The CD-ROM contains a documentation model and documentation development tool, implementation plan and schedule, quality manual, 57 operating procedures and work instructions, 54 control forms, master lists, and a detailed checklist of requirements of ISO 9001:2008 to be used for the assessment, development and review of documentation and processes.
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 with business activities of the manufacturing, marketing, sales and distribution of their own product line as well as the manufacture of custom made products. The documentation model can easily be modified (using MS Word) to fit an organization's specific needs, and 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 9001:2008, 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.
According to the standard ISO 9001:2008, 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 with requirements of ISO 9001:2008.
System requirements: Windows and MS Word.