COURSE CONTENT • What is Quality Management System • What is the purpose of QMS • What is ISO 9001 and related other standards • Basic Documentation of ISO 9001 WHAT IS QUALITY MANAGEMENT SYSTEM? Quality Management System is a written document which directs us to achieve • the companies quality policy, • client requirements, • regulatory requirements & • quality product, Through systematic approach and continual improvement in the process, procedures and techniques, It involves the documented guidelines , process procedures and approved formats for processes, along with a technique for continual improvement to achieve a better product, Through which a customer will get belief of receiving a quality product, on time delivery and reduced wastages . PURPOSE OF QUALITY MANAGEMENT SYSTEM • Achieving customer requirements • Attaining customers confidence in our organizations activities towards achieving the quality product • Attracts more customers and increased sales • Reduces the probable hurdles in the project by defining, controlling & improving the process • Reduce wastage of materials • Do not allows mistakes to happen • Saves time caused due to errors • Encourages training activities for improved performances • Determines the roles and responsible person for the process • Ensure the procedures are correct and approved. WHAT IS ISO 9001 AND RELATED OTHER STANDARDS ISO 9001 is the worlds most widely used Quality Management System guidelines It gives guidelines for a company to produce their own Quality Management System. Other Similar Standards ISO 9000 Series (including ISO 9000 and ISO 9004), ISO 14000 series (environmental management systems), ISO 13485 (quality management systems for medical devices), ISO 19011 (auditing management systems), ISO/TS 16949 (quality management systems for automotive-related products). QUALITY MANAGEMENT SYSTEM BASICS The process approach is the key to an effective Quality Management System. It basically means that every operation of the company must be observed as a process, meaning you should identify all inputs, necessary resources, documents, activities, and outputs from each operation. Once you set up your system based on the processes, you will be able to monitor and measure your processes, their effectiveness, and efficiency and improve them, which is the reason why it is emphasized at the beginning of the implementation, before going into any other details regarding the standard requirements In simple terms, the process approach represents the concept of observing all operations in the company as processes. This includes breaking the company down into its processes, and determining their sequence, interaction, inputs, and outputs; as well as identifying the processes in the company, which processes can start before other processes are finished, resources and information needed to start the process, and what results we expect from the process. The best way to start implementing the process approach is to create a process map that will include all processes in your company and their interconnections. For example, the delivery process cannot be done before the production and sales process, and the production cannot be done before the purchasing of raw materials. Once you create this global process map and identify all the processes and their interrelations, you can start defining your processes in terms of what are necessary inputs, what controls need to be applied, and what are the outputs of the process. But this will be done throughout the implementation; it doesn’t have to be done at once. SAMPLE PROCESS FLOW CHART PLAN-DO-CHECK-ACT CYCLE In order to have an effective management system a Plan –do-check-act cycle is carried out TERMS AND DEFINITION – PAGE 1 It is very important to understand the terms and detentions used in the standard in order to understand the standard requirements Top management – An individual or group of individuals who coordinate and control an organization at the highest level. In cases when the scope of the management system covers just part of an organization, then top management refers to the individuals who direct and control that part of the organization. Organization – A person or group of people who has their own functions with responsibilities, authorities, and relationships to achieve the objectives. Context of the organization – A combination of internal and external factors that can have an effect on purpose, objectives, performance, and sustainability of the organization. Internal factors include values, culture, knowledge, and performance of the organization. External factors include legal, technological, competitive, market, cultural, social, and economic environment. Interested party (stakeholder) – A person or organization that is involved in or perceives itself to be affected by activities and actions taken by the organization. Interested parties can be customers, suppliers, contractors, local community, government, etc. Process – A sequence of activities that use inputs to deliver an intended result. For example, the production process has several steps that must be conducted in the appropriate sequence; inputs in this process are raw materials, product specifications, and work instructions, while the outputs are the product, quality check report, etc. TERMS AND DEFINITION –PAGE 2 Procedure – A defined way to execute an activity or a process. Procedures can be documented or not. Quality – Quality is the difference between a customer’s expectations and the customer’s perception of the product or service that he received – the higher the difference, the better perceived quality. Nonconformity – The failure to meet a requirement. Risk – Risk is the “effect of uncertainty on objectives,” and an effect is a positive or negative deviation from what is expected. For example, the company plans to deliver its products to the customers, but there is a risk of product nonconformity due to a poorly controlled production process. Effectiveness – The level of success in achieving or producing a desired result. For example, the production process is effective if it is able to produce the products. Documented information – Information required to be controlled and maintained by an organization, and the medium on which it is contained. For example, the documented policies, procedures, work instructions, and records represent documented information. WHICH DOCUMENTS AND RECORDS ARE REQUIRED? Mandatory Documents Required Documents Reference Clause Scope of Quality Management System 4.3 Quality Policy 5.2 Quality Objectives and Plan 6.2 These are the documents and records that are required to be maintained for the ISO 9001 Quality Management System, but you should also maintain any other records that you have identified as necessary to ensure your management system can function, be maintained, and improve over time. Mandatory Records Reference Clause Record of Maintenance and Calibration of Monitoring and Measuring Equipment Competence Records 7.1.5.1 7.2 Product/Service Requirements Review Record 8.2.3.2 Record of New Requirements for Product or Service Design and Development Inputs Record 8.2.3.2 8.3.3 Record of Design and Development Controls Design and Development Outputs Record 8.3.4 8.3.5 Record of Design and Development Changes 8.3.6 Record of Evaluation of External Provider (supplier) Record of Product/Service Characteristics Record of Changes on Customer’s Property 8.4.1 8.5.1 8.5.3 Record of Changes in Production/Service Provision Evidence of Product/Service Conformity Record of Nonconformity Monitoring Performance Information Internal Audit Program and Results Management Review Results Nonconformities and Corrective Action 8.5.6 8.6 8.7.2, 10.2.2 9.1.1 9.2.2 9.3 10.2.2 COMMONLY USED NON-MANDATORY DOCUMENTS Non-Mandatory Procedures Determining Context of the Organization and Interested Parties ISO 9001 Clause 4.1, 4.2 Procedure for Addressing Risks and Opportunities 6.1. Competence, Training and Awareness Procedure 7.2, 7.3 Procedure for Control of Documents and Records Sales Procedure Procedure for Design and Development 7.5 8.2 8.3 Procedure for Control of Externally Provided Processes,Products and Services (outsourced processes) 8.4.1 Procedure for Production and Service Provision Warehousing Procedure 8.5 8.5.4 Procedure for Measuring Customer Satisfaction Procedure for Internal Audit Procedure for Management Review 9.1.2 9.2 9.3 Procedure for Nonconformity and Corrective Action 10.2 SAMPLE
