ISO Compliance Software

The ISO 9000 family of standards represents an international consensus on good quality management practices which can be achieved by implementing ISO software. ISO compliance software can help your company navigate what are often confusing ISO quality standards to ensure that your company’s products and quality management meet regulatory requirements.

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Importance of ISO 9000/9001 Compliance

ISO software standards are important because they provide companies with a benchmark for quality with which their products can achieve compliance with regulators. ISO compliance software plays an important role in helping companies ensure that their quality management system (QMS) and compliance levels are meeting the ISO standards so that they can be ISO certified and get their products to market faster.

Features and Benefits of ISO Software

Effective, integrated ISO management software should provide a company with the following:

  • Document Management: Automate and manage your product, quality and other documents across the enterprise and throughout the entire product life cycle.
  • Incident Response: Integrate your corrective actions with all quality subsystems (customer complaints, audits, change control, etc.)
  • Audits and Preventative Actions: Streamline and automate your planning, scheduling and execution of audits from beginning to end.
  • Risk and Mitigation: Unify all risk-related activities and documentation within a single, centralized database.
  • Training and Nonconformance: Automates assignment and monitoring of training tasks and manages the process of evaluating and handling nonconforming materials and products.

Differences in ISO 9000/9001 Software

ISO 9000 refers to the ISO 9000 quality standard, which specifies definitions and vocabulary for efficient ISO software, and all the variations and revisions within the ISO 9000 family of standards. ISO 9001 relates to the actual requirements of ISO for establishing a QMS.

Single Solution ISO Software

The ideal ISO software solution integrates all the capabilities and benefits of disparate software systems into a single, configurable management suite of tools interconnected with a company’s digital systems and specifically designed to facilitate adherence to ISO 9000 compliance and ISO 9001 compliance.

ISO Compliance Software and MasterControl

MasterControl, a leading software solutions company, offers cloud-based ISO compliance modules designed to facilitate the documentation, implementation, maintenance and continuous improvement of a quality management system. MasterControl’s document control and management system is particularly critical for ISO certification in that it provides quick access to an array a company’s QMS components.

MasterControl and the FDA

MasterControl and its partner, i4DM, have served as the QMS providers for the U.S. Food and Drug Administration’s (FDA) Office of Regulatory Affairs since 2009. They also serve as QMS providers for the Division of Pharmaceutical Analysis, part of the FDA’s Center for Drug Evaluation and Research (CDER).