How to Audit a Quality Management System with ISO 9001-2015 Standard.
An audit is a systematic, independent, and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which the audit criteria is fulfilled.
However, ISO 9001-2015 has minimal requirements for documentation.
In order words, it requires less QMS Documentation. Documentation has always been used as audit evidence in most cases.
How correctly can you audit such a system that has limited QMS documentation?
Let’s look at the documented information and some other lead that will help us to answer the question.
1. Documented information.
ISO 9001-2015 Requirements exist for what is called documented information. Documented information is mentioned in about ten places and 24 references in the standard. I know some auditors will be worried about the limited documentation in ISO 9001-2015, But it has some provisions for documented information. Every organization must have its own documented information for an auditor to look into during audits.
The format for the documented information may vary between and possibly even within an organization.
This documented information gives room for flexibility during audits.
During an audit planning, An auditor has to ask the auditee the documented information about the QMS that is available and the formats it can be found. This can serve in developing your audit plan and audit checklist.
2. Check for the process existing in the organization.
Some aspect of the ISO 9001-2015 does not require the documented procedure, Then what do you do as an auditor?
The key is to realize that the requirements in ISO 9001-2015 are fulfilled by processes found in your organization.
The questions you have to ask when planning your audit is WHAT PROCESS IS IN PLACE….? in places where there are no requirements for documented information.
For example, what processes are in place to identify and maintain organizational knowledge? Or what processes are in place to determine people needed for efficient QMS operation?
Processes do not mean a written down document, or formalized document. Whenever you can identify output and its inputs and the steps to achieve the output. The ownership and whom the process has been assigned to, then you have a process.
Activities in an organization can address one or more ISO 9001:2015 Requirements even without any documented process. Auditors must be observable in these processes and their relationship to ISO 9001:2015 requirements. However, auditing with ISO 9001:2015 requirements has to be approached based on the set of process-focused questions and less from the standpoint of what documentation is available.
3.Using word of mouth to generate audit evidence.
Auditing with a set of process audit questions for a QMS with no documentation, the audit criteria will be from the statement of fact from the owner of the process being audited.
The process owners response will establish the audit criteria and will prompt further questions from the auditor. This will help to establish the objective evidence that is relevant to the QMS process that is undergoing an audit.
This approach will help to develop appropriate audit questions on the spot rather from the prescribed audit checklist.
Most times, word of mouth are not verifiable. Audit evidence includes the statement of facts, records or other information which can be relevant and verifiable. Word of mouth does not fit into this definition, but an auditor has to ask open-ended questions during the interview. Paying close attention to the auditee’s response. This will help to lead to audit evidence which can be verifiable and relevant.
QMS ISO 9001:2015 are challenging the auditors to come up a bit higher in their auditing skills. The changes to the documentation have had a blow in meeting the definition of audit evidence which should be statements of fact, verifiable and relevant. The article answered those challenges. The attention has to be on a process approach to auditing and not mainly on documentation.
Then while auditing, listening skills will pay more in helping the auditor to generate audit questions on spot and audit evidence and while looking at the audit trails. These will provide a more accurate objective insight into how the QMS of an organization has performed.
Onyeka Emma is a QHSE Professional, a business person, and an entrepreneur. He is very passionate about health and safety, Business and Entrepreneurship.