Several questions on ISO 9001 transition

1. We are in middle of some changes in company personnel distribution and work organization. This is effecting the quality procedures and documentation which is not being done the way our quality policy requires. The next external audit is in a few months. The question is: Can the external audit be prolonged for a few months so we have time to change the quality procedures to meet our new work organization policy?

Yes, you can prolong the certification audit, but you need to contact the certification body and talk with them. Keep in mind that there is possibility that you wont be having certificate until the certification audit is conducted.

2. Based on the first question. Will the external audit require the documentation that hasn't been done correctly as an result of the new work organization or the audit will accept the new documentation?

The auditors will examine only the documents that are part of your Quality Management System at the moment of the certification audit, they wont examine the documents that are still not a part of your QMS documentation.

3. What is the required number of internal audit's in a company of 275 workers, or is this number in hands of the company quality manager?

The standard does not define number of internal audits that needs to be conducted, but the usual practice is to cover entire scope of the QMS within one year period. How many audits will be needed depends on the capacity of the company, if you have several auditors you can cover entire scope of the QMS in one day and if you have only one auditor you will need several days or several internal audits.

4. What are the requirements to become company's quality manager? Does ISO 9001 define this?

The standard doesn't define required competency for quality manager, but usually it includes knowledge about the standard and processes within the organization. For more information, see: What is the job of the Quality Manager according to ISO 9001? https://advisera.com/9001academy/blog/2016/08/23/what-is-the-job-of-the-quality-manager-according-to-iso9001/

5. What are the requirements to be an internal audit in the company?

The standard doesn't define competency for internal auditor, but it is usually required from the auditor to be familiar with the standard and auditing techniques. For more information, see: ISO 9001 internal auditor training: Is it for me? https://advisera.com/9001academy/blog/2015/06/02/iso-9001-internal-auditor-training-is-it-for-me/

6. What if we don't pass the external audit because of faulty documentation? What are the consequences, and what is the procedure to get back on track with quality certification?

In case when your documentation is not compliant with the standard, the certification audit will issue you nonconformities and will define some deadline for your organization to remove these nonconformities. Once the nonconformities are removed, the certification body will issue your organization the certificate. For more information, see: How to deal with nonconformities in an ISO 9001 certification audit https://advisera.com/9001academy/blog/2015/06/09/how-to-deal-with-nonconformities-in-an-iso-9001-certification-audit/

These materials will also help you regarding internal audit:
- Book Preparing for ISO Certification Audit: A Plain English Guide https://advisera.com/books/preparing-for-iso-certification-audit-plain-english-guide/
- Free online training ISO 9001:2015 Internal Auditor Course https://advisera.com/training/iso-9001-internal-auditor-course/
- Conformio (online tool for ISO 9001) https://advisera.com/conformio/