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IMDRFIMDSAP WG/N11FINAL:2014 MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization - PDF (422kb)

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MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization - PDF (422kb)[附网盘链接]是IMDRF MDSAP Working Group发布的GHTF标准，适用于世界范围。

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MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization - PDF (422kb)[附网盘链接]
MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization - PDF (422kb)[附网盘链接](截图)

 

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Introduction

This is one document in a collection of documents produced by the International Medical

Device Regulators Forum (IMDRF) intended to implement the concept of a Medical Device

Single Audit Program (MDSAP).

Two documents, IMDRF MDSAP WG N3 – “Requirements for Medical Device Auditing

Organizations for Regulatory Authority Recognition” and IMDRF MDSAP WG N4 –

“Competence and Training Requirements for Auditing Organizations,” are complementary

documents. These two documents N3 and N4 are focused on requirements for an Auditing

Organization and individuals performing regulatory audits and other related functions under

the respective medical device legislation, regulations, and procedures required in its

regulatory jurisdiction.

Two additional documents, IMDRF MDSAP WG N5 – “Regulatory Authority Assessment

Method for the Recognition and Monitoring of Medical Device Auditing Organizations” and

IMDRF MDSAP WG N6 - “Regulatory Authority Assessor Competence and Training

Requirements,” are complementary documents. These two documents N5 and N6 are

focused on how Regulatory Authorities and their assessors will evaluate or “assess” medical

device Auditing Organizations’ compliance to the requirements in the IMDRF MDSAP N3

and N4 documents.

The purpose of this document, IMDRF MDSAP WG N11 is to explain the assessment

process and outcomes, including the method to “grade and manage” nonconformities

resulting from a recognizing Regulatory Authority(ies)’s assessment of an Auditing

Organization; and, to document the decision process for recognizing an Auditing

Organization or cessation of recognition. To prevent the confusion between audits of

manufacturers performed by auditors within an Auditing Organizations and audits of

Auditing Organizations performed by medical device Regulatory Authority assessors, in this

document, the latter are designated as “assessments.”

This collection of IMDRF MDSAP documents will provide the fundamental building blocks

by providing a common set of requirements to be utilized by the Regulatory Authorities for

the recognition and monitoring of entities that perform regulatory audits and other related

functions. It should be noted that in some jurisdictions the recognition process is called

designation, notification, registration, or accreditation.

IMDRF developed MDSAP to encourage and support global convergence of regulatory

systems, where possible. It seeks to strike a balance between the responsibilities of

Regulatory Authorities to safeguard the health of their citizens as well as their obligations to

avoid placing unnecessary burdens upon Auditing Organizations or the regulated industry.

IMDRF Regulatory Authorities may add additional requirements beyond this document when

their legislation requires such additions.

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18 September 2014 Page 4 of 36

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