Nội dung text E EXTERNALLY PROVIDED PRODUCTS AND SERVICES PROCEDURE QP-6.6.pdf
EXTERNALLY PROVIDED PRODUCTS AND SERVICES PROCEDURE Conformity assurance Electrical lab – Dammam Issue date: 01.04.2024 V:01 Code: QP-6.6 controlled E copy EXTERNALLY PROVIDED PRODUCTS AND SERVICES PROCEDURE QP-6.6 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
EXTERNALLY PROVIDED PRODUCTS AND SERVICES PROCEDURE Conformity assurance Electrical lab – Dammam Issue date: 01.04.2024 V:01 Code: QP-6.6 controlled E copy 1. Purpose The purpose of this document is to outline and determine procedure for the selection and qualification of purchasing of services and supplies it uses that affects the quality of the tests carried out by Conformity Assurance “ceramic and WEL” lab. 2. Scope 2.1 This procedure is applicable to the purchase, reception and storage of reagents and laboratory consumable material relevant to the tests. 2.2 This procedure is applicable to purchasing services and supplies. 3. Definitions/Abbreviations 3.1. Provider/ supplier Organization that provides a product or a service. EXAMPLE Producer, distributor, retailer or vendor of a product or a service. Note 1 to entry: A provider can be internal or external to the organization. Note 2 to entry: In a contractual situation, a provider is sometimes called “contractor”. 3.2. External supplier provider External supplier provider that is not part of the organization. EXAMPLE: Producer, distributor, retailer or vendor of a product or a service 3.3. Product output of an organization that can be produced without any transaction taking place between the organization and the customer. Note 1 to entry: Production of a product is achieved without any transaction necessarily taking place between 3.4. Service Output of an organization with at least one activity necessarily performed between the organization and the customer. Note 1 to entry: The dominant elements of a service are generally intangible. Note 2 to entry: Service often involves activities at the interface with the customer to establish customer requirements as well as upon delivery of the service and can involve a continuing relationship such as banks, accountancies or public organizations, e.g. schools or hospitals.
EXTERNALLY PROVIDED PRODUCTS AND SERVICES PROCEDURE Conformity assurance Electrical lab – Dammam Issue date: 01.04.2024 V:01 Code: QP-6.6 controlled E copy 4. References 4.1. ISO 9000:2015 Quality management systems — Fundamentals and vocabulary 4.2. ISO 9001:2015 Quality management systems — Requirements 4.3. ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories 5. Responsibilities 5.1. Purchasing officer 5.2. Quality manager 5.3. Technical manager 5.4. Lab staff 6. Process 6.1. Product / services supplies qualification and specifications. 6.1.1.Lab manager/ quality manager /technical manager shall establish and document specification for products/ services and supplies which affect laboratory activities. NOTE Products can include, for example, measurement standards and equipment, auxiliary equipment, consumable materials and reference materials. NOTE: Services can include, for example, calibration services, sampling services, testing services, facility and equipment maintenance services, proficiency testing services and assessment and auditing services. 6.1.2.Lab manager/ quality manager /technical manager shall retain specification records for externally provided items and services 6.2. Selection of services / supplies providers 6.2.1. The quality manager in consultation with the technical manager shall select the product and service providers, according to specified selection criteria: 6.2.1.1. Legal documentation 6.2.1.2. Quality and specifications 6.2.1.3. Productivity and availability
EXTERNALLY PROVIDED PRODUCTS AND SERVICES PROCEDURE Conformity assurance Electrical lab – Dammam Issue date: 01.04.2024 V:01 Code: QP-6.6 controlled E copy 6.2.1.4. Payment terms and delivery conditions 6.2.1.5. Documentation 6.2.2. Purchasing officer shall collect samples and necessary documents as for example certificate of analysis from externally product and service providers who have direct and indirect affect to laboratory activities. 6.2.3. Quality manager and laboratory staff shall test and evaluate sample and relevant documents and inform purchasing officer with the results. 6.2.4. Purchasing officer shall establish and document externally product and service providers approved list, and include the following information: 6.2.4.1. External provider name and address 6.2.4.2. Contact person (name, phone #, email and Fax) 6.2.4.3. Product name and service name 6.2.5.Quality manager shall select and evaluate Service and supplies providers according to the following criteria: 6.2.5.1. Price 10% 6.2.5.2. quality specifications 30% 6.2.5.3. Communication and response 10% 6.2.5.4. capability/ productivity 30% 6.2.5.5. Delivery terms and conditions 10 % 6.2.5.6. Documentation 10% 6.2.6.The service and/or supplies providers will be considered as approved service and/or supplies providers in case of merit 80 % or more and in condition that quality provided should also merit 80 % or more. 6.2.7.Lab staff and lab manager shall take appropriate corrective action for any supplier who does not meet evaluation criteria as per corrective action procedure code QP 8.7 6.2.8.If the service and/or supplies providers do not met the evaluation criteria, hence the service and/or supplies provider will be excluded from the approved supplier list. 6.3. Purchasing of product/ service / supplies NOTE: Products can include, for example, measurement standards and equipment, auxiliary equipment, consumable materials, and reference materials. Services can include, for example, calibration services, sampling services, testing services, facility and equipment maintenance services, proficiency testing services and assessment and auditing services.