Quality Management System (QMS)

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Learn how Interfacing can help make your Quality Management System program better

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

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:

Common QMS Issues

Limited traceability of processes & documentation
Too many progress check meetings for all attendees
Access to paper archive is a challenge
Complex process to complete accurate risk management and risk analysis
High risk of lost or misfiled documentation
Out of sync or obsolete records in circulation
Missing signatures during an audit are a high risk
Lack of accountability and visibility within teams
Inefficiency and mistakes lead to high cost to maintain quality

EQMS Advantage

Detailed log kept of all revisions, signatures, and updates, stored in a secure central repository.
Change & request notifications Sto specific personnel sent automatically
Change & request notifications Sto specific personnel sent automatically
Change & request notifications Sto specific personnel sent automatically
Electronic document control with API integration on Cloud- based data centers
Document control in place with status and versioning
Any unsigned document would be automatically flagged
Log of revisions, dates, and employees who authored or reviewed the documents.
Significant reduction of costs as margin of error is decreased

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

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

Our approach can help with all regulations and compliances related to pharma production and medical devices (GxP, CFR, GCP, GLP, GMP, HIPAA, ISO9001, medical devices regulations, SOX, BITS, CSA, FDA, FedRAMP, FIPS, FISMA, MHRA, NISP DoD, PCI DSS, SOC 2, U.S. SEC 17a-4 among others).

Manage Content

Manage the individual pieces of information, assign owners, and ensure governance through approval cycles, and change requests.

Digital Signature

We fully support digital signature to ensure that the audit trail of all content is secure, time-stamped, with accurate and complete copies of records available for inspection throughout the retention period.

Ensure Transparency

Full visibility to understand where records are used and their applicability. You can also maintain digital content with clear accountability, including roles and responsibilities.

Conduct Impact Analysis

Analyze your records for downstream impacts, and analyze the potential impacts on policies, SOPs, business units and related records.

Digital SOPs

Generate complete customizable output of processes and related records such as regulations in a ready-to-print and exportable Word format. You no longer need to manage SOP on paper! The digital SOP is in-sync all the time.

Approval and Governance Workflow

Integrated and embedded approval workflows to ensure strict control over the change of your records, including validation of changes, evaluation of impacts and highlighting changes.

Encourage Collaboration

By uniting goals and creating a common framework for your teams, they will be able to cooperate strategically, create change requests, and assign tasks to implementers.

Commitment to Compliance

At Interfacing, compliance is at the core of our mission. We continuously strive to help our clients achieve and maintain full regulatory compliance, ensuring their operations align with global standards.

ISO 27001 Certified Excellence

Interfacing proudly holds ISO 27001 certification, reflecting our dedication to robust information security management. This certification underscores our commitment to delivering secure and reliable solutions for our clients.

AWS Partnership for Advanced Cloud Hosting

By partnering with Amazon Web Services (AWS), we ensure top-tier cloud-hosting services backed by proven compliance. AWS global data centers meet stringent standards, including SOC 1 Type II and ISO 27001. For details on AWS compliance with ISO 18345, FDA QSR, and GxP, explore their comprehensive compliance program.

Why Choose Interfacing?

With over two decades of AI, Quality, Process, and Compliance software expertise, Interfacing continues to be a leader in the industry. To-date, it has served over 500+ world-class enterprises and management consulting firms from all industries and sectors. We continue to provide digital, cloud & AI solutions that enable organizations to enhance, control and streamline their processes while easing the burden of regulatory compliance and quality management programs.

To explore further or discuss how Interfacing can assist your organization, please complete the form below.

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• Gain real-time, comprehensive insights into your operations.
• Improve governance, efficiency, and compliance.
• Ensure seamless alignment with regulatory standards.

eQMS: Automating Quality & Compliance Workflows & Reporting

• Simplify quality management with automated workflows and monitoring.
• Streamline CAPA, supplier audits, training and related workflows.
• Turn documentation into actionable insights for Quality 4.0

Low-Code Rapid Application Development: Accelerating Digital Transformation

• Build custom, scalable applications swiftly
• Reducing development time and cost
• Adapt faster and stay agile in the face of evolving customer and business needs.

AI to Transform your Business!

The AI-powered tools are designed to streamline operations, enhance compliance, and drive sustainable growth. Check out how AI can:
• Respond to employee inquiries
• Transform videos into processes
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• Generate forms, processes, risks, regulations, KPIs & more
• Parse regulatory standards into requirements

Learn more about EPC's AI Use Cases

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