ISO 14971 2019 Medical Device Risk Management

ISO 14971 2019 Risk Management ISO 14971:2019 is a quality management system that establishes risk management criteria for manufacturers of medical devices.  As defined in the standard, risk is the combination of probabilities that harm could occur and the degree of severity of that harm.  Harm is defined as injury to the health of persons, … Read more

EMC Testing and Risk Management

EMC Testing and Risk Management

It wasn’t long ago that EMC Testing and Risk Management wouldn’t have appeared in the same sentence.  Electromagnetic Interference (EMI) and Electromagnetic Compatibility (EMC) testing has normally been performed to meet the criterion established for a desired label.  Once compliance testing has been passed, it’s off to market. Medical Equipment Safety Concerns A modern medical … Read more

Counterfeit Parts and Quality Management Systems

Counterfeit Parts

Counterfeit Parts and Quality Management Systems (QMS) AS9100 and AS5553, provide a Quality Management System (QMS) approach to the problem of counterfeit parts for the aviation, space, and defense industries.  Unfortunately, counterfeit parts threaten equipment manufactured in every sector, most especially the electronics industry. Counterfeit Parts Pose a Threat to OEMs The best product design … Read more

ISO 9001 Business Management Beyond Quality

iso-9001 business management

ISO 9001 provides tools for business management beyond the scope of product quality.  Incorporating these tools can help an organization effectively and consistently manage specific issues and requirements strategically.  Furthermore, because ISO 9001:2015 requires involvement from top management and relevant stakeholders, it ensures that these issues will be addressed comprehensively.  Context of the Organization “Context … Read more

ISO 13485 2016 Quality Management
for Medical Devices

ISO 13485 2016 Quality Management System Applicability ISO 13485 2016, based on ISO 9001:2008, provides a quality management system for organizations involved with medical devices at any stage of that equipment’s life cycle.  It includes those organizations supplying materials, sub-assemblies, and components for those devices as well as those that are involved with design, distribution, … Read more

Supply Chain Quality Management in Uncertain Times

supply chain quality management

Recent events have illustrated the need for effective supply chain quality management.  Industries in any sector are vulnerable to unforeseen changes in global economic and political forces.  Indeed, the veracity of supply chains are even subject to microscopic viruses that can render entire companies inoperable. The Role of a Quality Management System in Supply Chain … Read more

Employee Cybersecurity Negligence a Risk

Employee Cybersecurity Negligence a Risk

Employee cybersecurity negligence is still a major cause of risk for businesses.  Despite an increased emphasis on training people, human error and bad habits continue to endanger sensitive information. Data Breaches on the Rise Institutions of all types have seen a dramatic increase in the number of cyber attacks.  This has been especially the case … Read more

Manufacturing Technology and Quality Management

manufacturing technology and quality management

The Only Constant is Change in Manufacturing Advances in manufacturing technology is affecting quality management strategies.  Companies are reassessing their manufacturing requirements, and many are reshoring to the United States.  According to studies conducted by the McKinsey Global Institute, the United States could boost annual manufacturing  as much as 20% by 2025.   To accomplish this, … Read more

Collaboration and Quality Management, Working Together

collaboration and quality management

  Collaboration and Quality Management Collaboration and Quality Management are concepts that should come to mind together.  It can, however, be difficult to institute collaboration in a manufacturing or service process.  There are challenges involved in bringing all stake holders to the table and engaging them in continuing cooperation. Working Between Departments Interdepartmental differences in … Read more

Export Compliance Program Management for Success

Export Compliance Program Management

Export Compliance Program Management Effective export compliance program management is important for a successful business.  International trade is more prevalent than in any time in history.  Failure to comply with export laws such as the Export Administration Regulations (EAR) and the International Traffic in Arms Regulations (ITAR) can lead to criminal penalties and imprisonment, civil … Read more

Cybersecurity Strategy and Business Management

cybersecurity strategy

Having a Cybersecurity Strategy is Essential Having an effective cybersecurity strategy is a necessity in today’s business world.  News stories and alerts appear daily, informing us of yet another threat or data breach that has put at risk the valuable data and security of millions of people.  This endless pressure can lead to paralysis induced … Read more

Information Security Management System

What is an Information Security Management System (ISMS) An Information Security Management System is a collection of policies, procedures, and controls that systematically address information security in an organization.  It is a framework based on risk assessment and risk management.  The most widely recognized and instituted ISMS in the business environment is ISO 27001.  It … Read more

ISO 27001 Cybersecurity Management System

ISO 27001 Cybersecurity

ISO 27001 provides businesses effective cybersecurity against today’s threats.  Microsoft notified nearly 10,000 customers, in 2018 that they had been targeted.  Most of these customers were businesses.  The Director of National Intelligence (DNI) has identified Russia, China, Iran, and North Korea as nation-states responsible for most cyberattacks.  Other players include corporate competitors, organized crime, and … Read more

Risks and Opportunities – Making Plans to Address

Diagram showing risks and opportunities

Risks and Opportunities are managed on a daily basis at every company. Businesses evaluate risks and opportunities every time they make a decision.  It is all about weighing the probability of a positive outcome versus the impact or cost of a negative outcome from an action taken. For most organizations ISO 9001:2015 provides a Quality … Read more

ISO 27001 Information Security Management System

ISO 27001 Protects Vital Sensitive Data ISO 27001 (ISO/IEC 27001) helps organizations treat data security seriously and confidently.  It is implemented through documented systems and processes that are designed to guard against the risk of security breaches or misuse of data while ensuring compliance to legal requirements.  The ISO 27001 2013 (Information and Data Security) … Read more