Tag Archives: ISO 9001:2015

Does Document Management Apply to Fish? The Answer is More Complicated Than You Might Think

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Document Management

In 2015, the Supreme Court of the United States (SCOTUS) ruled that a fish is not a document. While this might seem like an absurd problem for one of the most powerful legal organizations in the world to consider, the idea behind it is an important one that might have an impact on how you do your job. On August 23, 2007, John Yates, the captain of the fishing boat Miss Katie, was fishing off the coast of Florida when he was found to have caught and kept a number of red grouper fish that were under the legal minimum size limit of 20 inches. The field officer with the Florida Fish and Wildlife Conservation Commission instructed Yates to return to port and keep the fish for evidence. Instead, Yates threw the fish back into the sea, effectively destroying the evidence against him.

In response, the Department of Justice … Read more...

Why Risk-Based Thinking Should Be Part of Your Quality Management System

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While the concept of risk is easy enough to understand, figuring out how to apply it to your organization can be somewhat more complicated. Learning how to manage the effect of uncertainty in such a way as to determine the impact on how value is created and sustained requires a deep understanding of your organization’s processes. Many organizations are tempted to avoid these difficulties by ignoring risk management altogether, which can lead to cost overruns, time delays, waste, rework, or even to more serious problems that have an impact on health and safety or the environment.

Fortunately, ISO 9001:2015 for quality management systems (QMS) can provide some much-needed guidance on how to make risk-based thinking the cornerstone of your QMS. ISO 9001:2015 incorporates risk-based thinking throughout to help your organization make better quality decisions that anticipate and prevent process problems. It also incorporates the high-level structure of Annex SL to … Read more...

What Is a Quality Management System (QMS) and Why Do You Need One?

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A quality management system allows an organization to link business objectives with customer expectations, provide data that supports evidence-based decision making by leadership, reduce waste and prevent rework, and ensure transparency at each stage of the supply chain.

The cost of poor quality can be high for many organizations. Expensive waste, product rework or recalls, supply chains that lack accountability, and lack of insight into your customer requirements are symptoms of a quality management problem. If you’ve thought about implementing quality practices in your organization, you’ve probably heard the term “quality management system” or its acronym “QMS” and wondered what it means. Is it a software application? Is it a group of people? How can I learn about it? 

This short guide will help you to understand the basics of a quality management system and where to find the best guidance to get started on the path to continual quality improvement in your organization. 

What is a

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You Need More than Compliance to Achieve Operational Excellence in Quality

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Since its introduction in 1987, ISO 9001 for Quality Management Systems (QMS) has become the most popular standard in the world. The latest iteration, ISO 9001:2015, outlines a framework for improving quality and a vocabulary of understanding for any organization looking to provide products and services that consistently meet the requirements and expectations of customers and other relevant interested parties in the most efficient manner possible. It incorporates principles such as customer focus, process orientation, data-driven decision making, and systematic risk management to help organizations improve their operations across all areas. As a result, many organizations report reduced costs and improved quality and productivity after an ISO 9001:2015 implementation. 

However, not every ISO 9001:2015 implementation brings success. For some organizations, the time and effort dedicated to certifying to ISO 9001:2015 produce nothing but disappointing results such as increased costs, more bureaucracy, and even business failure. If ISO 9001:2015 is so … Read more...

“Documented Information” in ISO 9001:2015

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In the transition from ISO 9001:2008 to 9001:2015, some key definitions have shifted to support the more holistic philosophy of the revision. In particular, references to “documentation,” the “Quality Manual,” “procedures,” and “records” have been replaced by the more nebulous “documented information.”

What does this mean? Should you get rid of your Quality Manual?

The short answer is no – you shouldn’t stop documenting your processes, and you shouldn’t toss your Quality Manual if it’s facilitating communication in your organization and helping you meet your quality goals! You should, however, feel as if the requirements can be adapted to your organization’s unique situation. The key question to ask, following clause 4.4, is: What information is necessary to support the operation of processes?

Rather than focusing on how the process itself is conducted, look at what information you need to determine whether the process outputs conform to their stated requirements. Additionally, … Read more...

Why ISO 9001:2015 Is So Important for Your Organization

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Perhaps you’ve heard of ISO 9001:2015. Perhaps you know that it’s an important certification to have for your business. Perhaps you also believe that it’s a complicated and time-consuming process that is difficult to understand, and that it’s challenging to convince management that you need to do it.

In fact, ISO 9001:2015 is the simplest and most achievable version of the ISO 9001 standard for organizations of all sizes. More than 1 million organizations have certified to ISO 9001:2008 and realized the benefits of improved Quality Management, reduced operational waste and increased customer satisfaction. Certifying to ISO 9001:2015 will give you all that and more. It can also help your organization meet regulatory requirements and create new opportunities as many clients in the public sector and automotive industries begin to require it from their suppliers and partners.

The new Intelex Insight Report, Starting Your Certification to ISO 9001:2015 – … Read more...

The ISO 9001:2015 Transition Deadline Is Approaching. Are You Ready?

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The deadline for making the transition from ISO 9001:2008 to ISO 9001:2015 is September 14, 2018. After that date, organizations that have not certified to the new standard will lose their ISO 9001 certification until they have successfully moved to the new standard. Have you made the transition yet?

ISO 9001:2015 demonstrates to your customers and suppliers that you know how to meet customer needs with efficiency and insight, and that your organization understands Quality at every level from the leadership down. Further, ISO 9001:2015 certification is considered a prerequisite to doing business in many industries. Organizations that miss the deadline and lose their certification are therefore at considerable risk of brand damage and lost business opportunities.

The new Intelex Insight Report on ISO 9001:2015 can help you navigate your way around the new standard. If you’re rushing to meet the transition deadline and need a quick summary of what … Read more...

What Can Go Wrong, Will Go Wrong: Deepwater Horizon

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ISO 9000:2015 Quality Management Systems – Fundamentals and Vocabulary gives the definition of Quality as the “degree to which a set of inherent characteristics of an object fulfills a requirement.” While this broad definition might bring to mind many of the traditional Quality ideals, such as process efficiency and customer delight, perhaps less obvious are the potential costs of Quality failures and the impact they can have on the environment, a company brand, and human lives.

On April 20, 2010, the Deepwater Horizon, an oil rig leased to BP Exploration & Production from Transocean for extracting oil from the Macondo well 50 miles off the coast of Louisiana, suffered a series of explosions caused by the uncontrolled flow and ignition of oil from the well onto the rig platform during exploratory drilling. Explosions, and the resulting inextinguishable fire, continued to rock the Deepwater Horizon for 36 hours, killing 11 … Read more...

Quality Management Requires a Cross-Industry Approach

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The fundamental guiding principle of Quality Management lands squarely upon the business need for continuous process analysis and improvement. Doing it successfully results in increased customer satisfaction, employee engagement and organizational efficiency. Every organization, regardless of industry or size, should have Quality Management as a core pillar upon which objectives and strategy are based.

Yet there is no single way to apply Quality Management that makes it effective for all. While you can certify to a standard like ISO 9001:2015, those standards don’t tell you how to uniquely apply quality to your businesses or provide a simple path to achieve a Culture of Quality. Every industry, from food production to automotive manufacturing, has a myriad of different priorities, obligations, and requirements that shape the way they engage with and apply the principles of Quality Management.

Read Intelex’s new Insight Report, “A Cross-Industry Look at Quality Management,” to learn the … Read more...

How ISO 9001:2015 Can Lead You to Quality Excellence

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Let’s be honest. No matter how important ISO 9001 certification is, few people sit around and read ISO documents for fun. True, everything you need to know to get your organization certified to the most popular standard in the world is in there, but it’s a dense 40-page read, and it’s easy to get lost in the intricacy of the requirements for certification.

Yet the value of certifying to ISO 9001:2015 is undeniable. More than 1 million organizations have certified to ISO 9001:2008 and realized the benefits of improved Quality Management, reduced operational waste, and increased customer satisfaction. Certifying to ISO 9001:2015 will give you all that and more. It can also help your organization meet regulatory requirements and create new opportunities as many clients in the public sector and automotive industries begin to require it from their suppliers and partners.

The new Intelex Insight Report on ISO 9001:2015 can … Read more...