ISO 9000 for Chemicals Manufacturers

The quality system model and documentation development tool provides an overview of an ISO 9000 quality system for chemicals manufacturers, and assists with the development of required documentation such as quality manual and procedures as well as records of evidence of compliance with requirements.

Included are:

• Documentation model and documentation development tool, implementation plan and schedule
• Quality manual
• 57 operating procedures and work instructions
• 54 control forms
• Master lists
• Detailed checklist of requirements of ISO 9000:2000, for the assessment, development and review of documentation and processes, and compliance with requirements.

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 9000:2000 quality management system. The manual is structured according to the clauses of the standard ISO 9000:2000, 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 9000:2000, 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.

Minimum system requirements: Windows 98 and MSWord 97 (or greater).