Understand Iso - English

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ISO & ISO 9000 STANDARDS What is ISO? ISO is the International Organization for Standardization and has its headquarters at Geneva. It is made up of some 140 national standards institutes from countries large and small, industrialized and developing, in all regions of the world. ISO develops voluntary technical standards which contribute to making industrial production and supply more efficient, safer and cleaner, and to making trade between countries easier and fairer. ISO standards also serve to safeguard consumers and users in general of products and services - as well as to making their lives simpler. How ISO works? The work of preparing international standards is normally carried out through ISO technical committees. Each member national institute interested in a particular subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. Draft international standards adopted by technical committees are circulated to the member bodies for voting. Publication as an international standard requires approval by at least 75% of the member bodies casting a vote. ISO standards are adopted by all countries as their national standards, with or without any changes. What are ISO 9000 standards? ISO 9000 series of standards are quality management system standards, and are among the most widely known and successful of the 13000 plus standards published by ISO since its inception in 1947. These standards have become an international reference for quality requirements in business to business dealings. First edition of these standards were published in 1987. These were revised in 1994 and again in December 2000. While 1994 revision was restricted to some editorial changes and providing clarifications on some requirements, year 2000 revision is very extensive. General principles & concepts of ISO 9000 standards ISO 9000 standards are systems standards ISO 9000 standards bring transparency in working ISO 9000 standards work on checking and controlling deficiencies at each stage, both in working and in product quality Analyzing & correcting problems to avoid their repetition ISO 9000 systems are person independent ISO 9000 systems are internally audited Provides complete customer satisfaction

Systems means way of working. If working is strictly as per specified systems, quality will always be OK. Systems include procedures for working – what, when & how. Everything is in written form. What is not written, is not accepted. Write what you are doing & then Do what you have written. Check & ensure that you are working as per written procedures. Correct any deficiencies observed and work as per corrected system. Deficiencies in way of working – not following written procedures, not filling up forms, not recording what you have done, Deficiencies in product quality – at incoming stage (raw materials), in-process stages (products at various stages of production), final product , Products having any problem should be stopped at that stage and should not be used till problem is solved. Problem can be in any area. Problems are properly analyzed for possible reasons. Both short term and long term actions are decided and implemented to avoid repetition of the problem in future. Procedures, specifications, work instructions, check list etc., are all in written form. Responsibility and authority of each person is clearly defined. Alternative arrangement for each function is also defined to make the system person independent. Implementation of ISO 9000 systems is periodically audited by company’s auditors to determine its adequacy and effectiveness & to continually improve it. Customer satisfaction is defined for all areas such as, conformance to standards, delivery, after sales service and other related activities (both stated and implied).

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QMS Management Services Consulting Services for Effective Management Systems

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ISO 9001:2000 specifies requirements for a quality management system for any organization that needs to demonstrate its ability to consistently provide products that meet customer and applicable regulatory requirements and aims to enhance customer satisfaction. This standard has been organized in a userfriendly format with terms that are easily recognized by all business sectors. It is now the only standard in the ISO 9000 family against whose requirements a quality management system can be certified by an external agency. The standard recognizes that the word "product" applies to services, processed material, hardware and software intended for, or required by the customer. There are five sections in the standard that specify activities that need to be considered when you implement the system. The organization will need to describe the activities it uses to supply its products and may exclude the parts of the Product Realization section that are not applicable to its operations. The requirements in the other four sections – Quality management system, Management responsibility, Resource management, and Measurement, analysis & improvement– apply to all organizations and the organization will be required to demonstrate how it applies them in the organization, and specify the same in its quality manual or other documentation. Together, the five sections of ISO 9001:2000 define what an organization should do consistently to provide products that meets customer and applicable regulatory requirements. In addition, organization will also seek to enhance customer satisfaction by improving its quality management system. ISO 9004:2000 can be used to extend the benefits obtained from ISO 9001:2000 to all parties that are interested in or affected by organization’s business operations. Interested parties include organization’s employees, owners, suppliers and society in general. New ISO 9000 standards apply a process approach. Processes are recognized as consisting of one or more linked activities that require resources and must be managed to achieve predetermined output. The output of one process may directly form the input to the next process and the final product is often the result of a network or system of processes. The eight quality management principles provide the basis for continual improvement of organizational performance. Typical goals of any organization may be : • Be more efficient and profitable • Produce products and services that consistently meet customer requirements • Achieve customer satisfaction • Increase market share • Maintain market share • Improve communications and morale in the organization • Reduce costs and liabilities • Increase confidence in the production system. Most new users of ISO 9000 standards obtain measurable benefits early in the process of deploying the standard requirements in their operations. These initial benefits are generally due to improvements in their organization and internal communication. The benefits must be strengthened through effective internal auditing and management review of system performance. Like all systems, it either improves or becomes less effective. It does not remain static for long. When an organization adopts ISO 9001:2000, it must strive for the satisfaction of its customers and the continual improvement of the quality management system. Continual improvement is a process of increasing the effectiveness of the organization to fulfill its quality policy and quality objectives. ISO 9001:2000 requires planning and managing the processes necessary for the continual improvement of the quality management system. It is recommended that the organization obtains data from various sources, both internal and external, to assess the appropriateness of its quality system goals. This information can also be used to improve the performance of organization’s processes. 315, Pragati Apartments, Punjabi Bagh Club Road, Paschim Puri, New Delhi – 110 063

QMS Management Services Consulting Services for Effective Management Systems

Phone: 25216144, 9810073862 Website: www.qmsservices.com E Mail: [email protected]

Some organizations may expand their management systems by extending the ISO 9001:2000 structure to include the requirements of ISO 14001, Environmental management systems. The structural and organizational requirements of the two management systems have been designed to be compatible. Benefits of ISO 9000 standards There are number of benefits associated with the revised quality management systems standards. The benefits are: • Applicability to all product categories, in all sectors and to all sizes of organizations • Simple to use, clear in language, readily translatable, and easily understandable • Significant reduction in the amount of required documentation • Connection of quality management systems to organizational processes • Provision of a natural move towards improved organizational performance • Greater orientation toward continual improvement and customer satisfaction • Compatibility with other management systems such as ISO 14000 • Provision of a consistent basis to address the needs and interests of organizations in specific sectors (e.g. medical devices, telecommunications, automotive, etc) • The concept of the consistent pair - ISO 9001 covering the requirements and ISO 9004 for going beyond the requirements in order to further improve the performance of the organization • Consideration of the needs of and benefits to all interested parties. Customers and users will benefit by receiving the products that are: • conforming to the requirements • dependable and reliable • available when needed • maintainable People in the organization will benefit by: • better working conditions • increased job satisfaction • improved health and safety • improved morale • improved stability of employment Owners and investors will benefit by: • increased return on investment • improved operational results • increased market share • increased profits Suppliers and partners will benefit by: • stability • growth • partnership and mutual understanding Society will benefit by: • fulfillment of legal and regulatory requirements

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QMS Management Services Consulting Services for Effective Management Systems

• • •

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improved health and safety reduced environmental impact increased security

ISO 9001: 2008 requirements

Section 4 4 4.1 4.2 4.2.1 4.2.2 4.2.3 4.2.4

Quality management system General requirements Documentation requirements General Quality manual Control of documents Control of records

Clause 4.1 is the most important clause of ISO 9001. In a nutshell it gives what ISO 9001 requires from a company. Clause 4,2 deals with preparing documentation - quality manual, quality procedures, forms and work instructions etc.

Management responsibility Management commitment Customer focus Quality policy Planning Quality objectives QMS planning Responsibility, authority and communication Responsibility and authority Management representative Internal communication Management review General Review input Review output

A pro-active top management is an essential requirement of ISO 9001. Commitment of the top management towards effective & efficient implementation of QMS should be visible. Top management should establish a single purpose in the organization and should provide leadership and direction to all persons in achieving organizations aims and mission. Top management should establish quality policy & objectives, define organizational structure, responsibility & authority of personnel, appoint a management representative, conduct management review of system at defined intervals and strive for continually improving the system ad its processes. Top management should communicate all the above to all concerned at all levels in an effective manner. Top management should establish an efficient and effective system for internal communication. While doing all above and any other activity, customer should be at the focus.

Documented procedures are required to be established for 4.2.3 and 4.2.4

Section 5 5 5.1 5.2 5.3 5.4 5.4.1 5.4.2 5.5 5.5.1 5.5.2 5.5.3 5.6 5.6.1 5.6.2 5.6.3

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Section 6 6 6.1 6.2 6.2.1 6.2.2 6.3 6.4

Resource management Provision of resources Human resources General Competence, awareness and training Infrastructure Work environment

Top management should identify and provide resources needed for effective implementation of quality management systems. It should also regularly review the adequacy and effectiveness of resources. Resources include infrastructure (building,machinery, equipment etc), suitable work environment for processes and personnel, and competent man power to perform quality functions in an effective & efficient manner.

Section 7 7 7.1 7.2 7.2.1 7.2.2 7.2.3 7.3 7.3.1 7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 7.4 7.4.1 7.4.2 7.4.3 7.5 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.6

Product realization Planning of product realization Customer related processes Determination of requirements related to the product Review of requirements related to the product Customer communication Design and development Design and development planning Design and development input Design and development output Design and development review Design and development verification Design and development validation Control of design and development changes Purchasing Purchasing process Purchasing information Verification of purchased product Production and service provision Control of production and service provision Validation of processes for production and service provision Identification and traceability Customer property Preservation of product Control of monitoring and measuring devices

Identifying and planning various processes for product/service realization. Identifying and establishing various customer related processes to achieve and enhance customer satisfaction. Determining and reviewing customer requirement before accepting any contract. Establishing an effective & efficient system for communication with customer. Design & development processes, if applicable. Identifying and establishing purchasing processes, information and verification of purchased products. Planning and control of production/service provision. Identification and validation of processes required for product/service provision. Establishing a system for identification and traceability during product/service realization. Identification and control of any customer property. Establishing systems for proper handling, storage, and condition monitoring of materials in stores. Identifying monitoring/measurement parameters, suitable monitoring & measuring devices and ensuring their accuracy through calibration.

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QMS Management Services Consulting Services for Effective Management Systems

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Section 8 8 8.1 8.2 8.2.1 8.2.2 8.2.3 8.2.4 8.3 8.4 8.5 8.5.1 8.5.2 8.5.3

Measurement, analysis and improvement General Monitoring and measurement Customer satisfaction Internal audit Monitoring and measurement of processes Monitoring and measurement of product Control of nonconforming product Analysis of data Improvement Continual improvement Corrective action Preventive action

Identifying monitoring and measurement processes and their controls. Establishing suitable systems and processes for measuring customer satisfaction. Organizing internal audits through trained internal/external auditors and reviewing audit reports for any corrective and preventive actions. Reporting audit results to top management for review. Identifying data for analysis, review and continual improvement. Taking corrective actions on observed nonconformities. Taking actions for preventing potential nonconformities.

Why Get Certified? There are many reasons to implement a ISO 9000 compliant Quality Management System (QMS). Often, the market is the driving factor. However, once an ISO 9000 QMS is in place companies realize that there are internal benefits that are as important as the external benefits. When you start the implementation process you should start to see the following benefits: Process Improvements: as you implement the system, you have the opportunity to improve your processes. You will outline the current process, add the requirements of the Standard and then optimize the process with input from the process users. Increased Quality Awareness: as the system is implemented, quality awareness will increase because all staff must be regularly trained on ISO 9000 and company’s processes. After certification you should see the following benefits: Market Advantages: surveys of registered companies show that 41% were asked by a client to obtain certification. When a client requests a vendor to seek ISO registration, it can take up to 6 months or more to obtain the certification. Therefore, the vendor who has already taken ISO certification has a distinct advantage. This can be used as a strong marketing tool. ISO is becoming a requirement to do business in many markets. Certified companies currently have an advantage over their competition. Internal advantages: once certified, companies often find the greatest payoffs are internal as processes experience continual improvement. A survey of 100 registered firms reported the average improvement in operating margin at 5% of sales. Firms also report improvements in order turnaround time, scrap, and overtime. The QMS has built-in systems to report on key quality indicators: Correction and Preventive Action, Internal Audits and Management Review. Management is required to take action based on this information. These built-in systems also contribute to continual improvement by significantly reducing the reoccurrence of problems. Corrective actions issued must be addressed, the root cause determined, and action taken to prevent reoccurrence. Follow-up will make sure the action was effective. Internal audits will evaluate the effectiveness of the system, and identify opportunities for improvements. 315, Pragati Apartments, Punjabi Bagh Club Road, Paschim Puri, New Delhi – 110 063

QMS Management Services Consulting Services for Effective Management Systems

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Nonconformity identified in internal audits must be addressed. Internal auditors are also able to make observations and suggestions. Management Review is a chance for management to evaluate the performance of the QMS using information provided from the implementation of QMS. The operation will run more smoothly, with fewer crises. The QMS promotes consistency in how work is done and recorded. It helps employees learn more easily and quickly what should be done. It reduces misunderstandings with customers. When a problem occurs, it is corrected at the root cause. It does not have to be "fixed" again next week by someone else, and next month by another person. There is a strong Quality Culture due to the QMS. Internal Audits, Corrective Action and Training result in "Top of Mind" awareness of the QMS. Increased confidence in workmanship results in a more confident staff. Systems in place allow staff to address problems. Staff recognizes problems as systems or process issues. Problems are solved, not blamed on someone.

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