Category Archives: Quality Management Systems

updated ISO 9001 2015-header

The Updated ISO 9001:2015 is Coming: Are You Ready for the Six New Requirements?

The Updated ISO 9001:2015

Introduced in September 2015, the updated ISO 9001:2015 represents a significant change to ISO 9001:2008 requirements. The new standard is scheduled to take effect on September 14, 2018. This gives organizations three years to prepare from the date of release, and more than half that time is now passed. Only 15 months remain for you to comply. If you aren’t already on the path to compliance, now is the time to begin.

The new updated ISO 9001:2015 standard includes fewer clauses (eight instead of ten), a revised high-level structure that forms a new common core for all quality standards (Annex SL), and several terminology differences. It also includes the following six new major requirements that you’ll need to incorporate into your quality management system (QMS). Continue reading…

Share this
Digital Quality Management System - Medical Device Organizations

Digital Quality Management Systems for Medical Device Organizations

As part of the medical device industry, you face significant regulatory pressures. FDA compliance is key in ensuring your products pass clinical trial phases and come to market. The cornerstone of FDA compliance is the Current Good Manufacturing Practices (CGMP). The CGMP emphasizes the necessity of having a quality management system (QMS) in place to track, monitor, and review all of your production and management processes. Continue reading…

Share this
Quality Management Practices for Aerospace Manufacturers

Quality Management Practices for Aerospace Manufacturers

Aerospace Manufacturers are Ditching Paper and Going Digital

Across all tiers of aerospace manufacturing and supply, the functionality and reliability of an organization’s QMS is an essential component to the safety and success of products. Original equipment manufacturers (OEM) require strict adherence to rigorous production standards. This sets a quality management precedence across all production, manufacturing, and supply chain lines across the aerospace production industry.

Continue reading…

Share this

How to Choose the Right Digital Quality Management System (QMS)

Choosing the right digital quality management system means matching your needs with product features. Some vendors offer systems that have multiple, robust features, while other vendors offer a simplified digital QMS product. The QMS system you purchase largely depends on your organization’s current processes and anticipated future strategic objectives.

Making the best investment for your organization is a two-step process.

  1. Addressing if your QMS requires adherence to any standards.
  2. Identifying key features that are necessary for your company.

QMS Industry Standards

Most organizations require adherence to some industry standards. For example, the new ISO 9001:2015 standards include Risk Management, Integrated Expectations, and Voice of the Customer. These new standards involve a variety of technical and human capital considerations, ranging from the development of an audit trail to greater process integration with their clients and employees.

When exploring QMS solutions, it’s important to know if your vendor can provide you with feature functionalities necessary to be compliant with industry standards. Also, if you anticipate that adherence to new standards will systematically change critical business processes, check to see if the QMS can be customized to respond to these changes.

Aligning Your QMS Needs with Product Features

After addressing adherence to quality standards, you can start building the features you know you need now and the ones you may need later.

Critical features will typically include:

  • Business Process Management – Official documents including order processing, production planning, and policies.
  • Risk Management – A matrix that offers information related to the probability and severity of risks.
  • QMS Oversight Reporting – Dashboards that run in the background and grant you access to automatic reporting so you can monitor goals, trends, and issues.
  • Audit Features – Full control over the auditing management process, including content auditing, scheduling, and results.
  • Corrective Action Preventive Action (CAPA) – Formal documentation of how a non-conformance was resolved with automated workflows to approve and document resolution.
  • KPIs – The ability to set key performance indicators that allow your organization to measure the steps necessary to stay on task to complete performance goals.

One of the challenges faced when moving to a new quality management system is cutting redundancy. Perhaps you”re already using software that addresses some of your required critical features. As you survey the digital QMS product landscape, you may notice that few vendors offer everything you need. Having a QMS functional requirement checklist will ensure you acquire the solution you need along with any additional inputs outside of the vendor offering.

Download our eBook on selecting the right QMS to learn more about the new industry standards and the key product features you should consider when investing in a digital quality management system.

qms-ebook-ad

 

Share this

3 Ways a Digital QMS Can Boost Your ROI

Moving from a manual to a digital QMS is no easy decision. After explaining to upper-level management the benefits of a digital QMS, you will be asked the inevitable question: “What is our ROI?”

Since the move from a manual QMS to a digital QMS is a considerable investment in time and resources, you’ll need to be able to show how a digital system cuts costs, improves efficiency and saves time.
Continue reading…

Share this

3 Key Questions to Help Determine if You’re Ready to Adopt a Digital Quality Management System

Thinking about adopting a Digital Quality Management System?

Choosing the right digital quality management system for your organization begins with figuring out if you’re ready to adopt a new solution. Not all digital QM systems are created equal. Some only deal with specific problems while others offer a broad range of solutions. Depending on the size and scope of our business, some systems will be a better fit than others. Continue reading…

Share this

ON-DEMAND WEBINAR | Quality Management Best Practices: Moving Beyond Excel Spreadsheets

Building the Case for Going Digital with BPA Solutions’ Quality Management Software

view-quality-management-best-practices-webinar
Quality management is a cornerstone for many organizations…

Often, it is driven by compliance requirements such as ISO 9001:2015, but is increasingly being recognized as integral to business plans that drive toward excellence, safety and customer satisfaction.
Continue reading…

Share this

Webinar on 8/23: Controlling Quality Processes with QMS

With increasing regulatory compliance and global economic pressure—now more than ever—it’s important to ensure your quality management is on-point.

At General Networks, we want to make sure you have the information and tools you need to comply with regulatory requirements, and keep your business competitive. Which is why we’re partnering with M-Files. M-Files QMS is a practical, scalable solution for ensuring compliant quality processes like auditing, training and CAPAs.

We’d like to invite you to attend an upcoming M-Files webinar, where you will learn how to:

  • Improve the efficiency of your quality procedures such as auditing and deviation management
  • Gain visibility into actions taken as a result of a recorded CAPA, such as revising an SOP or requiring a new training event
  • Report on quality procedures and actual actions taken

Register Here

Share this

M-Files in the News: iGas Taps M-Files for Quality Management and ISO 9001 Certification, and Gains Much More

Clients deploying M-Files Quality Management have learned that the M-Files platform can be leveraged to manage business processes throughout their organizations.  iGas Energy, a British on-shore oil and gas exploration and production company, selected M-Files to better manage the ISO 9001 certification process and other safety and compliance activities.

“We originally deployed M-Files for compliance purposes, specifically to help us meet an ISO 9001 requirement to manage our Integrated Management System documentation,” said Chris Holly, Head of IT at IGas, “but since then, we’ve expanded our use of M-Files across the business as a comprehensive platform to manage as much of our company information and related processes as possible.

“From the outset it was clear M-Files could be easily configured to meet our specific needs. It was simple and straightforward to integrate M-Files into the various parts of our business and thus enable a deeper level of collaboration and secure information sharing from department to department.”

For more details and short video explaining how iGas has automated many of their core business processes, from oil and gas exploration, to managing licenses to processing expense reports, please view the full article here:  iGas Taps M-Files for Quality Management and ISO 9001 Certification, gains much more.

 

General Networks Corporation uses the M-Files platform to help organizations build solutions for quality management and compliance, document and records management and other business processes.

Please contact Cathy Ashbaugh, cashbaugh@gennet.com to discuss how M-Files can help your organization.

Share this