Instructions Application for accreditation

Centre d’expertise en analyse environnementale du Québec
Analytical Laboratory Accreditation
Program
INSTRUCTIONS
APPLICATION FOR ACCREDITATION
DR-12-01-01 (eng)
Original Edition: September 3, 2015
English Edition: September 3, 2015
CONTENTS
INSTRUCTIONS ............................................................................................................................ 5
1.
GENERAL .......................................................................................................................... 5
2.
INSTRUCTIONS FOR FILING AN APPLICATION FOR ACCREDITATION ............. 7
3.
DOCUMENTS FOR FILING AN APPLICATION FOR ACCREDITATION
OR A SCOPE EXTENSION .............................................................................................. 8
4.
REVIEW OF THE APPLICATION FOR ACCREDITATION OR THE
APPLICATION FOR EXTENSION .................................................................................. 9
DR-12-01-01
Responsable : Head of Accreditation Programs Division
Page 3 of 9
INSTRUCTIONS
1.
GENERAL
For a laboratory to obtain accreditation, it must meet the standards and requirements set out in the
document Programme d’accréditation des laboratoires d’analyse (PALA – Analytical Laboratory
Accreditation Program).
In applying for accreditation, the laboratory must show that it has the expertise to perform the
specified analyses. It must also agree to comply with the terms and conditions of the Program and to
meet all requirements specified in the documents listed therein.
These requirements are as follows :
Name and number of document
Subject
Lignes directrices concernant les travaux
analytiques
en
chimie
[Guidelines
concerning analytical work in chemistry]
(DR-12-SCA-01)
Requirements regarding quality assurance and
control for the accreditation in chemistry
Lignes directrices concernant les travaux
analytiques en microbiologie [Guidelines
concerning analytical work in microbiology]
(DR-12-SCA-02)
Requirements regarding quality assurance and
control for the accreditation in microbiology
Lignes directrices concernant les travaux
analytiques en microbiologie de l’air
[Guidelines concerning analytical work in air
microbiology] (DR-12-SCA-08)
Requirements regarding quality assurance
and control for the accreditation in air
microbiology
Lignes directrices concernant les travaux
analytiques en toxicologie [Guidelines
concerning analytical work in toxicology]
(DR-12-SCA-03)
Requirements regarding quality assurance and
control for the accreditation in toxicology
Lignes directrices concernant les stations
d’un réseau de surveillance de la qualité de
l’air [Guidelines concerning stations of an
air quality monitoring network] (DR-12SCA-09)
Technical requirements regarding quality
assurance and control for accreditation of
air quality monitoring stations.
Protocole pour la validation d’une méthode
d’analyse en chimie [Protocol for the
validation of an analytical method in
chemistry] (DR-12-VMC)
Requirements for the validation of an
analytical method in chemistry
DR-12-01-01
Page 5 of 9
Name and number of document
Subject
Directive sur la validation des méthodes
d’analyse en chimie [Directive on the
validation of analytical methods in
chemistry] (DR-12-VAL)
Details on the types of materials to use for the
validation of analytical methods in chemistry
Guide d’estimation de l’incertitude des
mesures pour les analyses chimiques [Guide
for estimation of measurement uncertainty
for chemical analyses] (DR-12-INC)
Procedures for estimating the uncertainty of
analytical methods in chemistry
Protocole pour la validation et la vérification
d’une méthode d’analyse en microbiologie
[Protocol for the validation and verification
of an analytical method in microbiology]
(DR-12-VMM)
Requirements for the validation and
verification of an analytical method in
microbiology
Exigences relatives à la qualification du
personnel [Requirements regarding staff
qualifications]
(DR-12-PER)
Requirements for the training and experience
of staff in the roles of supervisor, authorized
signatory, laboratory technician, chemistry
technician, microbiology and toxicology
technician, sampling technician, or science
officer for drinking water sampling
Protocole pour les essais d’aptitude des
laboratoires d’analyse [Protocol for
proficiency testing of analytical laboratories]
(DR-12-SCA-04)
Description of the proficiency test process,
including planning, preparation, performance,
information processing, data interpretation,
report and follow-up
Modalités d’accréditation [Terms and
conditions of accreditation] (DR-12-SCA05)
Provisions, conditions and particularities of
requirements with regard to the granting,
extension,
renewal,
suspension
and
withdrawal of accreditation
Exigences applicables à la déclaration de
l’accréditation [Requirements regarding the
statement of accreditation] (DR-12-SCA-06)
Description of the terms and conditions for use
of the statement of accreditation in advertising,
and rules regarding the use of laboratory
information management systems (LIMS)
Lignes directrices concernant l’échantillonnage de l’eau potable [Guidelines
concerning the sampling of drinking water]
(DR-12-SCA-07)
Requirements
sampling
regarding
drinking
water
All of the above documents are available on the website of the Centre d’expertise en analyse
environnementale du Québec of the Ministère du Développement durable, de l’Environnement et de
la Lutte contre les changements climatiques, at the following address: www.ceaeq.gouv.qc.ca.
Page 6 of 9
DR-12-01-01
Once completed, the Application for Accreditation form (FO-12-01-02), the General
Information form (FO-12-01-03) and the Compliance Chart (DR-12-GCA) comprise the basis of
the application for laboratories seeking accreditation. All information divulged is treated
confidentially, in accordance with the provisions of the Act respecting access to documents held by
public bodies and the Protection of personal information (CQLR c. A-2.1). The Direction de
l’accréditation et de la qualité of the Centre d’expertise en analyse environnementale du Québec does
not reveal to third parties the names of laboratories seeking accreditation.
2.
INSTRUCTIONS FOR FILING AN APPLICATION FOR ACCREDITATION
Begin by reviewing the requirements of the program concerned by the application, ensuring that
their implications are understood and verifying that the laboratory is in compliance with them.
To complete the Compliance Chart, refer to the corresponding parts of the laboratory’s quality
manual, or any other relevant document it may append to the application, making sure to answer
every element on the chart. Additional information provided, if necessary, should be clear and
concise. Where the laboratory deems an element not relevant, it can indicate “N/A” (not applicable).
The personnel, equipment, facilities, policies, procedures and tests referred to must be those of the
laboratory concerned by the application for accreditation.
Where copies of documents are required, such as organizational charts, legal authentication
documents, resumes or diplomas, they should be appended to the application if already present in
the quality manual.
For an application in chemistry, the following elements must be included: the methods validation in
accordance with the Protocol for the validation of an analytical method in chemistry (DR-12-VMC),
calibration curves for the parameters of the domains identified in the application, and a copy of the
analytical methods used by the laboratory.
For an application in microbiology, the following elements must be included: the methods validation
in accordance with the Protocol for the validation and verification of an analytical method in
microbiology (DR-12-VMM) and a copy of the analytical methods used by the laboratory.
For an application in toxicology, the laboratory must include a copy of its analytical methods and
the validation data for those methods.
The Application for Accreditation form (FO-12-01-02) and the laboratory’s statement of
commitment must be approved by the manager. The latter is identified as the person with the
authority to commit the laboratory or business to respect the rules and requirements of the
accreditation program.
DR-12-01-01
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3.
DOCUMENTS FOR FILING AN APPLICATION FOR ACCREDITATION OR A
SCOPE EXTENSION
For its first application for accreditation, the laboratory must submit the following documents:
 the Application for Accreditation form (FO-12-01-02) indicating the scope of accreditation
requested. It must be signed by the manager;
 the completed General Information form (FO-12-01-03) with copies of all of the required
documents. The Commitment included in the form must be signed by the manager;
 the duly completed Compliance Chart (DR-12-GCA);
 the quality manual and any other documents pertaining to the Compliance Chart, including
quality system procedures;
 copies of the laboratory’s analytical methods;
 validation data and calibration curves, if applicable.
If applying for an extension of the scope of accreditation, the laboratory must submit the
following documents:
 the Application for Accreditation form (FO-12-01-02) indicating the scope of accreditation
requested. It must be signed by the manager;
 any sections of the General Information form (FO-12-01-03) to be updated in the laboratory’s
accreditation file, along with copies of all the documents required, all duly signed by the manager;
 copies of the laboratory’s analytical methods or sampling protocol;
 validation data and calibration curves, if applicable.
The information in these documents is used to:
 ensure that the laboratory has examined all the requirements and is in compliance with them;
 detect any potential non-compliance;
 provide a basis for comparison and verification during the on-site assessment.
The application fee is payable to the Minister of Finance on reception of the invoice, in accordance
with the document Tarification relative aux programmes d’accréditation des laboratoires d’analyse
[Fee schedules for analytical laboratory accreditation programs] (DR-12-TARIF), or by cheque
when submitting the application for accreditation.
A laboratory that has not paid the application fees, or is in default of payment on any other
accreditation fees, will not obtain accreditation until the amounts owed are paid in full.
Payment should be sent to the following address:
Ministère du Développement durable, de l’Environnement
et de la Lutte contre les changements climatiques
Centre d’expertise en analyse environnementale du Québec
Complexe scientifique
2700, rue Einstein, bureau E-2-220
Québec (Québec) G1P 3W8
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DR-12-01-01
4.
REVIEW OF THE APPLICATION FOR ACCREDITATION OR THE
APPLICATION FOR EXTENSION
On receiving the application, the designated program officer ensures that the information received is
complete and if necessary, asks the laboratory for whatever complementary information may be
needed. Then the program officer analyzes the laboratory’s documentation to ensure full compliance
with accreditation requirements. If appropriate, the laboratory will be sent a review report on its
documentation. Subsequently, the following steps are performed:
 for a first application, or for an application for extension if deemed necessary by the program
officer, an on-site assessment is planned, to verify compliance with accreditation requirements;
 a preliminary proficiency test is performed, to establish the laboratory’s mastery of analytical
methods;
 a report is presented to the Accreditation Committee for recommendation;
 the Committee examines the report, and based on the laboratory’s compliance with the
requirements in force, agrees to recommend that the Minister accredit the laboratory;
 the Minister accredits the laboratory for two years and delivers a provisional accreditation
certificate.
Details concerning the accreditation process may be found in the document Modalités
d’accréditation [Terms and conditions of accreditation] (DR-12-SCA-05).
DR-12-01-01
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