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Application of Risk for Medical Devices (ISO 13485) and Medical Laboratories (ISO 15189) through ISO 14971 and ISO 22367

Under the present conditions with Covid-19, it is imperative to ensure the Application of Risk for Medical Devices ISO 13485:2016 and for Medical Laboratories Requirements for Quality and Safety ISO 15189.

Both ISO 13485 and ISO 15189 standards are to comply with FDA requirements and the implementation medical devices and medical laboratories impact human injuries,  identification, and mitigation of potential risks involved in the manufacturing and distribution of medical devices and conducting medical laboratory testing are essential while we face ever-increasing possibilities of Coronavirus(Covid-19) and other disasters. Medical devices’ accurate functionality is essential to ensure human ventilators used to monitor Covid-19 patients which in part controlled through ISO 13485 certification. Similarly, Covid-19 laboratory testing should produce accurate medical laboratory test results to indicate positive or negative to Coronavirus which in part controlled through effective implementation of ISO 15189 certification.

ISO 14971 Medical Devices – Application of Risk Management to Medical Devices and ISO 22367 Medical Laboratories – Application of Risk Management to Medical Laboratories were developed specifically with a focal point on risk assessment and mitigation.

What is ISO 13485 Medical Devices – Quality Management Systems?

The ISO 13485 Standard was designed for all facilities engaged in the production of medical devices requiring ISO 13485 Certification. ISO 13485:2016 is an international standard dedicated to developing a disciplined management system  to produce and maintain consistent quality of medical devices for any facility regardless of their size or medical sector.

The ISO 13485:2016 Standard specifies Quality Management System(QMS) requirements for organizations needing to provide medical devices/services that consistently meet customer and applicable regulatory requirements. ISO 13485:2016 Medical Devices – Quality Management Systems can also be used by suppliers / external parties providing medical devices o related services.

Why ISO 13485 Medical Devices – Quality Management Systems?

ISO 13485:2016 is aligned with ISO 9001 and additionally requires demonstration of effective implementation and maintenance instead of improvement for the control of:

  • Work environment to prevent adverse effects to product safety
  • Risk identification and mitigation
  • Design activities
  • Verification of corrective and preventive action effectiveness

Implementation leading to ISO 13485:2016 certification provides a solid foundation for Medical Device production / service to for organizations to identify hazards/risks, control the risks, and implement / monitor controls for effectiveness.

What is ISO 14971 Medical Devices – Application of Risk Management to Medical Devices?

The ISO 14971 Standard provides an extensive process for risk management of medical devices including medical software and in vitro diagnostic devices.

With the ISO 14971 focus on hazard identification and risk management associated with the actual medical device or service, it is ideal for use with ISO 13485 which focuses more on the business and process risks. 

Requirements for all stages of the medical device life cycle include risks from:

  • Medical devices
  • Medical device services
  • Software data control
  • Security systems
  • Biocompatibility
  • Moving Parts

Why Use 14971 Medical Devices – Application of Risk Management to Medical Devices to Support ISO 13485?

The ISO 14971:2019 Standard was developed for application of risk management of medical devices specifically related to an ISO 13485:2016 Quality Management System. Risk management is essential to a QMS such as ISO 13485 but implementation of ISO 14971 expands risk coverage to provide more thorough and effective risk management.

The ISO 14971 Standard requirements for risk management to provide medical device safety and supports the ISO 13485 Standard in meeting required risk-related activities.

ISO 14971 is a nine-part standard providing the risk analysis, evaluation, control, and review, including procedures monitoring during production and post-production and evaluation of the risk management effectiveness.

What is ISO 15189 Medical Laboratories – Requirements for Quality and Safety Quality?

ISO 15189:2012 Medical laboratories — Requirements for Quality and Competence is an international standard that specifies the QMS requirements specific for medical laboratories necessary to provide valid technical results through.;

  • Medical emergency testing methods
  • Education and training of health care staff
  • Requirements for competence of medical care staff
  • Environmental medical device requirements
  • A robust system to producing quality products and services
  • Risk-Based Thinking, Process Approach, and Continual Improvement
  • Provision of services including patient scheduling / sample processing / patient sample collection / test result interpretation / turnaround times / reporting and advice,
  • Environmental issues related to medical laboratory activities

Why Use ISO 15189 Medical Laboratories – Requirements for Quality and Safety Quality?

This ISO 15189:2012 Standard can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies, including assessment of risk activities related to the business / process.

Those having medical laboratory applications should take into consideration implementation of special Disaster Recovery processes in the event of any possible emergency situation such as the recent Covid 19 virus. It is essential to follow cGMP requirements without any violation. To be ahead of standard requirements, the Disaster Recovery Plan should include social distancing, increased sanitation, and use of Personal Protective Equipment (PPE). This Disaster Recovery Plan must cover the initial handling of incoming raw materials and all processes up to and including dispatch.

For effective implementation of ISO 15189, using ISO 22367 Medical Laboratories – Application of Risk Management to Medical Laboratories for more extensive identification/mitigation of risk is essential.

What is ISO 22367 Medical Laboratories – Application of Risk Management to Medical Laboratories?

Medial laboratory systems complaint to ISO 22367 specify a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks.

The ISO 22367 standard is applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record and other technical and management processes described in ISO 15189.

This document does not specify acceptable levels of risk; apply to risks from post-examination clinical decisions made by healthcare providers; management of risks affecting medical laboratory enterprises that are addressed by ISO 31000 Risk Management, such as business, economic, legal, and regulatory risks.

Why Use ISO 22367 Medical Laboratories – Application of Risk Management to Medical Laboratories to Support ISO 15189?

The ISO 15189 Standard requires that “The laboratory shall evaluate the impact of work processes and potential failures on examination results as they affect patient safety, and shall modify processes to reduce or eliminate the identified risks and document decisions and actions taken”.

ISO 22367 Medical Laboratories – Application of Risk Management to Medical Laboratories was created specifically to address potential risks to patients, laboratory workers and service providers that are   identified per the ISO 15189 Laboratory Standard. The risks identified by the ISO 15189 QMS are to be assessed based on patient care risk probability, severity, and impact. Whenever a risk is identified a process must be implemented to control or mitigate the risk. ISO 22367 Medical Laboratories – Application of Risk Management to Medical Laboratories provides a detailed process for addressing risks and managing new risks due to process changes, and unexpected disasters such as Coronavirus.

In the vast majority of instances, risk cannot be fully eliminated. The ISO 15189 accredited laboratory will take appropriate steps to control risks. This may require mistake-proofing of an existing process or complete redesign of a process if risk is severe. Care must be taken that process changes do not introduce new, unanticipated risks.

How Does QSE Assist in Development of a Simplified Quality Management System That Focuses on Mitigation of Risk

A competent ISO consulting company or ISO consultant can provide detailed explanation on the intent of the standard while developing an ISO 13485 or ISO 15189 compliant Quality Management Systems (QMS)

QSE Difference: Quality Systems Enhancement Inc is a premium AuditingConsulting and Training firm involved in coaching, assisting and auditing, facilities to be certified / accredited to international standards.  QSE will make sure that all changes to regulatory requirements are communicated to manufacturers during consultation and that documentation change requirements are fully met. For over 27 years, the firm has been engaged in this business and has helped over 800 facilities in achieving their certification/accreditation goals. QSE has a disciplined 10 Step disciplined path towards certification/accreditation which is insensitive to failure. QSE has the experience to help organizations get certified or accredited to ISO 13485 or ISO 15289 and has also provided certification guidance for many other International Standards such as ISO 9001, ISO 14001ISO 45001 and sector specific standards such as, IATF 16949:2016, AS 9100 D, TL 9000, FSSC 22000:2019,SQF edition 9. BRCGS-9 IFS in food safety version 7 and many more.

QSE’s 10-step disciplined path for ISO Certifications and Accreditation achieves organizations success in the shortest possible time. Usually within 5 months.

Please visit our website www.enhancequality.com or contact for immediate assistance on Phone 770-518-9967, email: info@qsebackup.atlcreative.co

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