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

Trends in quality manufacturing are emerging in reaction to Covid-19 and various international political issues.  Industries are having to rethink products, processes, markets, and strategies to remain competitive and viable.  Many analysts have suggested that at this time a fundamental paradigm shift is required for many businesses to achieve resiliency.  This view is echoed in

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

Sensors are transforming manufacturing and moving us toward what is being called Industry 4.0.  Today’s sensors provide cost effective solutions to measurement and monitoring requirements.   What is Industry 4.0? Industry 4.0 builds on the computer revolution of Industry 3.0 by combining intelligent devices by way of the Internet of Things (IoT) and the Internet

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,

Supply Chain Challenges in a Changing Global Market COVID-19 has introduced additional electronics supply chain challenges.  This is especially the case for the electronics industry.  As a result companies will have to: Reconsider product designs.  Develop new procurement strategies. Provide effective risk management for data security. Further guard against counterfeit parts. Electronic products require a

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