“Documented Information” in ISO 9001:2015

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 In particular, references to “documentation,” the “Quality Manual,” “procedures,” and “records” have been replaced by the more nebulous “documented information.”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...

What’s Your Quality 4.0 Strategy?

In ISO 9001:2015, quality is the “degree to which a set of inherent characteristics of an object fulfils requirements.” (3.6.2) Quality 4.0 describes the technological innovations that will help us more quickly assess compliance and customer satisfaction and optimize business processes through systems integration — whether the object we’re working with is a process, a product, a person or an intelligent software system.

Quality 4.0 systems are:

  • Connected— electronic, networked, and capable of communicating in real time with people and systems.
  • Intelligent— autonomous, reactive, proactive, social and/or adaptive to new data or new environmental conditions.
  • Automated — able to carry out instructions with or without human participation.

As a result, Quality 4.0 strategies emphasize real-time visibility, intelligent decision support, and improved communication — between people, systems and machines.

For example, Nikon’s recently announced Quality 4.0 strategy focuses on real-time measurement: improving and automating measurement systems, automating inspections and … Read more...

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

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

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...

What is Quality Management?

When people use the word “Quality,” it’s usually as a synonym for “good.” Many brands tout their products as “high quality” or “superior quality” in just this way without really defining what the characteristics of “Quality” are, and we’re more likely to see it in marketing material than in integral business process or policy documents. This is the first in a series of blogs that will explore the fundamental concepts of Quality and how you can apply them to your organization.

Quality is about much more than describing a product or service as “good.” Quality Management professionals see Quality as the following:

  1. Satisfying a set of explicitly or implicitly defined inherent characteristics.
  2. Providing products or service features that customers need. These features lead to customer satisfaction and exceeding customer expectations, which, in turn, lead to increased revenue for the producer. Ensuring Quality by adding features that customers want while ensuring
Read more...

Quality Management Requires a Cross-Industry Approach

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

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...

Are you Ready for ISO 9001:2015?

Three years in the making, the latest and greatest revision to the Quality Management Systems standard was published on September 23, 2015 as ISO 9001:2015.  It felt like Christmas morning waiting to get the new standard – well almost.  I’ve already purchased my copy from ASQ  for $173 USD and it was immediately available for download as a PDF once the payment processed.  I’m excited to learn more about how ISO 9001:2015 can help organizations improve and deliver value to customers in a variety of industries and markets.  For anyone that is currently certified to ISO 9001:2008, you have a 3 year grace period to become certified to the new standard’s requirements.  This means you have until September 2018 in order to adopt and demonstrate compliance to the new requirements of ISO 9001:2015.  According to a recent webinar with Quality expert Peter Merrill hosted by the ISO 9001 clubRead more...

What Has ISO 9001 Done for Me Lately?

I know…you’ve all been wondering – What has ISO 9001 done for me lately? 

Well, fasten your seat belts and get ready for a wild ride. The new ISO 9001:2015 standard is not just about compliance. It’s about implementing a Quality Management System that is practical, proactive, and progressive. With the release date of September 15, 2015, we, as quality professionals and organizations are excited about what could be possible and how the new standard can help transform our businesses. All of this despite the 3 year grace period to adopt the new standard.

There are many reasons for this building excitement.

First, it puts an end to those confusing debates that I’m sure you’ve had at some point about whether an action was a corrective action or a preventive action. What is the difference? If you identify the root cause of the problem and take appropriate action to prevent … Read more...

Town of Ajax Uses Intelex Document Control to Support a Culture of Quality

The Town of Ajax is located in Ontario, Canada and holds the distinct honour of being the first North American municipality to have been fully registered to the ISO 9001 standard – all nine of its departments have been certified since 1997!

Of course, as many businesses certified to ISO 9001 know, remaining in compliance with the standards’ requirements can demand a fair bit of effort. The municipality was keeping 27 sets of binders across their departments with copies of their ISO 9001 quality documentation, and every time a document was created, edited or updated, 27 copies had to be printed, distributed and added to each binder. Managing this documentation became a daunting task. As the Manager of Quality Service and Special Projects, David Forget knew that they needed a better way to ensure version control and audit readiness.

“It was an administrative nightmare,” says David. “There was just so … Read more...