The purpose of this supplier quality manual is to clearly communicate macoms quality expectations to all new and existing external suppliers, including raw material, component, original equipment manufacturers oem, contract manufacturers of finished. Supplier primary customer service sales contact name, title, email, and phone. Boston scientific strives to be the highest performing medical solution provider. Gm nameplates quality management system qms described by. Medical devices quality management systems requirements for regulatory purposes. Phsqrm, july18 page 7 of 44 supplier code of conduct suppliers shall ensure operations are being performed in a manner that is appropriate, as it applies to their ethical, legal, environmental, and social responsibilities. The regulations require that the facilitys qa manual must contain the following seven elements. The supplier is expected to identify its necessary procedures and records that ensure effective operation and control of its processes. Supplier quality requirements manual village marine watermakers.
General requirements the supplier shall document, implement and maintain a management system that is. A medical device quality manual is a document required by iso 485 2016 which is one of the most famous standards for quality management system of medical device companies. Quality issues as a result of supplier product or services will result in discussions with the supplier to determine. Supplier requirements manual template 3 4m industries, inc. Definition of sunrise medicals requirements for ontime delivery, product compliance, quality. Management system qms and ra internal documents primarily the corporate 900 manual that support the ra quality policy 9002001, as well as to give a general company overview and to answer questions commonly asked regarding our quality management system. Gm nameplates document structure and document definitions are as such. Medical equipment, green energy, transportation, and recreational equipment.
Terms and definitions the term and definitions are stated within the supplier manual. This supplier quality manual contains a basic quality format to lay the foundation of an effective supplier quality assurance system which can be referred to in the below model. Figure 1 supplier quality manual process it also outlines the process of supplier selection, assessing the capability and performance of. Quality assurance manager and global supply quality ci and sustainability manager. Scope this supplier manual as it may be amended describes the purchasing policies of 4m and shall be. It may not be reproduced or disclosed in whole or in part. The purpose of the quality manual is to document the quality system and policies and to inform alspis customers of the controls implemented to assure product quality. The signed acknowledgement of receipt shall be electronically submitted to materion amgs supplier quality manager, gina.
The purpose of the quality manual is to help you navigate your quality system. Introduction the supplier quality manual has been developed in order to describe processes and requirements that should be met by a supplier of sma magnetics sp. Kerry supplier requirements manual is effective as of january 2017. Quality management system if supplier is a manufacturer or distributor of medical devices, then supplier must maintain a quality. This supplier manual describes the purchasing policies of 4m. Phsqrm, july18 page 5 of 44 parker hannifin corporation corporate overview parker hannifin corporation is the worlds leading diversified manufacturer of motion and control technologies and. Supplier quality requirements manual any procedure changes within this manual will result in an update of the complete manual revision date and number. Shannon claggett, supply chain manager date revision history rev date createdrevised by summary approvers 00 12616 t.
Iso 485 medical devices quality management systems requirements for. But you can also apply this for the fda 21 cfr part 820. Nrl various remove revision with over one year of information m. Supplier quality manual sqm001 forward uncontrolled if printed 2 of. This document is meant only as a highlevel overview of the structure and content of. It is the vision of haldex ab that suppliers shall. Purpose the purpose of this supplier quality requirements manual sqrm is to specify mei quality system. Supplier agrees to meet or exceed all requirements and guidelines defined in this document. The quality manual provides for a quality management system to.
Definition of sunrise medical s requirements for ontime delivery, product compliance, quality. Philips ultrasound solutions bring excellent image quality and advanced. The harris health system board of managers bom is the governing body of. Because purchased items and services affect the level of quality of every order we ship, our suppliers must be committed to delivering 100% defect free product, ontime. Continually improve by proactively improving the quality and value of products and services over time. Purchasing will provide the candidate supplier an ier supplier manual. No changes or revisions to be made unless submitted by johnson controls inc. Supplier quality requirements manual parker hannifin.
This supplier quality manual describes our standard ways of working. Any purchasing agreement or supplier quality agreement that the supplier. Next to the general purchase agreement as the official document, we request you as a supplier to acknowledge this manual and adhere to the mentioned statements and descriptions. Supplier quality manual scmquality rev 10 process owner. Phsqrm, mar08 page 5 of 25 scope this manual applies to all suppliers providing parker with materials, products, processing, and related services, including intracompany suppliers, and when applicable, to supplier subtier sources. The supplier completes the selfassessment and returns it along with a copy of their supporting documents. Quality control personnel the facility shall identify the individual. Quality manual page 1 of 34 quality manual litron, inc. The purpose of this supplier quality manual is to define the requirements and detailed documentation required to verify conformance required by thai summit america tsa of the supplier quality standards and a mechanism for rating supplier conformance to the standard.
A supplier quality system audit may be performed at the suppliers manufacturing location by a haltec corporation quality representative. A quality manual is a toplevel document that describes an organisations quality management system qms. Our suite of systems is designed to meet the many unique challenges of clinical practice. Supplier shall include a copy of the c of c inside the suppliers shipping container. A quality manual is a document that was first required by the iso 9001 standard for quality management systems. The supplier is expected to identify essential documents relating or pertinent to the quality system. Elements that the quality assurance manual must contain. Key global zimmer biomet quality system requirements. A quality manual defines the structure of their quality system, by defining the scope of the.
It is the poliy of c haldex ab to achieve a clear competitive advantage through continuous improvement in quality, service, delivery, and cost from our suppliers in the total supply chain. This manual is the property of jet precision metal, inc. Supplier quality manual sq 2107 rev 1 page 5 of 36 i. General requirements the supplier shall document, implement and maintain a. Duratech industries supplier quality manual page 7 of 11 revision 032017 2. Sager electronics supplier quality requirements manual sqr001 page 5 of revision 3. Pur024 supplier quality agreement v1 mevion medical systems. Pegasus manufacturing supplier quality requirements. This document has been created by the vp global supply. The purpose of this supplier quality standard is to communicate the expectations and requirements. The information in this manual supports sunrise medicals quality management system. Iso 485 quality management system requirements medical1.150 1131 223 1298 1222 1202 1518 1106 747 1160 616 648 97 957 767 1055 436 1336 81 402 1026 1264 1240 1048 1128 160 197 934 452 367 252 140 1349 33 14 739 688 1240 412 50 1065 1394 533