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B.Pharm 8th Sem


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ISO By:- Chintan Patel

What is ISO? :

What is ISO? ISO (International Organization for Standardization) is the world’s largest developer of voluntary International Standards. International Standards give state of the art specifications for products, services and good practice, helping to make industry more efficient and effective. Developed through global consensus, they help to break down barriers to international trade .

What they do? :

What they do? ISO develops International Standards. We were founded in 1947, and since then have published more than 19 500 International Standards covering almost all aspects of technology and business. From food safety to computers, and agriculture to healthcare, ISO International Standards impact all our lives .

Popular standards:

Popular standards ISO 9000 Quality management ISO 14000 Environmental management ISO 3166 Country codes ISO 26000 Social responsibility ISO 50001 Energy management ISO 31000 Risk management ISO 22000 Food safety management ISO 4217 Currency codes ISO 639 Language codes

ISO 9000 Quality management :

ISO 9000 Quality management ISO 9001:2008 - sets out the requirements of a quality management system ISO 9000:2005 - covers the basic concepts and language ISO 9004:2009 - focuses on how to make a quality management system more efficient and effective ISO 19011:2011 - sets out guidance on internal and external audits of quality management systems. ISO 9001:2008 - sets out the requirements of a quality management system

Elements of ISO:

Elements of ISO

Elements of ISO:

QMS - Document processes necessary to ensure product or service is of high quality and conforms to customer requirements. Management Responsibility - Provide a vision. Show commitment. Focus on the customer. Define policy. Keep everyone informed. Resource Management - Assign the right person to the job. Create and maintain positive workspace. Product Realization - Clearly understand customer, product, legal and design requirements. Ensure specifications are followed. Check your suppliers. Measurement, Analysis & Improvement - Identify current and potential problems. Monitor and measure customer satisfaction. Perform internal audits. Fix problems . Elements of ISO


Interpretation Introduction The ISO 9001:2000 uses the process approach to implement the Quality Management System (QMS). The process approach includes: (i)identifying the processes necessary for the effective implementation of the quality management system (ii ) understanding the interactions between these processes. ( iii) documenting the processes to the extent necessary to assure their effective operation and control documenting . The standard has eight clauses . The interpretation of each requirement manifested in different clauses is explained with the aim of suitably deploying the same in respective food safety related application areas.

Quality Management System:

Quality Management System General Requirements Documentation Requirements General Quality Manual Control of Documents Control of Records Interpretation

General Requirements:

General Requirements The company shall establish, document, implement and maintain a quality management system. It shall also need to continually improve it . The company must: Identify the processes needed by the system to enable them to meet customer requirements and identify their application toward this task. This includes broad business processes as well as work processes, Determine the sequence and any interaction between these processes ( It needs to map out the processes ) Determine criteria and methods by which will ensure proper operation and control of these processes. For determining criteria the company can focus on outputs and objectives of the process concerned, It must measure the performance of the processes as a tool to continuously improve them. Ensure availability of resources of all kinds to support these processes to make sure that everything that is needed is available, otherwise this commitment to a quality system is futile, Monitor , measure and analyze these key processes, and Implement actions necessary to achieve planned results (objectives with respect to effectiveness, efficiency, cost etc.). Quality Management System

Documentation Requirements:

General: The quality management system documentations system must include : Documented statements of quality policy and quality objectives. A quality manual (which will explain how the company has planned to fulfill the requirements of ISO 9001:2000 standard.). Documented procedures required by ISO 9001:2000. There are six of them. Documents required by the company to ensure effective planning, operation and control of the processes. This consists of process profiles (which outlines the characterization of identified processes in terms of objectives , resources, roles, responsibilities, inputs, outputs, procedures, suppliers , customers, monitoring, documents and records pertaining to the process concerned) and associated documents. Quality records required by ISO 9001:2000. Documentation Requirements

Documentation Requirements:

Quality manual : The organization must establish a quality manual that includes : The scope of the quality system including details of/justification for any exclusions. The documented procedures or reference to them. A description of the interaction between the processes. You may use any topological representation e.g. charts, tables, schematics, relation diagram etc ., for the same. The generation, use and control of documentation should be evaluated with respect to the effectiveness and efficiency of the organization against following criteria : Functionality (e.g. speed of processing), User friendliness, Resources needed, Policies and objectives, Current and future requirements related to managing knowledge, Benchmarking of documentation system, and Interfaces used by organization's customers, suppliers and other interested parties. Documentation Requirements

Documentation Requirements:

Control of documents: Documents must be controlled. A documented procedure must be established to define controls for: Approving documents (who approves which document). Reviewing and updating documents (frequency may be defined for the same ). Ensuring changes and current revision status of documents are identified (an amendment register may be maintained for the same ). Ensuring relevant versions of documents are available at point of use (controlled copies may be made available to the concerned ). Documentation Requirements

PowerPoint Presentation:

Ensuring documents remain legible and identifiable (the documents need to be properly protected and maintained from getting damaged from heat ,dust , fire, dirt etc.). Ensuring documents of external origin are identified and distribution is controlled e.g. ISO 9001:2000, ISO 9000:2000 etc. Preventing unintended use of obsolete document (retain them in a separate file or folder if they are to be retained for any specific purpose. Otherwise destroy them. This is one of the mandatory documented procedures. Control of documents:

Documentation Requirements:

Control of records : Records must be established and maintained to provide evidence of conformity of the quality system. Records must remain legible, identifiable and retrievable. Procedures must exist to establish controls for identification, storage, protection, retrieval, retention time, and disposition of records. The formats used for records may be appropriately controlled e.g. by maintaining their master copies in a separate file and tracking the changes if any. This is one of the mandatory documented procedures . Documentation Requirements

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