Risks and Opportunities are Everywhere 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. Strengths, Weaknesses, Opportunities, and Threats (SWOT) For most organizations ISO 9001:2015 provides a Quality Management

  ISO 13485:2016 Applicability  Implementation of ISO 13485:2016 Quality Management System (QMS) is applicable to organizations involved with the any of the steps in a medical devices life cycle, including design, calibration, production, and disposal.  This voluntary international standard allows for the variances in regulatory requirements particular to the organization’s region of application.  Because ISO

Opportunities for Improvement – Internal Audits and Management Review. Opportunities for improvement can be identified during the performance of a Quality Management System (QMS) Internal Audit.  When findings are analyzed with a critical review by management, valuable insights can be gained into increased profit, efficiency, and customer satisfaction.  The Benefits of Effective Auditing Often an

Using Your QMS to Enhance Profitability Using your Quality Management System (QMS) to improve processes can enhance customer satisfaction and increase profitability.  The key to achieving these goals is for the management team and senior leadership to identify the strategic direction of the organization and align the QMS to achieve those goals.  Certification body quality

ISO 9001: 2015 Quality Management System Requirements Proper documentation is the cornerstone of ISO 9001:2015.  Creating a system of documentation that is appropriate to your company’s requirements is crucial.  This is because the documentation defines the manner in which it will conduct business.  Paying attention to the design of your Quality Management System (QMS) at

Corrective Actions Provide Opportunities for Improvement Corrective Actions are excellent opportunities for process improvement and increasing profitability.   It is necessary however, to implement a process to these control corrective actions.  This is often perceived by some as being a cumbersome, unnecessarily complicated, and time consuming process.  However, a properly constructed Quality Management System can ensure

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

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