Centre d expertise en analyse environnementale du Québec. Analytical Laboratory Accreditation Program INSTRUCTIONS APPLICATION FOR ACCREDITATION

Transcription

1 Centre d expertise en analyse environnementale du Québec Analytical Laboratory Accreditation Program INSTRUCTIONS APPLICATION FOR ACCREDITATION DR (eng) Original Edition: September 3, 2015 English Edition: September 3, 2015

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3 CONTENTS INSTRUCTIONS GENERAL INSTRUCTIONS FOR FILING AN APPLICATION FOR ACCREDITATION DOCUMENTS FOR FILING AN APPLICATION FOR ACCREDITATION OR A SCOPE EXTENSION REVIEW OF THE APPLICATION FOR ACCREDITATION OR THE APPLICATION FOR EXTENSION... 9 DR Page 3 of 9 Responsable : Head of Accreditation Programs Division

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5 1. GENERAL INSTRUCTIONS 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 Lignes directrices concernant les travaux analytiques en chimie [Guidelines concerning analytical work in chemistry] (DR-12-SCA-01) Lignes directrices concernant les travaux analytiques en microbiologie [Guidelines concerning analytical work in microbiology] (DR-12-SCA-02) Lignes directrices concernant les travaux analytiques en microbiologie de l air [Guidelines concerning analytical work in air microbiology] (DR-12-SCA-08) Lignes directrices concernant les travaux analytiques en toxicologie [Guidelines concerning analytical work in toxicology] (DR-12-SCA-03) 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-12- SCA-09) Protocole pour la validation d une méthode d analyse en chimie [Protocol for the validation of an analytical method in chemistry] (DR-12-VMC) Subject Requirements regarding quality assurance and control for the accreditation in chemistry Requirements regarding quality assurance and control for the accreditation in microbiology Requirements regarding quality assurance and control for the accreditation in air microbiology Requirements regarding quality assurance and control for the accreditation in toxicology Technical requirements regarding quality assurance and control for accreditation of air quality monitoring stations. Requirements for the validation of an analytical method in chemistry DR Page 5 of 9

6 Name and number of document Directive sur la validation des méthodes d analyse en chimie [Directive on the validation of analytical methods in chemistry] (DR-12-VAL) Guide d estimation de l incertitude des mesures pour les analyses chimiques [Guide for estimation of measurement uncertainty for chemical analyses] (DR-12-INC) 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) Exigences relatives à la qualification du personnel [Requirements regarding staff qualifications] (DR-12-PER) Protocole pour les essais d aptitude des laboratoires d analyse [Protocol for proficiency testing of analytical laboratories] (DR-12-SCA-04) Subject Details on the types of materials to use for the validation of analytical methods in chemistry Procedures for estimating the uncertainty of analytical methods in chemistry Requirements for the validation and verification of an analytical method in microbiology 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 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-SCA- 05) Exigences applicables à la déclaration de l accréditation [Requirements regarding the statement of accreditation] (DR-12-SCA-06) Lignes directrices concernant l échantillonnage de l eau potable [Guidelines concerning the sampling of drinking water] (DR-12-SCA-07) Provisions, conditions and particularities of requirements with regard to the granting, extension, renewal, suspension and withdrawal of accreditation 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) Requirements regarding drinking water sampling 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: Page 6 of 9 DR

7 Once completed, the Application for Accreditation form (FO ), the General Information form (FO ) 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 ) 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 Page 7 of 9

8 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 ) indicating the scope of accreditation requested. It must be signed by the manager; the completed General Information form (FO ) 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 ) indicating the scope of accreditation requested. It must be signed by the manager; any sections of the General Information form (FO ) 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 Québec (Québec) G1P 3W8 Page 8 of 9 DR

9 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 Page 9 of 9

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