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ISO 9001 : 2008
QUALITY MANAGEMENT SYSTEM
24 November 2009
EXTERNAL AUDIT PROGRAMME
TIME
9.00am-9.15am
ACTIVITY TO BE ASSESSED
Opening
AUDITOR/TEAM
MEMBER
INVOLVED
Audit Team
Site tour Check on clients location and site specific
conditions
9.15am-12.30pm
Document Review- Adequacy on level 1(Manual) and Level 2
(Procedure)
RAR
Check on Quality Policy(5.3), Objectives (5.4.1 & 7.1)
Internal Audit (8.2.2) and Management Review (5.6)
12.30pm-1.30pm
Working Lunch
Check on Clients understanding with respect to identification
of key performance aspects(7.1) and process(4.1)
1.30pm-5.00pm
Check on scope of management system (4.2.) and related
statutory and regulatory(7.2.1)
Check on Clients QMS and site operations/ remote site
operations and possible significant aspects to be considered
1.30pm-5.00pm
Discussion with QMR and preparation for Closing Meeting
RAR
WHAT IS ISO ?
ISO is International Organization for Standardization, a
worldwide federation of national standards bodies since
1947.
Based in Geneva, Switzerland.
ISO establishes and promotes the use of international
standards through its various Technical Committees
consisting of well-known experts in various fields.
The ISO 9000 standards were established by ISO Technical
Committee 176.
DEFINITION OF ISO 9000
1)
ISO 9000 is a series of Quality Management System
standards;
2)
ISO 9000 is not a product standard;
3)
ISO 9000 is not an alternative to product (technical)
requirements;
4)
ISO 9001 contains the Quality Management System
requirements.
WHAT IS QUALITY MANAGEMENT SYSTEM ?
Quality Management System (QMS) is a management system
to direct and control an organization with regard to quality.
Quality Planning
Quality Assurance
QMS
Quality Control
Quality Improvement
EVOLUTION OF QMS STANDARDS
BS 5750
1979
ISO 9000
1987
ISO 9000
1994
ISO 9000
2000
ISO 9001
2008
THE ISO REQUIREMENT FOR QMS
To demonstrate its ability to consistently provide
product that meets customer and applicable
regulatory requirements; and
To enhance customer satisfaction through effective
application and continual improvement of the system.
SCIENTIGE QUALITY MANAGEMENT SYSTEM
Scientige has established the Quality Management System (QMS)
for continual improvement in accordance with International Standard.
Scientige QMS is structured and adapted to the companys nature of
business and takes into account the followings:
Process for the QMS and their application;
Sequence and interaction of these processes;
Determine criteria and methods to ensure effective operation and control
of these processes;
d) Ensure availability of resources and information to support operation and
monitoring of these processes;
e) Monitor, measure, and analyze these processes; and
f) Implement actions to achieve planned results and continual improvement.
a)
b)
c)
QMS DOCUMENTATION
The QMS documentation includes the followings:
a)
b)
c)
d)
e)
f)
g)
Quality Manual;
Job Descriptions/Specifications;
Quality Procedures;
Forms;
External Documents;
Work Instructions; and
Documents and records needed to ensure the effective planning,
operation and control of the companys processes.
The related document for quality procedure of documentation is
SCI-QA-P001 : QUALITY PROCEDURE
(Documentation Requirements)
HIERARCHY OF DOCUMENTATION
Quality
Manual
Level 1
Quality Procedures
Level 2
Forms and Checklists
Correspondences (Letters, Memos, Circulars, etc.)
Level 3
Level 4
QUALITY MANUAL & QUALITY PROCEDURES
The Quality Manual contains the following documented
statements:
i.
ii.
iii.
iv.
v.
Vision & Mission;
Quality Policy guide company direction;
Quality Objectives companys Quality KPI;
Quality Procedures processes; and
Quality Records.
Quality Procedures stipulate how things should be done in
sequence of steps to execute what have been prescribed in
the Policy.
SCIENTIGE VISION
To be the Forefront of Specialized Engineering and
Niche Technology Solution Partner.
SCIENTIGE MISSION
Providing integrated multi-discipline specialized
engineering solution globally.
SCIENTIGE QUALITY POLICY
Ensuring the technology provided are the Niche Technology
and the provision is at the right place and time.
All company representative are professionals in their field and
presentable to the Clients/Customer.
Maintaining excellent communications with clients and
principals at all time.
Maintaining the quality of services provided in any installation
or consultancy.
SCIENTIGE QUALITY OBJECTIVES
To achieve a customer satisfaction level of 75%;
To ensure that all employees are given a proper
training in their field at least 5 hours a year for each
employee;
To ensure that less than 5 complaints from each
clients/principal per year; and
To ensure satisfactory performance from supplier
and subcontractor to a level of 75%.
CONTROL OF DOCUMENTS AND RECORDS
All documents required by the QMS are controlled.
Records providing evidence of conformity to requirements
and for effective operation of the QMS are also controlled.
A documented procedure should be established to define
the controls needed for identification, storage, protection,
retrieval and disposition of records.
Records should remain legible, readily identifiable and
retrievable.
QUALITY PROCEDURES
Quality Procedures stipulate how things should be
done in sequence of steps to execute what have
been prescribed in the Policy.
QUALITY PROCEDURES
1)
2)
3)
4)
SCI-QA-P001:
Documentation Requirements
SCI-QA-P002:
Internal Audit
SCI-QA-P003:
Monitoring & Measurement of Project/Product
& Non-Conformity Control
SCI-QA-P004:
Continual Improvement
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QUALITY PROCEDURES
5)
6)
7)
8)
(cont.)
SCI-HR-P001:
Employer Training & Development
SCI-ICT-P001:
Information, Communication & Technology
Process
SCI-FN-P001:
Purchasing
SCI-ADM-P001:
Handling & Maintenance of Company Vehicle
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QUALITY PROCEDURES
9)
SCI-MBD-P001:
Process & Tendering Exercise
10)
SCI-PO-P001:
Project Execution Plan
11)
SCI-PO-P002:
Project management
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(cont.)
MANAGEMENT REVIEW
The Top Management should review the organizations QMS at
planned intervals to ensure its continuing suitability, adequacy
and effectiveness.
The MR will notify the Management Review Committee (MRC) for
convening the Management Review meetings.
The MRC comprises the Top Management, MR and
representatives from each Department.
The input to Management Review include the followings:
a)
Results of audit;
b)
Customer feedback;
c)
Process performance and product conformity;
d)
Status of preventive and corrective actions;
e)
Follow-up actions from previous management reviews;
f)
Changes that could affect the QMS; and
g)
Recommendations for improvement.
CONTINUAL IMPROVEMENT
Scientige works towards continual improvement
of quality management system through the use of
the quality policy, quality objectives, audit results,
analysis of data, corrective and preventive actions
and management.
DOCUMENT MASTER LIST
The Document Master List contains the following
Scientige Quality Management System documents:
(i)
(ii)
(iii)
(iv)
(v)
Quality Manual;
Quality Procedures;
Job Descriptions/Specifications;
Forms; and
Working Instructions.
The Document Master List is as attached below:
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Document
MANAGEMENT COMMITMENT
Scientige Management is committed to develop, implement and
maintain the QMS, and to continually improve its effectiveness
through the followings:
Establishing the quality policy and quality objectives.
Ensuring the importance of meeting customer as well as statutory and
regulatory requirements are communicated throughout the
organization.
Conducting Management Reviews Meetings 28/10/09.
Ensuring the availability of resources.
Training to ensure the quality of work carried out by employees
contributes towards the Quality Policy and Quality Objectives.
ISO MANAGEMENT REPRESENTATIVE
AND COORDINATOR
The Quality Management Representative (QMR) has the authority
and responsibility to ensure the QMS is effectively and efficiently
implemented and maintained continuously.
The QMRs authority and responsibility include the followings:
a)
Report on the performance and any need for improvement of the
quality management system to the Management;
b)
Ensuring the promotion of awareness of customer requirements
throughout the company; and
c)
Liaise with external bodies on matters relating to the ISO 9001
quality management system.
The ISO Coordinator (Ms Affaiza Yati), acting as the Documents
Controller, assists in the preparation and finalizing the ISO QMS
documents.
AUDITS
Internal audits
29 & 30 Sept. 2009
External audits
Documents review done,
Stage 1 Early November 2009,
Stage 2 End of November 2009.
INTERNAL AUDIT
Internal audits will be conducted at planned intervals to determine
whether the QMS conforms to the planned arrangements, and is
effectively implemented and maintained.
The internal audits are carried out by trained internal auditors.
Selection of internal auditors and conduct of internal audits
should ensure objectivity and impartiality of audit process.
Internal auditors should not audit their own work.
All non-compliances are reported and actions for rectification are
recommended.
Actions for rectification are taken within specific time period to
eliminate the detected nonconformities and their causes to ensure
effective implementation of the QMS.
Records of audits are documented, maintained and distributed to
Heads of Departments.
IMPLEMENTATION PLAN
ROLE OF SCIENTIGE OFFICERS
Ensure that the Scientige QMS and all the Quality Procedures
developed and documented are strictly and effectively
implemented in the process of delivering our work and products.
Take necessary actions to achieve the planned results and
continual improvement of work processes.
Keep all records and proofs that the Quality Procedures are being
followed.
THANK YOU
