ISO 9000 quality standards are used by many manufacturers and companies around the world to ensure that manufactured products meet customer and regulatory requirements. First published in 1987 by the International Organization for Standardization (ISO), the ISO standard has evolved to encompass a wide variety of standards and these standards continue to evolve and improve over time. While adherence to ISO standards is voluntary, many customers prefer venders and suppliers that are ISO-certified, and many countries require ISO certification. ISO standards continue to evolve through the continuous improvement of the ISO standards, such as the recent evolution of ISO 9001:2008 to the new standard ISO 9001:2015.
Intellect’s QMS product suite provides the industry’s most configurable solution designed to enable users to adjust and adhere to new quality standards. Learn how Intellect QMS can help meet key ISO requirements today and tomorrow, and how to keep costs down while doing so.
ISO 9000:2000 CLAUSE 4.2
🗸Approve documents before distribution
🗸 Provide correct version of documents at points of use
🗸 Use records to prove that requirements have been met
🗸Develop a procedure to control records
Intellect Document Control for ISO 9000 standards includes routing, escalation, approval, and delivery of SOPs, policies, and other documentation. All documentation resides in a centralized and secure data repository accessible to users based on permissions levels granted to each user. Provides version control that tracks who made what changes and when, and who approved changes. The system ensures that only the most recent version is available for users, while previous version are securely stored for audit purposes.
ISO 9000:2000 CLAUSE 5.6
🗸 Requires an evaluation of the performance of a quality system and the examination of audit results by management
🗸 Requires an examination of all Corrective and Preventive Actions (CAPA) by management
🗸 Requires an examination of customer feedback and complaints by management
🗸 Requires an examination of product conformity data
Intellect CAPA provides Corrective and Preventive Action solutions to ensure that team members and management have detailed reports to perform management reviews. CAPA captures data from multiple sources and forms, eliminating human errors through manual data entry. Intellect CAPA offers standard and highly customizable reports, including dashboard to monitor the entire quality management life cycle according to ISO 9000 standards.
ISO 9000:2000 CLAUSE 6.2
The people responsible for collection, processing, compatibility testing, storage or distribution of blood and blood components shall be adequate in number, educational background, training and experience, including professional training as necessary to assure competent performance. This approach ensures that the final product has the purity, safety, potency, identity and effectiveness it purports or represents to possess.
Intellect Training Management provides a central system to monitor and assign all training tasks and certifications to help achieve ISO 9000 compliance. Intellect Training Management informs users of required coursework and certifications by automatically sending notices and reminders.
ISO 9000:2000 CLAUSE 7.3
Establish a system to identify, document, and control design changes.
Intellect Change Management software can manage and streamline the change control process leveraging industry best practices, including prioritization, automated risk assessment prompts, and customizable reports with real-time data for smarter decision making.
ISO 9000:2000 CLAUSE 8.3
Control of nonconformity requires documentation pertaining to nonconformance product, corrective actions, concessions, and customer reports
Organizations must ensure that product which does not conform to product requirements of ISO 9000 standards is unintended and controlled to prevent its unintended use or delivery
Intellect Nonconformance helps organizations to ensure that products that do not conform to product requirements of ISO 9000 is identified and controlled to prevent is unintended use. Intellect offers a highly configurable solution to automate, manage, and streamline the process to identify, evaluate, review, and handling of nonconforming materials.
ISO 9001 is one of the fundamental standards in the family of 9000 standards. ISO 9001 sets the foundation because they establish the standards for creating and maintaining a quality management system. Changes to ISO 9001 will very likely impact many other processes and documents. Change is inevitable, as can be demonstrated with the evolution of ISO 9001:2008 to ISO 9001:2015.
Organizations that have been independently audited and certified to be in conformance with ISO 9001 standards may publicize that it is “ISO 9001 certified”.
REQUIREMENTS OF ISO 9001
🗸 Maintain a set of procedures that cover all key processes in the business
🗸 Monitor processes to ensure that they are effective
🗸 Keep adequate records
🗸 Check product output for defects, and use appropriate corrective action when necessary
🗸 Regularly review individual processes and the quality system itself for effectiveness
🗸 Facilitate continual improvement according to ISO 9001 standards
All companies certified to ISO 9001:2008 have three years to transition to the new standard ISO 9001:2015 due to the complexity of the new requirements. ISO 9001:2015 is the latest revision of the world’s most widely applied international standard on quality management systems. The update focuses largely on risk management.
INTELLECT FOR ISO COMPLIANCE
Intellect QMS helps to address ISO 9001 standards in a wide range of industries to produce the safest and highest quality products available. Intellect QMS consists of document control, CAPA, nonconformance, audit management, customer complaints, training and additional modules that automate and streamline the quality process and provide reports for making better and safer products.
ISO 13485 is an international management standard developed specifically for medical device manufacturers, and provides a model for an effective quality management system (QMS) for the design and manufacture of medical devices. ISO 13485 was revised in 2016 to address suppliers and incorporate risk. ISO 13485:2016 requires device makers to apply a risk-based approach to all quality processes, including any outsourced processes, and more structure to validation, verification, and design transfer. Companies certified on ISO 13485:2003 have three years to transition to ISO 13485:2016.
INTELLECT FEATURES FOR ISO 13485
Intellect helps medical device companies comply with ISO 13485 with Document Control, Supplier Management, Training Management, CAPA, Audit Management, Customer Complaints, and Nonconformance. Our solutions automate the assignment and monitoring of training tasks and certification level, with automatic reminders about next course requirements or upcoming certifications that need to be renewed. Intellect helps to streamline and manage audit processes, scheduling and planning for recurring audits, integrating corrective and preventive action process, reduce data entry and eliminate human errors.
Intellect provides analytics and reporting capabilities to help with audits, customer complaints, and nonconformance. Intellect is designed to help medical device manufacturers comply with ISO 13485 by automating, managing, and streamlining the process for identifying, evaluating, reviewing, and handling of nonconforming materials, components, parts, and finished products.
ISO 14000 and ISO 14001 were designed to incorporate environmental aspects into manufacturing operations and product quality standards. These standards are applicable to organizations of all sizes, and is the world’s most recognized environmental management system framework.
ISO 14000 REQUIREMENTS
🗸 Storing and managing environmental policy
🗸 Management of document control processes
🗸 Controlling nonconformance according to ISO 14000
🗸 Managing implementation and reporting of CAPA
🗸 Documentation of management review of EMS
🗸 Facilitates communication at various levels
🗸 Managing training implementation and documentation
🗸 Maintaining an ISO 14000-compliance EMS.
BENEFITS of ISO 14000
🗸 Reduces risk and liability with ISO 14000 compliance
🗸 Improves overall environmental performance
🗸 Increases efficiency, thereby improves costs savings
🗸 Reduces costs associated with emissions, discharges, waste handling, and disposal
🗸 Saves money by proving a safer workplace
The FDA recognizes ISO 14971as an acceptable risk management model and the European Union has made it mandatory. ISO 14971 requires manufacturers to use specific processes in order to identify the hazards associated with medical devices, including in vitro diagnostics (IVD) medical devices, at all stages of the lifecycle of a medical device. Organizations must adhere to strict process guidelines to estimate and evaluate associated risks, to control these risks, and to monitor the effectiveness of these controls.
The ISO 15189 standards provide a quality management framework that enables medical laboratories to meet international standards for patient care and laboratory responsibility. ISO 15189 standards can also improve laboratory services, products, and business processes. Training for ISO 15189 is critical, and compliance requires that an organization must ensure that there are sufficient qualified personnel with adequate documented training and experience to meet the needs of the laboratory.
ISO 17025 laboratory standards apply to first, second, and third party laboratories that perform testing and calibration services. ISO 17025 accreditation assures potential customers and financial supporters that laboratories meet international standards, including document control, supplier management, CAPA, nonconformance, change control, training, audit management, and continued improvement. Document control within the laboratory environment is critical and includes documents, policies, procedures, programs, systems, and instructions.
Intellect helps organizations to meet ISO 17025 laboratory standards by providing document control management, including quality documentation, quality plans, sampling and testing documentation, quality manuals, SOPs, pre-audit checklist, training records and certifications, test reports and calibration certificates. Our solution is highly flexible, and can be set-up to meet your unique requirements, with users given various permissions view, edit and approve documentation. All documentation is available in a secure and centralized environment accessible by desktop and mobile devices.
Workflow automatically routes documentation and tasks to the appropriate person for approval. Intellect’s powerful and flexible workflow technology can accommodate any unique business process. Documentation, processes, and tasks can all trigger next steps, such as the release of training tasks, follow-ups, and escalations. The system tracks all activities and provides a complete electronic trail for audit purposes, and then leverage all data for analytics and reporting.