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SECTION1: INTRODUCTION
1.1 About the Company
Company adopts the ISO 9001:2015 Quality Management System.
Requirement as the principle for developing this Quality
Management System (QMS). The extent of this QMS established is
based on the nature of our organization, complexity and interaction
of the processes and competency of our personnel. The Top
Management of Company shall demonstrate its full commitment in
establishing, documenting, implementing, maintaining and continual
improvement of this QMS in accordance with the ISO 9001:2015
requirements.
To implement this quality management system, Company has :1. Identified the processes needed for the quality management
system;
2. Determined the sequence and interaction of these processes;
3. Determined criteria and methods required to ensure the
effective operation and control of these processes
4. Ensured the availability of information necessary to support the
operation and monitoring of these processes;
5. Measured, monitored and analyzed these processes, and
implemented action necessary to achieve planned results and
continual improvement.
Company shall be committed to control outsourced process to
ensure such processes are carried out based on the contractual
requirements. The extent of control shall be as followed:
1. Potential impact that the product is provided
2. Degree to which the control of the process is shared
3. Capability of achieving the control through clause 7.4
Communication of this Quality Manual
1.2 Objective of this Quality Manual
This Quality Manual specifies requirements for a quality
management system (QMS) to be applied to [Company] when an
organization:
regulated.
Note: This section is addressed to meet the requirement
of 6.2.1 and 6.2.2 Quality Objectives and planning to achieve them
of ISO 9001
6.3 Planning of changes
When Company determines the need for changes to the QMS, the
changes shall be carried out in a planned manner (according to
clause 4.4.1 and 4.4.2 of the standard).
It shall consider:
a) the purpose of the changes and their potential
consequences; see clause 6.1 (Risk Management of this Quality
Manual)
b) the integrity of the quality management system; (See 7.5 of
this Quality Manual)
c) the availability of resources; (see clause 7.1.1 of this Quality
Manual
Where the changes is applied, it shall follow according
to Documented Information Control Procedure
7.3 Awareness
Company shall ensure that persons doing work under the
organizations control are aware of:
a) the quality policy;
b) relevant quality objectives;
c) their contribution to the effectiveness of the quality
management system, including the benefits of improved
performance;
d) the implications of not conforming with the quality
management system requirements
Where necessary, training should be conducted and process should
follow according to section 7.2 Competence of this Quality Manual.
Management Document
Quality Policy
Quality Objectives
Resources
Monitoring & measurement document
Competency document
Operation
Planning document
Service requirement review
Control of external provider
Process control document
Identification & traceability
Customer property document
Process changed document
Release of product
Non-conformity
Design and development
Design input
Design control
Design output
Design change
Monitoring and evaluation
Performance monitoring
Internal audit
Management review
Improvement
Nonconformity
Corrective action
Control of documented information shall follow according
to Documented Information Control Procedure
Note: This section is addressed to meet the requirement of
clause 7.5.1 and7.5.2 Documented Information, of ISO 9001
8. OPERATION
8.1 Operational Planning
Company shall plan, implement and control the processes;
amendment process.
Also, the team member shall aware of the changed requirements,
when the requirements for products and services are changed
according to clause 7.4 Communication of this Quality Manual
Where applicable, the process shall follow according to Documented
Information Control Procedure
Note: This section is addressed to meet the requirement of
clause 8.2.4 Changes to requirements for products and services, of
ISO 9001
8.3 Design and development of products and services
Review the applicability
8.4 Control of externally provided processes, products and
services
Company shall ensure that externally provided processes, products
and services or commonly known as purchasing process conform to
requirements.
Note: Scope of activity of externally provided processes has been
elaborately explained in Annex A.8 Control of externally provided
processes, products and services of the ISO 9001 standard.
Control of externally provided process are including
a) Determination of purchasing control including selection,
evaluation, re-evaluation and monitoring of external provider
(supplier)
b) Type and extent of control of purchasing process
c) Effective communication to external provider or supplier
Detail of externally provided process control should refer to
Purchasing Procedure Result of performance of external provider
shall be reviewed by top management of Company as it required by
clause 9.3 Management Review of this Quality Manual
9. PERFORMANCE EVALUATION
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
Company shall
1. Determine:
a) what needs to be monitored and measured;
b) the methods for monitoring, measurement, analysis and
evaluation needed to ensure valid results;
c) when the monitoring and measuring shall be performed;
d) when the results from monitoring and measurement shall be
analysed and evaluated.
2. Evaluate the performance and the effectiveness of the
quality management system.
3. Retain appropriate documented information as evidence of
the results according to Documented Information Control
Procedure
9.1.2 Customer satisfaction
Company shall monitor customers perceptions of the degree to
which their needs and expectations have been fulfilled.