The Customer is Key: Why a Digital QMS is Core to Business Success

Little is more important to your business than your customers. They are the heart of your business – what keeps your people employed and your products and services in production. This is why keeping your products and services in compliance with the top quality standards, such as ISO 9001, is so important – high quality leads to happier customers.

But keeping in compliance with these standards isn’t always easy, particularly if you aren’t currently using an automated QMS solution. Find out the 3 top ways an automated QMS solution can help you stay in compliance, and keep your customers happy below.

  1. Automation means faster resolution

Quality issues with your product or service are always a frustrating task to resolve, but they become even more frustrating if it’s hard to target where the issue stems from. This is where non-automated QMS processes fall short. If your Quality processes rely on your employee’s ability to, and patience with, sifting through mounds of paper or folders of Excel files, your ability to recognize quality issues or improve them is significantly stunted. Automating these processes, however, gives you the ability to more easily identify performance, find holes in processes, non-compliance with various mandates, and more – enabling you to attain faster resolution, and ultimately, keep up with customer expectations.

  1. Consistency keeps you competitive

Part of maintaining a high quality product is maintaining consistency. But maintaining consistent quality goes beyond the product itself. Your processes behind the scenes must also be consistent. This is where an automated QMS can help. An automated QMS can help you control your processes by enabling you with clear targets, clear metrics, and the ability to adjust accordingly. With more control, and ultimately, higher consistency with your processes, you’re bound to produce a consistent quality with your products, maintaining your ability to keep up with your competitors and maintain (even obtain new) customers.

  1. Obtain recognition as a leader in quality

One reason that many organizations seek ISO 9001 compliance is the corresponding recognition as an organization with high quality standards. Nothing screams “we care about our customers” more than proving to them that producing a high quality product is a goal of your organization – and automation helps you get there. With an automated QMS solution, your organization is equipped with the tools to more easily view gaps in quality, avoid potential operational risk, maintain consistency in the quality of your product and the quality of your processes, and finally – meet the ISO 9001 compliance.

If your customers are the true heart of your business, show them that producing a quality product or service for them is your top priority. Obtain ISO 9001 compliance by automating your Quality Management processes with an automated QMS solution.

BPA Quality is dedicated to helping your organization achieve success. Download our eBook or contact one of our quality specialists today to learn more.

Medical Device Quality Management Software for Small Businesses

Quality management software for medical device manufacturers is usually complex, expensive and out of reach for small and medium companies.

However this is no longer the case, BPA has just released an integrated quality and risk management software, affordable, flexible and adapted to small and mid-sized medical device companies. A new digital signature module has been developed to comply with 21 Part 11 CFR regulations (view video here).

Built on the CFR 21-compatible Microsoft Office 365 technology, BPA Quality and Risk Management is a cloud-enabled, secure, and scalable solution, delivering superior document management, workflow, collaboration and reporting tools in one single interface and providing an unequaled user experience.

No need for cumbersome and costly paper systems anymore, our digital QMS software facilitates communication between siloed departments, increases efficiency with automated processes and saves cost.

Office 365 + BPA Quality is the ideal QMS solution for small and mid-sized medical device companies.

Read more about BPA Quality

How a Quality Approach will facilitate Your GDPR Journey

GDPR will be enforced in 4 months. Any company located in Europe or dealing with European companies will be impacted.

To be compliant, organizations have to answer complex subject access requests, track data assets, manage voluminous GDPR documentation, plan audits, identify risks, and set controls, paying out exorbitant fines if any breach occurs.

When reading the new regulation, this sounds horribly complex.

So, where should you start? How can you make it work for your organization?

Let’s take a closer look at important GDPR management processes:

  • Identify data-related assets
  • Lead GDPR assessment audits
  • Identify risks and non-conformances
  • Implement controls and corrective actions
  • Treat customer requests
  • Set objectives and indicators

Does it sound familiar to you?

These processes are exactly the same as in a Quality Management System (QMS). This is great news because you can reuse the same QMS approach to manage your GDPR system.

From a regulation point of view, GDPR is not very different from ISO 27001 for IT security. We can imagine the upcoming versions of ISO 27001 or even ISO 9001 will include the main GDPR requirements.

In practice, it is a good option to include your quality team in your GDPR project journey as they are already familiar with the processes and tools.

BPA Solutions has developed an all-in-one GDPR compliance solution built on our proven and award-winning quality and risk management software. BPA GDPR Compliance runs on the GDPR-compliant Microsoft Office 365 technology.

BPA makes GDPR compliance easy and affordable.

Learn more about our GDPR solution

3 Reasons to Move Away from Paper-Based Quality and Risk Processes

If you’re part of the Quality and Risk Management team at your organization, you know that the job isn’t easy. Avoiding or mitigating risk to maintain the highest quality for your company’s product or services oftentimes entails numerous disparate and even tedious processes. Further complicating things – many organizations today still rely on paper-based processes: hundreds of disconnected, hefty Excel files, a seemingly endless number of filed-away compliance documents, and more.

Luckily, in today’s technology era, there are integrated digital solutions that exist to simplify the jobs of Quality and Risk Managers. The problem? Not everyone is embracing digital transformation. If you’re still finding yourself buried in Excel files or stacks of paper documents, here are 3 reasons you should embrace a digital QMS solution.

  1. Efficiency is key to any organization

Regardless of what industry you’re in – you and your colleagues don’t have time to waste sifting through stacks of paper documents or clicking through Excel files. It’s a massive waste of time, energy, and ultimately – company dollars. In fact, companies today can lose up to 20-30% of revenue due to inefficient processes. Stop sifting through piles of paper and move to an automated system to increase efficiency and reduce unnecessary company spend.

  1. Reliance on paper increases risk

If you are focused on quality and/or risk management, your job is to reduce potential risk in your business – not add to it! So why rely on cumbersome processes that could potentially increase room for error? What happens if that Excel file containing patient or customer information gets unintentionally deleted, or that intake form lands in the trash rather than a file cabinet? The truth of the matter is that relying on paper-based processes pokes holes in your ability to maintain quality in your organization – widening your room for error and opening your business up to risk.

  1. Digital QMS solutions put the power in your hands

What if you could manage all your company’s important documents in one integrated system, in a format that enables you to easily identify compliance issues, areas for quality improvement, and KPIs? That’s what going digital with your Quality and Risk processes allows you to do. Having this information easily accessible and identifiable to those in management puts the power back into your hands. Rather than feeling lost, confused, or frustrated, your QMS can enable you to feel empowered and in control of your business.

Move away from archaic paper-based quality and risk management processes and adopt a digital solution to reduce cost, increase efficiency, and empower your organization – fulfilling the highest quality your organization can and the necessary compliance mandates. To learn more about the benefits of moving to a digital QMS solution can empower your organization, contact one of our quality experts at BPA solutions or read more here.