All of us want to build quality products and provide quality services. For many of you quality is an absolute requirement
based your industry’s demand for high product reliability, or because of regulatory and competitive pressures. Heinsights can help satisfy your quality needs by working with you
to implement quality management systems that allow you to produce the high quality products you require.
If you produce software/hardware-based products and use a product definition, design, construction, test, deployment,
and support life cycle, we can help you implement a Quality Management System (QMS) that addresses the policies, technical
and management processes required to produce and maintain quality products.
Standards, regulations, and industry models constrain the format and content of the quality management systems we implement.
Standards such as the ISO 9000 series of quality process standards (and the associated guidelines for software), the Software
Engineering Institute's (SEI) Capability Maturity Model (CMM), the nuclear industry NQA1/NQA2 standards, FDA standards, etc.,
will shape the Quality Management System framework and content we will implement. Depending on your needs, one or more of
these standards may be used to design and implement your quality management system. In addition to these, industry accepted
standards such as the IEEE software engineering standards, the Project Management Institute's Body of Knowledge, and object
oriented development methodologies (such as UML and OPEN) and technology standards will be used to guide the implementation
of your quality management system. Please
reference the Characteristics of the QMS we help you to implement.
Heinsights provides the following
QMS Pre-Assessment Service – we help you pave the way for ISO 9000 registration. We assist you with your ISO 9000 QMS
implementation by doing a pre-assessment of your current QMS and providing an assessment report which includes findings and
recommendations for improvement based on ISO 9000/2000. We have a strong Information Technology focus
and can provide valuable assistance in evaluating, documenting and improving your IT project management, systems development,
quality assurance and training practices.
Our QMS pre-assessments are formal examination of your policies,
procedures, working instructions, standards, and guidelines to determine compliance with ISO 9000/2000 and fitness of use
in producing quality products. We use the same rigor, assessment protocol, questionnaires, and checklists used during a formal
assessment by an ISO registrar. And our staff includes experienced ISO assessors and process improvement engineers.
QMS Implementation Service – we help you implement a QMS
that is compliant with ISO 9000 standards and ready for an ISO 9000 Registrar assessment. But, we don’t
start and stop with the documentation of your QMS. Our charter is to help you become more effective and efficient as an organization.
We will help you implement practices that meet your effectiveness and efficiency goals and other expectations,
while meeting the ISO requirements. Assessment of your current practices (see QMS Pre-Assessment
Service) is an essential step in implementing your QMS. W e help you determine your best practices, determine your
general QMS requirements/expectations, and then use your practices and industry best practices to implement your
QMS. We know that transition to your new QMS is the most important part of the implementation – this step can make the
difference between a well-accepted and used QMS vs. shelf-ware. We help you identify and remove roadblocks
to improvement and QMS implementation – please see The Blame Game paper in the Common Sense web page. And we provide QMS training, mentoring and pilot project assistance for QMS transition into your organization.
QMS Internal Audit Program Implementation Service – we provide you with the ability to do your own in‑house
and supplier product and process audits by helping you build an effective internal audit program. This service may also be integrated into the QMS
Implementation Service described above. We help you with the following:
Develop tailored audit procedures,
working instructions, auditor qualifications, auditor certification testing, checklists, forms and report standards.
Provide auditor training based on your tailored audit program and on the specifics of your
QMS. The training will cover ISO QMS requirements, audit protocol, audit processes
Provide certification of your internal auditors (with a goal of lead auditor certification)
through trial audits of your QMS.
QMS Training Service – we provide a training and mentoring service for your entire
QMS or key components of it. Components can include procedures and working instructions used for project
management, product development and quality assurance, etc. Please see the Heinsights IT Education and Mentoring web page for the types of training available.