ISO 9001 – What Is It & Why Is It So Important?

What is ISO 9001?

ISO 9001 is recognized as the international standard for creating "Quality Management Systems" (QMS). This was created by the ISO (the International Organization for Standardization).

This well-known standard had its most recent updated back in 2015 and is now referred to as the 9001:2015 version of the ISO. For this version to be updated and made effective, it first had to have been approved by most member countries to be known as the current updated to the internationally recognized standard.

What is quality management systems?

According to the ISO definition, quality management systems are the standard in which a company's QMS requirements are defined. This system creates the processes, policies, and procedures necessary to provide products and services designed to meet customer and regulatory demands and improve overall customer satisfaction.

Quality management systems are the foundation of any quality assurance activity.

Why is it critical to have?

ISO 9001:2015 is known internationally as the recognized standard for creating, implementing, and maintaining a company's quality management system.

This standard was designed to be used by companies, no matter their size or industry. As the international standard, 9001 is recognized as the basis behind any company that wants to create a system that is designed to ensure customer satisfaction. As such, many corporations today require this certification from their suppliers.

Having the certification provides your customers the needed reassurance saying you have implemented a Quality Management System in place that is created on the seven quality management principles.

This certification is such an influential and essential industry standard that industry groups often use parts or all of the 9001 standards, such as the ISO 13485 for the medical devices industry, the AS9100 for the aerospace industry, and the AITF 16949 for the automotive industry are just a few examples.

A recent survey performed in 2017 for ISO certifications under 900 1 showed that, despite the global recession, the total number of companies that have implemented the ISO 9001 standard is still growing worldwide.

What is the current ISO 9001 standard?

The current ISO version is 9001:2015. The ISO 9001 2015 standard is often called ISO 9001 revision 2015. This version was released back in October 2015 and replaced any of the previous revision ISO 9001:2008.

This update includes many of the processes from the previous revisions to the ISO standard, with a greater emphasis on understanding the context of the organization and risk-based thinking.

Is ISO 9001 worth it?

The benefits behind having the certification cannot be overstated; companies of all sizes have used the standard to significant effect, securing cost savings and additional revenue.

Here are just a few of these benefits:

Improve your image and credibility –

If your customers see that a recognized certification body has certified you, it will show them that you have implemented a system focused on meeting customer requirements and improvement.

This will improve their trust that you will deliver what you have promised, and it will help you get new clients.

Improve customer satisfaction –

One of the main principles behind the ISO 9001 QMS is the concept of improving customer satisfaction by identifying and meeting customer needs and requirements. By providing this, you will grow your repeat business.

Fully integrated processes –

By using the ISO, you look at the individual functions within your organization, but you also interact with those processes. By doing this, you will discover areas for improvement and savings within your organization.

Use of evidence-based decision making –

Ensuring that you and your team are making decisions based on factual evidence is key to success. Ensuring that your choices are based on accurate information will help you target the resources to correct any problems and improve your organizational efficiency and effectiveness in a timely manner.

Create a culture of continual improvements –

With ongoing continual modifications as the main output of the QMS, you can saving time, money, and other resources. By making this the culture behind your company, you can focus on your workforce by improving the processes that they are directly responsible for.

Is ISO 9001 a legal requirement?

No, there are no legal requirements, even though the certification is a requirement for many contracts. There are even awards, such as the Malcolm Baldridge National Quality Award.

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What Exactly is Metrology

Metrology is defined by the International Bureau of Weights and Measures (BIPM) as “the science of measurement, embracing both experimental and theoretical determinations at any level of uncertainty in any field of science and technology”.

Metrology is how companies guarantee certain comparisons of global measurement results. As an example, metrology is used to help ensure that the parts in the vehicles we drive are accurately and precisely measured, manufactured, and assembled despite the different manufacturing processes language barriers, and measurement systems (such as US and metric) that are used by the manufacturers.

Metrology also incorporates precision measuring tools like the coordinate measuring machines (CMMs) also the precision measurement sensors.

Globally Standardizing Precision Machined Parts

Today’s global supply chains are using the international measuring standards to help precisely manufacture, distribution, and assembly machined parts through out the world.

All different types of factories from different countries can precisely machine identical parts from CAD or drawings. Each manufacturer’s measuring instrument is calibrated with the same specific thresholds.

These calibrations are designed to ensure that all of the parts created will fit together and work as they were intended to. After the calibration phase is over, the production machines are then set and the quality assurance and controls are confirmed.

Types of Metrology Equipment

A coordinate measuring machine is a system that measures the testing product by combining a probe with the coordinate system to measure the geometric physical points of the product. Metrology equipment comes in various different models and utilities, many of which we’ll go over below.

In addition to accurate measurements, CMMs have the advantage of providing real-time information on the condition of the manufacturing process to the CMM operator. All global CMMs must comply with the ISO 10360 international measurement standards and can be controlled by either an operator or a computer. Five major types of CMMs are used in today’s metrology:

Cantilever:

This is used primarily for measuring master parts.

Bridge:

Most popular with digitizing and scanning jobs for the mold, stamping, and machining markets.

Gantry:

Used for measuring heavy, large parts such as large dies and molds.

Horizontal Arm:

This is used to measure parts in industries such as defense, aerospace, and appliances.

Portable (PCMM):

Handheld 3D and geometric tolerance and dimensioning measurements which can also be ISO 10360-certified.

Touch-trigger:

Touch-trigger probes are the most commonly used type of probe in metrology because they remove touch bias and can be used with computer control.

There are also two major groupings of probes: contact and non-contact. Contact or tactile probes include:

Hand Probes:

Hand probes are designed to measure curved surfaces, but one must watch out for tactile differences that can be caused by the operators.

Touch-Trigger Probes:

This is the most popular type of probes. It simply removes touch bias and can be used by direct computer control.

Analog Probes:

Use CAS technology to measure irregular shapes and contorted surfaces, like sheet metal. Non-contact probes are used for large, complex geometric, flexible parts. They include:

Laser Probes:

Laser probes are a triangulation with a beam of light designed for high-speed component measurements.

Vision Probes:

Vision Probes are designed for high-speed measurements of small, 2D parts with images taken from a camera.

As previously noted, manufacturers from all over the world need to meet or exceed the set specified tolerances of each item tested so they will fit and work exactly as they were designed to.

This quality assurance covers components manufactured from medical devices to rocket engines and everything in-between. In fact, precision measurement technology is used to ensure the quality assurance of measurements up to one-thousandth of a millimeter.