Stage 2 Audit definition

Stage 2 Audit means a comprehensive and thorough audit of the Organisation’s MS in order to assess and determine the Organisation’s compliance with the Scheme. If any provision in a definition is a substantive provision conferring rights or imposing obligations on any Party, notwithstanding that it is only in the definition clause, effect shall be given to it as if it were a substantive provision in the body of this Agreement.
Stage 2 Audit means examination and assessment of relevant management system of the Applicant performed by the Audit Team or Auditor in order to determine whether the said system conforms to the requirements of ISO 9001 and/or ISO 14001 and/or OHSAS 18001.

Examples of Stage 2 Audit in a sentence

  • After the findings of the Stage 1 Audit have been resolved and issues from stakeholders have been identified, the Applicant is required to inform the Audit Team Leader on the readiness to proceed to Stage 2 Audit.

  • It is recommended that all proposed actions to address the issues of concerned identified during Stage 1 audit are submitted to the Audit Team Leader at least two weeks before the conduct of Stage 2 Audit.

  • It is necessary that client completes appropriate correction and corrective actions latest before the start of the Stage 2 Audit.

  • When the Stage 1 & 2 Audits are planned back to back, BVC has the right to postpone the Stage 2 Audit at the expenses of the Client if the results of the Stage 1 Audit are not satisfactory to proceed with the Stage 2 Audit.

  • If at the end it cannot be established positively that the customer is ready for the Stage 2 Audit, the audit is broken off after the Stage 1 Audit.

  • If an application is refused, then the Application Money will be refunded.

  • Women still face discrimination in terms of income, senior leadership and governance, particularly in the private sector, as well as high levels of unpaid work through caregiving, household and voluntary activities.

  • When the Stage 1 & 2 Audits are planned back to back, Bureau Veritas Certification has the right to postpone the Stage 2 Audit at the expenses of the Client if the results of the Stage 1 Audit are not satisfactory to proceed with the Stage 2 Audit.

  • The Stage 2 Audit reports shall be submitted for the written agreement of the planning authority prior to the commencement of development.

  • The next part of the process is the completion of the Stage 2 Audit.

Related to Stage 2 Audit

  • Development Phase means the period before a vehicle type is type approved.

  • Stage 2 means the construction of the second hotel and other developments facilities and amenities referred to in the Development Proposals;

  • Phase II Study means a study in humans of the safety, dose ranging or efficacy of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent thereof outside the United States).

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Stage 1 means the area at Port Xxxxxxx which is the subject of this Agreement and of the ERMP and which is shown bordered in purple as “stage 1” on Department of Land Administration 4 Miscellaneous Plan No. 1743;

  • project completion period means the period of sixty (60) months commencing from and expiring on for the construction and obtaining of Temporary Occupation Permit or Permits for the whole of the Development as provided in clause 3.3;

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Phase 1 means the first implementation phase of this section, beginning June 1, 2018 and ending May 31, 2022.

  • Phase 2 Trial means a human clinical trial conducted on study subjects with the disease or condition being studied for the principal purpose of achieving a preliminary determination of efficacy or appropriate dosage ranges, as further described in 21 C.F.R. §312.21(b) (including any such clinical study in any country other than the United States).

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Commissioning test means tests applied to the Generating Facility, after completion of the construction of the Generating Facility, in order to verify that the Generating Facility may be released for Operation.

  • Phase III means human clinical trials, the principal purpose of which is to establish substantial evidence of both safety and efficacy in patients with the disease or condition being studied, as more fully defined in 21 C.F.R. §312.21(c) or similar clinical study in a country other than the United States. Phase III shall also include any other human clinical trial intended to serve as a pivotal trial to support the submission of an application for regulatory approval.

  • Feasibility Study means a comprehensive study of a deposit in which all geological, engineering, operating, economic and other relevant factors are considered in sufficient detail that it could reasonably serve as the basis for a final decision by a financial institution to finance the development of the deposit for mineral production;

  • Phase II means the second part of the tuition incentive assistance program which provides assistance in the third and fourth year of 4-year degree programs.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Commissioning Period means, with respect to each Subproject, the period commencing upon the first delivery of Feed Gas to the Subproject in accordance with Sections 4.8 and 11.1 of the Agreement continuing through achievement of RFSU, commissioning, Start Up, Performance Testing and achievement of Substantial Completion for such Subproject.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • POC (Proof of Concept) means testing the Software for evaluation purposes.

  • conformity assessment body means a body that performs conformity assessment activities including calibration, testing, certification and inspection;

  • Commissioning Tests means all of the procedures and tests which, in accordance with the Reasonable and Prudent Standard, and in compliance with industry guidelines, practices and standards, are:

  • Phase II Trial means a clinical trial of a Licensed Product on patients, including possibly pharmacokinetic and dose ranging studies, the principal purposes of which are to make a preliminary determination that such Licensed Product is safe for its intended use and to obtain sufficient information about such Licensed Product’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR §312.21(b), or its successor regulation, or the equivalent in any foreign country.

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;