Fully comprehensive ISO 9001 Quality Management System Kits, $197 - $297
For any service provider or any business that designs their own products or any business
that builds-to-Customer print. ISO 9001 quality system kits include policies, forms and procedures to implement and certify to
an ISO 9001 quality system or you can implement and operate the ISO 9001 quality control program
and assert your compliance - you know best how the ISO 9001 quality management system will
support your business goals.
All Customers want their Suppliers to consistently provide quality
products and a Customer's decision to buy from you could be improved if
you implement an ISO 9001 quality assurance program.
At-PQC™ is an "open-book" website; that is, our demo documents are WYSIWYG,
which means you never take a chance with our products. What you see in our PDF evaluation
documents is precisely what you receive in editable MS Word format. This
guarantees you will make a well-informed decision about the documents
you select for your ISO 9001 quality assurance program.
Click here to evaluate the
ISO 9001 Build-to-Customer-Print Kit
You can apply the purchase of a Starter Kit to upgrade to the complete ISO 9001 Kit - no time limit - call for details.
ISO 9001:2000 recognizes and employs basic rules:
the Customer establishes the meaning of quality...
if measurements are not performed then improvements cannot be made...
do it right the first time...
The ISO 9001 quality system process approach can
be simplified by stating:
continuously improve…
create partnerships with Suppliers...
focus your business on Customer satisfaction...
make decisions based upon factual measurements...
provide leadership and steering...
share the vision, objectives and plans with everyone...
structure the organization to work in a natural process flow...
systemize the processes to meet Customer requirements...
At-PQC(tm) can help you implement the
principles of ISO 9001 quality assurance
by providing an effective and efficient business infrastructure that
focuses on Customer satisfaction and continuous improvement. At-PQC(tm)
can enable your business to realize desirable cost savings using practical business
tools that focus on profit and growth.
1) Management Buy-In...
Requires the business owners to take part in reviewing and guiding
the system.
The owners must rate their acceptance in
ascending order from 'buy-in with resources' to 'participation' to
'leadership' to 'evangelism'. If acceptance ranges from
'negativism' or 'apathy' or 'tolerance' or 'verbal support' then there
is no chance to economically transition.
2) Create or Modify the Business Plan to Integrate the System...
This is the next most important step in creating an environment or
culture that will meet or transition to ISO 9001 quality program on the first attempt. The
existing business plan needs to be amended by the owners to incorporate
an ISO 9001 quality manual to provide for its most costly or time-consuming
features. The owners need to agree on the content of the plan for use by
the Company.
The "what-to-do" functions to integrate the manual need to
be addressed in the business plan, then the "how & when-to-do" functions
become the workload for the Company. The plan needs to define the
operations that will be excluded from the transition process.
Time:
approximately 40 hours to release an initial draft of the business plan
3) Produce 3 Basic Documents Essential to Conformance to ISO 9001: Vision,
Strategy to Achieve Company Objectives and Policies...
The Vision is the basis for all aspects of the Company's business plan.
Operational plans become the basis for achieving the Vision, which
assignment, involvement, commitment and responsibility. The strategy
must include the ISO 9001 implementation plan, identification of required
resources and measurements for success.
4) Select the Leaders to Produce a Tentative Implementation Schedule,
Define the Cost of Implementation and Develop an Initial Implementation
Plan...
Time: approximately 3 months
5) Evaluate Current Conformance...
Make team assignments, collect documentation and compare them to ISO
9001 quality system requirements.
This step is intended to organize and train teams and
individuals to perform multi-functional shortfall analyses. This step
involves many employees (almost everybody).
6) Determine the Shortfalls...
Assess procedural adequacy, identify gaps and omissions and scope tasks
and resources.
This step permits the evaluation of compliance variances and proposed
remedial actions and then it deals with the organization of the results
for the final implementation plan.
This step involves many employees (almost everybody).
7) Finalize the Implementation Plan...
Define tasks and assignments, schedule actions and employ a rigorous
work discipline.
This step covers all of the project management activities associated
with the development, organization and scheduling of the final
implementation plan, including all the factors that will make the plan
succeed. This step involves few employees (5% to 15% of the workforce).
8) Define the Documentation Process...
Develop a documentation structure, a document control system and a
writing-review process. This step examines ISO 9001 quality management
system documentation activities,
including its structure, purpose, usefulness and how to assure user
ownership, as well as the factors that contribute to developing
satisfactory documentation. This step involves functional management (up
to 50% of the workforce).
9) Refine the Implementation Activity...
Involve users, conduct awareness training and assure usability of
procedures.
All employees must know the policy's content and how their
assignment supports its achievement. This step examines how to achieve
the new responsibilities and roles expected of management and employees.
This step involves functional management (up to 50% of the workforce).
10) Perform an Internal Compliance Audit...
Documentation versus performance - internal audit structure - prepare
for the Registrar.
This step involves users and management efforts to develop, implement
and document compliance verification activities. This step involves
multiple functions and intensive auditing (15% to 20% of the workforce).
11) Perform Registrar Audit...
Close corrective actions and demonstrate compliance. This step provides
the methods for selecting a Registrar, defines how to deal with the
audit process, handles audit activities and responds to Registrar audit
findings. This step involves facilitation of the Registrar (5% to 15% of
the workforce).
Six (6) Required Procedures:
Control of nonconforming product (8.3)
Control of documents (4.2.3)
Control of records (4.2.4)
Corrective action (8.5.2)
Internal audit (8.2.2)
Preventive action (8.5.3)
Eighteen (18) Required Records:
Calibration (7.6)
Contract review (7.2.2)
Control of nonconforming product (8.3)
Corrective action (8.5.2)
Customer property (7.5.4)
Design and development change (7.3.7)
Design and development inputs (7.3.2)
Design and development review (7.3.4)
Design and development validation (7.3.6)
Design and development verification (7.3.5)
Identification and traceability, if required (7.5.3)
Internal audits (8.2.2)
Management review minutes (5.6.1)
Monitoring and measurement of product (8.2.4)
Preventive action (8.5.3)
Planning of product realization (7.1)
Supplier evaluation (7.4.1)
Training (6.2.2)
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