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GHTF/SG3/N17:2008 GHTF SG3 - Quality Management System - Medical Devices - Guidance on the Control of Products and Services Obtained from Suppliers - December 2008 - PDF (593kb)

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GHTF SG3 - Quality Management System - Medical Devices - Guidance on the Control of Products and Services Obtained from Suppliers - December 2008 - PDF (593kb)[附网盘链接]由GHTF Study Group 3于December 11, 2008发布，适用于全球范围。

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GHTF SG3 - Quality Management System - Medical Devices - Guidance on the Control of Products and Services Obtained from Suppliers - December 2008 - PDF (593kb)[附网盘链接]
GHTF SG3 - Quality Management System - Medical Devices - Guidance on the Control of Products and Services Obtained from Suppliers - December 2008 - PDF (593kb)[附网盘链接](截图)

 

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标准文档类型为GHTF SG3 - Quality Management System - Medical Devices - Guidance on the Control of Products and Services Obtained from Suppliers - December 2008 - PDF (593kb)[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。

标准部分原文

Introduction

This guidance document is intended for medical device manufacturers and it is expected that the

reader is familiar with regulatory quality management system requirements within the medical

devices sector. This guidance document may also be useful to regulatory authorities and

suppliers. This guidance document is intended for educational purposes and it is not intended to

be used to assess or audit compliance with regulatory requirements.

Existing regulatory requirements, such as Sections 4.1 and 7.4 of ISO13485:2003, Articles 5 and

37 through 39 of the Japanese Ministerial Ordinance on Standards for Manufacturing Control

and Quality Control for Medical Devices and in vitro Diagnostics (MHLW Ministerial

Ordinance No. 169, 2004), and the FDA 1996 Quality System Regulation 21 CFR Part 820,

sections 820.50 Purchasing controls, and 820.80 Receiving, in-process, and finished device

acceptance, which require organizations to control products and services obtained from

suppliers. These requirements call for the type and extent of controls to be established and

documented within the organization’s quality management system. Control could be defined and

documented in the form of contractual arrangements, quality plans or other types of documents.

Several medical device quality management system regulations have their requirements

harmonized around ISO 9001. Clause 4.1 of ISO 9001:2000 utilizes the term “outsourced

processes”, however, it is not defined in the vocabulary standard ISO 9000:2005. There are no

requirements within ISO 9001:2000 related to outsourced processes beyond what is found in

clause 4.1. Clause 7.4 defines purchasing requirements in the terms of “purchased product” and

“suppliers”, but does not include or reference outsourced processes from clause 4.1. This has led

to differing interpretations regarding the controls of outsourced processes as they relate to

purchasing controls in clause 7.4 of ISO 9001:2000 and the quality management system

requirements for medical device manufacturers derived from this standard.

ISO TC 176, the authoring group of the ISO 9000 series of standards, has published a guidance

document intended to clarify ISO 9001:2000 clause 4.1, regarding the control of outsourced

processes titled ISO 9000 Introduction and support package: Guidance on outsourced processes.

Clause 2.2 of this document states:

The intent of Clause 4.1 of ISO 9001:2000 is to emphasize that when an organization

chooses to outsource (either permanently or temporarily) a process that affects product

conformity with requirements (see ISO 9001:2000 clause 7.2.1) it cannot simply ignore

this process, nor exclude it from the quality management system.

The organization has to demonstrate that it exercises sufficient control to ensure that this

process is performed according to the relevant requirements of ISO 9001:2000, and any

other requirements of the organization's quality management system. The nature of this

control will depend, among other things, on the importance of the outsourced process,

the risk involved, and the competence of the supplier to meet the process requirements.

Outsourced processes will interact with other processes from the organization's quality

management system (these other processes may be carried out by the organization itself,

December 11, 2008 Page 4 of 21

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