About Quality Management System (QMS)
According to ASQ (American Society of Quality): quality management system (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.
ISO 9001:2015, the international standard specifying requirements for quality management systems, is the most prominent approach to quality management systems. While some use the term “QMS” to describe the ISO 9001 standard or the group of documents detailing the QMS, it actually refers to the entirety of the system. The documents only serve to describe the system.
Click the picture below to view a basic design breakdown of QMS as a general structure.
Enterprise Quality Management System (EQMS)
Organizations today are bound to their responsibility to ensure quality, compliance and many other industry specific regulations are met with respect to their production and service delivery processes. In order to ensure these regulations meet industry standards, enterprises will adopt an eQMS quality management system solution.
These eQMS solutions have progressively changed over time, having begun as basic spreadsheets originally. Company’s would leverage these spreadsheets in the monitoring and management of their quality processes. With the evolution of computing resources, eQMS systems emerged as reliable software solutions running processes, identifying responsibilities and detailing procedures for the achievement of goals and policies compliance. Think of it as a QMS platform that is integrated with an IT infrastructure and data model facilitating cross-functional collaboration and communication.
While there are variable custom capabilities integrated depending on industry, delivery platforms, organization size etc., there are a few typical capabilities that are commonly invested in. These would include:
- Web-based platform
- Taking a BPM approach to functionality involves applications that are built on a platform with integration to other applications.
- Interoperability with other Enterprise Resources Planning (ERP) applications.
- The GUI is role-based and focuses on execution of the workflow process.
ISO 9001:2015
Definition
ISO 9001 is the global standard that determines and defines the requirements for a quality management system (QMS). This standard is used by organizations to consistently provide products and services that must meet customer and regulatory requirements. Of all the ISO 9000 standards, this is the most popular and the only standard which organizations globally can certify.
History
First published in 1987 by the International Organization for Standardization (ISO), ISO 9001 was introduced and accepted among the national standards bodies of more than 160 countries. The most recent version of ISO 9001 was released in September 2015 (ISO 9001:2015).
EQMS Functionalities
There are many reasons to use EQMS: facilitating an investigation of adverse events and preceding factors in order to implement corrective actions, management of compliance, managing risk and many others. The list below is an extensive one supporting EQMS:
- Non-Conformances / Corrective and Preventive Action (NC/CAPA)
- Compliance Management
- Supplier Quality Management
- Risk Management
- Failure Mode and Effects Analysis (FMEA)
- Complaint Handling
- Environment, Health, and Safety (EH&S)
- Audit Management
- Change Management
- Reporting
- RIMS
- Vigilance
- Document Control
- Calibration Management
- Employee Training
Goals of a Typical EQMS Implementation
With the proper planning, implementing a typical EQMS can be incredibly beneficial to any organization. The list of goals that typically accompany an EQMS implementation includes:
- Standardize, metrics, processes and expectations
- Integrate quality system from suppliers through customers
- Listen to the voice of customer
- Create one global web-based quality system
- Empower people with data
- Drive performance improvement
- Have a single source of truth
- Enable data sharing and continuous improvement
- Provide real-time business data to all stakeholders
- Be flexible enough to support changing business needs
The EQMS Advantage
Paper-based QMS possess the right tools to guide an organization through specific events individually. Over time though, there were challenges that came up with some of the most basic aspects of keeping events organized and easy to access across the organization. By moving into an EQMS, organizations take the manual process of QMS and create data flows where historical data retrieval and recovery, event analytics, trending analysis, and a host of other analytics are introduced that provide deep insight, reporting and solutions immediately. A few advantages of an EQMS are noted below:
A Solution Designed for the needs of Modern Industry
Companies moving to EQMS have partnered with Interfacing to deploy workflow solutions involving management and automation of point-to-point business processes. This includes health sciences (including patient-related), manufacturing, administrative, financial and industry processes for example.
Interfacing’s process optimization & automation, SOP documentation digitalization and proactive regulatory vigilance solution, Enterprise Process Center© Suite has brought about significant time savings with accelerated approval & validation, improved visibility and operational improvements for customers including the following:
End-to-end alignment – Single Source of Truth
The EPC allows your organization to easily align departments, regulations, procedures, controls, within a single repository to enable quick and standardized continuous improvements. Our technology allows information fragmenting to build reusable data fragments.
Accelerated approvals and validation
Interfacing EQMS solution delivers sustained time saving by reduced training, updating and re-training time. The integrated approval, review and endorsement workflow also helps streamline the validation of new version of the standard operating procedures (SOPs) through fragmented content review and approval cycles to aid decision-making.
Digital Signature and Multi-Factor Authentication
EPC meets the very stringent requirements associated with compliance for FSA QSR, ISO 9000, ISO 13845, GxP programs for example, and all SOPs and processes are parsed and documented, providing the audit trails meeting compliance with 21 CFR Part 11 Electronic Record and Electronic Signature (ERES) and a host of other regulatory requirements through RSA encryption, vault key story, and multi-factor authentication (MFA)
Improved Speed and Agility
Interfacing’s Enterprise Process Center© Suite is fully mobile and digital, providing your organization with the flexibility of quality documentation readily visible through a variety of means including phone, tablets, graphical and textual to boost employee agility and self-training.
Multi-language support, auto-translation and localized content
Interfacing’s Enterprise Process Center© Suite provides insightful ways to manage global content, whether by automated translation suggestions for all fragments of content, or the ability to collect variance for SOPs by country, region or product-type
Global corporations, government agencies and their verticals, trust Interfacing to provide a best-in-class solution to manage their quality content, data and workflows with scalability and security in mind. By implementing Interfacing’s Enterprise Process Center© Suite, many organizations globally, have optimized their quality management system, boosted their regulatory digital data management, while leveraging user-specific quality content visualizations and intelligent downstream impact & assessment models.
Understanding compliance: ISO 9001, ISO 13485, FDA QSR and GxP
We understand that the requirements placed on organizations in terms of compliance are very high and that ISO 9000, ISO 13845, FDA QSR and GxP is an essential part of that program. By using our solutions, your company gains the accountability and consistency that will give you a cutting edge over your competition. Our tools ensure full visibility from end-to-end, all the way from the creation and amendment of a regulation to the approval and revision of the content through to the update and retraining of employees for standard operating procedures (SOPs). We see the full lifecycle management as moving parts of a complete ecosystem and that’s why are unique approach that combines regulatory requirements, documents, processes, work instructions, and governance.
ISO 9001
International standard that specifies requirements for a QMS. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify.
First published in 1987 by the International Organization for Standardization (ISO). The current version of ISO 9001 was released in September 2015.
ISO 13485
In short, ISO 13485 is an internationally recognized standard that the following countries have adopted: Europe, Canada, Australia and other markets. Excluding Canada, the application of ISO 13485 is not a requirement but is the de facto standard in use today as a measurement of full QMS compliance set forth on medical device regulations.
US FDA QSR
The US FDA QSR (also known as 21 CFR Part 820) was introduced prior to ISO 13485. All medical device companies in the US are required to meet this standard for national distribution but must comply with both regulations in order to distribute devices internationally. US FDA QSR must also be met by international companies wanting to do business with US customers.
Nuanced QMS
Other countries will have their own criteria to meet nuanced QMS requirements. For example while both Brazil and Japan have their own requirements, they are both based on existing US FDA QSR and ISO 13485 standards. On a positive note, these standards achieve harmonized quality management requirements to meet US, Canadian, European and all other QMS standards in effect.
GxP Compliance
Manage Content
Digital Signature
Ensure Transparency
Conduct Impact Analysis
Digital SOPs
Approval and Governance Workflow
Encourage Collaboration
ISO 27001 Cloud-solution
As part of our ongoing commitment to compliance and ensuring that our clients meet their regulatory requirements, we are always on the lookout for ways to help our clients attain and maintain full compliance. Interfacing is ISO 27001 certified and we are partnering with Amazon Web Services (AWS) for cloud-hosting since their commitment to compliance is proven, with global data centers compliance to SOC 1 Type II and ISO 27001. For more information on AWS compliance for ISO 18345, FDA QSR and GxP, please refer to their compliance program.
Why Interfacing?
Eliminate the compliance burden and improve product quality by automating critical quality processes like document, quality event, training, value chain and audit management in a single end-to-end Enterprise Process Center EQMS solution.
Life Science & Pharmaceutical
By adopting a strong, process-centric culture, your company can smoothly transition from chaotic and ad hoc management systems to a smooth running regulatory compliant operation.
Medical Device Technology QMS
Every aspect of the medical technology process must be controlled and monitored as per ISO 13845 and US FDA QSR requirements. Read more here.
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Discover how your organization benefits from an Interfacing EQMS focused solution.
A key differentiator of Interfacing to other digital and business transformation consulting firms is that Interfacing offers its own innovative technology solution in support of transformation programs. Interfacing’s EQMS supported solutions deliver the transparency required to reduce complexity, improve execution and facilitates agility and change.
Interfacing’s EQMS integrated management system solution is a one-stop-shop for managing transformation programs. We know it’s a very competitive environment out there. It is for that reason our strength is in our commitment to maintain flexibility throughout the project lifecycle whether it is in our innovative products or in our team of experts.
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