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ISO – The International Organization for Standardization

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Best ISO Software and ISO 9001 2015

ISO – The International Organization for Standardization

Driving ISO initiatives with Business Process Management (BPM) creates far-reaching value for your organization, going beyond the ISO audit certification. While ISO standards are extremely useful to organizations, some of the standards lack a comprehensive outlook of the needs of modern businesses. Beyond a standard designed to facilitate international trade, ISO certification provides value in the form of marketing appeal and by fulfilling customer requirements. In order to achieve optimal business practices that will maximize your ROI, industry best practices provide ISO’s missing components.

Understanding ISO: Definition

ISO Standards are documents which provide guidelines, requirements and specifications to ensure products, processes and services fit their purpose. Economic uncertainty has forced companies to find ways to become more efficient in order to maintain profitability and be globally competitive. Formal performance improvement programs like ISO 9000 help to improve quality and operational efficiency, granting your company a competitive edge.

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.

ISO 14000

Environmental Management ISO 14000 ensures that a company minimizes the effect its activities have on the environment by implementing specific controls at the process level. ISO 14000 enables companies to reduce the penalties and fines conferred when environmental laws are breached. Furthermore, the adoption of ISO 14000 reduces waste, cutting down overhead, and ensuring the efficient use of materials.

ISO 20000

Technology Management ISO 20000 is an IT governance initiative intended to standardize IT policy by adopting standard best-practice processes in IT service. IS0 20000 is quickly becoming integral to modern business, as IT and business become more and more reliant on each other. By attaining compliance under ISO 20000, your company can increase efficiency in its delivery of IT services by providing a solid technology framework.

ISO 27000

The ISO 27000 international series of standards is the leading measurement metric for Security techniques as they relate to Information Security Management Systems. It is composed of a combination of policies and processes for organizations to form a framework to protect their information through the adoption of an Information Security Management System (ISMS). ISO 27001 is the most referenced standard in this series for certification.

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.

Understanding BPM for ISO

Creates far-reaching value

Driving ISO initiatives with Business Process Management (BPM) creates far-reaching value for your organization, going beyond the ISO audit certification.

Fulfill customer requirements

Beyond a standard designed to facilitate international trade, ISO certification provides value in the form of marketing appeal and by fulfilling customer requirements.

Maximize your ROI

In order to achieve optimal business practices that will maximize your ROI, industry best practices provide ISO’s missing components.

Create Consistency & Transparency

With BPM you will meet ISO requirements faster while engaging your employees and creating consistency and transparency across your organization.

Continuous Improvement Management

The Enterprise Process Center® (EPC) allows users to manage the continuous improvement of your processes and policies.

Process Optimization

Achieve ISO compliance and produce comprehensive process optimization by leveraging best practice frameworks such as Supply Chain Operational Reference (SCOR) and the Information Technology Infrastructure Library (ITIL).

Understanding ISO compliance with Enterprise Process Center® (EPC)

We understand that the requirements placed on organizations in terms of compliance are very high and that ISO 9000, ISO 13845, ISO 14000, ISO 20000, ISO 27000, is an essential part of that program. By using our customized 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 information security, regulatory requirements, documents, processes, work instructions, and governance.

Conduct Impact Analysis

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

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.

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.

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.

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.

How Interfacing can help

The EPC is the most user-friendly way to implement a process management system that meets ISO regulations, while providing a full audit trail and robust reporting features. Out of the box best practice frameworks allow you to easily and effectively model your business processes based on proven standards. The EPC ensures transparency for audits and accreditation, complements your other organizational goals and initiatives, and allows you to adapt your processes for the future. In addition, EPC’s process management capabilities allow you to constantly maintain your ISO certification. Often companies gain ISO certification but future audits reveal that the requirements have not been upheld. Easily maintain your ISO certification and take the headache out of ISO audits with the Enterprise Process Center.

Our software allows you to:

  • Document processes to meet ISO regulations.
  • Manage controls and standards.
  • Improve operational efficiency.
  • Engage your employees in process lifecycle.
  • Increase ownership and transparency.

Need more info? Learn how we can help you manage Compliance

Why Interfacing?

Eliminate your organization’s ISO compliance burden and improve performance by automating critical processes like document, quality event, training, value chain and audit management in a single end-to-end Enterprise Process Center solution.

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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.

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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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Gain Agility with the Digital Business Platform

Interfacing’s Low-Code Rapid Application Development software solution provides all the tools to create and deploy  Custom, Scalable, Secure and Mobile ready Applications in days vs. months!

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Read Our Blogs 

Take a moment to read blogs about GXP, Regulatory Compliance, today’s trends, and much much more!

Discover how your organization benefits from an Interfacing solution supporting ISO compliance.

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 ISO supported solutions deliver the transparency required to reduce complexity, improve execution and facilitates agility and change.

Interfacing’s 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.

Try It Now For Free!

Document, improve, standardize, and monitor your business processes, risks and performance with Interfacing’s Business Process Management Software (BPM Software) the Enterprise Process Center®!