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The
CD-ROM contains:
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documentation model and documentation
development tool, implementation
plan and schedule
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quality manual
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57 operating procedures and
work instructions
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54 control forms
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master lists
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detailed checklist of requirements
of ISO 9001:2000, for the assessment, development and review of documentation
and processes
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Minimum system requirements for the CD-ROM and
documentation development tool are Windows 98 and MS Word 97 (or greater).
Based on the principle "one picture is
worth a thousand words", this quality system model documents a complete
quality management system of a manufacturer of chemicals, who's business
activities are the manufacture, marketing, sales and distribution of their own
product line as well as the manufacture of custom made products. The
documentation model, which can easily be modified (using MS Word 97 or greater)
to fit an organization's specific needs, can be used by any chemicals
manufacturer as an example or guidance for preparing the required documentation
and procedures for an ISO 9001 quality management system. The manual is
structured according to the clauses of the standard ISO 9001:2000, references
procedures and processes, defines the interaction of processes and
responsibilities, outlines the company's quality policy and how activities which
affect quality are performed. Operating procedures and work instructions
describe activities of the departments of Quality Assurance, Manufacturing,
Engineering-Laboratory, Quality System Administration, Environment and Safety,
Purchasing, Sales/Customer Service and Warehouse. Important issues of the
chemicals industry are addressed, such as Material Safety Data Sheets,
Certificates of Analysis, Product Shelf Life, Emergency Response Plan,
Dangerous-Product Incidents, Responsible Care, etc.. Since the model provides
real examples, it eliminates guess work, setbacks and uncountable moments of
frustration when developing and implementing a quality management system in an
organization.
According to the standard ISO 9001:2000, only 6 procedures must be documented,
and it is up to the discretion of the organization to document the other
procedures contained in this quality system model or just to implement these
procedures in order to meet requirements and create evidence of compliance. |