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Compliance with ISO Standards

Ideagen offers a range of ISO solutions based on our quality, compliance and risk management software products. The approach and degree of process automation you choose can be partial, stepped or complete. Whatever your choice, the Ideagen Customer Experience and Professional Services teams are available to help you every step of the way

ISO 9001 Compliance

Q-Pulse - the world’s number one ISO compliance application since 1992

The world’s most popular standard – ISO 9001 – is changing: a substantially updated and revised version published in 2015 replaces the 2008 edition.

We work closely with compliance and risk industry analysts around the world and the most frequently asked questions we have all been receiving lately relate to the changes in ISO 9001:

  • How do I extend my quality management system out to third parties in my supply chain?

  • In practice, how do we implement a risk-based model of quality management?

  • Where should we start?

Ideagen ISO compliance solutions can help you comply with any risk-based standard.

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Q-Pulse is a single, centralised solution that helps streamline, and effectively manage, all compliance activities for ISO standards.

  • Document control
  • Management of non-conformances
  • Implementation and reporting of corrective and preventive action (CAPA)
  • Audit management
  • Reporting and management of incidents and investigations
  • Management of third parties, assets and customers
  • Risk management
  • Automated communications
  • Training implementation and documentation

Q-Pulse can help your laboratory achieve and maintain ISO 15189 accreditation

Ideagen supports more than 140 medical laboratories around the world in managing the requirements of laboratory accreditation, including ISO 15189, in order to improve the quality and reliability of services and contribute to the continual improvement of care.

  • Ensuring effective diagnosis through accurate analytical work

  • Improving patient care with streamlined and robust quality processes

  • Releasing resources to help improve service quality and reliability

 

Contact us to learn more about ISO compliance systems for laboratories

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Alignment with ISO 31000: Enterprise Risk Management

While ISO 9001:2015 has adopted a risk-based model to become the world number one operational risk management standard, ISO 31000 represents best practice in Enterprise Risk Management. Issued for guidance only, it is not possible to become certified to ISO 31000.

Our federated best in class compliance management applications Q-Pulse and Pentana help customers implement the practices and recommendation of ISO 31000. Ideagen Coruson provides a cloud solution.

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ISO 14001 Compliance

Implementing an ISO 14001 Environmental Management System (EMS) requires active participation from all staff members and departments, and even top management committing and endorsing activities. Employees frequently focus on documentation and gathering data for audits rather than activities or actions that can help the company improve.

Ideagen helps customers to achieve ISO 14001 and the business benefits that go with it: overall operational performance, increasing efficiency, and cost savings associated with emissions, discharges, waste handling and disposal.

From multi-national, multi-site organisations to local workshops, users have found Q-Pulse easy to use and valuable in improving staff engagement with their EMS.

ISO 13485 Compliance

ISO 13485 is a globally recognised medical device standard and specifies requirements for a quality management system in order to ensure and verify that customer and regulatory conditions are met by the medical device industry.

Compliance with ISO 13485 can enable medical device companies to implement and streamline robust processes and procedures to ensure quality, reliability and safety are achieved throughout the product lifecycle. Within a shifting global market, consistently delivering high quality products or services can create competitive advantage for medical device companies. A robust product lifecycle that follows the principles of ISO 13485 can accelerate time to market and mitigate future risk for organisations.

This paper examines how the quality management product, Q-Pulse, matches up against specific ISO 13485 clauses in order to create a holistic and streamlined approach to quality management to achieve continuous improvement and competitive advantage.

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Comply with other ISO standards, including;

ISO 27001

Protect your information assets with an ISO 27001 certified Information Security Management System (ISMS). We provide a solutions based on Q-Pulse and Gael Risk that offers a full ISMS solution with Risk Identification, Risk Management and Framework Assurance.

OHSAS 18001/ISO 45001

Organisations without an Occupational Health and Safety Management System (OHSMS) notice that many incidents result from poor control of organisational and technical change. They find it difficult to plan for hazard identification, getting staff to engage with health and safety procedures and being able to stand up to unexpected audits.

Our software benefits organisations by providing a centralised framework to manage safety, quality and risk. By having information available at the point of need it reduces the bureaucratic burden of a paper-based system and promotes the ownership of key compliance activities, providing easy access to relevant documents and non-conformances.

ISO 22000

Whether you are a manufacturer, packager, processor or a restaurant chain, the consequences of unsafe food can be serious and potentially business critical. Our software can help organisations comply with ISO 22000, making it easier to both identify and control food safety hazards and ensure food safety levels are never compromised.

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