Insight Auditing® from TÜV SÜD America
ISO 9001 is strict and exacting. It should be more than a checklist of what is done or not done to requirements. Used properly, it can be empowering and dynamic, providing information that can help drive organizational improvements. Over the years, TÜV SÜD America has refined its approach helping companies maximize the value of ISO 9001 certification. Our auditors are trained to think outside-the-box to maximize the value of the ISO 9001 certification process. We call this the IDEAL Process.
The four phases of this process include:
PHASE 1 - INFORMATION GATHERING
The process begins with an informational meeting between your company and the TÜV SÜD team. We summarize our role and explain the auditing process.Most importantly, we listen. We listen to understand your business goals and strategies so we can help you develop a quality initiative that can best support your organization now and into the future. During this meeting we'll answer any questions about our services and explore how we should work together as a team. You will also have the opportunity to talk with an auditor.
Team chemistry is an important part of any audit. We want to set the foundation for a lasting relationship. During our initial series of information meetings we will identify any specific issues that need to be resolved prior to the actual audit.
One important consideration in the information phase is the opportunity for a pre-audit. It is not a formal requirement for certification. A pre-audit is a high level evaluation indicating where your company currently stands in compliance with ISO 9001. If you are new to ISO 9001, this will help educate your management and staff on what is about to occur.
You'll become more familiar with our auditors and our Insight Auditing approach and we'll learn more about the processes within your company. Your auditor will point out any areas of concern. Addressing issues at this point reduces risk of nonconformance during the actual audit. This early observation can be immediately implemented into your management system, so you can benefit from our insights before the actual audit even starts.
PHASE 2 - DISCOVERY EVALUATION
Most Certification Bodies call this phase "documentation review," performing a quality manual review prior to the audit. At TÜV SÜD America, we conduct a more thorough "discovery evaluation" of your documentation. Over the years we've found many audit nonconformances result from documentation problems and the procedures relating to documentation. So we've added a process to help your team at this stage.
We review the quality manual and the supporting procedures. Most auditors only review the quality manual. We can discover a significant amount of documentation-related problems at this stage. In some cases we make 10-20 observations during this review. You can use the supplied report to make any necessary changes before the audit. This saves time, money and reduces the stress surrounding the audit.In addition, TÜV SÜD reviews your organizational profile, which is an outline of your organization's operating environment. This profile includes a description of your organization, customer and market requirements, supplier and partnering relationships, competitive situation and strategic context of your operations. This review allows our audit team to better understand your business before we come to your site, so our Insight Auditing can begin long before we audit your facility.
During the entire discovery evaluation process the audit plan is being developed. Our auditors gather all pre-audit and relevant data and construct more than a checklist. The Insight Auditing approach to creating the audit plan is designed to reflect your company's audit priorities and help align your overall business goals/objectives with the quality initiative.
PHASE 3 - AUDIT
After all the planning and preparation comes the actual audit.The length of the audit depends on the size of the business. A small business may be audited by a single auditor in one day. A large organization may require a team of auditors working over several days. If a number of facilities perform identical tasks, we use sampling techniques to minimize the number of locations visited. Audits are typically performed by:
- Touring your facility and observing ongoing operations.
- Interviewing employees working at various levels in your organization.
- Reviewing documentation and evaluating quality records.
The audit team collects evidence that your company has implemented a quality management system in compliance with the ISO 9001 standard and that your practices match the descriptions captured in your quality documentation.TÜV SÜD America's Insight Auditing process then takes it one step further. The quality management system is then evaluated against your business objectives, strategies and vision statement. All must be aligned to ensure overall success and continuous improvement.
During the auditing process our auditors will probably ask a number of intriguing questions. During the closing meeting you'll see the value of these questions and Insight Auditing. Our auditors are sensitive to the needs of your business and the integrity of the ISO 9001 process. In addition to the ISO requirements, we'll also present a series of observations. We can't consult but we can point out areas for improvement. Our auditors are trained to look beyond the numbers and uncover findings you can use to increase efficiency, process effectiveness and quality. This is what Insight Auditing is all about.
A closing meeting is conducted at the audit's completion and all identified problems are reviewed. The audit team will also share its recommendation regarding your certification. If all goes well, your company will be recommended for certification and issued an ISO 9001 certificate. If nonconformances are identified, the audit team will confer with you and agree upon the required follow-up actions. Certification is not a "pass/fail" activity. It is an eventual certainty unless you decide not to proceed or can't correct the nonconformance.
PHASE 4 - LEARNING
Following the certification audit, an auditor will return periodically (once or twice a year) for routine surveillance visits. This ensures that your management system continues to comply with ISO requirements and continuously improves.The audit team will evaluate portions of your quality system for evidence that the system's original baselines are still being followed.
A quality system is dynamic. The audit team also looks for evidence of continual improvement. If processes or procedures change and the changes are beneficial in meeting organizational objectives that indicates your system is working well.While this seems like the end, this is a phase that never ends.TÜV SÜD America's Insight Auditing® approach, including the IDEAL Process, is a unique combination of longer-term business strategy and shorter-term operational tactics.
We don't simply monitor procedures. Using the IDEAL Process, we strive to bring findings to your attention that may directly improve your quality program. At the same time our Insight Auditing discipline continues to align your business strategy and corporate vision with your organization's operational process. We constantly keep an eye on your business so you can use your quality system to improve today and set the stage for future growth tomorrow.
Following Through on Your ISO 9001 Certification
ISO 9001 certification is the first step in a never-ending journey toward continuous improvement. Now you have the foundation to integrate your quality process into your company's overall business plan. You can also use this certification as springboard toward more advanced high-performance business models such as Six Sigma or the Malcolm Baldrige National Quality Program Criteria.So where do you begin? Contact TÜV SÜD America today. We'll show you how to get started on the road to ISO 9001 certification and how our Insight Auditing approach can bring your quality management system to a new level of effectiveness.