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QUALITY MANUAL
ISO 9001
Title : Title :
Title :
Distribution Controlled
COPY NO NAME OF RECIPIENT
Company ABC
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REVISION RECORD
BY BY
Company ABC
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With a workforce of 20, ABC presently occupies premises at Lot 1234, North West of
Malaysia. It’s steady growth backed by the precision forming machinery and
technology coupled with consistent quality control always fulfill customers’
satisfaction through total quality management.
Our Policy:-
Company ABC
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2. Quality problems arising in various areas are identified promptly, efficiently and
technically overcome and in economical manner.
4. Upkeep the Competency and skill of our personnel through various training
development in management, quality and technical.
Authorized by,
Company ABC
…………………………………………………
(Managing Director)
Quality Monitory
Target Processes/Function
Objectives method
2.3 Strategies
Company ABC shall apply following strategies in order to successfully implement the
Quality Policy and Quality Objectives:-
Ensure the policy is understood by
shall assure that every employee in the Organization understood and clear in mind
the Quality Policy and Quality Objective by displaying at prominent location.
shall fully utilize the function of notice board. Any information, announcement,
memorandum and notice shall be placed on the notice board. The related
personnel shall make sure the information on the notice board is always up-to-
date.
carry out Management Review regularly to ensure that the Quality Policy and
Quality Objective are achieved.
carry out Internal Audit and necessary training periodically to enforce the quality
management.
promote employees’ motivation, employees’ safety, health and general needs as
an important issue.
The Quality Management System described within this manual establishes Company
ABC quality assured management system. Scope of Certification under this Quality
Management System is:-
Premise address:-
Malaysia
2.7 Exclusion
This Quality Manual as written addresses all the requirements of ISO 9001 except for the
exclusion shown, with justification, in the table below:-
ISO 9001
Clause Exclusion Element Justification
7.3 Design and Development As does not involve in the product design
and development.
All the products are manufactured based
on customer’s requirements defined in
the drawing or specifications or sample
provided by customer.
The Top Management has established a steering committee for the development and
implementation of the Quality Management System. The steering committee comprises of:-
No. Designation
1 Managing Director
2 Factory Manager (Management Representative)
3 Production Manager
4 Administration Manager
5 Accounts Executive
6 QC Head
7 Store Head
Company ABC shall establish, document and maintain Quality Management System
and continually improve to achieve compliance with ISO 9001 standard.
shall:-
a) Identify entire processes needed for the Quality Management System and their
applications throughout the Organization by the Organizational Chart (Appendix
A) and Business Process Mapping (Appendix c).
b) Make use of Business Process Mapping to illustrate the order and interaction of
processes with the functional departments. The order and interaction of specific
Quality Management System processes can be found on flow charts as well as
operation procedures.
c) Ensure the availability of resources and information needed to support the
operation and monitoring of the Quality Management System processes.
d) Monitor, measure and analyze the Quality Management System processes.
e) Implement actions necessary to achieve planned result and continual
improvement of the Quality Management System processes.
4.2.1 General
The documentation structure for Quality Management System is as below:
Level I Quality
Manual
Level II Procedures
Level IV
Quality Records
Managing Director shall approve the Quality Manual before release for
official uses. Any amendment made shall be approved by the Managing
Director and recorded in the revision history.
The master copy of the Quality Manual shall be kept at the Document
Control Centre and controlled copies shall be distributed to the related
personnel in accordance with Document Control Procedure.
The Procedures shall describe and illustrate how the specify Quality
Policy and Quality Objectives are achieved. It works as the associated
supporting procedures to define the Quality Management System within
the Organization. It also explains how implementation of the
requirements of ISO 9001 in accordance with Quality Policy.
Any changes or revisions made shall be reviewed and approved by the same
authority person who reviewed and approved the original document. A
Document Change Notice Form shall be filled by the staff who proposed a
change or revision submitted Document Control Center. The staff shall
provide all pertinent background information or justification for the authority
to base their review and approval of the changes. The nature of the change
shall be identified in the document or the appropriate attachments as well.
A Control of Document Procedure has been prepared to ensure that all the
documents and important sources are controlled and maintained accordingly.
The Head of Department shall responsible to provide a save place for keeping
the Quality Records that prevent from lost and damage. The Quality Records
shall only be destroyed after the specified retention period. The respective
departments shall determine the retention period of the records under its
charge according to customer, regulatory or requirements as appropriate.
A Control of Records Procedure has been prepared to ensure that all the
records are kept, arranged and placed accordingly at the desired placed.
The Top Management also dedicated to ensure utmost safety conditions for all the
workers, staffs, suppliers, customers as well as the members of public in compliance
to all application legislative or code of practices.
Through the policy, objectives and processes as illustrated in this Quality Manual, the
Top Management shall provide a desirable environment to consistently fulfill the
customers’ needs and attempt to go beyond their expectations. The top management
optimizes the likelihood of continual achievement through continuos assessment of
customer satisfaction.
In the absence of the Factor Manager, Administrative Manager will act as the
Management Representation. Within this role, the Management
Representative shall be responsible and authorized for the following:-
Company ABC
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All resources required in the operation of COMPANY ABC are reflected and
determined during the Management Review of Quality Management System, Internal
Audit, New Product Introduction and Training Needs Analysis as well. As for
material resources required, these information defers from one project to another,
therefore, it will be reflected in the individual project quality plan.
6.2.1 General
COMPANY ABC shall ensure all the employees whom performing activities
that affecting the quality of products are adequately trained. All the employees
are provided training which appropriate to their level of skill and beneficial to
their job performance. They shall able to demonstrate a satisfactory level of
skill and knowledge before engaging in Production, Purchasing, Maintenance,
Storage and Inspection works.
A job description for all positions in COMPANY ABC are prepared to serve
as an organizational aid to identify experience and/or education requirements,
appropriate delegation of responsibilities and coordination of work.
All new employees shall undergo an Orientation Program which shall include
instructions and explanations on COMPANY ABC’s Quality Policy and
Quality Management System. An in-house on-the-job training shall be offered
to those new employees before being placed in their respective areas.
All functions that required skills, absence of which would adversely affect
quality, shall be identified and documented by respective Department Heads.
In this aspect, every Department Heads shall review the level of competence
of employees within their department and identify additional training required.
Administration manager shall gather the necessary information or training
needs from the each Department Heads to draw up an Annual Training Plan.
All of the training records shall be maintained according to procedure control
of records.
COMPANY ABC has determined and provided the infrastructure needed to the
employees which including workspace, equipments and any supporting hardware and
software to achieve conformity to specifications.
A record for all the machinery and tools required shall be prepared and updated every
time a new machine or tools is purchased in order to record the latest status of the
machines. A procedure has prepared for preventive maintenance.
COMPANY ABC shall ensure that appropriate work environment is provided. The
considerations shall include, but not limited to:-
a) Cleanliness of workplace
b) Health and safety conditions
c) Work and handling methods
d) Adequate light at inspection areas
e) Ambient working conditions
Company ABC
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COMPANY ABC shall plan and establish the processes needed for product
realization. Planning of product realization shall refer to product quality plan and
procedures. In the process of product realization planning, COMPANY ABC shall
determine the following, as appropriate:-
a) Quality objectives and products requirements
b) The need to establish processes, documents and provide resources specific to the
product.
c) The required verification, validation monitoring, inspection and test activities
specific to the product and criteria for acceptance
d) Any records necessary to provide confidence of conformity of the processes and
resulting products.
Refer to Quality Control Plan.
COMPANY ABC shall review the requirements related to the product prior to
the submission of a quotation or order acceptance. The sales and/or marketing
personnel shall carry out a formal review to ensure:-
The customer’s requirements for the product are clearly defined, agreed
by both parties and documented
COMPANY ABC has the ability to meet the defined requirements
The contract or order requirements differing from the previously
expressed are resolved, where applicable
Company ABC
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The Sales & Marketing is fully responsible in either communicating with the
existing customers or exerts a pull on attracting any potential customers. The
related personnel shall monitor and maintain the customer satisfaction
effectively. All the complaints and feedbacks from the customer shall be
handled through customer survey and information gathered shall be analyzed
followed by the corrective action. For reference of Customer Survey, please
refer to Customer Complaints And Satisfaction Survey Procedure.
This clause has been excluded. Please refer to Quality Manual Clause 2.7 for
exclusion and justification.
7.4 Purchasing
7.4.1 Purchasing Processes
The procurement of raw material, child parts, packaging material as well as
services are under controlled in order to ensure conformance to specified
requirements which in turn contribute significantly to the quality and
reliability of the finished products. COMPANY ABC shall assess all the
suppliers’ or vendors’ capabilities and performance according to quality
requirements.
Company ABC
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COMPANY ABC has adopted several methods to ensure the purchased items
are conforming to the requirements:-
a) Evaluation and Qualification of new supplier or new vendor
COMPANY ABC employs an evaluation and qualification method to
observe the performance of supplier or vendor in order to make sure the
supplier or vendor is able to meet the procurement requirements.
All the purchased items or services shall be verified upon according to the
Inspection and Testing procedure to ensure the purchased items or services are
conform to specified purchase requirements at source in addition to relevant
inspection and/or test. Any incoming shall pass the inspection and test before
transfer it for the use of production. Any item rejected for non-conformance
shall be recorded and return to the supplier.
COMPANY ABC shall provide facilities to verify that the purchase items or
services are conform to requirements either at COMPANY ABC or at the
customer’s premises prior to delivery. The verification by customer shall not
absolve COMPANY ABC of the responsibility to provide an acceptable
finished product to the customer, nor shall it prelude the right of customer to
reject and return the product later if found to be unacceptable. The
arrangement, verification and release of such product shall determine by
purchasing personnel, and will be recorded on or referenced by the Purchase
Order.
Refer to Inspection And Testing Procedure.
COMPANY ABC shall plan and control its manufacturing processes in order
to ensure that the required standard of quality is achieved. All the
manufacturing processes as well as the operations shall be documented in the
Procedures which might include Work Instructions, Samples or any other
appropriate documents.
b) All the production equipments and tools are functioning correctly and
being maintained from time to time to ensure continuity of the process
capability. All the maintenance shall be kept in the Maintenance Record.
c) All the production workers are well trained for their tasks.
d) Accurate information is provided to related personnel in which specify
product characteristics, processing requirements and verification criteria
as appropriate.
e) Production operations are conducted and controlled in accordance with
Procedure.
f) Production monitoring shall be carried out to ensure the requirements for
the products are met at each stage of manufacture, while monitoring
processes conform to the continuing ability of each process to satisfy its
intended purpose.
COMPANY ABC shall validate any processes for production where the
resulting output cannot be verified by subsequent monitoring or measurement.
The special process that applies to COMPANY ABC is heat treatment.
COMPANY ABC shall establish control on this special processes through the
following methods, as applicable:-
Define criteria for review and approval of the processes
Approval of equipment and qualification of personnel
Use of specific methods and procedures
Requirements for records
Re-validation
All the incoming materials and child parts shall be identified by packing
documents, tags, labels, markings, stamps and/or other mean of identification.
Once received items are accepted , they shall be moved to appropriate storage
location to ensure that the identification is maintained.
COMPANY ABC shall ensure the related personnel complies with the method
and work instructions for handling of incoming materials or parts handling, in-
process and finished products. This is to avoid any unwanted incident and to
ensure the materials, parts as well as the end products are always available in
the good conditions.
Company ABC
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COMPANY ABC shall arrange for the protection of the finished products
during loading process until the delivery to desired destination.
COMPANY ABC shall provide necessary inspection, measuring and test equipments
to assure the products conform to the requirements. These equipments shall be
controlled, calibrated and maintained and their measurement capability and accuracy
shall be consistent with the intended application.
COMPANY ABC shall use external laboratories to calibrate the master inspection,
measuring and test equipments at appropriate interval. Labels shall be attached to all
calibrated inspection, measuring and test equipment to indicate the calibration status.
This shall include the calibration due date and equipment identification number and
other pertinent information as well. A master list of all inspection, measuring and test
equipments shall be established.
COMPANY ABC shall store and handle all the inspection, measuring and test
equipments in proper manner to prevent deterioration, damage, or alteration to the
functional or dimensional characteristics.
Any associated computer software used in the inspection, measuring and test
equipment shall be confirmed prior initial used.
8.1 General
Company ABC
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COMPANY ABC shall establish a plan for monitoring, measurement, analysis and
improvement activities occurs at two levels as below:-
a) Product level
In this level, COMPANY ABC shall assure and able to demonstrate the product
conformity through an effective and efficient manufacturing processes,
monitoring activities, daily inspection operation and records as well.
b) System level
In this level, COMPANY ABC shall ensure and able to demonstrate conformity
of the Quality Management System to ISO 9001 standard, Quality Policies and
Quality Objectives as well as Standard Operating Procedures.
The Sales and Marketing personnel shall collect and monitor information
relating to customer perception to determine whether customer requirements
are met through the customer satisfaction survey, customers complaints
received and customers’ feedback.. All these data and information obtained
shall be recorded and analyzed, and necessary actions shall be taken to
enhance the level of customers’ satisfaction.
COMPANY ABC shall form an internal audit team for performing the internal
quality audit at least once a year. The Management Representative is
responsible for scheduling and managing the audit program.
The audit activities shall be scheduled on the basis of :
the status and importance of the activity and processes to be audited .
previous audit results ( internal and external)
The members of the audit team shall be trained and qualified .The members of
the audit team shall also be independent of the area being audited.
All the findings from the audit shall be recorded and reported to the
Management Representative or discuss with the Department Head of the area
audited in order to carry out suitable corrective actions necessary to rectify the
deficiencies identified during the audit. Any corrective action required, shall
be taken timely. Once the action is performed, the audit team or management
representative or appointed representative shall follow - up the deficient area
to verify the effective implementation of corrective actions. The results of the
internal quality audit shall form an integral part of Management Review.
A procedure for planning, maintaining and conducting internal audit and its
reporting has been established.
All QC personnel are authorized and responsible in identifying and reporting the non-
conformities upon detection and to control further processing until the unsatisfactory
condition has been corrected. Upon detection of non-conformities, QC personnel shall
issue a Non-Conforming Report, pending review and disposition by the Managing
Director.
The rejected item shall be segregated while disposition is being determined to prevent
it from inadvertent use. Then, its details shall be documented and forwarded to QC
Supervisor as appropriate for further action. The disposition of non-conforming
products shall be as the following, as appropriate:-
Accept As It is
Rework/Repair
Hold for Evaluation
Scrapped
Company ABC
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Return to vendor
Other
COMPANY ABC shall communicate with the customer for the actual condition of
the product. An approval in writing, where applicable, shall be obtained from the
customers and the details of non-conformities shall be recorded.
Appropriate statistical techniques may be used for analyzing the data or information
collected so as to verify the acceptability of process capability and product
characteristic and subsequently to identify areas for further improvements.
8.5 Improvement
COMPANY ABC shall always plan for the continual improvement on the
effectiveness of the Quality Management System through the use of Quality
Policy, Quality Objectives, audit results, analysis of data, corrective and
preventive actions and the Management Review as well. All the QMS Steering
Committee member have the responsibility to identify and suggest any
necessary improvement to the top management.