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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