Greetings Leaders!
There are unlimited numbers of consulting firms that can help organizations create quality management systems that align to various ISO-based standards.
Most leaders who know their business operations and are willing to fill in the blanks on a template can create a quality management system "on paper" that perfectly aligns with ISO 9001, AS9100 or other similar standards.
But, the best stack of papers will not guarantee a successful certification audit with no major findings if the auditee doesn't know how to navigate the auditing landscape.
Instead of sharing tips on how to prepare for a successful audit, I'm going to share what you can do to definitely FAIL an ISO audit.
Just wing it. Failure to prepare for the audit will frustrate the auditor and make what should be a pleasant experience almost unbearable. Organize your files, create a comfortable workspace for the auditor, and give them your full attention.
Let Quality handle it. Even though the Quality Manager was assigned as the Management Representative and made sure everything got done, this certification effort involves everyone who works for your company. Every employee contributes to the success or challenges in your quality management system (QMS). Make sure everyone understands their role and their importance.
Copy templates from the internet. There are some very robust examples of QMS documentation online. But they are meant to be tailored to your organization. An auditor may ask or pick at any sentence in your beautiful stack of color coded and tabbed binders so you need to know what is in it. The documents represent processes and how you do business and should not simply restate the ISO requirement.
Document a quality management system that does not align to your actual business process. If your quality manual references things like design and development, calibration, and equipment maintenance, but you have no manufacturing, you may want to revamp your documents. Make sure all documents reflect what your business does everyday.
Argue about the clauses & how they don't make sense. Everyone knows that business professionals do not sit in the lounge talking about the context of the organization or the sequence and interaction of processes. It is the auditor's job to review and document evidence of your conformance to the requirements. It is your job to understand how the requirements will be met by your company, silly or not. Do your research in advance and be ready to show evidence.
Don't conduct Management Review meetings. The standards require that the leadership team discuss several inputs and outputs to determine the effectiveness of the quality management system. This is where strategic plans, improvements, resource needs, and performance data should be reviewed and analyzed.
Select the nit-pickiest staffer to conduct the internal audit. Just because Marla has the ability to spot a flea in a pepper shaker, it doesn't mean that she would serve as an effective auditor. Auditors should be experienced and trained to help you demonstrate conformance, not find as much fault as possible. Good auditors do not play "Gotcha".
Don't train the team in ISO or their own processes. Nothing frustrates an auditor more than a response of "I don't know, ask the Quality guy." Everyone does not have to know everything about the standard, but they should know a few things like the quality policy, quality objectives, how they fit into the QMS, and their daily responsibilities to ensure products & services meet requirements. Annual refresher training on ISO topics and job descriptions can help,
Dispose of records immediately because of the company's green initiatives. Yes, we all have an obligation to be kind to the planet, but if it isn't documented, it didn't happen. That does not mean that you must harm trees to pass the audit. Documented information can be in any media format including paper, magnetic, electronic, optical computer disc, photograph, master sample, video, scanned papers, or performance art. You get the picture.
Don't address any of the findings or opportunities for improvement from the last audit. If your auditor identified some trouble spots in your QMS or kindly shared some suggestions without writing it as a finding, do yourself a favor and address those first when they come back. Respond to major findings with a formal Root Cause & Corrective Action. Even if the team disagrees and chooses not to take the auditor's suggestions, simply address them in the Management Review with an explanation of what the team will do to correct the concern.
Advantage Quality Professionals can help your team experience "stress-free" audits by ensuring everyone is ready, trained, prepared, and confident during the audit.
Comments