As the backbone of many other industry-specific quality management standards, the ISO 9001 series of standards is critical to helping you manage quality processes from a company-wide point of view. In one manner of speaking, too many manufacturers today view ISO 9001 certification as an afterthought - until these companies fail an audit, which only raises total cost of quality. To give you a refresh of the ISO 9001 series for your next management review, this blog post covers the most important facts you should remember and the most common pitfalls to avoid in preparing for your next ISO 9001 management review.
Certified To ISO, Not By ISO
Your task as a quality management expert during your next ISO 9001 management review is to remind your colleagues that manufacturers become certified to ISO standards - not by ISO (the International Organization for Standardization). This distinction is very important to make to coworkers who may or may not have a deep understanding of what ISO certifications actually mean. This common misconception is understandable because many of your coworkers may still believe that "quality is a three-letter word," meaning that ISO certification is just another over-used buzz phrase from their point of view. Also, the ISO series does not refer to the quality of a specific product. It's the processes that matter most in the ISO 9001 series, and as a quality management professional, your task is to stay focused on this process-centric approach. Today, the global manufacturing industry moves forward at an astounding pace. The ISO 9001 approach (ideally) allows your company to be able to adapt to fast changes in quality standards domestically and abroad, which leads into the topic of certification.
Breaking Down the Three Types of ISO Certification
Manufacturers are certified to ISO standards in part because there is no agreed upon international enforcement mechanism, and this fact has been one of the main critiques of the ISO series in general. Depending on how your company operates from a global perspective (i.e., outsourcing, supply chain management, etc.), you may have to find new ways to weave different certification procedures into a holistic quality management system. As a quick example, you should remind your coworkers that some countries have nationally regulated accreditation procedures, but others rely completely on privately owned firms to certify companies to ISO 9001. In general, there are three basic ways to meet ISO standards: first-party certifications, second-party certifications and third-party certifications. A first-party declaration is simply a self-declaration of ISO compliance, but second-party certification involves one company auditing another company. The issue with these two types of certifications is that they may or may not actually involve formal certification at all. As such, third-party, independent certifications are the type that most of your coworkers will recognize when reviewing ISO 9001 standards.
Top Three Pitfalls of Certification
Without a doubt, the ISO 9001 series of standards are business-critical. Becoming certified to ISO gives your company credibility as a sound, responsible business partner, but there are several common mistakes to avoid during the ISO 9001 certification process. Here are the top three pitfalls in preparing for your next ISO 9001 management review.
Poor Document Management
Poor document management is still one of the top reasons why your company might fail its next ISO 9001 audit on first inspection. The reason is that the entire series of standards constantly emphasizes the importance of documentation. Your engineering change orders and revision histories may seem complete until an auditor visits a site and cannot retrieve all of the required documents in a reasonable amount of time - if at all.
Differences Between Certification Bodies
The second certification pitfall you need to avoid revolves around understanding the differences between the certification bodies of different countries. Simply put, being certified to ISO in the US does not necessarily mean your company will be certified in another country, even if you choose a well known certification firm to guide you through the process. You will have to work closely with several different government-regulated accreditation bodies if your company operates many manufacturing sites around the world.
Employee Awareness of Quality
The ISO 9001 series states very clearly that it is management's responsibility to make sure all employees understand their role in a quality management system. You can present ISO 9001 auditors with a wonderfully formatted quality management manual, but if your employees don't buy in to building a culture of quality, auditors will reveal this shortcoming during their interviews with employees. Since the ISO 9001 series is the backbone of your company's quality management system, you should review your certification posture carefully with upper management. To make the conversation more constructive, this refresh of ISO 9001 facts and pitfalls will help make the case for improvements.