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8/13/2019 9001 Quality Manual
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Quality Manual
Document Number AD-QM
Date 24-Apr-12
Revision No 1
Page 1 of 26
Company Internal
ISO 9001:2008 Quality Manual
Revision 1.0
Prepared by
Reviewed by
Approved by
XYZ Company
Address:
The contents of this Manual and the related documentation are confidential to the company and should not
be reproduced or copied, either in part or full nor issued to third party without prior approval of the XYZ
Company
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Quality Manual Amendment Sheet
Sl. No DatePage
Number
Revision StatusAmendment Details
Sign of
MROld New
List of Controlled Copy Holders
Copy Holder Copy No
Management Representative --
Library Copy 01
Certifying Body 02
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Table of Contents
INTRODUCTION ............................................................................................................. 5
QUALITY ........................................................................................................................ 5
SCOPE ............................................................................................................................ 6
Exclusions: ......................................................................................................................... 6
QUALITY MANAGEMENT SYSTEM .............................................................................. 7
General requirement ........................................................................................................ 7
Documentation requirements .......................................................................................... 7
MANAGEMENT RESPONSIBILITY ............................................................................. 10
Management Commitment ............................................................................................ 10
Customer focus ................................................................................................................ 10
Planning ........................................................................................................................... 10
Quality management system planning .................................................................. 10
Quality objectives ................................................................................................. 11
Responsibility, Authority and communication ............................................................ 12
Responsibility Matrix ..................................................................................................... 14
Management Representative ................................................................................. 16
Internal Communication ....................................................................................... 16
Management Review ....................................................................................................... 17
RESOURCE MANAGEMENT ....................................................................................... 18
Provision of resources ..................................................................................................... 18
Human Resources ........................................................................................................... 18
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PRODUCT REALIZATION ........................................................................................... 20
Planning of PRODUCT realization ............................................................................... 20
Customer Related Process .............................................................................................. 20
Procurement .................................................................................................................... 21
PRODUCTION & SERVICE PROVISION ................................................................ 22
MEASUREMENT, ANALYSIS AND IMPROVEMENT .................................................. 24
General ............................................................................................................................. 24
Monitoring and measurement ....................................................................................... 24
Control of Non-Conformities ......................................................................................... 25
Analysis of Data............................................................................................................... 25
Improvement ................................................................................................................... 26
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INTRODUCTION
QUALITY
Date:
Place:
XYZ Company is committed to deliveringenhanced value to customers, through
continual improvement of processes and
systems by way of innovation, technology and
knowledge management.
Authorized Signatory
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SCOPE
EXCLUSIONS:
DESIGN AND DEVELOPMENT
Design and development has been excluded as Organization does not conduct any design
activities.
Exclusions of the above clauses do not affect the organizations ability and responsibility to
provide products that meets customer, statutory and regulatory requirements.
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QUALITY MANAGEMENT SYSTEM
GENERAL REQUIREMENT
The Organization has established documented, implemented, maintained and would
continually improve the Quality Management system in accordance with the requirements of
ISO 9001:2008 International standard.
The Organization has determined the processes for Quality Management System and their
application throughout the organization.
The Organization has determined the sequence and interaction of these processes with the
criteria and methods required to ensure the effective operation and control of these processes.
The Organization has ensured the availability of resources and information necessary for the
process and measures monitors and analyzes these processes and implements action necessary
to achieve planned results and continual improvements.
DOCUMENTATION REQUIREMENTS
GENERAL
The Quality System is organized into the following elements.
Quality Policy
A Quality Statement prefaces the Quality Manual. This outlines the objectives of the Quality
System and the companys commitment to Quality.
The QMS Manual by the company is documented in the following levels of Documentation.
Level 1: QMS Manual.
This addresses the requirements stated in the ISO 9001:2008 Standards as applicable to theprocess followed in the ABC Company.
Level 2: Quality System Procedures as required by the organization and standards
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Master List of System related Procedures are as mentioned here below.
Procedure for Control of Documents AD-QSP1
Procedure for Control of Records AD-QSP2
Procedure for Internal Quality Audit AD-QSP3
Procedure for Control of Non Conforming Product AD-QSP4
Procedure for Corrective / Preventive Action AD-QSP5
Level 3: Process related Documents like Drawings, Forms and registers as required by ISO
9001:2008 and suitable for effective planning, operation and control of its processes
Level 4: Records required by the standard and the process
QUALITY MANUAL
The Organization has established and maintained Quality Manual that includes
Scope of the QMS including details of exclusion and its justification Documented procedures established for the or reference to them Description of the Interaction between the process and QMS.
CONTROL OF DOCUMENTS
The process for controlling the documents and amendment within the organization is explained
in the Procedure for Control of Documents.
Details of Amendments in Quality Manual, System procedures and any other documents are
recorded in the Document Amendment list. Current Revision status of all Documents starts
from 1 and subsequent changes will be 2, 3 and so on.
Current Issue status of Quality Manual is 1.0.
If the current status of the manual is x.y, minor changes will lead to increment in y and majorchanges will lead to increment in x. After 10 continuous minor changes or after 2 years of no
major changes, the revision will have a mandatory increment in x.
All documents are ensured that they are legible and easily identifiable. The Quality Manual is
identified as AD-QM and the page numbering is done at the header of each page.
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The Organization has ensured that Documents of External origin necessary for the planning and
operation of the quality management system are identified and their distribution controlled.
Reference: Procedure for Control of Documents AD-QSP1
CONTROL OF QUALITY RECORDS
The Organization has established the records required for the Quality management system,
which has been controlled.
All records are maintained to provide evidence of conformance and of effective operation of
the Quality management system. Records are maintained in either Hard copies or soft copies.
Procedure has been established for the identification, storage, protection, retrieval time,
retention time and disposition of quality records.
Records are maintained legibly, identifiable and retrievable
Reference: Procedure for Control of Records AD-QSP2
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MANAGEMENT RESPONSIBILITY
MANAGEMENT COMMITMENT
The Quality Management System has been implemented and its effectiveness is controlled by
continual improvement and by
Communicating to the organization the importance of meeting customer as well asstatutory & regulatory requirements.
Establishing the quality policy. Establishing Quality Objectives. Conducting Management Review meeting. Ensuring availability of necessary resources
CUSTOMER FOCUS
The Organization ensures that customer needs and expectations are determined through
interactions and feedbacks. The requirements of customers are fulfilled with the aim of
achieving customer satisfaction.
PLANNING
QUALITY MANAGEMENT SYSTEM PLANNING
The Organization has ensured that the planning of the Quality Management system is carried
out to meet all requirements as well as Quality objectives and integrity of the quality
management system is maintained when changes to the quality management system areplanned and implemented.
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QUALITY OBJECTIVES
The Quality Objectives has been established at relevant departmental level within the
Organization. This is tangible and consistent with Quality Policy.
S No Department Objectives
1.2.3.4.5.6.7.8.9.10.11.12.13.14.15.16.17.18.19.20.
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RESPONSIBILITY, AUTHORITY AND COMMUNICATION
The Responsibility & authorities are defined below. In addition to this Job Responsibilities are
issued to all the persons.
Responsibilities of Designation
1. Monitoring the Resource requirements2. Ensuring that the company meets all statutory and regulatory requirements.3. Chairing Management review meeting.4. In-charge of Marketing activities5. Handling customer enquiries and complaints6. Reviewing the requirements of customer.7. Sending Quotations to enquiries received8. Overall operations of the company.9. Implementing QMS in the company.10.Member of the Management Review.11.Identifying Training Needs and requirement of Resources.12.Recruitment of New Employees.13.Conducting Internal Quality Audits at regular intervals14.Responsible for Document and record control.15.Coordinating with the vendors16.Coordinating with the vendors for replacement of any faulty item found.17.Vendor Selection and Annual Re-Evaluation.18.Raising Purchase orders from the Approved Suppliers List and subsequent approval
from Director.
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Authority of Designation
1 Approval of all QMS related Documents2 Approval of Purchase Orders for capital equipments.3 Approval of Deliverables4 Deciding on the disposition of non conforming products during delivery process and
customer returns
5 Approval of new contracts.
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RESPONSIBILITY MATRIX
ISO 9001 : 2008 Reference Designation Designation Designation Designation Designation Designation Designation
Document & Record Control
QMS PlanningQuality Policy and Objectives
MR Functions
Management Review Meeting
Resource Requirements
Human Resources
Maintenance
Marketing
Purchasing
Verification of Purchased ProductProduction
Service, Installation
Identification & Traceability
Customer Property
Packing and Stores
Calibration
Continual Improvement
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Customer Satisfaction
Internal Auditing.
Process Measurement and Controls
Product Measurement
Control of Non Conforming Product
Data Analysis.
Corrective and Preventive Actions
PPrimary Responsibility; SSecondary Responsibility; A - Authority
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MANAGEMENT REPRESENTATIVE
Management has appointedName of the membera member of the organization as the
Management Representative who irrespective of other responsibilities and authorities has to
Ensure that processes needed for the QMS are established, implemented andmaintained by frequent internal audits and Management Review.
Ensuring the promotion of awareness of customer requirements throughout theorganization.
Liaison with external bodies regarding QMS. Appraisal on the performance of QMS and any need for improvement to the
Management.
INTERNAL COMMUNICATION
The M.R has ensured that communication between its various levels and functions regarding
the process of the Quality Management System are effectively carried out and effectiveness is
checked through management review meetings.
Internal Communication is done by means of review meetings, Information display on theNotice Board and e-mail notifications.
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MANAGEMENT REVIEW
GENERAL
Top management reviews Quality Management system every 6 Months. This is conducted to
ensure the continuing suitability, adequacy and effectiveness of QMS.
Opportunities are also identified during these meeting for improvement and need for any
changes in the QMS including the Quality Policy, Quality objectives and customer complaints
and feedbacks.
REVIEW INPUT
Review Inputs includes current performance and improvements opportunities related to:
Results of audits. Customer feedback. Process performance and product conformance. Status of preventive and corrective action. Change that could affect the quality management system. Follow up action from previous management review. Recommendations for improvement.
Agenda is prepared by MR and circulated to all the attendees before MRM.
Reference:Agenda of Management Review Meeting
REVIEW OUTPUT
Review Output includes, actions related to
Improvements of the quality management system and its process Improvement of product related to customer requirements Resource needs
Review outputs are recorded in the minutes of management review meetings and copies
circulated to all members.
Reference: Minutes of the Management Review Meeting
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RESOURCE MANAGEMENT
PROVISION OF RESOURCES
The resources needed are determined and provided in timely manner to:
Implement and improve the process of the quality management system Address customer satisfaction.
HUMAN RESOURCES
GENERAL
The Organization has ensured that personnel who are assigned responsibility defined in the
QMS are competent on the basis of applicable education, training, skills and experience.
COMPETENCY, TRAINING AND AWARENESS
The organization identifies the competency needs for personnel performing activities
affecting quality by means of Skill Matrix. Based on Skill Matrix and training needs Training
Calendar is prepared for the year.
Providing training to satisfy these needs and evaluate the effectiveness of trainingprovided.
Maintain appropriate records of education, training, skills and experience. The Organization also ensures that personnel are aware of their job description and
their contribution to the achievement of Quality Objectives.
INFRASTRUCTURE
The company activities are carried out in a spacious building. Computers with Local AreaNetwork, Internet connection, phone and Fax are available.
List of assets is prepared and all the assets are maintained by respective personnel.
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WORK ENVIRONMENT
The Organization has provided a work environment as per statutory requirements. Inaddition to physical factors, other factors like temperature, humidity, noise and human
element is crucial as regards to the company is concerned and hence a good layout
which enable safety; proper illumination, Exhaust fans, First Aid Box, Fire Extinguishers,
Smoke detectors are provided.
The work place is well illuminated and also has Generator to take care of the powershutdown.
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SERVICE REALIZATION
PLANNING OF PRODUCT REALIZATION
The Organization has determined the planning process for realization of product:
Determined the Quality Objectives and requirements of the product. Establish processes and documentation and provide resource and facilities specific to
the product.
Establish process for verification and validation, monitoring, inspection activities and thecriteria for acceptability.
Records necessary to provide evidence of conformity of the process and the resultingproduct meets customer requirements.
CUSTOMER RELATED PROCESS
DETERMINATION OF THE REQUIREMENTS RELATED TO THE PRODUCT
The Organization has implemented systems to determine that the customer requirements
including
Product requirements specified by the customer, including the requirements foravailability, delivery and support.
Product requirements not specified by the customer but necessary for intended use orspecifics.
Obligations related to product, including statutory, regulatory and any otherrequirements.
Reference:Customer Enquiry Register
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REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT
The Business Development department reviews the requirements of the Customerrelated to the product.
This review is done after receiving an order. The review would cover all Technical andCommercial Aspects.
In case of change in product requirements, the organization ensures that relevantdocuments are amended and relevant personnel informed.
As the Order is confirmed the Business Development department initiates the orderprocessing.
Reference: Contract Review
CUSTOMER COMMUNICATIONS
The Organization has implemented effective arrangements for communicating with the
customer through different Medias such as Telephone, Fax, website and email; Courier / Postal
Product with regards to Enquiry, Product Information, Contracts, Amendment, Customer
Feedback and Complaints.
PROCUREMENT
PROCUREMENT PROCESS
An Indent is raised by the required Dept. based on the needs the Managing Director defines the
procurement and ensures that it conforms to the requirements.
Indent is raised by relevant department HODs. Analysis is carried out as per the need. A List is maintained with details of suppliers and service providers including
Subcontractors.
Evaluation of all suppliers is carried out before empanelling them Re-evaluation of suppliers is done every year.
Reference: Approved Supplier List F23, Supplier Re-evaluation F24
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PROCUREMENT INFORMATION
Any procurement is conveyed to the Managing Director in the Indent in line with the Billof Material.
Purchasing information is communicated to the supplier through Purchase Order,wherein the requirements for the materials/services, delivery and commercial terms are
clearly defined.
The Purchasing Dept. prepares the Purchase order. Amendments if any are subsequently informed to the supplier with amendment details
mentioned in the Purchase Order.
Reference: Purchase Order
VERIFICATION OF PROCURED PRODUCT/SERVICES
All products/services procured are checked for Quantum by Admin department andrecorded in the Register.
The Admin department inspects all incoming materials in line with the orderedspecification,
Admin Department will also preserve all warranty certificates of these equipments.
PRODUCTION & SERVICE PROVISION
CONTROL OF PRODUCTION & SERVICE PROVISION
The Organization has provided information related to product in the form of schematics,and work instructions, required for carrying out the sourcing, interviewing and staffing
process.
Quality check activity is carried out by Business Heads at each & every step of productdelivery.
VALIDATION OF PROCESS FOR PRODCUTION & SERVICE PROVISION
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The Organization has established validation process to review and approve processesand procedures with respect to equipments, Operators and other personnel involved inthe activities that affect Quality of the product, generate relevant records and re-
validate annually.
IDENTIFICATION AND TRACEABILITY
Items in the work place are kept as per pre-designated places earmarked and Items inthe stores are kept in appropriate bins / Racks with identification.
Products are identified by Product numbers & details related to that Product ispreserved in relevant files.
Reference: List of Products
CUSTOMER PROPERTY
The Organization receives inputs and specifications for reference and provision of solutions
with respect to physical security.
All care is taken to ensure that the items and information under the custody of the organization
are secured against theft or damage during internal processing. If any item is found to be
damaged or lost during the processing the same is informed to the customer.
PRESERVATION OF PRODUCT
The organization preserves the conformity of product throughout the process cycle.
All Customer information are suitably identified, handled, stored and protected against
damage.
CONTROL OF MONITORING AND MEASURING EQUIPMENT
The Organization has determined and undertaken monitoring & measuring of equipments
needed to provide evidence of conformity & has ensured in a manner that it is consistent with
monitoring & measuring requirements of products to determine requirements.
All measuring equipments are calibrated and verified periodically prior to use againstmeasurement standards traceable to international or national measurement standards,
where no such standard exist the basis for calibration or verification is recorded.
All equipments have identification in order to trace its calibration status.
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Is safe guarded from adjustments that would invalidate the measurement result andprotect it from damage and deterioration during handling, maintenance & storage.
MEASUREMENT, ANALYSIS AND IMPROVEMENT
GENERAL
The Organization has planned and implemented the monitoring, measurement analysis and
improvement process needed to
Demonstrate conformity of the product. Ensure conformity of the QMS Continually improve the effectiveness of the QMS. Determine and implement statistical techniques for Data Analysis.
MONITORING AND MEASUREMENT
CUSTOMER SATISFACTION
The Organization has obtained information about the customers perception as towhether the company has met the requirements after delivery.
The feedback includes parameters on Quality, Delivery, and service. Information derivedfrom this has been reviewed and discussed in the Management Review Meeting
Customer feedback is collected from major customers at a frequency of 1 year.Feedbacks collected are reviewed and action initiated.
The customer feedback is reviewed on receipt and the index is calculated. The Sales department resolves customer Complaints requiring immediate attention.
Reference: Feedback Form
INTERNAL AUDIT
The Organization has established methods for conducting internal quality audits at every six
months to determine whether the quality management system conforms to the planned
arrangements to the requirements of the ISO 9001:2008 standard and to the quality
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management systems established by the organization and is effectively implemented and
maintained.
Reference: Procedure for Internal audit
MONITORING AND MEASUREMENT OF PROCESSES.
The Organization adopts methods for monitoring the QMS processes. These processesdemonstrate the ability of the processes to achieve planned results.
When planned results are not achieved, appropriate corrections and corrective actionsare initiated, to ensure conformity of process and product.
MONITORING AND MEASUREMENT OF SERVICE
Regular checks are carried out delivery team. Regular feed backsare recorded from the customer.
Reference: Project Sign-off Record
CONTROL OF NON-CONFORMITIES
The Organization has taken care to ensure that Nonconformance in the service is reduced or
eliminated.
Disposition of Nonconformities is carried out by the delivery team in-charge in liaison with
Production Manager.
Reference: Procedure for Control of Non-Conforming Product
ANALYSIS OF DATA
The Organization collects data, analyze and display appropriately in order to meet the Quality
Objectives and demonstrate the suitability and effectiveness of Quality Management System.
Data Analysis is directed towards
Enhancing Customer Satisfaction. Increasing the Quantum of Service Conformity to Service Requirements. Suppliers
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Characteristics of Processes and products including opportunities for Preventive action.All this data would be in the form of visual display like Bar chart, Graph or Pie chart.
IMPROVEMENT
CONTINUAL IMPROVEMENT
The Organization continually improves the effectiveness of the QMS through the declared
documents of Quality policy and Quality objectives, Audit Results, Data Analysis, Corrective and
Preventive Action and Management Review.
CORRECTIVE ACTION
The Organization has established methods to take action to eliminate the causes of Non -
Conformities in order to prevent recurrence. The corrective actions are appropriate to the
effects of the Non-Conformities encountered. Effectiveness of the Corrective action initiated is
reviewed
Reference: Procedure for Corrective and Preventive Action
PREVENTIVE ACTION
The Organization has established methods to determine actions to eliminate the causes of
potential non-conformities in order to prevent their occurrence and recurrence. Preventive
actions are appropriate to the effects of the potential problems. Effectiveness of the preventive
action initiated is reviewed.
Reference: Procedure for Corrective and Preventive Action