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SCOPE
4.2.2a
Provide contract services to government agencies.
This business model (quality manual)
fulfills 4.1/4.1a [establishing, documenting, implementing, and
maintaining a quality management system (QMS) based on processes needed for the QMS and
the application of those processes in a manner that pursues continual
improvement throughout the organization],
4.1c, 4.2.1b, and
5.4.2a. While this is nice, the really important thing is to
recognize it is our "Business Model". This means we are focused on
our business first, with ISO 9001:2000 serving as the platform to make
sure we have covered all the bases as it relates to sound business
performance.
Typical process flow and for the most part
processes directly interacting with one another.
DID YOU KNOW!
The little numbers shown throughout this document are clause numbers
from ISO 9001:2000 being fulfilled by the activities related to the step
or note referencing the clause.
MANAGEMENT
REPRESENTATIVE 5.5.2
The ISO Management Representative (person designated as such in
Organization
Chart) has been given the responsibility and authority by management
to:
-
ensure an effective quality management system is in place (this
Business Model and supporting documentation) and is
being maintained (through internal audits and by measuring key
performance objectives);
-
report to top management on the performance of this system and any
need for improvement (management review and
reporting on the objectives); and
-
ensure personnel are aware of customer requirements (see
the "communication" section of
Policy,
Objectives, & Communication).
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REQUIRED PROCEDURES
4.2.1c & 4.2.2b
Here is a list of the six
procedures required by ISO 9001:2000 and what we call them. Where it is
not intuitively obvious how these documents interact with other parts of
the QMS, the interaction is described herein.
1. Document Control (4.2.3) -
The Document & Records Control procedure
ensures the
documents related to the management system provide the latest and
greatest information and are available to those needing access. Also
ensures integrity of the QMS is maintained when approving changes
(5.4.2b)
2. Records Control (4.2.4) - The
Document &
Records Control procedure and the
Master
Control Plan ensure any required records are maintained so the vital
information included can be harvested as needed.
3. Nonconformance Control (8.3) -
Nonconformance Control points to
Improvement Systems, as we have embedded procedural
requirements related to nonconformance control into the
corrective/preventive action process.
Improvement Systems ensures we can deal with (identify and disposition)
and resolve the
affects of nonconforming product both internally and externally.
4. Internal Audit (8.2.2) -
Audit Procedure interacts with all processes
as part of monitoring and measurement of processes (8.2.3), ensuring the
business and the business model (management system) are operating
effectively.
5. Corrective Action (8.5.2) & Preventive Action (8.5.3) -
The Improvement Systems procedure ensures improvement opportunities (corrective action, preventive
action, and other improvement opportunities) are realized, facilitating
closed-loop processes intended to ensure implementation of effective
actions.
THE STUFF WE
LEFT OUT! 4.2.2a (exclusions and/or
non-applications based on 1.2)
-
7.5.2 (validation of processes) is excluded at
PCSI, as all of the products/services provided can be and are
verified as meeting requirements.
-
7.3 (design and development) and 7.6 (control of
monitoring and measuring devices) has a limited application, as some
groups do not perform design/development activities and some groups
do not require the use of monitoring/measurement devices for
verification of processes or products/services. Where these
requirements are applicable, the group or area specific documents
point out the applicability.
THE LAST WORD ON THE
QUALITY MANAGEMENT SYSTEM 4.1, 4.2.1d, 4.2.1f,
4.2.1 (implementing and maintaining all documented procedures,
activities, and special arrangements), 5.4.2a,
& 5.4.2b
This quality manual (business model) and the documents that support it
(referenced in this document or in those that support it and/or those
documents included in the Master Control Plan) are the processes needed for the quality management
system (QMS) at PCSI. These documents define or make reference to the
sequence and interaction of our processes, the criteria/methods needed
to ensure effective operation and control of these processes, and the
resources/information needed (including the provision of additional
resources as needed and any other documentation specified in national or
international regulations) to operate and monitor these processes. This QMS
includes the monitoring, measurement, and analysis activities necessary
to ensure our process will achieve the desired result now, while looking for
and acting on continual improvement opportunities as they arrive. In
other words, the documents we need to effectively plan, implement, operate,
control, and maintain our processes are in place.
Planning For Success serves as a guideline to further support the continued
effectiveness of this business model, ensuring we think about and act on
changes to the way we do business so this business model continues to
drive behavior, while maintaining the integrity of the QMS.
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