1. Internal Auditing ISO 9001:2015

2. What are the ISO 9001 Quality Management System document requirements?
ISO 9001:2015 refers to documented information and retained documented information .
Other documentation may be required by an organization in order to manage the processes that are necessary for the effective operation of the quality management system.
This will vary depending on the size of the organization, the kind of activities in which it is involved and their complexity.

3. What are the ISO 9001 Quality Management System document requirements?
Documents may be in any form or type of medium, ISO 9000:2005 clause gives the following examples:
paper
magnetic
electronic or optical computer disc
photograph
master sample

4. 8. 5 Production and service provision 8. 5
8.5 Production and service provision Control of production and service provision Controlled conditions shall include, as applicable: a) the availability of documented information that defines: 1) the characteristics of the products to be produced, the services to be provided, or the activities to be performed; 2) the results to be achieved;

5. 8. 5 Production and service provision 8. 5
8.5 Production and service provision Identification and traceability The organization shall control the unique identification of the outputs when traceability is a requirement, and shall retain the documented information necessary to enable traceability.

6. Internal Audit Quality Management System Documentation
Auditors should assess whether the company has established it’s document requirements and that these documents have been implemented and maintained.
Auditors will need to consider if any lack of documentation could lead to a loss of process control at each stage.
There are several requirements of ISO 9001 where you could add value to your quality management system and demonstrate conformity by the preparation of other documents, even though the standard does not specifically require them.

7. Internal Audit Quality Management System Documentation
Types of documents that are useful:
Process maps, process flow charts and/or process descriptions
Organization charts
Specifications
Work and/or test instructions
Documents containing internal communications
Production schedules
Approved supplier lists
Test and inspection plans
Quality plans

8. Internal Audit Quality Management System Documentation
Electronic Based Management Systems
During the audit initial phase Auditors should determine the degree to which its management system is electronically- based.
 The auditee should agree on how Auditors will access and use the Electronic Based Management System.
Auditors should check the policies for the use of its Information Technology infrastructure
Auditors should check the Instructions for accessing, and the necessary security clearances to access, pertinent documents and records

9. Internal Audit Quality Management System Document Control
 Auditors should confirm compliance with control elements such as document identification and document revision level.
 Auditors should confirm the controls for the management of obsolete documents are considered within the document control policies and procedures and are being applied.
 Auditors should ensure “Point-of-use” requirements are in practice.
Statutory and Regulatory Requirements
Auditors should ensure that methodology in place for identifying, maintaining and updating all applicable statutory and regulatory requirements
 Auditors should verify that these statutory and regulatory requirements are utilized as ‘process inputs’ while monitoring ‘process outputs’ for compliance with requirements
 Auditors should ensure that any claimed compliance to standards, statutory and regulatory requirements are demonstrated
 Auditors should seek evidence that specific information regarding statutory and regulatory requirements has been taken into account

10. Internal Audits Opening Meeting
Conduct an opening meeting without compromising the impartiality and integrity of the audit and hold open discussions with process or department management
This allows the effective use of audit resources and time and may provide major benefits for the department.
The Scope of the audit is confirmed at the opening meeting and should describe the processes and products, customer statutory and regulatory requirements to which the quality management system audit is being applied
The scope of audit should clearly define:
the scope of the audit including details of the products or services or both
the main processes and/or activities
any ISO 9001 requirement that has been excluded
The output of such audits is usually a report which covers the issues going beyond mere compliance with the requirements of the standard and identifies opportunities for performance improvement in general without offering specific solutions.

11. Internal Audits Procedure
Internal Auditors are responsible for carrying out the procedure as described below:
General Procedure detailing the correct method for completing internal department audits:
The site internal audit schedule determines which audits are to be carried out. Auditors must make sure they have the correct audit checklist form to carry out the audits.
A date and time for the audit to take place must be agreed with the department. A representative from the department must be present during the audit.
Auditors uses a specific audit form and checklist designed by the Quality Manager for each department or area.

12. Internal Audits Procedure
The audit report is rated based on the following criteria:
RED – Major Non-conformance(s) identified and imminent risk. Immediate documented Corrective Action is required and a written follow-up necessary. 
AMBER – Minor Non-Conformance(s) identified there is a potential risk. The Corrective Action required is documented and a verbal follow up is required.
GREEN – Satisfactory or Positive with comments or suggestions for improvement
The output of such audits should be a report which covers the issues going beyond mere compliance with the requirements of the standard and identifies opportunities for performance improvement.
When the audit is completed and the report given a rating. Positive as well as negative comments are included in the report. Major Non-conformities are immediate highlighted to the department manager, who will is responsible for the corrective and preventive action without undue delay.

13. Internal Audits Procedure
Internal Audits Corrective Actions
are reported using
QMR 012
Corrective Action Request