ISO 9000

• The ISO 9000 standards are a set of international standards that contain the requirements for building a basic quality management system (QMS).
• The roots of the ISO 9000 series date back to World War II, when the Ministry of Defense in Britain decided to implement a set of standards to reduce mistakes and the resulting accidents in the manufacturing of munitions.
• Recognizing and rewarding improvements and successes of suppliers and partners is important.
• Sharing information, expertise, and resources with interested partners benefits all.
• Measuring the performance of the entire system and providing feedback to all enhances improvement initiatives.
• Interested parties in a supply chain include suppliers, partners, investors, customers, employees, and the society as a whole, and these relationships need to be prioritized and managed.
• The first version of the ISO 9000 standards was introduced in 1987 by the International Organization for Standards (ISO) in hopes of establishing an international definition of the essential characteristics and language of a quality system for all businesses, irrespective of industry or geographic location.
• By the mid-1990s, increasing numbers of small and mid-sized companies had embraced ISO 9000 as well.
• The first revision of the ISO 9000 standards, released in 1994, focused on trying to clear up the indistinct elements of the 1987 version as well as place a greater concentration on quality assurance through preventative actions.
• The British Assessment Bureau reported that the new version, ISO 9001:2000, made it very obvious that process management was the main goal of the standard.
• The idea of the ISO 9000 standards was always intended to be “a documented system” rather than “a system of documents” but that idea wasn’t especially clear in the previous versions.
• The most current version of the standard is ISO 9001:2015, completed and released towards the end of 2015.
• People’s contribution should be acknowledged and rewarded.
• Organizations should ensure that the data is accurate, reliable, and secure.
• Organizations should enter into interdependent, mutually beneficial relationships with interested parties in order to enhance their abilities and create value for all.
• People at all levels should be involved in the pursuit of the chosen quality goals so that all their abilities are fully utilized for the benefit of the organization.
• Organizations should provide suitable rewards to recognize successful projects.
• Organizations should measure and monitor key indicators of performance of processes and the system and make the data available to relevant people.
• Organizations should make sure that the data are analyzed using proper methods by people who have the expertise in these methods, and that the results of analysis are used in making improvements—properly moderated by experience and intuition.
• Analyzing the organization and its activities as processes helps in gaining a good understanding of the individual processes and their interdependencies, improving the chances of discovering opportunities for making improvements to the processes and making them both effective and efficient.
• Organizations should continually look for opportunities to improve their processes in order to improve customer satisfaction and efficiency of internal processes.
• Surveys should be conducted to assess people’s satisfaction and results should be shared with them and acted upon where improvements are necessary.
• An enterprise is a process made up of several sub-processes, which are interrelated.
• Organizations should encourage and facilitate improvement projects throughout the organization; evaluate improvement projects for planning, implementation, and results; and publicize successes.
• Communication to people on the importance of their individual contribution, collaborative effort among people, open discussion and sharing of knowledge, and empowering people to take initiatives without fear is necessary for engaging people in the pursuit of quality goals.
• Organizations should establish improvement objectives and train people at all levels on how to apply basic tools and methods to achieve improvements.
• Organizations should encourage decision making based on evidence from data, or information gathered from processes, rather than on the feelings and beliefs of people.
• QMP 1: CUSTOMER FOCUS Organizations should know who their customers are and understand the current and future needs of those customers and strive to meet and exceed the customers’ needs and expectations.
• The standards of ISO 9000 detail 20 requirements for an organization's quality management system in the following areas: Management Responsibility, Quality System, Order Entry, Design Control, Document and Data Control, Purchasing, Control of Customer Supplied Products, Product Identification and Tractability, Process Control, Inspection and Testing Control of Inspection, Measuring, and Test Equipment, Inspection and Test Status, Control of Nonconforming Products, Corrective and Preventive Action, Handling, Storage, Packaging, and Delivery, Control of Quality Records, Internal Quality Audits,
• The current versions of the standards are: ISO 9000:2015 Quality Management Systems - Fundamental and Vocabulary (ANSI/ISO/ASQ Q9000:2015), ISO 9001:2015 Quality Management Systems - Requirement (ANSI/ISO/ASQ Q9001:2015), and ISO 9004:2009 Managing for the Sustained Success of an Organization - A Quality Management Approach (ANSI/ISO/ASQ Q9004:2009).
• QMP 7: MUTUALLY BENEFICIAL SUPPLIER RELATIONSHIPS Organizations should maintain mutually beneficial supplier relationships.
• ISO 9004: Contained guidelines on how to establish a QMS that is specified through the requirements in ISO 9001, ISO 9000.
• Advantages of ISO 9000 include increased marketability, reduced operational expenses, better management control, increased customer satisfaction, improved internal communication, improved customer service, reduction of product-liability risks, and attractiveness to investors.
• QMP 2: LEADERSHIP Leaders should establish the mission, vision, and strategy to achieve them, and communicate them throughout the organization.
• ISO 9002: Concerned with quality assurance at the production and installation stages.
• QMP 3: INVOLVEMENT OF PEOPLE Organizations should involve their employees in the quality management process.
• QMP 5: CONTINUOUS IMPROVEMENT Organizations should continuously improve their processes.
• ISO 9000: Had the preamble, definition of terms, and instructions on how to use the rest of the documents.
• Disadvantages of ISO 9000 include owners and managers not having an adequate understanding of the ISO 9000 certification process or of the quality standards themselves, inadequate funding for establishing the quality system, heavy emphasis on documentation, and length of the process.
• QMP 4: SYSTEM APPROACH TO MANAGEMENT Organizations should manage their resources in a systematic manner.