No records maintained

Records are the results of operations. Records demonstrate results and compliance achieved QMS standard identifies 20 records to be maintained. They provide evidence of successful completion of the QMS processes. If there is no evidence of records being maintained as per QMS and if it is observed that there is a need for records maintenance for any of the processes even when not specified, then it is essential to ensure the same.

No specific methodology defined

QMS defines process of value addition to achieve specific planned results. In order to achieve consistent results, processes/activities need to be controlled. One of the methods of controlling is to define a methodology. In the absence of the same, results are likely to be misleading and one cannot be sure for the achievement of the specific targets, specifically in the implementation of monitoring, measurement, analysis and improvement- one of the examples of specific methodologies is - measurement of customer satisfaction.QMS also specifies use of statistical techniques as one of the methodologies

Not documented

Documentation is the heart of the QMS. The Standard calls for documenting a quality policy, quality objectives, a quality manual, 6 mandatory procedures , 21 records and procedures for effective planning, operation and control of the processes. These documents are intended to address the various requirements of the QMS. While there can be no two opinions on an auditor " looking for" the mandatory documents and records, the identification of "documents and records determined to be necessary to ensure the effective planning, operation an control of the processes" is crucial for the organization. Even when a document exists for controlling the processes, if it is not brought under the purview of the QMS and controlled, it is not acceptable and considered to be "not documented". The document shall adequately describe the activities of the process and in such a manner "operable" by the process owner and the team.