Title FACILITIES AND ENVIRONMENTAL CONDITIONS PROCEDURE QP6.3.pdf ✅

FACILITIES AND ENVIRONMENTAL CONDITIONS PROCEDURE Conformity assurance Electrical lab – Dammam Issue date: 01.04.2024 V:01 Code: QP-6.3 Controlled E Copy FACILITIES AND ENVIRONMENTAL CONDITIONS PROCEDURE QP 6.3 Author Prepared by Reviewed and approved by Name Mohamed Abdelaziz Shaik aldien Function /position Quality Lead / Senior Quality Supervisor lab Manager Signature Date All rights reserved. These materials are confidential and proprietary to Conformity Assurance. No part of these materials should be reproduced, published in any form by any means (electronic or mechanical, including photocopy or any information storage or retrieval system), nor should the materials be disclosed to third parties without the express written authorization of Conformity Assurance
FACILITIES AND ENVIRONMENTAL CONDITIONS PROCEDURE Conformity assurance Electrical lab – Dammam Issue date: 01.04.2024 V:01 Code: QP-6.3 Controlled E Copy 1. Purpose This document describes guidelines for CONFORMITY ASSURANCE laboratory facilities to ensure that the environmental conditions do not adversely affect or invalidate sample handling, instrumentation and testing. 2. Scope This procedure applies to all CONFORMITY ASSURANCE laboratories. 3. Definitions/abbreviation 3.1. Facility Infrastructure including equipments, buildings and services needed for the operation of conformity assurance laboratory 3.2. Environment set of conditions under which work is performed 4. References 4.1 ISO 9000:2015 Quality Management System – Fundamentals and Vocabulary 4.2 ISO 9001:2015 Quality Management System – Requirements 4.3 ISO IEC 17025:2017 General requirements for the competence of testing and calibration laboratories 5. Responsibilities 5.1. Technical manager 5.2. Quality manager 5.3. Lab manager 6. Process 6.1. Environment 6.1.1.The technical managers responsible to ensure that laboratories are designed to provide space, and proper environmental conditions for optimal sample storage, sample handling, and testing, in accordance with general laboratory practices, and safety. 6.1.2.Facilities consist of laboratories, office areas, storage areas, and special purpose areas. Laboratories are sectioned by testing compatibility and design capabilities. 6.1.3.Laboratories are equipped with climate e.g., Temp. control. The temperature is maintained within the laboratories within limits for the proper performance of each test applied by the laboratories; and maintained according to the manufacturer’s specifications for the proper operation of instruments. A comfortable working environment is considered. 6.1.4.Separate storage areas within the lab of sufficient size are present in the laboratory to ensure that portable instrumentation; supplies, chemicals, reference materials are properly stored. 6.2. Environmental Monitoring 6.2.1. If Standard and customer don’t need control of environmental conditions (Temp & Humidity). however, Conformity Assurance Lab. has experience in environmental control
FACILITIES AND ENVIRONMENTAL CONDITIONS PROCEDURE Conformity assurance Electrical lab – Dammam Issue date: 01.04.2024 V:01 Code: QP-6.3 Controlled E Copy (Temp. 23 ± 20C & Humidity50 ± 5 %) for its lab activity, those are monitored and controlled using Form (QF-6.3-01) 6.2.2.Top management Conformity assurance has provided suitable and safe workplace for performing all activity related to the business 6.3. Segregation 6.3.1.Technical staffs as well as technical managers are responsible to ensure that separate areas are maintained for incompatible activities, and measures are taken. 6.3.2.Technical staffs are responsible to carry out the testing activities at the specialized testing area which separated from general work areas. 6.3.3.Technical manager is responsible to control the access to and use of areas affecting the quality of the tests performed. 6.4. House Keeping 6.4.1.Technical staff as well as technical manager are responsible to ensure that laboratory areas are maintained sufficiently clean 6.4.2.In case of special Housekeeping Requirement for certain equipment, area, tool, ...etc., technical manager responsible for mentioning special housekeeping in WI and/ or TM otherwise Normal housekeeping process will be used 7. Flow/charts NA 8. Forms /templates 8.1. Monthly temp and RH monitoring schedule (QF-6.3-01). 8.2. LAYOUT (QF-6.3-02). 9. Revision history The following list provides a key-word-based overview of the changes made to this QM document over time. SN Issue No. Revision No. Date Change Training 1. 1.0 0.0 01-04-2024 Initial issue Done