ReAgent Prepares for Transition to ISO 9001:2015

Dan Wiggins

by Dan Wiggins

19th October 2017

Here at ReAgent, quality is a value we hold extremely high. For this reason, we are entering the transition process  from one of our current systems, ISO 9001:2008, to ISO 9001:2015.

What is the ISO?

ISO, or the International Standards Organisation, is a quality management organisation used worldwide. They develop regulatory and management systems used by many businesses across the globe.  The organisation strives to set a standard of quality for businesses to adhere to. Their aim is to get those that use their quality systems to achieve high levels of customer satisfaction.

What is ISO 9001:2015?ISO_9001-2015

The ISO review their standards every five years. The system we currently use, ISO 9001:2008, has been updated to reflect trends in the business world.

The biggest change between the old standard and the new standard is how it is structured. The new model takes the same outline as other ISO systems, making the integration process much easier for those using it.

ISO 9001:2015 places extended focus on relationships between staff and high level management. This is to raise the morale of employees, leading to better customer relations.

The standard speaks of risks, taking them, and how to avoid unnecessary ones. It states that the two categories when evaluating risk are severity (seriousness) and probability (how likely). They also have a few factors to consider when thinking of risk. These include:

  • Potential Threats
    Identifying problems the business may come across.
  • Preventing Threats
    Dealing with things before they become threats.
  • Giving Responsibility
    Who will deal with the threats when they manifest?
  • Evaluating the System
    Evaluating, testing, maintaining and sticking to the system when needed.

Furthermore, it details how to identify strengths and weaknesses within a business and through that, identify’s the risks of them. The biggest difference between the ISO and a health and safety audit is that it features focus on positive risks as well as negative.

The new system also simplifies its language and use of technical terminology. This has made it more user friendly, particularly for people, such as our systems manager Graham Bayliss, using it along with other ISO systems.

What does this mean for ReAgent?

For ReAgent, transitioning to using ISO 9001:2015 means a few things. We will continue to set the incredibly high standard that we have always done. On top of this, we will assess the risks that affect the quality of our products. Our relationships with suppliers, staff and customers are absolutely paramount to us, and always will be.

Our quality manager, Colin Robinson had this to say:

“It’s very exciting to be moving forwards with the new standard. On top of all the other changes, it pushes quality to the forefront of everyone’s mind.  If this is the case, everybody gets a chance to shine.”

It also affects how all of our systems work. We use other ISO systems and as the new one operates in a similar fashion to them, it makes things much more efficient for us. Efficiency all over the business leads to better relationships and better custom. You can view our policies and other ISO accreditation’s ReAgent complies with by viewing our quality policy.

Graham Bayliss | Quality Systems Manager

Graham Bayliss, our quality systems manager looks after ReAgent’s training matrix and ensures all systems are ran in accordance to our quality policies.

Our systems manager, Graham Bayliss, said:

“It’s going to make it much more efficient using the new high-level structure when integrating with other ISO standards we have in place. It will also help with implementing our progression towards ISO 13485 Medical Devices standard.”

ReAgent always aims to keep our customers up to date, so you can expect a secondary post once the system is up and running.

Are you an existing customer with any questions about our quality policy? A business looking to work with ReAgent to develop your product? Contact our expert sales team today on 1-800-817-175.


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