Document No.

: Page: 1 of 14
MDSAP QMS
P0002.006
Responsible Office/Division Version Date: Effective Date:
2021-03-15 2021-03-15
Title: MDSAP QMS Document Control Project Manager:
and Approval Procedure Hiromi Kumada, PMDA

Table of Contents

1. Purpose/Policy .................................................................................................. 1
2. Scope................................................................................................................ 2
3. Definitions/Acronyms ........................................................................................ 2
4. Authorities/Responsibilities ............................................................................... 6
4.1 MDSAP Regulatory Authority Council Chair: ............................................ 6
4.2 MDSAP Regulatory Authority Council (RAC): .......................................... 7
4.3 MDSAP Regulatory Authority Secretariat (RAS): ..................................... 7
4.4 MDSAP QMS Management Representative:............................................ 7
4.5 MDSAP QMS Site Representative: .......................................................... 8
4.6 All MDSAP Regulatory Authority Representatives: .................................. 8
5. Procedures ....................................................................................................... 8
5.1 General Document Format ....................................................................... 9
5.2. Comprehensive Reviews .......................................................................... 9
5.3. New Document Development and Approval ............................................. 9
5.4. Revised Document Development and Approval ..................................... 11
5.5. External Documents ............................................................................... 13
5.6. Document Retention and Archiving ........................................................ 13
5.7. Forms ..................................................................................................... 13
6. Forms.............................................................................................................. 14
7. Reference Documents .................................................................................... 14
8. Document History ........................................................................................... 14
Approval Sign-Off Sheet

1. Purpose/Policy
This document describes the Medical Device Single Audit Program (MDSAP)
procedures to develop, review, approve, and publish the MDSAP documents on
the web site. Development and issuance (publication) of these documents
requires collaboration among various participating regulatory authority
representatives, including, in some cases, the MDSAP Regulatory Authority
Council (RAC).

Uncontrolled when printed:

For the most current copy, contact [email protected]
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Control and Approval Procedure

The Document Control and Approval process is one of the primary tools for all
work related to the development, management, maintenance, and expansion of
the MDSAP. It is important to keep all operational documents current to reflect
revisions to regulatory authority laws, regulations, procedures, and organizational
structure.

The MDSAP QMS Management Representative is responsible for establishing

and maintaining a uniform, controlled and centralized system for the creation,
revision, approval, publication, retrieval, distribution, and disposal of all internally
generated documents and reference documents affecting the MDSAP.

These documents may also be requested directly from the RAC Secretariat,
MDSAP QMS Site Representative(s), and/or [email protected].

These documents may be edited and updated frequently, to accurately reflect

current policies and procedures, and to assure that the quality system documents
used by regulatory authorities and MDSAP staff are properly developed,
approved, active and located where needed.

2. Scope
This procedure applies to the creation and control of documented information
which calls for quality requirements used by regulatory authorities to specify
requirements or prescribe activities affecting the MDSAP. This procedure
outlines the process for adding, modifying, or deleting documents within or
related to the MDSAP Quality Management System (QMS). This procedure is
revised as needed. Training will be provided (as necessary) when a document is
revised or a new document is implemented.

3. Definitions/Acronyms
Appendix: An appendix is a section added at the end of a document to provide
additional information.

Controlled Copy: A formal copy of the latest, approved version of a document. A

controlled copy must be systematically tracked, updated and stored for use.

Documented Information: information required to be controlled and maintained by

an organization and the medium on which it is contained. (ISO 9000:2015(E))

Document Control: Ensuring that documents are reviewed for adequacy,

approved for release, distributed to and used at the location where the prescribed
activity is performed. Obsolete documents are to be retained.

Uncontrolled when printed:

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Document History Record: The Document History Record contains version and
publication dates, document and version numbers, approval signatures, and
revision records.

Document Number: A unique identifier to differentiate documents (Procedure,

Form or Guidance) and their versions. All document numbers will include a
standard prefix “MDSAP” and a unique alpha-numeric identifier for a type of
document and its version. For example:

Procedure: MDSAP P0002.001 (Initial release of procedure .001)

Form: MDSAP F0002.1.002 (Second version of form 1.002)
Guidance: MDSAP G0001.003 (Third version of guidance .003)

To distinguish the two (2) programs “Audit” and “Assessment” listed within
MDSAP, all documents specific to the audit program will have the prefix “MDSAP
AU”, and all documents specific to the assessment program will have the prefix
“MDSAP AS”. For example:

Audit Program:
Procedure: MDSAP AU P0002.001 (Initial release of procedure .001)
Form: MDSAP AU F0002.1.002 (Second version of form1. 002)
Guidance: MDSAP AU G0001.003 (Third version of guidance .003)

Assessment Program
Procedure: MDSAP AS P0002.001 (Initial release of procedure .001)
Form: MDSAP AS F0002.1.002 (Second version of form 1.002)
Guidance: MDSAP AS G0001.003 (Third version of guidance .001)

All document numbers related to the internal Quality Management System (QMS)
within MDSAP will include a standard prefix (MDSAP QMS) and a unique alpha-
numeric identifier for a type of document and its version. For example:

Procedure: MDSAP QMS P0002.001 (Initial release of procedure .001)

Form: MDSAP QMS F0002.1.002 (Second version of form 1.002)
Guidance: MDSAP QMS G0001.003 (Third version of guidance .0001)

Effectiveness: Extent to which planned activities are realized and planned results
achieved. (ISO 9000:2015 (E))

Effective Date: Date the documents are signed by the Chair person and it
officially begins to be used.

Electronic Document Title: A unique identifier for electronic storage of

documents assigned by the MDSAP QMS Management Representative to
differentiate electronic draft documents and their revisions, or assigned by the
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RAS to differentiate electronic released document versions and their revisions.

Includes the Document Number and the Revision Date. For example:

MDSAP P0002.001 (yyyy/mm/dd) – Document Title.docx

MDSAP AU P0002.001 (yyyy/mm/dd) – Document Title.docx
MDSAP AS P0002.001 (yyyy/mm/dd) – Document Title.docx, or
MDSAP QMS P0002.001 (yyyy/mm/dd) – Document Title.docx.

Form: A document used to facilitate procedural implementation or document

procedural objectives

Form Number: A unique alpha-numeric identifier assigned by the RAS used to

differentiate forms and their versions. The Form Number consists of a prefix “F”
(Form) followed by five digits. The first four digits designate the procedure the
form is associated with. The next digit indicates the sequential number of the
form. For example, the first form associated with the procedure MDSAP P0002
would be:

MDSAP F0002.001
MDSAP AU F0002.1.001
MDSAP AS F0002.1.001, or
MDSAP QMS F0002.1.001

Implementation Date: Date that staff has received training and documents are
posted to the MDSAP web page.

Guidance: Guidance documents are developed as necessary to supplement,

direct the implementation of, or clarify approved regulatory, statutory, or MDSAP
policy. Guidance documents may also include work instructions that support the
implementation of a procedure.

Guidance Number: A unique alpha-number identifier assigned by the RAS

used to differentiate guidance documents and their versions. The Guidance
Number consists of a prefix “G” and a sequentially assigned four-digit number.
For example:

MDSAP G0001.001
MDSAP AU G0001.001
MDSAP AS G0001.001, or
MDSAP QMS G0001.001

Master Document List: A list of released documents maintained by the RCS

and including the Document Number, Version date, Revision Date and
Publication Date.

Uncontrolled when printed:

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Master file: This file includes all signed original documents and all electronic
files.

New Document Proposal (NDP) Template: A pre-developed page layout used to

make new documents with a similar design, pattern. This template includes work
instructions and is used to propose a new document as an attachment to a New
Document Proposal Form. The form may be initiated by anyone representing a
participating regulatory authority.

Non-significant Impact New Document or Revision: New documents or revisions

to existing versions that have minimal or no impact on the accomplishment or
maintenance of MDSAP objectives defined in the MDSAP P0001 Functional
Statement.

Originator: Any representative of a participating regulatory authority who

requests that a new document be created, or that a revision to an existing
document be made.

Procedure Number: A unique alpha-numeric identifier assigned by the MDSAP

QMS Management Representative to differentiate procedures and their versions.
The Procedure Number consists of a prefix “P” and a sequentially assigned four-
digit number. For example:

MDSAP P0002.001
MDSAP AU P0002.001
MDSAP AS P0002.001, or
MDSAP QMS P0002.001

Publication Date: Date that documents are published to the MDSAP website
(yyyy/mm/dd.) The publication date is recorded in the Master Document List.

Revision of Drafts: An iteration of document development that has not been

approved for release by the RAC Chair. Revisions of Drafts are distinguished by
a Revision Date and are not publically available on the MDSAP website.

Revision of Versions: An iteration of a released version that is the result of a

non-significant impact revision. Revisions of Versions are distinguished by a
Revision Date and are publically available on the MDSAP website.

Revision Date: A date assigned by the MDSAP QMS Management

Representative, when amendments were made to a draft document, or by the
RAS, when a non-significant impact revision was made to a released version
(yyyy/mm/dd.)
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Subject Matter Experts: Subject Matter Experts assist in the creation or revision
of documents. Subject Matter Experts may also review proposed new
documents or proposed document revisions for accuracy and appropriate
content.

Uncontrolled Copy: An informal copy of a document for which no attempt is made

to update it after distribution. Copies of documents made by users (in paper or
electronic form) are considered “uncontrolled copies”. The responsibility of
making sure a document is the most current approved document is with the user
of the document.

Version: A document that is publically available from the MDSAP website.

Version Date: Date the documents are signed by the Chair of the RAC or
MDSAP QMS Management Representative as applicable (yyyy/mm/dd.) The
version date is recorded in the Master Document List.

Version History: A summary of the cumulative history of the versions of a

document.

Version Number: A sequentially assigned number appearing at the end of a

Document Number. The version number is assigned by the MDSAP QMS
Management Representative or MDSAP QMS Site Representative after each
approval of a document by the RAC Chair. For example:

.001 (initial release)

.002 (second version)

4. Authorities/Responsibilities
4.1 MDSAP Regulatory Authority Council Chair:
• Maintains final document approval authority for all MDSAP documents

Note: Final document approval authority may be delegated to the

MDSAP QMS Management Representative or his or her designee
for non-significant impact new documents or revisions.

• Ensures resources are available to accomplish requirements specified

within the documents

Uncontrolled when printed:

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4.2 MDSAP Regulatory Authority Council (RAC):

• Reviews and recommends final document approval, disapproval or
approval with revision to the RAC Chair
• Works with the MDSAP QMS Management Representative, MDSAP QMS
Site Representative and document originator (as necessary) to resolve
questions and conflicts
• Provides a rationale for document disapproval or revision to the MDSAP
QMS Management Representative, MDSAP QMS Site Representative
and document originator as appropriate

4.3 MDSAP Regulatory Authority Secretariat (RAS):

RAC Secretariat will assist the RAC Chairperson for issues relating to the RAC
Board only. Those issues could be:
• Preparation of official communications – including application rejection
letters as applicable – to the candidate Auditing Organization
• Coordination and collection of the information for management review as
needed and maintains related management review records
• Assembling summary report and documents action items and plans
• Coordination of reviews and versions of MDSAP documents, including
assuring all proposed new and revised documents are available for review
and comment by the RAC
• Maintaining and controlling superseded or obsolete documents as related
to the RAC
• Maintaining a copy (electronic) of approved versions of documents as
related to the RAC
• Coordinating the clearance of MDSAP related documents
• Serving as a Liaison between the RAC and the MDSAP QMS
Management Representative, MDSAP QMS Site Representative or other
regulatory authority
Note: In the event of a vacancy in the MDSAP Secretariat position,
the aforementioned duties will be performed by the MDSAP QMS
Management Representative, with assistance from MDSAP QMS
Site Representatives.

4.4 MDSAP QMS Management Representative:

• Coordinates with the Regulatory Authority Council Secretariat to assure all
proposed new or revised documents are available for review and
comment by the RAC
• Reviews proposed new documents or proposed revisions to existing
documents to determine if they represent a non-significant impact new
document or revision

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Note: The MDSAP QMS Management Representative should

confer with his or her regulatory authority’s representative(s) to the
RAC; or other subject matter experts to assist in this determination
where necessary.
• Maintains final document approval authority for non-significant impact new
documents or revisions to existing documents
• Reviews and recommends approval of proposed new or revised
documents
• Works with the MDSAP QMS Site Representative and document
originator (as necessary) to resolve questions and conflicts
• Ensures training related to new or revised documents is provided as
necessary

4.5 MDSAP QMS Site Representative:

• Reviews, revises (as necessary) proposed new documents and the
revision of existing documents in their area of responsibility
• Verifies the necessity and technical accuracy of the documents
• Identifies training needs resulting from new or revised documents
• Works with the document originator to resolve questions and conflicts
• Assists the MDSAP QMS Management Representative in training affected
entities in new or revised documents as necessary
• Ensures comprehensive reviews of all documents used in his or her area
of responsibility are conducted

4.6 All MDSAP Regulatory Authority Representatives:

• Ensures implementation of document control system
• Ensures documents used within their area of responsibility are the most
current approved documents
• Performs comprehensive review of documents used within his or her area
of responsibility
• Identifies the need for new documents or the modification of existing
approved versions of documents
• Discusses proposed original document or document revision with MDSAP
QMS Site Representative and/or MDSAP QMS Management
Representative as applicable
• Authors and reviews for accuracy proposed original documents or
document revisions
• Originates document creation or revision by completing an Original
Document Proposal Template or revising an existing document

5. Procedures
This procedure should be used for the generation of new documents and the
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review and revision of existing documents.

5.1 General Document Format

The font for a proposed new or revised document (including procedures,
forms and guidance) should be Arial; font size 12 for narrative and font size
14 for main titles. The word “DRAFT” should appear as a watermark on each
page of each proposed new or revised document. To allow for editing a draft
document should:

• Not have the security function activated;

• Not be read-only;
• Not be password protected, and
• Employ limited use of hypertext or cross-referencing.

If published documents are provided in a PDF format, they must be

electronically searchable.

All required signatures and dates may be electronic or written.

5.2. Comprehensive Reviews

Documents should be reviewed and updated on an as-needed basis due to
changes in policies, standards, and other programmatic updates. In addition,
every sixty months, a comprehensive document review will be initiated based on
the latest date of review/version. The most current approved MDSAP documents
will be reviewed to ensure they continue to meet their defined purpose and
scope. The MDSAP QMS Management Representative and MDSAP QMS Site
Representatives are responsible to assure the comprehensive review is
conducted and revisions to documents are proposed as necessary. This review
includes verification of the consistency with other existing policies/procedures.

Minor document revisions such as typographical errors, page numbering

sequence errors, grammatical errors, spelling errors, etc. proposed between
comprehensive reviews that do not impact the utility of the document can be
saved by the Secretariat and addressed cumulatively at the comprehensive
document review; or approved as a non-significant impact revision.

5.3. New Document Development and Approval

The need for a new document can be recognized in many ways (e.g. group
discussion, a single originator’s initiative, external events, etc.).

The MDSAP QMS Site Representative and/or MDSAP QMS Management

Representative should agree with the concept of and necessity for the proposed
new document prior to the originator initiating the new document development
and approval process. Once agreed, the originator of the new document
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requests a document number from the RAC Secretariat or MDSAP QMS Site
Representative.

In case of approval, the originator will use the New Document Proposal (NDP)
Template to initiate the creation of a new document. The NDP template are
located on the MDSAP website and are to be completed and forwarded
electronically. The forms can also be obtained electronically from the RAC
Secretariat.

The originator should solicit input from various entities (e.g. subject matter
experts, colleagues who will use or be affected by the proposed new document,
MDSAP QMS Site Representatives, etc.) during the development of the
proposed new document.

The originator will provide an electronic copy of the completed NDP template to
the MDSAP QMS Site Representative, MDSAP QMS Management
Representative, or MDSAP RAC Secretariat in the event there is no MDSAP
QMS Site Representative or MDSAP QMS Management Representative
assigned.

The MDSAP QMS Site Representative (if applicable) will forward the completed
NDP template with a statement indicating review and concurrence (as well as
any other comments), to the MDSAP QMS Management Representative.

When the proposed new document does not have a significant impact on the
MDSAP as stated by the MDSAP QMS Management Representative (i.e. not a
new version), MDSAP QMS Management Representative or MDSAP QMS Site
Representative will revise the proposed new document as specified, assign a
revision date, revise the Master List of Documents, and provide the final
document to the MDSAP QMS Management Representative for final approval
and signature.

The MDSAP QMS Management Representative will sign and date the proposed
new document (that does not have a significant impact on the MDSAP)
authorizing its approval and return it to the MDSAP RAC Secretariat or MDSAP
QMS Site Representative who will publish the approved new document to the
MDSAP website.

When the proposed new document may have a significant impact on the
MDSAP, the MDSAP QMS Management Representative will provide the
completed NDP template along with the MDSAP QMS Site Representative
and/or MDSAP QMS Management Representative’s statement(s) of review and
concurrence (as well as any other comments) to the MDSAP RAC Chair.

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The MDSAP RAC Chair will collaborate as necessary with the MDSAP RAC and
reject, approve, or approve with revisions the proposed new document.

When a proposed new document is rejected, the MDSAP RAC Chair will provide
a documented rationale for rejection (in writing or electronically) and return the
completed NDP template and rationale to the MDSAP RAC Secretariat for
dissemination to the MDSAP QMS Management Representative, MDSAP QMS
Site Representative, originator, and RAC members, as applicable.

When a proposed new document is approved or approved with revisions, the

MDSAP RAC Chair will forward the completed NDP template with a statement of
approval or, a statement of approval with revisions to the MDSAP RAC
Secretariat and RAC members.

The MDSAP RAC Chair will sign and date the new document, or new version,
authorizing final approval and return it to the MDSAP QMS Management
Representative who will assign a revision date, publish the approved new
document to the MDSAP website, and notify the RAC members that the new
document has been published.

The MDSAP QMS Management Representative or MDSAP QMS Site

Representative will ensure training is provided on the new document as
necessary.

Note: The review of a new proposed document includes verification of the

consistency with other existing policies/procedures.

5.4. Revised Document Development and Approval

The need for a revision to a published document can be recognized in many
ways (e.g. group discussion, a single originator’s initiative, external events, etc.).

The originator should discuss the concept of and necessity for the revision to a
published document with the MDSAP QMS Site Representative and/or MDSAP
QMS Management Representative, as applicable. The MDSAP QMS Site
Representative and/or MDSAP QMS Management Representative should agree
with the concept of and necessity for the proposed revision to the published
document prior to the originator initiating the process for the revision and
approval of a published document.

The originator should prepare a new draft of an existing document as an MS

Word file with the “Track Change” feature activated. A Microsoft Word copy of
the document to be revised may be obtained from a non-public area of the

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MDSAP website, the MDSAP RAC Secretariat, or MDSAP QMS Site

Representatives.

The Originator will provide an electronic copy of the draft document to the
MDSAP QMS Site Representative or MDSAP QMS Management
Representative.

The MDSAP QMS Site Representative (if applicable) will forward the draft
document with a statement indicating review and concurrence (as well as any
other comments), to the MDSAP QMS Management Representative.

When the proposed revisions to a published document do not have a significant

impact on the MDSAP as stated by the MDSAP QMS Management
Representative, the MDSAP QMS Management Representative or MDSAP QMS
Site Representative will revise the existing document, and assign a Revision
Date, revise the Master List of Documents and provide the revised document to
the MDSAP QMS Management Representative for final approval and signature.

The MDSAP QMS Management Representative will sign and date the revised
document (when the proposed document revisions do not have a significant
impact on the MDSAP) authorizing its approval and return it to the MDSAP RAC
Secretariat or MDSAP QMS Site Representative who will remove the previous
revision of the document from the MDSAP website and publish the approved
revised document.

When the proposed revisions to a published document may have a significant

impact on the MDSAP, the MDSAP QMS Management Representative will
provide the draft document (as well as any other comments) to the MDSAP RAC
Chair through the MDSAP Secretariat.

The MDSAP RAC Chair will collaborate as necessary with the MDSAP RAC and
reject, approve, or approve with revisions the draft document.

When a draft document revision is rejected, the MDSAP RAC Chair will provide a
documented rationale for rejection (in writing or electronically) and return the
document and rationale to the MDSAP QMS Management Representative,
MDSAP QMS Site Representative, originator, and RAC members, as applicable.

When a draft document revision is approved or approved with revisions, the

MDSAP RAC Chair will forward the approved draft revised document with a
statement of approval or, a statement of approval with revisions to the MDSAP
QMS Management Representative and RAC members.

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The MDSAP QMS Management Representative will revise the existing

document, revise the Master List of Documents and provide the final document to
the MDSAP Chair for final approval and signature.

The MDSAP RAC Chair will sign and date the revised document authorizing final
approval and return it to the MDSAP RAC Secretariat or MDSAP QMS
Management Representative who will assign a revision date, remove and archive
the previous version of the document from the MDSAP website, and publish the
newly approved version of the document.

The MDSAP QMS Management Representative or MDSAP QMS Site

Representative will ensure training is provided on the new document as
necessary.
Note: The review of the proposed document revisions includes verification of
the consistency with other existing policies/procedures.

5.5. External Documents

Document from external sources are controlled using a log to track the use of
versions as part of the quality system. The title, date, version and, if applicable,
page numbers are to appear on these lists. Lists are maintained for the
reference documents.

5.6. Document Retention and Archiving

Documents are retained and archived according to the MDSAP QMS P0007,
Control of Quality Records Procedure.

5.7. Forms
Forms may be created as necessary to assist in the implementation or
documentation of procedural requirements. New forms are to be developed in
conjunction with new procedures. New forms will be forwarded with the
associated new procedure for review and approval.

New versions of forms are to be identified in the form’s associated procedure.

Revised forms are to be forwarded with the related procedure when submitted for
approval.

Instructions for completing forms should be embedded within the form or form
template.

Any optional section that does not apply will be annotated with “Not applicable” or
“None”.

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6. Forms
MDSAP QMS F0002.2 - New Document Proposal (NDP) Template

7. Reference Documents
MDSAP P0001- MDSAP Functional Statement
MDSAP QMS P0007- Control of Quality Records Procedure

8. Document History

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VERSION VERSION AUTHOR NAME/PROJECT

DESCRIPTION OF CHANGE
NO. DATE MANAGER
001 2013-07-15 Initial Release Liliane Brown, USFDA

002 2015-12-30 Changes were made throughout Liliane Brown, USFDA

the document to reflect the QMS
role and responsibilities for RAC,
Secretariat, and QMS Rep and
according to the MDSAP QMS
structure.
003 2016-10-11 Changes were made throughout Liliane Brown, USFDA
the document based on the
revision on ISO 9001:2015
004 2018-06-21 Changes were made throughout Kimberly Lewandowski-
the document to reflect current Walker/ Hiromi
practice and clarify roles. Biennial Kumada
document review.
Notes were added on section 5.3
and 5.4.
005 2019-01-11 Note made to section 4.3 to allow Hiromi Kumada,
for the MDSAP QMS Management PMDA/ Kimberly
Representative to assume duties Lewandowski-Walker,
of MDSAP Secretariat, if position US FDA
of Secretariat is vacant
Adjusted formatting
006 2021-03-15 Removed references to New Hiromi Kumada, PMDA
Document Proposal/Change
Request (NDP/CR) form.
Revised the frequency of
comprehensive document review
from 24 months to every 60
months in section 5.2.

Version 006
Approval

Approved: ON FILE Date: 2020-03-15

CHAIR, MDSAP RAC

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