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DOC. No.

QSM - 04
QUALITY SYSTEM MANUAL
REV. No. 01
MP QUALITY MANAGEMENT SYSTEM
DATE 01.01.2013
PAGE No. 1 of 4

4.1 GENERAL REQUIREMENT

 The Quality Management System (QMS) of ‘Mech Products ’ (hereafter called


Organisation) is established, documented, implemented and maintained in line
with the requirements of ISO 9001:2008. Continual improvement of the
effectiveness of this QMS, with the requirements of ISO9001:2008 standard is
constantly practiced.

 The Block diagrams in the QSM-10 identify the general process required for our
Quality Management system.

 The order and interaction of the specific (department) quality management system
processes can be found in QSM-10.

 The criteria and methods for effective control of processes are found in internal
audit section and Process control plan.

 Resources required for the processes are identified in the Resource Management,
to support the operation and control of these processes. The information necessary
for effective operation and monitoring of these processes is found within available
controlled documents throughout the organisation.

 Upon the completion of measurement and monitoring of the processes and


analysis of the data, appropriate action is taken to assure that intentions are
achieved and opportunities for improvement are acted on.

 Management of these processes is accomplished in accordance with the


requirements of ISO 9001:2008.

 No work process is being outsourced by the organization.


Reference:
PROCESS MAP & INTERACTION (QSM – 10)
LIST OF APPROVED SUPPLIERS (F-PUR-01)

4.2 DOCUMENTATION REQUIREMENTS


4.2.1 GENERAL
 The Organisation has documented its entire QMS requirements to facilitate
effective implementation, maintenance and continual improvement of the
systems. It includes the following:

 Documented statements of Quality Policy and Quality Objectives.

 Quality manual.

 Documented procedure required by the ISO 9001:2008 standards.

PREPARED BY APPROVED BY
DOC. No. QSM - 04
QUALITY SYSTEM MANUAL
REV. No. 01
MP QUALITY MANAGEMENT SYSTEM
DATE 01.01.2013
PAGE No. 2 of 4

 Document needed by the Organisation to ensure the effective planning, operation


and
 Control of QMS process.

 Records required by the ISO 9001:2008 standards.

Reference:
QUALITY POLICY AND OBJECTIVES (5.3)
QUALITY SYSTEM MANUAL (QSM)

4.2.2 QUALITY MANUAL

 Quality manual is in full conformity with the requirements of ISO9001:2008


standard and is supported by further levels of documentation as required in 4.2.1

 The scope of the QMS including the details of justification for any exclusion.

 The reference to the documented procedures established for the QMS.

 A detailed description of the interaction between the processes of QMS is


prepared.

 The Scope of the organisation is

Manufacture & Supply of Machined Components

 Exclusion of Clauses of ISO 9001: 2008 and Justification for exclusion is


explained below.

Clause Exclusion Justification


or Sub
Clause
7.3 Design & The organisation is manufacturing the components
Development as per the customer’s drawing. Hence it is
excluded.
7.5.2 Validation of The organization doesn’t have any process where
processes for the resulting output cannot be verified by
production & subsequent monitoring. Hence this clause is
service provision excluded.

 However, exclusion of the above clauses will not affect organisation’s ability or
responsibility to provide product that meets customer and applicable regulatory
requirements.

Reference:

PREPARED BY APPROVED BY
DOC. No. QSM - 04
QUALITY SYSTEM MANUAL
REV. No. 01
MP QUALITY MANAGEMENT SYSTEM
DATE 01.01.2013
PAGE No. 3 of 4

QUALITY SYSTEM MANUAL (QSM)

4.2.3 CONTROL OF DOCUMENTS – mandatory procedure

 All documents within organisation’s quality system are controlled as explained


below
 The Quality System Documents are Prepared, Reviewed and Approved as
explained below.

Sl. Documents Prepared & Approved by


No. Reviewed by
1 Quality System Manual MR Proprietor
2 Process Control Plan , MR Proprietor
Documents, Formats, Lists

 This is evidenced by the Signature of the respective authority in every sheets of


the manual.
 All the pages of the Manual and procedures are identified by Document number,
Revision number, Date of implementation of the system and Page number.

Document Numbering System


Document / Record Numbering System
Quality System QSM-XX where QSM for Quality System manual and XX
Manual (QSM) represents serial number.

Formats F-XXX-YY where XXX – Process, F – Format, YY – Serial


Number.
Control Plan CP-XX where CP-control Plan and XX- serial number.
Master Lists D-YY where D – Document, YY – Serial Number.

Document Issue
 All the Pages of the Manual belonging to MR are stamped with “MASTER
COPY” Stamp in Green on the back side and other copy holders are stamped with
“CONTROLLED COPY” Stamp in red on front side and only master documents
and controlled documents are subjected to changes.
 The Controlled Documents are issued to other copy holders except MR and it is
recorded in the List of Documents (D-MR-01).

Document Changes
 Changes to the documents can be initiated by any one in the organization. Its
relevance and advantages discussed by MR.
 All the changes are reviewed and approved by same authority that has done the
original review and approval.
 The Changes are reviewed by the MR and initiates the changes in the respective
documents.
 When a particular page has undergone revision, the revision number of that page
is incremented by one and date in that page will be changed to the Date of
Implementing the revision.

PREPARED BY APPROVED BY
DOC. No. QSM - 04
QUALITY SYSTEM MANUAL
REV. No. 01
MP QUALITY MANAGEMENT SYSTEM
DATE 01.01.2013
PAGE No. 4 of 4

 On Revision, the Amendment record in front page of the manual is updated for
revision details and Revision Record is also updated for the latest revision.
 The revised Documents are issued to the copyholders .On issue of revised
documents, obsolete copy of the document is collected back. One copy of
obsolete copy is Stamped “OBSOLETE COPY” and retained by MR for reference
purpose and other obsolete copies are destroyed.
 Whenever there is lot of revision in a particular Manual, then the whole manual is
re – issued and Issue number of the manual is Incremented to next Alphabet
number and revision number in all the pages is made 00 and Date of revision will
be changed to new implementation date in all pages.
 External Documents such as ISO standards & IS standards are maintained by the
MR and reviewed every year for changes and updated accordingly.

Reference:
DOCUMENT DISTRIBUTION REGISTER (F-MR-01)
DOCUMENT CHANGE REQUEST (F-MR-02)
DOCUMENT AMENDMENT RECORD (F-MR-03)

4.2.4 CONTROL OF RECORDS –mandatory procedure

 The relevant records have been identified in the Quality System Manual.
 All data supporting the achievement of requirements and effectiveness of the
quality system are included as records.
 The records are written legibly and are identified by format code, in all the pages
when the record is in the form of forms and in case of register, the identification
details are identified in the front page of the register.
 The records are filed systematically for easy retrieval.
 The records are stored and protected till the retention period and after retention
period the records are destroyed by incinerating or shredding.

Reference:
LIST OF RECORDS (D-MR-10)

PREPARED BY APPROVED BY

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