6F” section C). It is preferable that the Attachments and Quality Manual be submitted as “text searchable” documents. AIHA-LAP, LLC will not attempt to interpret the documents submitted, so be certain that the documents are clearly labeled for each attachment.
c) International laboratories should ensure that all application forms, Quality Assurance Manual, and lab policies and procedures are submitted in English. Records not translated into English may be acceptable, but AIHA-LAP, LLC staff and/or the assessor may contact the lab for assistance in translating.
5. The laboratory must submit all requested attachments. The application includes forms for all AIHA-LAP, LLC programs. Please see Table of Contents to determine which forms to complete. Failure to submit the appropriate attachments initiates requests for more information, which delays the accreditation process. Policy 3.3.2 and Policy 3.3.3: The AIHA-LAP, LLC staff shall have twenty (20) business days to complete the application review upon receipt and, if requested, the laboratory shall supply all requested information to complete the application within thirty (30) business days.
a) Attachments are required, as specified on Forms 6A through 6F.
b) Attachments must be complete and clearly labeled as required on Form 6.
6. Please delete all forms that the laboratory is not required to complete before submitting the application to AIHA-LAP, LLC.
Revision14 Effective February 10, 2017 AIHA-LAP, LLC Application for Laboratory Accreditation Page 41 of 41
Revision14 Effective February 10, 2017 AIHA-LAP, LLC Application for Laboratory Accreditation Page 41 of 41
TABLE OF CONTENTS
Page Number(s) / Description / Form Number / Forms Needed for ApplicationIHLAP / ELLAP / EMLAP / Unique Scopes / FoodLAP
2-3 / Instructions / N/A
4 / Table of Contents / N/A
5 / General Information / 1A / ü / ü / ü / ü / ü
6 / Special Requirements for Assessment / 1B / ü / ü / ü / ü / ü
7-15 / Methods and PT Participation (all programs) / 2 / ü / ü / ü / ü / ü
16 / Management Summary / 3 / ü / ü / ü / ü / ü
17-18 / Management - Documentation of Experience / 4 / ü / ü / ü / ü / ü
19-23 / Analysts/Technicians:
IHLAP
ELLAP
EMLAP
Unique Scopes
FoodLAP / 5A
5B
5C
5D
5E / ü / ü / ü / ü / ü
24-25 / Instructions – Forms 6A through 6F / N/A
26-27 / Quality Assurance – General Requirements (Policy Module 2A) / 6A / ü / ü / ü / ü / ü
28-29 / Quality Assurance – IHLAP (Policy Module 2B) / 6B / ü
30-31 / Quality Assurance – ELLAP (Policy Module 2C) / 6C / ü
32-33 / Quality Assurance – EMLAP (Policy Module 2D) / 6D / ü
34 / Quality Assurance – Unique Scopes (Policy Module 2E) / 6E / ü
35 / Quality Assurance – FoodLAP (Policy Module 2F) / 6F / ü
36 / Certifications Regulatory Compliance / 7 / ü / ü / ü / ü
37-38 / Indemnifications and Certifications Compliance with Requirements / 8 / ü / ü / ü / ü
39 / Affidavit (See form 6A, attachment 6A.1) / 9 / ü / ü / ü / ü
Revision14 Effective February 10, 2017 AIHA-LAP, LLC Application for Laboratory Accreditation Page 41 of 41
FORM 1A – GENERAL INFORMATION
Date: / Please check appropriate box(es):¨ Initial
¨ Reaccreditation
¨ FoT Addition
¨ Pre-Assessment
¨ Transfer of Accreditation / Lab is seeking accreditation in:
¨ IHLAP
¨ ELLAP
¨ EMLAP
¨ Unique Scopes
¨ FoodLAP
Number of Methods Applicant is Seeking Accreditation
Less than 75 ¨
75 or more ¨
Laboratory Name (to be officially listed on the certificate and scope of accreditation): / Laboratory ID (If not assigned, contact the Manager of Operations: ):
Company Name (If different from laboratory name. Indicate relationship of Laboratory to larger corporate entity, if any): / Street Address and phone number (to be officially listed on the certificate and scope of accreditation): (i.e., physical location and number to be covered by the scope of accreditation, P.O. Boxes not acceptable):
Website Address (if applicable): / Locations where Lab ID Symbol is used (i.e., report, brochure, website):
Owner(s) (If privately held) and Legal Status (e.g., “wholly owned subsidiary”): / Mailing Address (If different from street address, P.O. Boxes are acceptable):
Primary Contact Name: / Billing Address (if different from street address):
Primary Contact Title: / Billing Contact Name:
Primary Contact Telephone Number: / Billing Contact Telephone Number:
Primary Contact E-Mail Address: / Billing Contact E-Mail Address:
Is the laboratory currently under investigation or suspension by a governmental or private accreditation /certification agency?
¨ Yes ¨ No
If yes, attach a separate sheet describing the dates and circumstances of the investigation or suspension and discuss any applicable corrective actions. / Check the laboratory type and/or type of activities that apply to this application (Please note that each laboratory/facility type requires a separate application):
¨ Fixed Site Laboratory
¨ Field Sampling Activities
¨ Mobile Laboratory
¨ Field Operations Laboratory
Has the laboratory previously applied for AIHA-LAP Accreditation?
¨ Yes ¨ No
Laboratory Type:
¨ Commerce (fee for service) ¨ Academia ¨ Navy ¨ other Government ¨ Other (explain:______)
Has the laboratory ever been accredited to ISO/IEC 17025 by AIHA-LAP or another accrediting body? ¨ Yes ¨ No
If yes, please indicate the accrediting body, certificate number, expiration dates and the programs for which this accreditation is held.
For international applicants, please attach a statement as to why you are seeking accreditation from AIHA-LAP, LLC.
FORM 1B – SPECIAL REQUIREMENTS FOR ASSESSMENT
Please note below any special requirements that AIHA-LAP, LLC should be aware of while arranging for your site assessment. If there are any other special requirements not specifically listed, please describe them under “Other”.Contractual P/O Requirements (i.e., indicate if terms of PO that require SA to supply receipts to your organization)?
Safety Requirements (e.g., training)?
Security Requirements (e.g., clearance levels, security check-in, and anticipated delays)?
Can the assessor bring a laptop computer on-site?
Can the assessor park a car on-site? Any special parking arrangements?
Should the assessor contact the laboratory before making lodging arrangements for special rates, etc.?
Normal hours of operation (e.g., 8am–5pm, Monday–Friday):
Are there any other requirements we should be aware of? Please specify.
Revision14 Effective February 10, 2017 AIHA-LAP, LLC Application for Laboratory Accreditation Page 41 of 41
FORM 2– IHLAP Methods & PT Participation Plan
INSTRUCTIONS: For each Field of Testing for which you are applying, please list all internal method numbers and the corresponding published reference method. If more space is needed, the cells will expand to accommodate each method listed. Each published method reference should be listed individually (“Various NIOSH and OSHA Methods” is not sufficient). Include both analytical and preparation methods. Also list the PT participation plan for each Field of Testing or method (refer to Policy Module 6 and the Scope/PT Table on the AIHA-LAP, LLC website). Policy 3.9: A laboratory may add a FoT to an existing Core Scope category via FoT application. Those FoTs outside an already accredited Core Scope category will be submitted to site assessor review to determine of a site visit is necessary. For FoT additions at the time of assessment, not included on the laboratory’s Form 2 upon application submission, the laboratory must first give sufficient notice (a minimum of ten (10) business days) notice, subject to agreement by the assessor.
PLEASE INDICATE CHANGES (ADDITIONS/DELETIONS) FROM THE LAST ON-SITE ASSESSMENT.
ASSESSORS: If changes are made to this form onsite, either request an updated form from the laboratory or make changes as follows: If deleting a FoT and/or method, cross out the line and write “DELETE”. If adding FoT/methods make a note of the addition including all relevant information on this page, marking addition with “ADDED”.
AccreditationProgram / Scope Category / Fields of Testing (FoT)
(the following FoTs cover all relevant IH matrices) / Technology
sub-type/Detector / Approximate Number of Analyses performed annually for each FoT selected / List In-House Laboratory Method Number (e.g., SOP M-1) / List Corresponding Published Reference Method or Title/ Analyte of In-House Method (e.g., NIOSH 1400) / PT Participation Plan / Scope Verification
(Verified by Assessors who mark observed methods with an *) Do not complete with application /
SAMPLE / Chromatography Core / Gas Chromatography / GC/FID / 4000 / SOP XYZ / NIOSH 1400 / IHLAP Organics
Industrial Hygiene / Chromatography Core / Gas Chromatography / GC/FID
GC/TCD
GC/ECD
GC/NPD
GC/FPD
GC/AED
GC/TEA
GC/
Chemiluminescence
GC/PID
GC/DID
GC/MS
Gas Chromatography
(Diffusive Samplers)
Ion Chromatography (IC)
Liquid Chromatography / HPLC/FL
HPLC/UV
LC/MS
Accreditation
Program / Scope Category / Fields of Testing (FoT)
(the following FoTs cover all relevant IH matrices) / Technology sub-type/ Detector / Approximate Number of Analyses performed annually for each FoT selected / List In-House Laboratory Method Number (e.g., SOP M-1) / List Corresponding Published Reference Method or Title/ Analyte of In-House Method (e.g., NIOSH 1400) / PT Participation Plan / Scope Verification
(Verified by Assessors who mark observed methods with an *) Do not complete with application /
Industrial Hygiene / Spectrometry Core / Atomic Absorption / CVAA
FAA
GFAA
Inductively-Coupled Plasma / ICP/MS
ICP/AES
X-ray Diffraction (XRD)
UV/Vis (Colorimetric)
Infrared (FTIR, IR, SIR)
Accreditation
Program / Scope Category / Fields of Testing (FoT)
(the following FoTs cover all relevant IH matrices) / Technology sub-type/ Detector / Approximate Number of Analyses performed annually for each FoT selected / List In-House Laboratory Method Number (e.g., SOP M-1) / List Corresponding Published Reference Method or Title/ Analyte of In-House Method (e.g., NIOSH 1400) / PT Participation Plan / Scope Verification
(Verified by Assessors who mark observed methods with an *) Do not complete with application /
Industrial Hygiene / Asbestos/Fiber Microscopy Core / Polarized Light Microscopy (PLM)
Phase Contrast Microscopy (PCM)
Transmission Electron Microscopy (TEM)
Accreditation
Program / Scope Category / Fields of Testing (FoT)
(the following FoTs cover all relevant IH matrices) / Technology sub-type/ Detector / Approximate Number of Analyses performed annually for each FoT selected / List In-House Laboratory Method Number (e.g., SOP M-1) / List Corresponding Published Reference Method or Title/ Analyte of In-House Method (e.g., NIOSH 1400) / PT Participation Plan / Scope Verification
(Verified by Assessors who mark observed methods with an *) Do not complete with application /
Industrial Hygiene / Miscellaneous Core / Titrimetric
Gravimetric
Ion-selective electrode (ISE)
Thermo-optical Analysis (TOA)
Anodic Stripping Voltammetry(ASV)
Accreditation
Program / Scope Category / Fields of Testing (FoT)
(the following FoTs cover all relevant IH matrices) / Technology sub-type/ Detector / Approximate Number of Analyses performed annually for each FoT selected / List In-House Laboratory Method Number (e.g., SOP M-1) / List Corresponding Published Reference Method or Title/ Analyte of In-House Method (e.g., NIOSH 1400) / PT Participation Plan / Scope Verification
(Verified by Assessors who mark observed methods with an *) Do not complete with application /
Industrial Hygiene / Compressed/
Breathing Air Testing / Gas Chromatography / GC/FID
GC/TCD
GC/ECD
GC/XSD
GC/MS
UV/VIS (Colorimetric)
Gravimetric
Infrared
Accreditation
Program / Scope Category / Fields of Testing (FoT)
(the following FoTs cover all relevant IH matrices) / Technology sub-type/ Detector / Approximate Number of Analyses performed annually for each FoT selected / List In-House Laboratory Method Number (e.g., SOP M-1) / List Corresponding Published Reference Method or Title/ Analyte of In-House Method (e.g., NIOSH 1400) / PT Participation Plan / Scope Verification
(Verified by Assessors who mark observed methods with an *) Do not complete with application /
Pharmaceutical Testing / Liquid Chromatography / HPLC/EC
Industrial Hygiene / HPLC/FL
HPLC/UV
LC/MS
GC/MS (appropriate only when the sampling methodology is a filter for collection of pharmaceutical dusts)
Accreditation
Program / Scope Category / Fields of Testing (FoT)
(the following FoTs cover all relevant IH matrices) / Technology sub-type/ Detector / Approximate Number of Analyses performed annually for each FoT selected / List In-House Laboratory Method Number (e.g., SOP M-1) / List Corresponding Published Reference Method or Title/ Analyte of In-House Method (e.g., NIOSH 1400) / PT Participation Plan / Scope Verification
(Verified by Assessors who mark observed methods with an *) Do not complete with application /
Industrial Hygiene / Beryllium Testing / Atomic Absorption (GFAA)
Inductively- Coupled Plasma / ICP/MS
ICP/AES
Optical Fluorescence
To be completed during site assessment: The laboratory hereby consents to release and submittal of any AIHA PAT Programs, LLC or other AIHA-LAP, LLC – approved third-party proficiency testing results with which the AIHA-LAP, LLC has a Memorandum of Understanding that are a requirement for the above Fields of Testing to and for use by AIHA-LAP, LLC.
The site assessor certifies that the laboratory scope of accreditation shown above was verified with laboratory management and that all scopes listed were reviewed during this assessment:
Laboratory Signature & Date ______Laboratory Number: ______
Site Assessor Signature & Date ______FORM 2– ELLAP Methods & PT Participation Plan
INSTRUCTIONS: For each Field of Testing/Matrix for which you are applying, please list all internal method numbers as well as published reference methods corresponding to the internal method numbers. Each published method reference should be listed individually (“Various NIOSH and OSHA Methods” is not sufficient). Include both analytical and preparation methods. If more space is needed to capture methods not defined on this form, please add lines to this table. For FoT additions at the time of assessment, not included on the laboratory’s Form 2 upon application submission, the laboratory must first give sufficient notice (a minimum of ten (10) business days) notice, subject to agreement by the assessor.