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ISO 9000 (ISO 9001)

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Establish an Internal Audit Program

Internal ISO 9001 Audit Program

 

Choose your audit team

You will want to have a number of trained internal auditors for your audit program. You will be auditing each area of your facility once or twice a year, with an audit team of 1 to 4 auditors depending on the size of the area. You will want to have enough auditors trained so that the auditors will not audit their own area, and so that you are not pulling one person away from their work too often. A general guidance number is 10% of the total number of employees; a company with 50 employees would train 5 auditors, and company of 100 would train 10. As the number of employees goes up, the percentage would go down.

Look for employees that have a strength in investigating issues and that are good communicators. The better people skills the auditors have, the smoother your audits will be performed.

Audit Tips

Internal Audits are a Quality Management System's best friend...

ISO 9001 Internal Auditor Training Materials

ISO 9001 Internal Auditor Training Materials

The purpose of this training is to:

This training is for:

The length of the training::

This training is conducted by:

This training includes:

Use this training to train your auditors and give them practice with each step of the audit process. The training covers the ISO 9001:2000 Standard, gives the students a chance to work with it and get familiar with the requirements. Then the training guides the students through the audit process. They will prepare an audit plan, conduct opening meetings, audit documents and records, document their findings, hold a closing meeting and write the audit report.

Your trainer’s guide prepares you to conduct this training. The training is recommended for groups of 6 to 12 students at a time.

View samples from the training package:

 

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This training is also available in Spanish.
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The ISO 9001 Registration Audit

Registration Audit

When the day of your Registration Audit has arrived, it is time to showcase your Quality Management System. The Auditor or Auditors are coming in to see how you have addressed the requirements of ISO 9001, and how you have designed your QMS.

Preparing for the Audit

Prepare the employees

Before the Audit you will want to make sure that all employees know that the audit will be taking place, and the purpose of the audit. This will help them understand how to respond to the auditors' questions. You want employees to respond openly and honestly to the auditor.  The auditor is looking for evidence that you are complying with the requirements of ISO 9001, your employees are the ones that will be providing that evidence. Preparing them to answer the auditors questions will make the audit go more smoothly.

  • This is not a test. If the auditor asks a question, they are looking for information on how something works, not if the employee has all the answers but how the employee goes about finding answers and information. Do procedures provide information? If the information is not in a procedure, where does the employee go next, do they ask a supervisor? Use our Employee ISO 9001 Implementation Package to update employees on this issue and other implementation steps throughout your project.

Prepare the facility

  • Make sure all areas of the facility are clean and neat; there are potential nonconformances hiding in any given mess.
  • Make sure documents are available where every they need to be used.
  • Check bulletin boards, counters, cupboards, drawers for uncontrolled documents, un calibrated measuring and monitoring instruments and unidentified parts or supplies.

Prepare for the Auditor

  • Have a copy of the Quality Manual and Quality System Procedures available for the auditor.
  • Designate a place for them to work when they are not out in the facility. They will need to work on their documentation and reporting.
  • Assign someone to go with the Auditor to show them where different areas and departments are. Coach this person to let employees answer the auditors questions, not answer the questions themselves unless the question was directed to them.
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