Cal. Code Regs. tit. 22 § 64802.00

Current through Register 2024 Notice Reg. No. 52, December 27, 2024

Section 64802.00 - Application Package

(a) A Complete Application Package for initial or renewal accreditation shall contain:

(1) Laboratory identifying information, which includes:

(A) Name of the laboratory;

(B) Details on the laboratory's type, location, ownership, contact information, and the regulatory agencies the laboratory reports to;

(C) Name and qualifications of Technical Manager(s), including copies of applicable degrees and/or Laboratory Analyst/Water Quality Analyst Certificates from CWEA or CA-NV/AWWA;

(D) Name of Quality Manager;

(E) Signed declaration to comply with applicable ELAP statutes and regulations;

(F) Signature of the laboratory Owner, corporate officer authorized to act on behalf of the laboratory, or Owner's Agent (include documentation of authority to act on behalf of the Owner) attesting to the truthfulness of the information submitted; and

(G) Date of signature;

(2) A copy of the laboratory Quality Manual meeting the requirements of:

(A) 2016 TNI Standard Volume 1 - Revision 2.1, Module 2, Section 4.2.8.3 and 4.2.8.4, herein incorporated by reference; or

(B) Section 64802.05(b)(1);

(C) Subdivision (a)(2)(B), above, will become invalid three (3) years from the effective date of these regulations at which time accredited laboratories will be required to comply with subdivision (a)(2)(A), above;

(3) Signed and populated Field(s) of Accreditation tables for which accreditation is being requested;

(4) Proficiency Testing report(s) with Acceptable Scores for each Field(s) of Accreditation for which accreditation is requested in accordance with Section 64802.15;

(5) A copy of the most recently completed on-site assessment report from an Assessment Agency in accordance with Section 64802.20, including all findings and an approved Corrective Action Plan; and

(6) For aquatic toxicity testing, a current reference toxicant control chart for each method, species, and endpoint requested.

(b) A Complete Application Package for accreditation by reciprocity shall contain:

(1) Laboratory identifying information, which includes:

(A) Name of the laboratory;

(B) Details on the laboratory's type, location, ownership, contact information, and the regulatory agencies the laboratory reports to;

(C) Name and qualifications of Technical Manager(s), including copies of applicable degrees;

(D) Name of Quality Manager;

(E) Signed declaration to comply with applicable ELAP statutes and regulations;

(F) Signature of the laboratory Owner, corporate officer authorized to act on behalf of the laboratory, or Owner's Agent (include documentation of authority to act on behalf of the Owner) attesting to the truthfulness of the information submitted; and

(G) Date of signature;

(2) A copy of the laboratory Quality Manual meeting the requirements of:

(A) 2016 TNI Standard - Revision 2.1, Volume 1, Module 2, Section 4.2.8.3 and 4.2.8.4, herein incorporated by reference; or

(B) Section 64802.05(b)(1);

(C) Subdivision (b)(2)(B), above, will become invalid three (3) years from the effective date of these regulations at which time accredited laboratories will be required to comply with subdivision (b)(2)(A), above;

(3) Signed and populated Field(s) of Accreditation tables for which accreditation is being requested;

(4) Proficiency Testing report(s) with acceptable scores for each Field(s) of Accreditation for which accreditation is requested in accordance with Section 64802.15;

(5) A copy of the most recently completed on-site assessment report, including all findings and an approved Corrective Action Plan;

(6) For aquatic toxicity testing, a current reference toxicant control chart for each method, species, and endpoint requested; and

(7) Proof of accreditation from a Primary Accreditation Body, including:

(A) Official certificate of accreditation and scope of accreditation;

(B) Official on-site assessment report and findings; and

(C) Corrective Action Plan(s) reviewed and approved by the Primary Accreditation Body.

(c) A complete amendment application package shall be submitted to ELAP in accordance with Section 64808.15.

Cal. Code Regs. Tit. 22, § 64802.00

1. Amendment of article heading, repealer of former article 2 (section 64803), new article 2 (sections 64802.00-64802.20) and new section filed 11-19-2020; operative 1-1-2021 (Register 2020, No. 47). (Filing deadline specified in Government Code section 11349.3(a) extended by 60 calendar days pursuant to Executive Order N-40-20.)

Note: Authority cited: Sections 100829 and 100830, Health and Safety Code. Reference: Sections 100825, 100829, 100830, 100840, 100860.1 and 100870, Health and Safety Code.

1. Amendment of article heading, repealer of former article 2 (section 64803), new article 2 (sections 64802.00-64802.20) and new section filed 11-19-2020; operative 1/1/2021 (Register 2020, No. 47). (Filing deadline specified in Government Code section 11349.3(a) extended by 60 calendar days pursuant to Executive Order N-40-20.)