ISO 9001 ISO Document Control & Quality Management system
The ISO 9001 standard sets out specific requirements for a quality management system that will enhance your ability to consistently provide products and services that meet customer requirements as well as rules and regulations. Applicable to all types of companies in any industry, the standard is based on a set of quality management principles including strong customer focus, top management motivation and involvement, a process approach and continuous improvement. ISO 9001 is based on a plan-do-check-action approach and provides a process-oriented approach to documenting and reviewing the structures, responsibilities and procedures needed to achieve effective quality management in an organization.
ISO Document Control
QMS leaders in their organizations should develop a document control process that is easy to use, easy to control and effective in preventing the use of incorrect ISO documentation such as quality manual, job description, standard operating procedure, works instruction, and supporting documents. If the standards and operational information required for your quality assurance processes are contained in external documents, they should be available and controlled within your QMS.
Document Controls within the QMS should ensure that superseded documents (previous drafts and iterations of quality documents) are clearly marked as such. A good QMS should be able to distinguish between issues and draft documents. The control procedures for ISO quality management system documents, in addition to stating the purpose of the document, should also describe how changes are made, analyzed and approved, by whom, and how long the retention period should be.
ISO document management procedures define the measures that can be used to control quality assurance documents and meet the requirement to withdraw released documents when they are out of date and to replace them when changes are approved. ISO document validation means keeping track of documents so that employees who refer to them always have the correct document in hand. Ensure that the required documents are available to the appropriate personnel.
Ensuring that changes to quality system documents are reviewed and approved by the same departments that performed the original review and approval. Compile, review and update quality system documents applicable to their areas of expertise and process responsibilities.