Unlocking the Value of ISO Certification Beyond Compliance

 Is QMS just for ISO CertificationIs ISO certification the only reward you’ll receive for jumping through all those QMS hoops? And is it really worth all the late nights and raised stress levels involved in getting ready for the audit?

ISO certification; beyond the box-ticking

Meeting all the standards required by ISO can be time-consuming, but it shouldn’t be unduly stressful. What’s more, it shouldn’t be viewed simply as a cost centre for your business.

In fact, there are many, weighty academic studies available which demonstrate a real link between implementation of ISO standards in a company and improved financial performance.

But if you can’t be bothered to read them (and who can blame you) - here’s how meeting the quality standards set by ISO can improve your productivity while actually saving you money.

Document management in ISO 9001:2015

A robust document management solution is required to meet the standards of ISO 9001. It demands you have a set process in place to approve all your Quality Management documentation, such as those that define critical business procedures.

 It also requires you have the controls in place to review these documents at will, update them, limit approval rights and track their review and approval history over time.

There are clearly many commercial benefits to a business of having properly defined quality procedures that are accessible and well understood. The ability to control by whom and how such documents are approved and made available to staff is also key to the smooth running of an organisation.

Document control requirements in ISO 9001:2015: What you need to know.

Saving money and meeting standards with an eQMS

In high tech sectors where both time and resource are costly, expensive mistakes can be avoided by ensuring that proper attention is paid to the way procedures are followed. It also pays to make sure only correct and current versions of relevant documents are available for staff.

Of course, these standards can be met more easily by deploying an eQMS within your business. These systems can flag documents that require review at set time intervals, sending them to key stakeholders by email and collating updates ready for reapproval. These systems will also allow for rapid tracking and auditing of documents via an intuitive interface.

Features like these will undoubtedly make it easier to demonstrate compliance with ISO standards during an audit, but will also control the potential for chaos in your electronic filing as your business grows.

Real cost savings through ISO standards

These quality control processes, as defined by ISO and implemented with an eQMS, will save your business time and money by standardising the way tasks are executed. In the same way, better quality auditing will allow you to capture and correct mistakes before they start costing you money.

 And the savings from all this could be considerable, as numerous studies bear out:

  • McKinsey’s key study estimates documentation versioning errors cost business $1.3 million an hour globally in production delays
  • A study by Interact has found nearly 20% of business time - the equivalent of one day per working week is wasted by employees searching for information to do their job effectively

No matter the size of your business, a document management solution can deliver increased efficiencies, as well as equip you to meet ISO’s quality standards.

An eQMS scaled for every business

However, if you are a growing SME in the high tech sector, it may only be possible to satisfy ISO and achieve efficiencies by deploying an eQMS (electronic Quality Management System).

A small business outsourcing some of its production to specialist manufacturers needs to share documentation in a highly controlled and secure way while allowing partners to make material changes to the documents they are working on.

The right eQMS will allow you to share certain documents externally, setting the review and approval privileges of third parties contributors as required. In this way, your overall control and auditing capabilities will be maintained and enhanced. And having complete oversight of any outsourced processes can stop projects spiralling out of control, ensuring specifications are understood and preventing effort being wasted.

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ISO 13485 and your QMS

When it comes to medical device development, ISO 13485 requires an even greater scrutiny of development processes extending deep into the operations of your collaborators. The latest iteration of these standards makes you responsible for the compliance of the third parties you work with.

Shared work environments within an eQMS where documentation and business process mapping can be created and viewed by all parties could go a long way to satisfying this requirement.

It’s worth remembering that ISO does not dictate the exact way your processes should work. It is, for example, agnostic about whether a waterfall or agile development process is best. ISO just requires a consistent, well documented and controlled approach that can be shown to support the required quality standards.

But is it worth it?

ISO certification indicates your business is consistently meeting internationally recognised standards in Quality Management, so it is certainly worth maintaining its exacting requirements if you can.

For some sectors, however, such as medical device development, gaining certification is all but essential for securing regulatory approval.

Where current QA solutions are paper-based, have been developed in an ad hoc way, or implemented in a piecemeal fashion, ISO audits can generate extra work and prove a headache for Quality Managers.

But where the right eQMS has been deployed, correctly scaled against the size of an operation, ISO certification nearly always proves easier to achieve.

And if you haven’t been through the process before, it should be seen as more than a series of hoops to jump through to satisfy the demands of pedantic officials or nit-picking customers.

With the right eQMS to drive the process, it can help you find efficiencies, save money and control standards even in today’s highly agile, collaborative and virtualised working environment.

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Tags: ISO 9001:2015, Quality Management System, Compliance

Joe Byrne

Written by Joe Byrne

Joe Byrne is the CEO of Cognidox. With a career spanning medical device start-ups and fortune 500 companies, Joe has over 25 years of experience in the medical device and high-tech product development industries. With extensive experience in scaling businesses, process improvement, quality, medical devices and product development, Joe is a regular contributor to the Cognidox DMS Insights blog where he shares expertise on scaling and streamlining the entire product development cycle, empowering enterprises to achieve governance, compliance, and rigour.

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