INTEGRAL TRANSFORMATION GROUP, INC.: November 2011

THE 21 RECORDS REQUIRED BY ISO 9001:2008
(Rafael Pablo M. Fernando)

Implementing an ISO 9001:2008 quality management system (QMS) means you will be maintaining records that most likely you don’t already keep. Some of these records may be confusing until you become more familiar with the quality standard. Quality records are defined as those records maintained to demonstrate conformance to specified requirements and the effective operation of the quality system. Pertinent subcontractor quality records will be an element of these data. Records can be in the form of hard copy, or they can be in electronic or other media. Generally, all quality records must be legible and will be stored and retained in such a way that they are readily retrievable in facilities that provide a suitable environment to prevent damage or deterioration and to prevent loss. Retention times of quality records will be established and recorded. Where agreed contractually, quality records will be made available for evaluation by the customer or the customer’s representative for an agreed period.

The 21 records required by ISO 9001:2008 is over and above the required documents—quality manual and the six (6) mandatory quality procedures. The following are the required 21 records:
• 5.6.1 Management reviews
• 6.2.2(e) Education, training, skills and experience
• 7.1(d) Evidence that the realization processes and resulting product fulfill requirements
• 7.2.2 Results of the review of requirements related to the product and actions arising from the review
• 7.3.2 Design and development inputs relating to product requirements
• 7.3.4 Results of design and development reviews and any necessary actions
• 7.3.5 Results of design and development verification and any necessary actions
• 7.3.6 Results of design and development validation and any necessary actions
• 7.3.7 Results of the review of design and development changes and any necessary actions
• 7.4.1 Results of supplier evaluations and any necessary actions arising from the evaluation
• 7.5.2(d) As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement
• 7.5.3 The unique identification of the product, where traceability is a requirement
• 7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use
• 7.6(a) Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist
• 7.6 Validity of the previous measuring results when the measuring equipment is found not to conform to requirements
• 7.6 Results of calibration and verification of measuring equipment
• 8.2.2 Internal audit results and follow-up actions
• 8.2.4 Indication of the person(s) authorizing release of product
• 8.3 Nature of the product nonconformance and any subsequent actions taken, including concessions obtained
• 8.5.2 Results of corrective actions
• 8.5.3 Results of preventive actions

-OM-

Rafael Pablo M. Fernando is currently the Officer-in-Charge of the Total Quality Management group of the Subic Bay Metropolitan Authority (SBMA). He is also connected with Integral Transformation Group, Inc., a transformative management group that offers organizations and its people alternative forms of managing and living life to the fullest. Formed 1992, ITG-TheGroup extends management services, education & training, and advocacy activities in the areas of: quality management-ISO implementation, organic agriculture, cooperatives, sustainable development, Vedic culture, good governance, among others. (March 2, 2011)