Quality Management System Solutions by AssurX

AssurX Quality Management Systems (QMS) provide comprehensive solutions to automate and streamline compliance processes. Our platform enhances visibility and control, ensuring adherence to industry standards like ISO 9001 and FDA regulations. Experience seamless integration and real-time insights to improve quality management across your organization.

17 08, 2023

Aligning Incident Management with ISO 45001 Requirements
Aligning Incident Management with ISO 45001 Requirements

Aligning Incident Management with ISO 45001 Requirements

By Stephanie Ojeda|2025-03-18T09:29:45+00:00August 17th, 2023|Energy & Utilities Industry, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Quality Management|

The number of ISO 45001 certificates is growing fast, jumping 54% from 2020 to 2 [...]

8 08, 2023

EHS Incident Management and Root Cause Analysis
EHS Incident Management and Root Cause Analysis

EHS Incident Management and Root Cause Analysis

By Stephanie Ojeda|2023-08-08T16:57:29+00:00August 8th, 2023|Energy & Utilities Industry, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Quality Management|

Workplace safety incidents are a key driver of risk in manufacturing organizatio [...]

26 07, 2023

Risk Management in ISO 13485
Risk Management in ISO 13485

Risk Management in ISO 13485

By Stephanie Ojeda|2024-06-03T14:04:45+00:00July 26th, 2023|Document Management, FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Quality Management, Risk Management|

In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue i [...]

12 07, 2023

SOP in QMS
SOP in QMS

SOP in QMS

By Stephanie Ojeda|2025-03-18T09:37:38+00:00July 12th, 2023|Document Management, Manufacturing Industries, Medical Device Industry, Quality Management|

Mistakes around standard operating procedure (SOP) management are widespread an [...]

6 06, 2023

Linking Design Controls and Risk Management in the QMS
Linking Design Controls and Risk Management in the QMS

Linking Design Controls and Risk Management in the QMS

By Stephanie Ojeda|2024-03-12T13:25:01+00:00June 6th, 2023|Document Management, FDA Regulated Industries, Food & Beverage Industry, Quality Management, Regulatory Compliance Management|

Design controls are a frequent citation in 483 observations and warning letters [...]

30 05, 2023

Complaint Management for Life Sciences with an Automated QMS
Complaint Management for Life Sciences with an Automated QMS

Complaint Management for Life Sciences with an Automated QMS

By Stephanie Ojeda|2025-05-07T23:01:07+00:00May 30th, 2023|Complaint Management, Document Management, Manufacturing Industries, Medical Device Industry, Quality Management|

Effective complaint handling is fundamental to life sciences quality management [...]

27 04, 2023

AssurX Exhibiting at ASQ World Conference on Quality & Improvement (WCQI)
AssurX Exhibiting at ASQ World Conference on Quality & Improvement (WCQI)

AssurX Exhibiting at ASQ World Conference on Quality & Improvement (WCQI)

By Tim DeMuth|2025-05-07T23:05:35+00:00April 27th, 2023|Complaint Management, Document Management, Manufacturing Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

AssurX will be exhibiting at this year’s ASQ World Conference on Quality & [...]

25 04, 2023

Update: EU Medical Device Regulation Deadlines Extended
Update: EU Medical Device Regulation Deadlines Extended

Update: EU Medical Device Regulation Deadlines Extended

By Stephanie Ojeda|2024-03-04T21:19:23+00:00April 25th, 2023|Document Management, eMDR, EU IVDR, EU MDR, Manufacturing Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

European Union (EU) Medical Device Regulation (MDR) and In-Vitro Device Regulati [...]

6 04, 2023

Key Priorities for Proactive EHS Risk Management
Key Priorities for Proactive EHS Risk Management

Key Priorities for Proactive EHS Risk Management

By Stephanie Ojeda|2024-03-12T13:26:55+00:00April 6th, 2023|Document Management, Manufacturing Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

In 2021, the U.S. Occupational Safety and Health Administration (OSHA) conducted [...]

4 04, 2023

7 Ways to Enhance Quality Management Training
7 Ways to Enhance Quality Management Training

7 Ways to Enhance Quality Management Training

By Stephanie Ojeda|2025-05-07T23:09:54+00:00April 4th, 2023|Document Management, Manufacturing Industries, Quality Management, Regulatory Compliance Management|

In regulated environments, quality management training is a requirement for goo [...]