Blog Posts Business Management

8 Mandatory Elements of a QMS System

Blog: Interneer blog

 

Managing NonConformance (NCM) is an integral part of an organization’s continual improvement plan. Intellect’s QMS Platform enables organizations to capture, track and maintain accurate, auditable nonconformance records through a centralized database to have transparency for departments, sites, or locations. This allows organizations the ability to exceed audit, nonconformance, and corrective and preventive action requirements of common standards including ISO 9001, ISO 14001 and OHSAS 18001.

Complaints Management software is needed for customer retention, compliance with industry regulations and avoidance of potential product liability lawsuits. Quality, compliance, safety, efficiency, and costs are impacted in addition to poor communication without a proper QMS in place. Intellect QMS includes change management, automation, version control, and workflows to communicate, acknowledge, and then implement any requirements.

Change Management software is imperative for closed-loop quality and requires automation, version control, and workflows. Intellect QMS integrates with any enterprise system, so full transparency is included in the change management process. The submission of change requests and control plan revisions can be included at any point in production.

CAPA (Corrective and Preventive Action) and product registration tracking are standard features to allow implementation of corrective and preventive actions. This will meet compliance with industry regulations including GMP, ISO 9001 and 14001, TSCA, REACH, etc. CAPA process workflows provide a controlled environment and reduce the risk of repeat issues by ensuring that defined CAPA solutions and processes are met.

Document Control/management organizes all documents into a centralized database with approval workflows and audit trails. This eliminates document redundancy, reduces the risk of manufacturing products with out of date SOPs, and creates efficiency in organizing documents.

Supplier Quality Management manages the process of qualifying, selecting, and monitoring suppliers and supply chain partners. Other requirements are supplier qualification workflows and tracking systems for supplier non-conformances and CAPA. Intellect QMS offers the flexibility and configurability to adapt to company specific business processes, requirements and needs. This allows organizations to define, track, manage, and report actions.

Audit Software reduces risk by enforcing consistent and harmonized processes while securely managing all information in a centralized system. In addition, it facilitates compliance with global government regulations and industry standards providing management the data needed to evaluate audit system effectiveness. It also provides auditors authoring tools required in the field.

Employee Training Software creates a single interface to develop and manage training initiatives organizationally. This allows enterprises to maintain a complete inventory of employee education levels, job descriptions and certification records. This will maximize the effectiveness of developing employee skills internally. Intellect QMS keeps employee certifications up-to-date as a full employee life-cycle enterprise management system.

If you’d like to learn more and create a QMS Proof of Concept app with Intellect, click here for a free trial. http://www.intellect.com/free-trial

 

Leave a Comment

Get the BPI Web Feed

Using the HTML code below, you can display this Business Process Incubator page content with the current filter and sorting inside your web site for FREE.

Copy/Paste this code in your website html code:

<iframe src="https://www.businessprocessincubator.com/content/8-mandatory-elements-of-a-qms-system-2/?feed=html" frameborder="0" scrolling="auto" width="100%" height="700">

Customizing your BPI Web Feed

You can click on the Get the BPI Web Feed link on any of our page to create the best possible feed for your site. Here are a few tips to customize your BPI Web Feed.

Customizing the Content Filter
On any page, you can add filter criteria using the MORE FILTERS interface:

Customizing the Content Filter

Customizing the Content Sorting
Clicking on the sorting options will also change the way your BPI Web Feed will be ordered on your site:

Get the BPI Web Feed

Some integration examples

BPMN.org

XPDL.org

×