What is an audit?

Make no mistake about it, an eQMS system is your first line of defense in an audit.

The FDA has announced that it is drastically increasing the auditing of companies, small or large, foreign and domestic.

Be ready!

“You get what you inspect, not what you expect!”

Louis V. Gerstner, Jr.

An Audit is the on-site verification activity of a process or quality system, to ensure compliance to requirements. An audit can apply to an entire organization or might be specific to a function, process, or production step.

In a simple word, it means checking to ensure you are actually doing what you say you are doing.

As it is mentioned in the first paragraph, an audit can be applied to different parts, and as such, there are three types of audits (depending on its scope):

  1. Product audit applies to a particular product or service. It is the assessment of the final product/service and its qualification for use evaluated versus the intent of the purpose of the product/service.
  2. Process audit to verify that processes are working properly.
  3. System audit which is conducted over a management system. It evaluates an existing QMS to determine conformance to company policies and regulatory requirements.

System audits are one of the key management tools for accomplishing the aims set out in the policy of the organization. A system audit is a disciplined method to evaluate and improve the efficiency of a system. Audits are carried out in order to confirm that the individual elements within the system are effective and suitable in achieving the stated objectives.

The system audit also delivers objective evidence concerning the need for the reduction, elimination and most importantly, prevention of nonconformities. The outcomes of these audits can be used by the management for improving the performance of the organization. They are conducted by the trained auditors who can be organization own staff or staff of an external auditing agency or independent professional auditors. They are conducted by looking for objective evidence.

In nearly every industry, audits are increasingly used as important management, compliance, quality and process improvement tool.

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5 replies to “What is an audit?”

  1. IĉŠ³e read several good stuff here. Certainly worth bookmarking for revisiting. I surprise how much effort you put to create such a fantastic informative site.

  2. Jj Oli says:

    Great article guys. Definitely we need to understand what is an audit and how important this is. It is very simple, for all the readers, an audit is the process of systematic examination of a quality system carried out by an internal or external quality auditor or an audit team. It is an important part of an organization’s quality management system and is a key element in the ISO quality system standard, ISO 9001. My recommendation for everyone who is looking for a proper qms that can help them in this process, my recommendation and as a current user, qmsWrapper, for our company it was a lifesaver.

  3. Ben Bohn says:

    Good day all,

    This is very interesting topic,not many people like audit and auditors. But without audit there will be no control ,so their job is very important and some times underappreciated by other people. But shouldn’t be the case , some people who never done similar type of a job do not realize how important an audit is and having a software that can assist you and your auditor to get the correct document at any time is amazing and mind blowing .

  4. Louis W says:

    Definitely, audits can be sometimes a headache but when you are prepared with the right tools, these processes can become just one more task of the day. I am a believer and user of qmsWrapper and i totally recommend it to all of you who are reading this great article.

  5. Jason says:

    I know few things about the audit, the most important thing for audit is in a small details. If you don’t have a skill to notice little things and mistakes you will never be good in that field , that is why some people use programs to assistem and helped them raise awareness for those tiny details.

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