STANDARD OPERATING PROCEDURE SOP No.
MR-42-03
Revision No 03
Superseded No 02
Title : Issue Month December 2017
PROCEDURE ON DOCUMENT CONTROL Revision Due November 2020
Page No. 1 of 8
Effective Date :
Owner of the SOP : Quality Compliance
Cross Functional Area: QCI, QCL, Production Department, Injection Molding & Extruder,
Sterilization, Utility, Maintenance, HR& Admin., PMD & IMD , SCD, Design
& Development, QA Manager
Distribution List :
Distribution To Distributed Copy Distribution Type
QCI Photocopy
01
QCL Photocopy
01
Quality Compliance Photocopy
01
Production Department Photocopy
01
PMD & IMD Photocopy
01
Design & Development Photocopy
01
SCD Photocopy
01
HR& Admin Photocopy
01
Injection Molding & Extruder Photocopy
01
Sterilization Photocopy
01
Maintenance Photocopy
01
Utility Photocopy
01
QA Manager Photocopy
01
Quality Compliance (Archive ) Master Copy
01
Signature/
Name Designation
date
Prepared by Sazzad Karim Executive, Quality Compliance
S.M. Saiduzzaman Executive, HR & Administration
Checked by
Shamir Kumar Dey Asst. Manager, Quality Compliance
Approved by Kazi Mohammad Rafiqul Islam Manager, Quality Assurance
Property of NIPRO JMI Company Limited, Vitikandi, Gazaria-1510, Munshiganj, Bangladesh
STANDARD OPERATING PROCEDURE SOP No MR-42-03
Revision No 03
Superseded No 02
Issue Month December 2017
Title : Revision Due November 2020
PROCEDURE ON DOCUMENT CONTROL Page No. 2 of 8
1. PURPOSE
To define a system for the management (i.e. preparation, numbering, review, approval,
implementation, distribution and archive) of Quality Documents.
2. SCOPE
This procedure is applied to the quality documents (hereinafter called “documents”),
Holder of Original Document except External document which consist of reference,
national / international standard, customer contract, specification issued by supplier, EU
Laws related to quality management systems and medical device, CE Marking
Operation Manual, Tripartite Agreement on CE Marking etc.
3. RESPONSIBILITIES
3.1 Section Document Controller
Is responsible for document control and archiving document in each
Department/Section here In Charge of department shall nominate the Section
Document Controller (SDC).
3.2 In Charge of Department/Section
Is responsible to supervise the SDC for document controlling.
3.3 HR & Admin Responsibilities
Is responsible for preparation & approval specimen signature of management
personnel.
3.4 In Charge of Quality Compliance
In Charge of Quality Compliance is the document controller . DC is responsible for
overall coordination of activities related to SOPs. These activities include document
control, circulation for review , tracking, distribution and filing. and also responsible for
all master document control in Quality Compliance by instructor of in-charge of QA.
3.5 In charge of Quality Assurance,
In charge of Quality Assurance is the General document controller. Is responsible for
Approval & ensure that the procedure outlined in the SOP is followed.
4. REFERENCES / CROSS REFERENCES
4.1 References:
MQ-01 : Quality Manual
EN ISO 13485: Medical devices- Quality Management Systems- Requirements For
Regulatory Purpose.
4.2 Cross References
Prepared by/date Approved by/date
Property of NIPRO JMI Company Limited, Vitikandi, Gazaria-1510, Munshiganj, Bangladesh
STANDARD OPERATING PROCEDURE SOP No MR-42-03
Revision No 03
Superseded No 02
Issue Month December 2017
Title : Revision Due November 2020
PROCEDURE ON DOCUMENT CONTROL Page No. 3 of 8
MR-42-04 : Procedure on Control of Quality Records.
MJ-42-01-003 : Operational procedure on External Document Control
MJ-42-03-002 : Operational Procedure on Establishment of Standard Operating
Procedure(SOP)
MJ-73-02-003 : Operational Procedure on Document Change
5. DEFINITION
5.1 Definition
5.1.1 Approve Date:
This is the final date when the document is approved by in charge of QA for the
execution at the designated area.
5.1.2 Obsolete definition:
The definition is obsolete of something that is no longer being used or is out of date
and no longer appropriate for the purpose it was obtained due to either to availability
of better alternatives or change in user requirement.
5.1.3 Effective date:
The effective date listed on any approved document is the date by which compliance to
the standard required & training done on the particular date.
5.1.4 Forms / Attachments:
A version controlled document with pre-designed spaces and /or check boxes to
capture specific information or to invite narrative comments, input, or decisions related
to the activities. Forms may be managed as bank format or as part of the SOP.
5. 2 External Documents:
5.2 Various Procedures and Laws means the Law and/or equivalent documents
.1 which related to Quality Management System and Medical Device
5.2 Harmonized Standard means the Standard related to Quality Management
.2 System and Medical Device which is titled with “EN” and has been published
in the “Official Journal of the European Communities”
5.2 Applicable Standard means the international or national reference standard
.3 including the guidance for Medical Device e.g. NB-MED, MEDDEV, which is not
titled with “EN” and are used in the Essential Requirements Check List.
5.2 Contracts means the Basic sales contract, basic purchase agreement, Quality
.4 specification, Quality System contract (included Tripartite Agreement on CE
Marking), Delivery Specification and customer/ supplier supplied the document.
Prepared by/date Approved by/date
Property of NIPRO JMI Company Limited, Vitikandi, Gazaria-1510, Munshiganj, Bangladesh
STANDARD OPERATING PROCEDURE SOP No MR-42-03
Revision No 03
Superseded No 02
Issue Month December 2017
Title : Revision Due November 2020
PROCEDURE ON DOCUMENT CONTROL Page No. 4 of 8
6. ABBREVIATIONS, ACRONYMS AND SYMBOLS
QA : Quality Assurance
QCL : Quality Control Lab
QCI : Quality Control Inspection
SDC : Section Document Controller
GDC : General Document Controller
PMD &IMD : Product Management Department & International Marketing Department
7. PROCEDURE
7.1 The “documents” shall be controlled as per requirement outlined in this SOP shown in the flow
chart (Refer # Attachment-01), Document Control Flow Chart.
7.2 Preparation of New Documents
7 Documents shall be
. prepared and approved
2 as per the process flow
. mentioned in #
1 Attachment-1
7 The initiator of the
. document shall be the
2 process owner. However,
. minimum requirement of
2 good documentation
practice (GDP) as shown
below shall be
implemented while
preparing or revising the
document.
7 Good Documentation
. Practices
3
7 Provide reason and
.7 objective evidence
All documents shallfor
be
. numbered, signed and
3
7 dated byerror
For any the appropriate.
correction
. follow general rules of no
3 obliteration, explanation
7 The procedure must detail the
. following key elements but
4 not limited to the following,
Prepared by/date Approved by/date
Property of NIPRO JMI Company Limited, Vitikandi, Gazaria-1510, Munshiganj, Bangladesh
STANDARD OPERATING PROCEDURE SOP No MR-42-03
Revision No 03
Superseded No 02
Issue Month December 2017
Title : Revision Due November 2020
PROCEDURE ON DOCUMENT CONTROL Page No. 5 of 8
7 Purpose of the procedure.
.
4
.
1
7 Person or Department
. responsible for the
4 implementation of the
. procedure.
2
7 Who is / are the next
. customer(s) downstream
4 and who is / are the last
. supplier(s) up stream.
3
7 The date the procedure is
. effective.
4
.
4
7 Detailed procedure
. including the handling of
4 technical issues.
.
5
7 Control points in the
. procedure
4
.
6
7
.
5 Preparation of Flow Charts
7
.
6 Revision of Documents
Prepared by/date Approved by/date
Property of NIPRO JMI Company Limited, Vitikandi, Gazaria-1510, Munshiganj, Bangladesh
STANDARD OPERATING PROCEDURE SOP No MR-42-03
Revision No 03
Superseded No 02
Issue Month December 2017
Title : Revision Due November 2020
PROCEDURE ON DOCUMENT CONTROL Page No. 6 of 8
7 In case of revision on
. documents, authorized
6 person who has the same
. function that performed
1 the original review and In
Charge of Quality
Compliance shall review
all types of QMS
documents and In charge
of QA is responsible for
approval the document.
7 The person in charge of
. revision (initiator) shall
6 remark the position,
. sentence of change
2 clearly. The details of
revision shall be defined in
History of Revision.
7
.
7 Review of Document
7 New or revised documents
. shall be submitted to the
7 reviewer with review seal.
. The reviewer shall review
1 the documents thoroughly
with respect to the
contents and details of the
revision.
7 The comments /
. suggestions provided by
7 the reviewers are then
. incorporated in the SOP by
2 the Initiator. The final
document is then printed
for approval.
7 The final document shall
. be submitted to the
7 Person in charge for
. approval and registration
7
. Management of
8 Document Control
Prepared by/date Approved by/date
Property of NIPRO JMI Company Limited, Vitikandi, Gazaria-1510, Munshiganj, Bangladesh
STANDARD OPERATING PROCEDURE SOP No MR-42-03
Revision No 03
Superseded No 02
Issue Month December 2017
Title : Revision Due November 2020
PROCEDURE ON DOCUMENT CONTROL Page No. 7 of 8
7 In Charge of Quality
. Compliance shall register
8 and maintain issued
. documents on document
1 distribution log and shall
verify that the obsolete
document is removed and
destroyed from the usage
point.
7.9 Document
Review process
7 Section Document
. Controller shall review
9 quality of document
.
1
7 New standards and
. regulations are issued
9 or revised.
.
1
.
1
7 The contents and
. details of documents
9 are adequate and
. valid.
1
.
2
7 Up-date revision are
. controlled except
9 audit plan ,
. production plan and
1 material plan.
.
3
Prepared by/date Approved by/date
Property of NIPRO JMI Company Limited, Vitikandi, Gazaria-1510, Munshiganj, Bangladesh
STANDARD OPERATING PROCEDURE SOP No MR-42-03
Revision No 03
Superseded No 02
Issue Month December 2017
Title : Revision Due November 2020
PROCEDURE ON DOCUMENT CONTROL Page No. 8 of 8
7 The review procedure
. shall follow the
9 “Operational Procedure
. on Establishment of
2 Standard Operating
Procedure (MJ-42-03-
002)”. Each section shall
review the documents as
per shelf life of the
documents or as per
revision required.
7 Each Section Document
. Controller shall record the
9 result of reviewing in
. revision history. The
3 record should be included
the items, “The reason
why reviewed (Annual or
whenever)”, “document
name, document number,
revision no “date of
reviewing”, “name of the
person who reviewed”.
7.10 Distribution,
Storing and
Withdrawal of old
version:
7 Distribution of Documents
. (Protocols, SOPs, and
1 Standards etc.) their
0 controls, withdrawal of old
. version shall be conducted
1 as described below.
7 Owner of the original
document shall
.
distribute necessary
1 number of copies,
0 which shall be
. identified as controlled
document every pages
1
with the stamp “DO
. NOT COPY”.
1
Prepared by/date Approved by/date
Property of NIPRO JMI Company Limited, Vitikandi, Gazaria-1510, Munshiganj, Bangladesh
STANDARD OPERATING PROCEDURE SOP No MR-42-03
Revision No 03
Superseded No 02
Issue Month December 2017
Title : Revision Due November 2020
PROCEDURE ON DOCUMENT CONTROL Page No. 9 of 8
7 Quality compliance
shall confirm the
.
distribution by getting
1 the signature of
0 document receiver on
. “Document Distribution
Prepared by/date Approved by/date
Property of NIPRO JMI Company Limited, Vitikandi, Gazaria-1510, Munshiganj, Bangladesh
STANDARD OPERATING PROCEDURE SOP No MR-42-03
Revision No 03
Superseded No 02
Issue Month December 2017
Title : Revision Due November 2020
PROCEDURE ON DOCUMENT CONTROL Page No. 10 of 8
In case the document
7
are revised ,SDC shall
. return the old version
1 Controlled Copy which
0 is out of use to
Quality
.
Compliance .Return
1 Returned version shall
4 be scrapped and
Original shall be stamp
superseded and kept
in separate file at
Quality Compliance.
Returned version shall
be scrapped and
original shall be stamp
superseded and kept
in separate file at
Quality Compliance .If
any document is out
of QMS practice or
irrelevant then it is
7 made invalid with
. proper stamping and
kept in separate file at
1
Quality Compliance. If
0 any document is out of
. QMS practice or
1 irrelevant then it is
made with proper
5
stamping and kept in
separate file at Quality
Compliance. The
storing of document
and quality records
7 shall be followed in
. accordance with
1 operational procedure
0 of control of Quality
records.(MR-42-04).
.
Prepared by/date Approved by/date
Property of NIPRO JMI Company Limited, Vitikandi, Gazaria-1510, Munshiganj, Bangladesh
STANDARD OPERATING PROCEDURE SOP No MR-42-03
Revision No 03
Superseded No 02
Issue Month December 2017
Title : Revision Due November 2020
PROCEDURE ON DOCUMENT CONTROL Page No. 11 of 8
Fire hazards include
7. which are potential for
11 ignition, or that
.2 aggravate
Fire to become large
and uncontrolled. Fire Record form
7.12 Period for approval and 7.13.1 Record form shall be
execution of document identified with form number
7.12.1 After for each record in
the final approval of the accordance with
document, the owner of the Operational Procedure on
document Control Quality Record
shall (MR-42-
giving training relevant 04) in each Section.
personnel before execution
document.
7.13 Record form
7.13.1 Record form
shall be identified with form
number for each record in
accordance
with Operational
Procedure on Control Quality
Record (MR-42-04) in each
section.
7.13.2 Record form shall
be treated as part of document
7 Limit Sample 7.13.2 Record form shall
.
1 7.14.1 Limit sample is
4 defect of parts or products
that could not be described
by
written description
or figures clearly or could
not made decision by
individual
7 inspector (good or
. defects). Details are
1 specified in
7.14.1 Limit sample is defect
8.FORMS/ATTACHMENT
Forms/ Attachment No Title
Prepared by/date Approved by/date
Property of NIPRO JMI Company Limited, Vitikandi, Gazaria-1510, Munshiganj, Bangladesh
MR-42-03 F01-03 Specimen signature of Management personnel.
Attachment #1 Document Control Flow Chart.
STANDARD OPERATING PROCEDURE SOP No MR-42-03
Revision No 03
Superseded No 02
Issue Month December 2017
Title : Revision Due November 2020
PROCEDURE ON DOCUMENT CONTROL Page No. 12 of 8
9. REVISION HISTORY
Version No. Issue Month Reason
00 November, 2012 First time issue
01 December, 2013 As per CR Ref# DC-QC-13K-007 (Point 6.1.1 corrected
with Head of QA instead of General manager) along with
serial number harmonization, 7.9.1, 7.9.2, 7.10.1 &
inclusion of new point as 7.10.1.6 (inclusion of additional
control copies distribution), attachments to include in
point 8
02 March’2015 As per document change proposal DC-QC-14J-002
update the SOP as per new organogram and also the
SOP as per current practice.
03 December,2017 .SOP has been harmonized with New organogram and as
per CR Ref # DC-QC-17H-003. ( Include point 3.3).
.DC-QC-17L-003 include 7.15 (Form : MR-42-03F01-03)
& 3.3 ( HR & Admin responsibilities)
.And also Inclusion point 3.3 ,5.1.2,7.11.2, 7.15 and
exclusion point 7.5
Prepared by/date Approved by/date
Property of NIPRO JMI Company Limited, Vitikandi, Gazaria-1510, Munshiganj, Bangladesh
