Quality Management internal auditing is performed in an organization to assess strengths and weakness, and identify areas of noncompliance. These audits are usually conducted by employees of the organization to assess processes they are not directly involved in to ensure an unbiased analysis.  Information gathered from a well performed internal audit can provide insights for

Preparing for ISO audits can greatly enhance the quality of information received from the process.  This information can provide insights for improvements in the organization and increased efficiency.  Regardless of the standard being employed, some simple steps can be taken to get the desired results. ISO Standards The International Organization for Standardization (ISO) publishes and

Integrating multiple management systems can provide businesses with a more coordinated approach to addressing growing numbers of organizational concerns and responsibilities.  This integration can be accomplished prior to implementing a management system or after implementing any number of systems.  Once accomplished however, an organization can realize enhanced planning, accountability, and reduction of costs. The International

Collaboration and Quality Management are concepts that should come to mind together.  It can, however, be difficult to combine teamwork and quality management in a manufacturing or service process.  There are challenges involved in bringing all interested parties to the table and engaging them in working together to continuously improve products and services.  These challenges

Implementing ISO 9001:2015 properly can benefit an organization across the board if executed appropriately.  The first steps of an effective implementation process should include determining what the intended results of the program should be.  These quality objectives may include factors beyond meeting customer expectations and ensuring the quality of products and services.  For example, a

Achieving quality objectives is a goal when implementing and maintaining any ISO 9000 family quality management system (QMS).  To achieve goals however, an organization must first clearly delineate what those objectives are.  Establishing quality objectives is a requirement under the planning clause of ISO 9001:2015.  However, to obtain the greatest value, care should be taken

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

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