Fluid Components International Quality Assurance Manual - Manual (Page 24)

DOCUMENT NUMBER
07QA070003
SUBJECT
Quality Manual
CAGE CODE
64818
Date
10-8-2012
SECTION
1
PAGE
2
CURRENT
REVISION
L
1.0 SCOPE
The requirements described in this section, Section One, of the Quality Manual
provide an overview of FCI‟s minimum quality system requirements.
Issuance and changes to the manual shall be performed in accordance with
“Document and Data Control, paragraph 4.2.3 of this section of the manual.
Changes to this Manual that substantially effect the Quality System e.g. Change
of Quality Assurance Manger or EX Representative (ATEX, IECEx, etc.),
Certifications i.e. ISO, etc., shall be submitted to a Notified Body (ATEX, IECEx,
etc.) by the appropriate Representative (EX Representative, Management
Representative, Quality Assurance Manager, etc.) if required by the standard.
In addition, FCI shall know and understand the monitoring requirements and
applicable performance criteria for AMS and the impact of these requirements on
instrument design, manufacturing and certification pursuant to EN15267.
2.0 REFERENCED DOCUMENTS
This manual is supplemented by numerous procedures as identified in Appendix
“B” and referenced throughout this manual. Procedures other than those
referenced may also be used to implement the Quality Management system.
3.0 REFERENCES
ISO 9001 (current revision), Quality management systems - Requirements
4.0 QUALITY MANAGEMENT SYSTEM
4.1 GENERAL
FCI has established, documented, implemented, and maintains and continually
improves a quality management system in accordance with the requirements of
ISO 9001.
To implement the quality management system FCI will:
a) Determine the processes needed for the quality management system and their
application throughout the organization,
b) Determine the sequence and interaction of these processes,
c) Determine criteria and methods needed to ensure that both the operation and
control of these processes are effective,
d) Ensure the availability of resources and information necessary to support the
operation and monitoring of these processes,