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Chapter 5. Quality management Standardization and Certification. Objectives. After going through this chapter, you will be able to understand: The meaning of ISO 9000, Accreditation benefits and operational details of 1S09000, The meaning of QMS,
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Chapter 5 Quality management Standardization and Certification
Objectives • After going through this chapter, you will be able to understand: • The meaning of ISO 9000, • Accreditation benefits and operational details of 1S09000, • The meaning of QMS, • The international / national regulating bodies for Health care QMS
Introduction • The Outside-in Organisation is about bad news and good news. The bad news is that few managers actually run their companies from the outside in, starting with customers and prospective customers and making sure that all their strategies and actions are chosen and implemented from a strong customer perspective. • The good news is that the outside-in discipline, a commonsense yet revolutionary approach can turn the bad news into opportunity.
ISO 9000 • ISO 9000 is series of standards for maintain effective quality assurance system for manufacturing and service industries, developed and published by International Organization for Standardization (ESO). • ISO 9000 deals with the fundamentals of Quality Management Systems (QMS), including management principles on which the family of standards is based. ISO 9000 was first published in l987.
Evolution • Base for ISO 9000 is BS 5750 series of standards proposed by BIS in year 1979 to ISO • However history of ISO 9000 can be traced back up to MIL-Q-9858 standard published in year 1959 by US, Department Of Defence. BSI has been certifying agency for their quality management systems since l974. • Today, BIS claims to certify organizations at nearly 70,000 sites globally.
What is ISO 9000? • ISO 9000 is important in the first instance because it gives organizations some guidance on how to manage quality. Secondly, mechanisms exist by which an organization can be certified for conforming to ISO 9000 specifications. • With this certification in hand, an organization can better sell its product or service to its customer. It can say that the product or service is the result of a process that continually tested for quality.
What is ISO 9000? • Rules exist for how such certification should be done, and organizations exist which certify other organizations as performing reliable ISO 9000 certifications. • In the United Kingdom, Australia and India 3rd party audits of ISO 9000 compliance involves a system audit every three years and five- six mini-audits within each three year span. To receive certification a company must show that its documentation follows the quality standard and that its people follow the documentation
Benefits of Accreditation to ISO 9000 • Benefits to organization: • Provides senior management with an efficient management process, • Sets out areas of responsibility across the organization, • Mandatory if you want to tender for some public sector work, • Communicates a positive message to staff and customers,
Benefits of Accreditation to ISO 9000 • Benefits to organization: • Identifies and encourages more efficient and time saving processes, • highlights deficiencies, • Reduces costs, • Provides continuous assessment and improvement, • Marketing opportunities.
Benefits of Accreditation to ISO 9000 • Benefits to customers: • Improved quality and service, • Delivery on time, • Right first time attitude, • Fewer returned products and complaints, • Independent audit demonstrates commitment to quality.
ISO Manual of Standard • The term ‘ISO 9000’ is usually used to refer to a set of intimately related standards. One standard is a roadmap for the others. These standards cover quality design, quality management, and quality assurance for different kinds of companies depending on the extent to which they design as well as manufacture products. • Another one of the standards covers risks, costs and benefits, management responsibility, quality system principles, and other building blocks that help users customize quality standards to conform to real—life situations.
ISO Manual of Standard PROCESS Design Production Distribution QUALITY CONTROL QUALITY RECORDS
ISO 9001 • It’s an international Standard. This Standard sets out all the elements that should exist in a sound quality management system. • The elements are written as ‘requirements’ - things you are ‘required’ to do.
ISO 9001 • They can be applied to any quality management system where you: • Need to demonstrate that your organization can consistently provide services (or products) that meet the requirements of your customers, and any applicable regulation • Want to enhance the satisfaction of your customers through the effective use of your system
ISO 9001 • The Standard has 8 sections. The requirements are in sections 4 — 8: • Section 4 is an ‘overall’ one for the system. It contains requirements applicable to the system throughout, including requirements to define processes, for documentation, and for records • Section 5 is about the responsibility of management, particularly ‘top management’ - the decision-makers. It includes requirements for customer focus through quality policy, planning, defining responsibilities, setting objectives and reviewing performance,
ISO 9001 • The Standard has 8 sections. The requirements are in sections 4 — 8: • Section 6 is about resources. its aim is to ensure that people performing work affecting service/product quality are competent, and that suitable infrastructure (from facilities to tools & equipment) is provided. • Section 7 is on service/product ‘realization’ or core business activities — all the processes & activities involved in delivering your services or products. It contains the most requirements, from communicating with customers
ISO 9001 • The Standard has 8 sections. The requirements are in sections 4 — 8: • Section 8 covers measurement, analysis and improvement. It sets requirements for checking how you are performing, assessing performance, identifying and fixing various problems, and improving your system.
ISO 9002 & 9003 • ISO 9002: • Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products. • ISO 9003: • Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced.
How does ISO 9000 Operates • The ISO 9000 certificate is suitable for all sizes of organization and is well established around the world as an invaluable quality management system. • It is suitable for organization in all industry sectors and will help your organization to improve management processes to compete locally and/or globally. • The process encompasses the entire organization and requires senior management buy-in, it is not just a function of the Quality Department.
Quality Manual • The Quality Management System first requires a Quality Manual to be written. This document is the backbone of the Management System, and is where announce organizational intentions. • This is often the document where the company records the Quality Policy and Objectives, and sometimes adds the company’s Mission and/or Vision Statement. • While preparing the Quality Manual Following points should be keep in mind,
Quality Manual • The scope of the Quality Management System: • This is in place to identify the limit of the system and is based on the scope agreed with the registrar to be placed on the ISO certificate. • The documented Procedures: • Established for the Quality Management System (or references): As is commonly pointed out, there are only six documented procedures required by the ISO standard • A description of the interaction of processes: • This is most simply done with a flowchart that identifies all the processes in the organization with arrows showing how they connect
Departmental Procedure • ISO 9000 specifically requires the organization to have documented procedures for the six Activities: Control of documents (clause 4.2.3), Control of records (Clause 4.2.4), Internal audit (Clause 8.2.2), Control of nonconforming product (8.3), Corrective action (8.5.2), & Preventive action (8.5.3). • From an ISO 9000 perspective, there are no mandatory procedures required for HR or IT departments as supporting functions for an organization. • It is recommended, however, that you have your processes documented to ensure accountability for actions, consistency and standardization.
Specification • The ISO 9000 standards are formulated on the Concept that the assurance of the consistent product quality is best achieved by application of two kinds of standards, one of them is Product Standards (Technical specifications) • Product standards provide the technical specifications that apply to the characteristics of the product and the characteristics of the processes by which the product is produced. Product standards are specific to the particular product
Quality System Management • The Management systems are that used to achieve, monitor, control, and improve the functional, financial, and human relations performance of organization. • Management system includes mechanisms for allocating, organizing, and improving resources. It should incorporate quantitative metrics and other criteria to monitor and evaluate the performance of the organizational units and personnel.
British Standards Institution (BSI) • The British Standards Institution (BSI) is the national standards body (NSB) representing the interests of the UK across all of the European and international standards organizations and through their committees. • BSI has published more than 21,000 standards that dictate proper procedures from apiculture to the transportation industry. • Independent of government, BSI is globally recognized as an independent body serving both the private and public sectors.
Joint Commission accredits (JCA) • The Joint commission accredits is an independent, non—profit Organization and certified more than twenty thousand health care organizations / programs in United States. • It and its certification is recognized US nationwide as a symbol of quality which reflects commitment to meeting certain performance standards.
Indian Counter parts in accreditation of hospital and Laboratories • To establish and operate national accreditation structure and promote quality through National Quality Campaign; an independent, not-for-profit Society, was set up jointly by the Government of India and the Indian Industry represented by the three premier industry associations (i.e. Associated Chambers of Commerce and Industry of India (ASSOCIIAM), Confederation of Indian Industry (CII) and Federation of Indian Chambers of Commerce and Industry (FICCI)).
Quality Council of India (QCI) • Quality Council of India is governed by a Council of 38 members with equal representations of government, industry and consumers. Chairman of QCI is appointed by the Prime Minister on recommendation of the industry to the government. • The Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, is the nodal ministry for QCI. It functions through the executive boards in the specific areas i.e. Accreditation for Conformity Assessment Bodies, Healthcare Establishments, Education & Vocational Training Providers
Quality Council of India (QCI) • Vision of QCI is to be among the world’s leading national apex quality facilitation, accreditation and surveillance organizations, to continuously improve the climate, systems, Processes and skills for total quality.’ Some of its Objectives are: • Establish and maintain an accreditation structure in the country, • Provide right and unbiased information on quality related standards, • Spread quality movement ¡n the country through National Quality Campaign, • Facilitate up-gradation of equipment's and techniques related to quality,
National Accreditation Board for Hospitals & Healthcare Providers (NABII) • National Accreditation Board for Hospitals & Healthcare Providers (NABH) is a constituent board of Quality Council of India, set up to establish and operate accreditation program for healthcare organizations. • The board is prepared to cater to much desired needs of the consumers and to set benchmarks for progress of health industry. The board is supported by all stakeholders including industry, consumers, government and has full functional autonomy in its operation.
National Accreditation Board for Testing and Calibration Laboratories (NABL) • National Accreditation Board for Testing and Calibration Laboratories (NABL) is an autonomous body under the guidance of Department of Science & Technology, Government of India. • NABL has been established with the objective to provide Government, Regulators and Industry with a scheme of laboratory accreditation through third-party assessment for formally recognizing the technical competence of laboratories.
Accreditation of Small Healthcare Organization • Small Healthcare Organization are those healthcare organizations having bed strength up to 50 beds and Day Care centers (up to 50 beds) are in control of supportive and utility facilities that are appropriate and relevant to the services being provided by organization. • Hospital Accreditation is a public recognition by a National Healthcare Accreditation Body, of the achievement of accreditation standards by a Healthcare Organization.
Accreditation of Small Healthcare Organization • In India, Heath System currently operates within an environment of rapid social, economical and technical changes. Such changes raise the concern for the quality of health care. • Small Health care Organization (SHCO) ¡s an integral part of health care system. Accreditation would be the single most important approach for improving the quality of SHCO.
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