ISO Control of Records Procedures

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ISO 9000 refers to a group of standards relating to the quality management systems of any organization. “ISO” is the International Organization for Standardization, which publishes hundreds of standards for many industries. For American businesses, the two standards that are most relevant are ISO 9000 and ISO 14000. While ISO 9000 deals with general quality management issues, ISO 14000 deals with quality management issues relative to environmental concerns. Both of these standards have quality document control requirements, which every company or organization seeking ISO certification must meet.

What Quality Documents Need to Be Controlled

  • ISO issued a clarification regarding document control to assist organizations seeking ISO certification. This clarification allows an organization flexibility regarding the way it creates and controls its quality system documentation. Each organization can decide for itself the minimum amount of documentation needed in order to show the effective planning, operation and control of its processes. In addition, ISO defined a “document,” and some examples are internal and external communications, evidence of conformity and knowledge sharing. ISO stressed that documentation can take many forms, such as paper, electronic and magnetic media. Before that clarification, the traditional view was that “documents” were limited to the quality manual, quality procedures, work instructions and records that demonstrate conformity to the relevant ISO standard.

ISO Section 4.2.3 - Control of Quality System Documentation

  • ISO section 4.2.3 mandates that all documentation necessary to the operation of the quality management system be controlled. “Controlled” means establishing procedures defining the approval of documents for adequacy prior to issue; reviewing and updating documents as necessary; ensuring that changes in the current revision status of documents are identified; ensuring that relevant versions of applicable documents are available at all points of use; ensuring that documents remain legible and readily identifiable; ensuring that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled; and preventing the unintended use of obsolete documents and applying suitable identification to them if they are retained for any purpose.

ISO Section 4.2.4 - Control of Quality System Records

  • ISO section 4.2.4 governs the control of records. There is a distinction between the control of documents and the control of records. A "document" is some type of instruction or mandate as to how the quality system will operate. A “record” is maintained to establish proof of conformity to the quality requirements as set forth in the ISO standard and quality system documentation. The documented procedure regarding record control must define controls necessary for the identification, storage, protection, retrieval, retention time and disposal of records.

Importance of Quality System Documents and Records

  • Aside from the ISO requirement that quality documents be maintained, it is important for an organization to maintain these records for internal validation -- to show that its quality management system is working effectively. Fooling an auditor is one thing, but properly used quality documents can increase the bottom line of an organization considerably. A classic definition of "quality" is meeting the customer’s expectations. Properly maintained quality documentation helps make that happen.

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