MAXZ TPS & Inspection

QUALITY MANAGEMENT SYSTEM MANUAL

PROCEDURE FOR MANAGEMENT OF DOCUMENTED INFORMATION

1. PURPOSE:

To establish a system for the control of documented information required for the QMS.

2. SCOPE:

Documented information of internal and external origin required by the ISO9001:2015 standard and those
determined by the organization as being necessary for the effectiveness of the quality management system.

3. DEFINITIONS:

Document Controller: The one who controls creation and updating of QMS documents within his / her
functional area. In our organization, the Quality Management Representative (QMR) and all Heads of
Departments are the designated document controllers in their functional area.

Chief Document Controller: The one who co-ordinates with all the document controllers within the
organization to ensure that creation and updating of documented information required by the ISO9001:2015
standard as well as the QMS of the organization are properly controlled. In our organization, the Quality
Management Representative (QMR) has been designated as the chief document controller.

4. REFERENCES:

ISO9001:2015 Standard - Clause 7.5: Documented Information.

5. AUTHORITY AND RESPONSIBILITY:

Quality Management Representative (QMR) / Chief Document Controller

The QMR is overall responsible for the implementation of this procedure throughout the organization.

He / she is authorised to provide the resources for implementation of this procedure throughout the
organization.

Heads of Departments / Document Controllers

They are responsible for the implementation of this procedure in their respective functional areas.

They are authorised to provide the resources for implementation of this procedure in their respective
functional areas.

6. METHOD:

Our organization understands the need for greater operational flexibility, and at the same time, higher level of
system integrity when it comes to the maintenance of documented information required for the QMS.

Prepared by Reviewed & Approved by Issued by Doc. Control

Doc ID: QMR-Q-M-PR-24
Signature Version: 001
Date 15-MAR-2019 15-MAR-2019 15-MAR-2019 Effective date: 15-MAR-2019
Designation QMR MD QMR Page 1 of 7
 MAXZ TPS & Inspection
QUALITY MANAGEMENT SYSTEM MANUAL
PROCEDURE FOR MANAGEMENT OF DOCUMENTED INFORMATION

6.A) Requirement for Documented Information

The ISO9001:2015 standard require the organization to maintain the following documented information:

Sl. ISO9001
No. Clause Required Documented Information
1 4.3 The scope of the organization’s quality management system
2 4.4.2 Documented information needed to support the operation of organization’s processes
3 5.2.2 The quality policy of the organization
4 6.2.1 The quality objectives of the organization
5 7.1.5.1 Appropriate documented information as evidence of ‘fitness for purpose’ of the monitoring
and measurement resources
6 7.1.5.2 The basis used for calibration or verification of monitoring and measurement resources, when
no measurement standards traceable to international or national measurement standards exist
7 7.2 Appropriate documented evidence of competence of personnel
8 7.5.1 Documented information of internal origin determined by the organization as being necessary
for the effectiveness of the quality management system, other than those required by the
ISO9001:2015 standard
9 7.5.3.2 Documented information of external origin determined by the organization to be necessary for
the planning and operation of the quality management system.
10 8.2.3.2 Applicable documented information on the results of customer order review, and, on any new
requirements for the products and services
11 8.3.3 Design and development inputs
12 8.3.4 Design and development activity records pertaining to definition of results to be achieved,
D&D reviews, D&D verification, D&D validation, and, any necessary actions taken on
problems determined during the reviews, or verification and validation activities.
13 8.3.5 Design and development outputs
14 8.3.6 Documentation of design and development changes, the results of reviews, the authorization
of the changes, and the actions taken to prevent adverse impacts
15 8.4.1 The criteria for the evaluation, selection, monitoring of performance, and re-evaluation of
external providers, and, the documentary evidence of these activities and any necessary
actions arising from the evaluations
16 8.5.1 The documented information that defines: (1) the characteristics of the products to be
produced, the services to be provided, or the activities to be performed, and, (2) the results to
be achieved
17 8.5.2 Documented information necessary to enable traceability of the outputs, when traceability is a
requirement
18 8.5.3 Documented information on what has occurred when the property of a customer or external
provider is lost, damaged or otherwise found to be unsuitable for use
19 8.5.6 Service provision: documented information describing the results of the review of changes,
the person(s) authorizing the change, and any necessary actions arising from the review
20 8.6 Documented information on the release of products and services that includes: (a) evidence of
conformity with the acceptance criteria, and, (b) traceability to the person(s) authorizing the
release
21 8.7.2 Documented information that: describes the nonconformity, describes the actions taken,

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Signature Version: 001
Date 15-MAR-2019 15-MAR-2019 15-MAR-2019 Effective date: 15-MAR-2019
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QUALITY MANAGEMENT SYSTEM MANUAL
PROCEDURE FOR MANAGEMENT OF DOCUMENTED INFORMATION

describes any concessions obtained, and, identifies the authority deciding the action in respect
of the nonconformity
22 9.1.1 Documentary evidence of the results of evaluation of the performance and the effectiveness of
the quality management system
23 9.2.2 Internal audit: implementation of the audit programme and the audit results
24 9.3.3 Documentary evidence of the results of management reviews
25 10.2.2 Documentary evidences of the nature of non-conformities and any subsequent actions taken,
and, the results of any corrective action

Apart from the above documented information, the organization may need to keep other documentation also for
the effective functioning of our QMS.

6.B) Co-ordination Among Document Controllers

The QMR issues QMS documents such as quality system manual, work instruction manual, forms, etc. that are
applicable to the entire organization.

Individual document controllers issue QMS documents required by their functional areas (and one or two
related functional areas also). For example, the Head (Service) issues teaching materials that are used by the
Inspector and laboratory personnel.

However, there is a possibility of document redundancy, duplicate numbering, and other problems arising out of
distributed document control. In order to prevent these problems, the QMR maintains a ‘Master List of
Document Controllers (QMR-Q-F-PR24-001)’ and allots a unique code for each of them. For example, the
document controller code for Quality Management Representative is ‘QMR’, code for Head (Service) is ‘SRV’,
and so on.

Only those included in the master list of document controllers can issue QMS documents.

Also, the QMR (as the chief document controller) holds periodic meetings of document controllers to ensure
that document redundancy and version mis-match (i.e., the use of different versions of same document in
different departments) are identified and eliminated.

6.C) Creating and updating documented information

When creating and updating documented information, our organization ensures, through document controllers,
that the documented information have appropriate:
a) identification and description (e.g. a title, date, author, or reference number)
b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic), and
c) review and approval for suitability and adequacy.

6,D) Document numbering and version numbering conventions

The following conventions are adhered to while numbering the QMS documents.

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Doc ID: QMR-Q-M-PR-24
Signature Version: 001
Date 15-MAR-2019 15-MAR-2019 15-MAR-2019 Effective date: 15-MAR-2019
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QUALITY MANAGEMENT SYSTEM MANUAL
PROCEDURE FOR MANAGEMENT OF DOCUMENTED INFORMATION

1. A unique document identification number is given to each new document.

2. Every document identification number must start with the alpha-numeric code of the respective document
controller (code allotted by the chief document controller).

The document numbering schematic followed by the QMR is explained below. Other document controllers also
use similar schematics (may not be same) for the QMS documents issued by them.

Document Classes Document Categories Section Codes

Q : Quality documents M : Procedure Manual GN - General
M : Marketing documents I : Work Instructions PR – Procedure
D : D& D documents F : Record Formats AX – Annex
T : Teaching documents S : Specification / Standard

For sections of quality management system manual issued by the QMR (this manual), numbering schematic is
QMR-Q-M-SC-NN where “QMR” is the document controller code, “Q” indicates the document class (quality
document), “M” indicates document category (procedure manual), “SC” indicates section code (GN for general
section, PR for procedure, and “NN” is the serial number under a given section code.

For example, the document ID for this procedure issued by the QMR is QMR-Q-M-PR-24 where ’QMR’ is the
document controller code, ‘Q’ is the document class, ‘M’ denotes procedure manual, ‘PR’ denotes procedure
(section code), and 24 is the procedure serial number (i.e., 24 th procedure of this manual).

For sections of work instruction manual issued by the QMR, numbering schematic is QMR-Q-I-SCNN-MM
where “QMR” is the document controller code, “Q” indicates the document class (quality document), “I”
indicates document type (instruction), “SCNN” indicates the section in the procedure manual to which the work
instruction is related to, and “MM” is the serial number under a given ‘QMR-Q-I-SCNN’ combination.

For example, if there is a work instruction associated with this procedure issued by QMR, the document ID for
that work instruction would be QMR-Q-I-PR24-01 where ’QMR’ is the document controller code, ‘Q’ is the
document class, ‘I’ denotes work instruction, ‘PR24’ points to the related procedure, and 01 is the work
instruction serial number (i.e., 1st work instruction related to the 24th procedure of this manual).

For quality record formats issued by the QMR, numbering schematic is QMR-Q-F-SCNN-MM/V-iii/W.e.f: dd-
Mmm-yyyy where “QMR” is the document controller code, “Q” indicates the document class (quality
document), “F” indicates document category (record format), “SCNN” indicates the section in the system
manual to which the record format is related to, and “MM” is the serial number under a given ‘QMR-Q-F-
SCNN’ combination, V-iii denotes version number, and ‘W.e.f: dd-Mmm-yyyy’ stands for ‘with effect from:
date’.

For example, the first record format related to this procedure is numbered QMR-Q-F-PR24-01/V-001/W.e.f.:
01-Oct-2015 where ’QMR’ is the document controller code, ‘Q’ is the document class, ‘F’ denotes record
format, ‘PR24’ points to the related procedure, and 01 is the record format serial number (i.e., 1 st record format
related to the 24th procedure of this manual). While referring this format, we would call it QMR-Q-F-PR24-01
only (not the entire length).

Prepared by Reviewed & Approved by Issued by Doc. Control

Doc ID: QMR-Q-M-PR-24
Signature Version: 001
Date 15-MAR-2019 15-MAR-2019 15-MAR-2019 Effective date: 15-MAR-2019
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 MAXZ TPS & Inspection
QUALITY MANAGEMENT SYSTEM MANUAL
PROCEDURE FOR MANAGEMENT OF DOCUMENTED INFORMATION

Note: In case of manual and work instructions, the version number and effective date are mentioned at the
bottom right corner of the document (footer). Please check the ‘Doc. Control’ box of this procedure on the
footer to understand the system.

6.E) Control of documented information

The required documented information is controlled to ensure that …

a) it is available and suitable for use, where and when it is needed, and
b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity).

For the control of documented information, the organization addresses the following activities, as applicable:
a) distribution, access, retrieval and use
b) storage and preservation, including preservation of legibility
c) control of changes (e.g. version control), and
d) retention and disposition.

6.E.1) Control of documents of internal origin

All document controllers (DC’s), follow the system described below for creation and updating of QMS
documents of internal origin.

Every Document Controller (DC) maintains a ‘Master List of QMS Documents and Records (QMR-Q-F-PR24-
002)’ controlled by them.

In case of documents, this master list contains the document ID, Title, Author, Reviewer & Approver, Issuer,
Format (e.g. language, software version, graphics), Medium (e.g. paper, electronic), Version, Effective Date,
and the List of recipients of controlled copies.

In case of records, this master list contains the record ID, Title, Format (e.g. language, text / software version,
graphics), Medium (e.g. paper, electronic), Custodian, and Minimum Retention Period.

a) Request for addition / modification

The Document Controllers receive document addition / modification request (could be from anybody) in the
format ‘Document Addition / Change Request (QMR-Q-F-PR24-003)’.

If the request is approved by the approval authority, the Document Controller gets the document prepared /
modified by the concerned author and submits to the approving authority for review and approval. Also, a
unique document identification number is given to each new document.

If the new / modified document is approved by the approving authority, the Document Controller releases it.
He / she also updates the version number and effective implementation date information in the master list of
documents and records. Then, the new version of the document (entire section that is getting changed) is sent to
the designated recipients of controlled copies.

Prepared by Reviewed & Approved by Issued by Doc. Control

Doc ID: QMR-Q-M-PR-24
Signature Version: 001
Date 15-MAR-2019 15-MAR-2019 15-MAR-2019 Effective date: 15-MAR-2019
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QUALITY MANAGEMENT SYSTEM MANUAL
PROCEDURE FOR MANAGEMENT OF DOCUMENTED INFORMATION

b) Document issue

The Document Controller readies the master document duly signed by the preparation, approval and issuing
authorities. Then he / she makes photocopies, stamps them in red colour with “Controlled Copy” rubber stamp,
and sends to the recipients along with a ‘Document issue-cum-receipt note (QMR-Q-F-PR24-004)’.

Recipients, on receipt of the documents, remove the older version (obsolete) of the documents from their folders
and file the new version of the documents. The recipients physically dispose off obsolete documents. Then, the
recipients send back the Document issue-cum-receipt note to the Document Controller, duly filled and signed by
them. A photocopy of the issue-cum-receipt slip may be kept by the recipients.

c) Document withdrawal

In case of withdrawal of an existing document that has become redundant / obsolete, the Document Controller
would notify all recipients, through a ‘Document Withdrawal Notice (QMR-Q-F-PR24-004)’, asking them to
remove those documents from their folders and physically destroy them.

Obsolete documents and records retained for legal/reference purpose are marked as ‘OBSOLETE’.

6.E.2) Control of Documented Information of External Origin

The Document Controllers identify documents and records of external origin (such as those from customers,
suppliers, certification bodies, regulators, etc.) relevant to their functional areas and control their circulation.

6.E.3) Storage, Preservation, and Disposition of Documented Information (of Internal / External Origin)

The Document Controllers and Custodians of Records are responsible for proper storage & preservation of
documented information (including preservation of legibility) and disposition.

Records are maintained in suitable form, such as registers and document files. Hard copy registers and files are
neatly stored in safe locations.

Records in the form of electronic media are kept in hard disk of the respective computers. A quarterly backup of
these records is taken in another hard disk / CD / DVD / Pen Drive in order to minimise the risk of data loss due
to computer failures. In case of CD / DVD / Pen Drive backup, they are kept under the custody of the HOD’s in
safe and dust-free environment.

If a customer demands a record, care is taken to give only photocopies or a separate CD / DVD, if the record has
to be taken out of the premises (where the original records are kept).

Prepared by Reviewed & Approved by Issued by Doc. Control

Doc ID: QMR-Q-M-PR-24
Signature Version: 001
Date 15-MAR-2019 15-MAR-2019 15-MAR-2019 Effective date: 15-MAR-2019
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 MAXZ TPS & Inspection
QUALITY MANAGEMENT SYSTEM MANUAL
PROCEDURE FOR MANAGEMENT OF DOCUMENTED INFORMATION

7. RECORDS:

The following records are maintained.

Sl. Retention Custodian(s)

No. Record Title / ID Format Medium Period
1 Master List of Document Controllers English, Text Electronic Perpetual QMR
(QMR-Q-F-PR24-001) (Word file)
2 Master List of QMS Documents and Records English, Text Electronic Perpetual Doc.
(QMR-Q-F-PR24-002) (Word file) Controllers
3 Document Addition / Change Request English, Text Paper Min 3 years Doc.
(QMR-Q-F-PR24-003) Controllers
4 Document Issue-cum-Receipt Note English, Text Paper Min 3 years Doc.
(QMR-Q-F-PR24-004) Controllers
5 Document Withdrawal Notice English, Text Paper Min 3 years Doc.
(QMR-Q-F-PR24-005) Controllers

8. DOCUMENT AMENDMENT HISTORY:

Version No. Summary of changes from previous version of the document Changes sought by Remarks of QMR
V-001 First version released for implementation. N/A Nil

Prepared by Reviewed & Approved by Issued by Doc. Control

Doc ID: QMR-Q-M-PR-24
Signature Version: 001
Date 15-MAR-2019 15-MAR-2019 15-MAR-2019 Effective date: 15-MAR-2019
Designation QMR MD QMR Page 7 of 7