ISO Industry Compliance

The International Organization for Standardization (ISO) has developed—and continues to refine—standards that determine manufacturing excellence and best practices. These standards govern the quality systems and practices of many of the world’s largest and most successful businesses.

Manufacturing throughout the world is becoming increasingly more competitive globally, thanks to the acceleration and proliferation of advanced technology. In order to stay ahead of the competition, manufacturers are constantly looking for new and ingenious ways to design and create products in a cost-efficient manner. All the resourcefulness in the world can’t save a manufacturer from failing to comply with ISO standards, though. Fortunately for manufacturers, quality management software solutions exist that allow them to maintain ISO compliance, efficiently connect quality processes, and get first-rate products to market as quickly as possible.

Free Resources

FDA/ISO Compliance Toolkit

Manufacturing and Compliance with ISO Standards

The International Organization for Standardization (ISO) publishes over 19,500 international standards that provide requirements, specifications, guidelines, or characteristics that can be used consistently to ensure that materials, products, processes, and services are fit for their intended purpose. Each ISO standard designates the quality requirements for specific aspects of various industries. While the ISO 9000 and ISO 9001:2000 standards relate to general quality management, other ISO standards are industry specific. Such standards include:

ISO 7218:2007 for Food Safety
ISO 9241 and ISO 10075 for Ergonomics
13485 for Medical Devices
ISO 14000 for Environmental Management
ISO 14416 for Libraries
ISO 15706 for Audiovisual
ISO 18416:2007 for Cosmetics
ISO/TC 67 for Petroleum
ISO/TR 27809:2007 for Health Software

These are just a sample of the ISO standards that are published to help companies manufacture safe, high-quality products.

How MasterControl Can Help Organizations in ISO Industries

Finding the right quality and document management system can help organizations that are subject to compliance with ISO standards to facilitate their mission to accelerate compliant manufacturing processes, function more efficiently, and reduce wasted resources. Hundreds of companies throughout the world seeking compliance with ISO standards use MasterControl’s quality and compliance software solutions to manage quality processes more efficiently. MasterControl’s end-to-end software solutions are specifically engineered to help companies achieve their quality and compliance goals.

MasterControl provides the foundation of a company’s quality management system (QMS) by automating all documents- and forms-based processes, connecting all quality processes, and providing a Web-based, centralized repository for all documents that must be maintained according to regulatory requirements. MasterControl also offers two major advantages that set it apart from lesser QMS software solutions: cloud-based services and mobile access. MasterControl’s cloud system provides a secure environment without requiring large up-front costs or excessive burdens on IT staff. Plus, users of the MasterControl system can perform tasks and access vital information using tablets or smartphones, thereby boosting their productivity and effectiveness.

The following MasterControl modules are particularly beneficial for companies striving to maintain compliance with ISO standards:

MasterControl Documents™: MasterControl’s document management software system is a comprehensive, market-leading solution that automates and accelerates the processes of changing, approving, notifying, and routing documents. It provides secure and sophisticated storage, versioning, metadata, security, retrieval, and indexing functionality and significantly reduces the time it takes to bring new products to market. The primary benefit of the MasterControl document management module is improved efficiency throughout the enterprise.

MasterControl BOM™: MasterControl’s bill of materials solution helps manufacturers simplify and standardize BOM management across all departments. A flexible, robust system, MasterControl BOM controls multiple iterations of a BOM generated during the design process and enables users to exchange BOM data with suppliers or other authorized external entities. MasterControl insures that all departments have an accurate, up-to-date view of the revision levels of every component in their specified configurations. Documents defining components are readily viewable directly from the BOM, ensuring that the right documents and revisions are used in the manufacturing process.

MasterControl Supplier™: This “one-stop shop” solution integrates supplier management with the overall quality management system and automatically manages supplier statuses and quality information (such as nonconforming material reports) all within a single, easy-to-access location. In addition to providing an easily maintainable Approved Vendor List (AVL), MasterControl Supplier also features a user-friendly interface for accessing all documentation and records related to each supplier.

MasterControl Process™: Many manufacturers use MasterControl Process in conjunction with MasterControl Documents as the keystone of a robust QMS that spans the entire enterprise. MasterControl Process automates any forms-based process and offers best-practice forms that prompt users with selected data to reduce data entry and prevent common data-entry mistakes. It gives process designers the choice to configure all aspects of workflows, including users, tasks, tracking, escalation, and approval.

CAPA and Quality Events Solutions: An effective corrective and preventive action (CAPA) software system—like the solution offered by MasterControl—improves product quality and safety, increases customer satisfaction, and, most importantly, ensures compliance with global ISO standards. MasterControl CAPA™ connects quality events such as nonconformance, deviations, and customer complaints and automates the management of the entire CAPA process, from initiation to investigation and all the way through closure. MasterControl CAPA and Quality Events solutions allow a CAPA form to be automatically launched from another form (such as a customer complaint) in order to streamline CAPA processes and avoid human data entry errors. Management is provided with a continuous, real-time overview of the CAPA process, which allows decision makers to be more proactive about improving the quality system.

MasterControl Risk™: A consistent approach to assessing and managing risk is crucial to successful quality management, which is why MasterControl has tailored its integrated risk management software solution to help companies identify and mitigate long-term systemic risks by tracking and analyzing the recurrence of issues. The system ensures that internal risk thresholds are followed precisely and it provides a complete and accurate picture of the risk landscape across product lines, business processes, and business units. This helps companies avoid reputation damage that otherwise may arise due to recalls or regulatory action. Risk assessments can be launched from anywhere within the MasterControl system to analyze hazards associated with any process or activity.

MasterControl Audit™: MasterControl’s audit solution automates all audit-related tasks and schedules. It enables manufacturers to deploy a single, flexible solution for ensuring quality and compliance across the enterprise. MasterControl Audit is cost-effective, easy-to-learn and use, and supported by IT departments and corporate management because it completely meets their needs. It also offers robust reporting tools and the capability to connect the audit management process with other critical quality processes.

MasterControl Training™: MasterControl Training automates the distribution and monitoring of training tasks to ensure competency across the enterprise. It provides the capability for online grading of tests and sequencing of courses. When a prerequisite course is completed within the MasterControl Training system, the next course in the sequence can be automatically instigated. MasterControl also offers a group sign-off feature for verifying trainings for large groups of employees.