The International Organization for Standardization's (ISO) ISO 9000 quality management standards dictate documentation requirements that an organization must adhere to in order to obtain ISO certification. These requirements include documentation of organization quality policies and objectives, publication of a quality manual, and written procedures indicating how documents and records will be controlled and audited. The ISO audit process requires that your organization provide evidence of certain record-keeping activities. In order to maintain your records for a quick, efficient audit, you should code the records according to the clause of the ISO 9001 documentation requirements.
Download a copy of the ISO's guidelines for documentation requirements for ISO 9001 compliance. The guidelines provide a list of all documents that must be produced in order to satisfy ISO 9001 requirements. The appendix at the end of the guidelines includes a list of relevant clauses of the ISO 9001 standards that specify specific documents that must be maintained.
Collect and label documents pertaining to employee information. The ISO9001 standards dictate that reviews of personnel by management and information pertaining to employee education, training, skills, and experience must be documented. Management review documents should be coded as satisfying clause 5.6.1, while employee histories should be coded as fulfilling clause 6.2.2 e).
Code documents that contain general product information. Documentation of the results of any production process that can't be verified by subsequent monitoring should be coded under clause 7.5.2 d). Documentation describing the unique identity of a product should be coded as fulfilling clause 7.5.3, while any documentation of lost or damaged property fulfills the requirements of clause 7.5.4. When a product is released, documentation of the individuals responsible for authorizing release of the product should be filed under clause 8.2.4.
Code documents that contain information about product realization, review, design, and development. Documents pertaining to product design and development fulfill clauses 7.3.2 through 7.3.7; review the appendix in the guidelines for the specific clause that you should use to code each document. Any documents that provide evidence that your organization's product realization process fulfills ISO 9001 requirements should be filed under clause 7.1 d), while reviews of product requirements should be coded under clause 7.2.2.
Code any documents that provide an evaluation of your organization's suppliers. These documents should be coded as fulfilling ISO clause 7.4.1.
Code documents that validate the calibration of measurement equipment under clause 7.6. If no measurement standards exist, then documents providing the basis for your measurements should be coded under clause 7.6 a).
Assemble a file containing all documents related to internal auditing. The results of any internal company audits should be filed under clause 8.2.2. If any product nonconformities are detected they should be filed under clause 8.2.4. The results of corrective actions resulting from an audit should be documented under clause 8.5.2 e), whereas the results of any preventative actions that are deemed necessary should be filed under clause 8.5.3 (d).
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