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In the first issue of Vision, the following questions
were asked:
·
Are you onboard for the OS Quality
Journey?
·
Who is responsible for quality?
·
Is it the responsibility of Quality
Assurance (QA)?
·
Is it the responsibility of Quality
Control (QC)?
·
The Quality Management Organization
(QMO)?
The truth is that all of the above are responsible.
The support and implementation is an internal undertaking by all OS
resources including consultants, suppliers and our customers through
feedback and other tracking media.
There are many measurements for quality and each
vary in importance to each
quality effort. Therefore, we searched for a tool to provide quality and the
implementation of measurements of success. In response to Customers and Suppliers, Management has
selected the ISO 9001 Model for quality assurance in design/development,
production, installation and servicing.
The QMO under the guidance of the Vice President of
Quality Management, Mike Smith, is taking the lead in Process Improvement and
System Level Procedure (SLP) Documentation development and the institutionalization
of the OS Quality Management System (QMS). The utilizes the 20 elements of ISO
9001 as a balance sheet and a measuring device for documented procedures and
the quality artifacts that support the QMS effort.
ISO is not a product quality label. When an organization has a management
system certified to ISO 9001, this means that an independent auditor has
checked that the processes that influence quality and the
impact of the organization’s activities conform to the standard’s requirements. The ISO logo is a registered trademark. ISO does not authorize its logo to be
used by a quality system or by system certification bodies. The certification
body for OS is the British Standards Institute (BSI).
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The following is a discussion of the six (6)
elements that have been addressed first by the QMO team:
The first element of ISO 9001 addresses the Quality Manual. OS
management is required not only to define its policy and objectives for and
commitment to quality, but shall also take steps to ensure that this policy
is understood, implemented and maintained at all levels.
The Quality Manual is responsible for defining
responsibility, authority and interrelationships of personnel who manage and
verify work that affects quality.
Through scheduled Management Reviews the total QMS is reviewed and
evaluated.
The fourth element of ISO-9001is Design Control. Design control relates to all OS
products by utilizing the verification and reviews phases as well as the
software development and support life cycle. This element looks at the resource support and the
business strategic planning.
The fifth element is titled Document and Data Control. This is a comprehensive requirement
whose scope covers ALL documents and data related to the requirements of the OS QMS. This element requires that all such
documents are reviewed and approved by authorized personnel prior to issue,
thus crossreferencing the requirement of Responsibility and Authority. Changes to documents must be reviewed
by the same functions/organizations that performed the original review and
approval prior to initial issue, unless specifically designated
otherwise. OS must establish
and maintain a Master List identifying the current revision status. That is why we state in the
footer of each document, "Check the Master List...."
Corrective and Preventive Action is the 14th
element and documents and tracks internal problems as well as those of the
customer. The preventive action
is needed to prevent the recurrence of problems in OS products.
Quality Records, element 16, identifies the requirement
for Quality Artifacts, the Responsibility for, and the retention period. In addition, the requirement for
actual storage of such records should be addressed.
Element 17 is titled Internal Quality Audits. We refer to these activities as
evaluations. A planned and
scheduled program will be carried out in accordance with documented
procedures and is one of major element for OS Management Reviews.
Next
Month: Design Control and S/W Dev
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