Internal Audits

Just to set the mood.  This is the most important part of the standard.  May I repeat.  This is the most important part of the standard.  And her are the requirements.

Your company conducts internal audits at planned intervals to determine whether the quality management system; a) conforms to the planned arrangements, to the requirements of the International Standard and to the quality management system requirements established by Company Name, and b) is effectively implemented and maintained.

And it continues.  An audit program is planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits.  The audit criteria, scope, frequency and methods are defined.  Selection of auditors and conduct of audits ensure objectivity and impartiality of the audit process.  Auditors do not audit their own work.  The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records are defined in a documented procedure.

And continues.  The management responsible for the area being audited ensures that actions are taken without undue delay to eliminate detected non-conformance and their causes.  Follow-up activities include the verification of the actions taken and the reporting of verification results.

Yep, a very big clause.  The most important clause for any quality management system.  Why?  When done properly, it the communication catalyst for review, for change, for improvement.  And isn’t that what quality is all about?

The key points are; planning, independence, defined criteria, there is a documented procedure, defined responsibilities, effective records, management commitment, follow up.  You can do what you please with the procedure, just make sure you cover all requirements.

I recommend external training of your audit manager and your auditors.  Yes, it is that important.  But before you go off and get too many auditors trained, read the following pitfalls / common mistakes.
•    Audits are not reviews, or management reviews, or desktop views, or stocktakes, quality assurance, etc.
•    Improvement auditing before compliance auditing
•    Lack of independence
•    Too many auditors
•    Not knowing the difference between process auditing, procedural auditing
•    Complex audit plans, complex reporting, complex or unique corrective actions
•    Not having a documented procedure
•    Lumping, batching audits into major events

Write a procedure.  Develop a plan.  Train two auditors.  Keep audits to less than 30 minutes.  Draft simple reports.  Agree on corrective actions with the right people.  Record (the verb), record, record.