RECORDS

Records are a way of documenting that the policies, procedures, and work instructions have been
followed. They provide data for corrective action and a way of recalling products. The main purpose
documentation is to provide guidelines for internal quality management. Its very important for the for
the quality improvement and success of the business. Before beginning with the documentation process
the implementation team should gather all the existing policies, procedures, work instructions, and
forms that are presently in use. Each document should be reviewed and an attempt should be made to
fit it into one of the elements.

The basic thought to keep in mind when writing the documents is to create simplicity out of complexity.
To accomplish this objective, the documents must be simple and concise. Some basic points to keep in
mind when writing the documents is that to be concise to the point ,remove the irrelevant and extra
information and avoid suing jargons ,consider the who , what ,when, where and how factors while
writing, always make use of diagrams and flow charts.

Internal audits-After the policies, procedures, and work instructions have been developed and
implemented, checks must be made to ensure that the system is being followed and the expected
results are being obtained. This activity is accomplished through the internal audit, which is one of the
key elements of the ISO 9000 standard. There are five objectives in the internal audit that is Determine
that actual performance conforms to the documented QMS ,initiate corrective action activities in
response to deficiencies, Follow up on noncompliance items from previous audits, Provide continued
improvement in the system through feedback to management, Cause the auditee to think about the
process, thereby encouraging possible improvements. Audits should be performed by qualified
individuals who have received training in auditing principles and procedures. To be able to audit
efficiently, an individual should possess good written and oral communication skills, be a good listener,
and be good at taking notes. Other skills should include the ability to concentrate on the task at hand
and not be distracted by other activities that are taking place at the same time, be observant and
questioning, and be able to separate relevant facts from other information. The auditor should be
objective, honest, and impartial. Of course, the auditor should be prepared by being knowledgeable
about the standards.