Manufacturers of consumer products should incorporate human factors into their Quality Management Systems (QMS).  Because human factors are directly connected to product safety, it is important that it be considered in all phases of product development and life cycle.  The Division of Human Factors, U.S. Consumer Product Safety and Health Canada’s Consumer and Hazardous Products

Creating Effective Quality Management Documentation Effective Quality Management Documentation is the backbone of a ISO 9001:2015 quality program.  The documentation created therefore should be clear, concise, and targeted for its intended audience.   Documents serve to explain and instruct all stakeholders on policies, procedures, and work instructions.  They also provide the basis for evaluation for continuous

What is Continuous Improvement? Continuous Improvement and Organizational Development are valuable tools in a Quality Management System (QMS).  For improvement to occur it is essential that each important process in an organization be identified and analyzed.  Once identified and documented, these processes can be regularly reviewed to access effectiveness by applying improvement based on metrics. 

Creating Effective Quality Management Systems. Effective Quality Management Systems (QMS) are the products of proper implementation.  For ISO 9001:2015, that implementation is dependent on a detailed assessment of what processes are required for by the context of the organization.  That assessment can also provide guidance for requirements of  the management team that needs to be

  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

Proper Implementation of ISO 13485:2016 is Essential Implementation of ISO 13485:2016 Quality Management System (QMS) is a requirement for manufacturers of products used for the diagnosis, prevention, and treatment of medical conditions in the U.S. market.  This requirement is established by the Food and Drug Administration (FDA).  To ensure compliance, the FDA conducts inspections of

Public Sector Quality Management Applications There have been numerous attempts at implementing public sector Quality Management Systems (QMS) in the past decades.  These attempts have had mixed results due to a number of factors.  Many programs at the federal level, such as those incorporated by the Department of Defense (DOD) in the 1970’s, have been

Why Have a Quality Management System for Service Industry Businesses? At first glance a Quality Management System (QMS) might appear inappropriate for service industry businesses.  There would appear to be a lack of metrics to serve as inputs, as a large portion of the product is not physical.  Customer satisfaction however is a very tangible

ISO 9001 Certification Audits Once an ISO 9001 program is in place, a company will face audits as part of the certification process.  These audits ensure that the company’s program is in compliance with the requirements of the standard.  This may seem like a process that would likely cause a great deal of stress, but

Implementing ISO 9001:2015 as a Powerful Tool ISO 9001: 2015 is a powerful tool for quality management but care must be taken in its implementation to ensure that your company’s vision remains.  Any tool is only as beneficial if it is used properly.  To be certain, any Quality Management System (QMS) requires processes.  While these

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

ISO 27001 Prevents Cyberattacks Implementing an ISO 27001 Information Security Management System (ISMS) prevents cyberattacks.  The Ponemon Institute in a 2017 study found that a typical firm experiences 130 security breaches each year.  Mitigating these breaches requires more than advanced IT practices, it requires a dedicated management system.  ISO/IEC 27001 is such a system.  It

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 every sector of manufacturing, most especially the electronics industry. Counterfeit Parts pose a Threat to OEMs The best product design is