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Today every organization work hard to get ISO approval certificates, as it plays an important role for conducting business internationally. I have chosen this topic to understand the following things: What is ISO? What is ISO 9000? Series of ISO 9000 Benefits of ISO 9000 What is ISO 14000? Series of ISO 14000 Benefits of ISO 14000
WHAT IS ISO?
ISO i.e. International Organization for Standardization is the world's largest developer and publisher of International Standards. ISO is a network of the national standards institutes of 157 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. The word ISO is derived from GREEK word ISOS, meaning, EQUAL, so only we notice abnormality when we use full form international organization for standardization i.e. IOS , shouldnt be but it is ISO because of its origin in GENEVA. ISO is a non-governmental organization that forms a bridge between the public and private sectors. On the one hand, many of its member institutes are part of the governmental structure of their countries, or are mandated by their government. On the other hand, other members have their roots uniquely in the private sector, having been set up by national partnerships of industry associations. The mission of ISO is to promote the development of standardization and related activities in the world. With a view to
facilitating international exchange of goods and services and to developing cooperation in the spheres of intellectual, scientific, technological and economic activity. ISO standards are developed by technical committees. The people who serve on these technical committees come from many national standards standards organizations. Consequently, ISO tend to have worldwide support. ISO revises its
standards during a period of time. ISO Management Systems are published six times a year by the Central Secretariat of ISO (International Organization For Standardization) and is available in English, French and Spanish editions.
The Plan Do Check Act (PDCA) cycle is the operating principle of ISO's management system standards.
Plan:
Establish objectives and make plans (analyze your organization's situation, establish your overall objectives and set your interim targets, and develop plans to achieve them).
Do:
Check: Measure your results (measure/monitor how far your actual achievements meet your planned objectives). Act: Correct and improve your plans and how you put them into practice (correct and learn from your mistakes to improve your plans in order to achieve better results next time).
map
of
standards
bodies
who
are
ISO
members
Key: members ISO ISO has 157 national members out of the 195 total countries in the world. ISO is made up of its members which are divided in to three categories:
correspondent members
subscriber members
Member bodies are national bodies that are considered to be the most representative standards body in each country. These are the only members of ISO that have voting rights. Correspondent members are countries that do not have their own standards about ISO's organization. work, but These members are in informed do not participate
standards promulgation.
Subscriber members are countries with small economies. They pay reduced membership fees, but can follow the development of standards.
A member body takes the responsibility for: Informing potentially interested parties in their country for international standardization. Ensuring that a concerted view of the countries interest is presented during international; negotiations dealing to standard agreements. Providing countries share of financial support for the central operations of ISO through payment of membership dues. Member bodies are entitled to exercise fill voting rights on any technical committee and policy committee of ISO. Participating members are called "P" members as opposed to observing members which are called "O" members.
I S O 9 0 0 0 is a set of quality management standards governing quality assurance. It provides a frame work for a systematic approach to process management that requires an organization to keep a detailed accounting of its procedures and work. This includes documenting the process for how a company designs, produces, inspects, packages, and installs product. The structure focuses on management of process, these results in continuous process improvement through a quality system. It focuses on writing down procedures and defining policies regarding how an order is processed? It starts with taking customers orders and follows the order through manufacturing and assembling to shipment and deliver the underlying. The unwritten message is that the product should meet the customers need. The decision to implement ISO 9000 is driven by two dominant factors: the desire to remain competitive and the desire to implement a quality system to lower operating cost.
ISO 9000 was written by international organization of standardization (ISO) of Geneva, Switzerland which was founded in 1946 to develop a common set of manufacturing, trade and communications standards that are widely used today. Standards developed by ISO are voluntary; there are no legal requirements to force a country or organization to adopt them.
GUIDES
CONFORMANCE MODEL
production,
ISO 9002
Quality
assurance
in
production,
ISO 9003
Guidelines for selection & use of the GUIDES ISO 9000 standards on quality management system assurance. elements & quality
ISO 9004
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11
3.
Contract Review
4.
Design Control
5.
6. 7.
8.
9. 10.
12
11.
12.
13.
14.
15.
16.
17.
Quality systems standards are published by ISO in order to built quality products and encourage quality improvements in organization. ISO 9000 has 3 models for quality assurance and quality improvements: ISO 9001, ISO 9002 and ISO 9003. QUALITY SYSTEM REQUIREMENTS: 1) MANAGEMENT RESPONSIBILITY: Quality is top managements responsibility. Hence it must organize plan and be committed to quality. 1.1) Quality Policy: Management shall define an document quality policy. It shall contain objectives for and commitment to Quality shall relevant to organizational goals and customer needs. It shall also ensure that it is understood and implemented at all levels. 1.2) Organization: define, document responsibility, authority and inter-
1.2.1) Responsibility and Authority: Under this management should relationship of personnel and also of those whose work affects quality. 1.2.2) Resources: In this management should identify requirement, provide requirement. Resources include trained personnel. 1.2.3) Management Representative: He is a member of suppliers own management. He shall:
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Have authority to ensure that quality system is established, implemented and maintained. He shall report to management on performance of the system. 1.3) Management Review: In this Management shall review quality systems at defined intervals to ensure suitability and effectiveness of system. 2) Records of such reviews shall be maintained.
QUALITY SYSTEM: maintain a quality system to ensure that product conforms to specified requirements in addition a: Quality manual is to be prepared covering requirements of this standard. Quality manual shall refer to or include quality system procedures. Quality manual should outline documentation structure.
2.2) Quality System Procedures: Procedures consistent with quality policy should be prepared carefully implement the same. 2.3) Quality Planning: Preparing of quality plans and how the requirements of quality are to be met. While doing quality planning supplier should pay attention towards products, projects or contracts. 3) 3.1) CONTRACT REVIEW: General: Pre-tender review before submission of tender. 15
Customer review after receipt of order but before its acceptance. 3.2) Review: Ensure that: Requirements are adequacy defined and documented. Differences between tender and order are resolved. Capability to meet requirements exists. 3.3) Amendments to a Contract: establish procedures for
amending a contract and for correctly transferring that information to appropriate functions. 3.4) 4) Records: Maintain records of contracts reviewed. DESIGN CONTROL: of design to ensure meeting customer requirement. 4.2) Design and Development Planning: To define responsibility for design and development activity. To assign the activity to qualified staff.
4.3)
Organizational and Technical Interfaces: Identify the above in various groups. Identify type of information flow across groups. Review the information flow regularly.
4.4)
Design Input:
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Identify
inputs
including
statutory
and/or
regulatory
requirements. Review inputs for adequacy. Identify personnel who will be responsible for documenting, verifying and resolving ambiguous or conflicting input requirements. Take in to account contract review results. 4.5) Design Output: It shall be verified and validated against input requirements. Output shall: Meet input requirements. Give acceptance criteria. Identify crucial characteristics for safe functioning. Review output before release. 4.6) Design Review: Decided on appropriate stages of review. Plan, conduct and document review. All functions concerned shall participate. Maintain records of review. 4.7) Design Verification: Verify design appropriate stages. Consider alternate calculations. Record verification measures. Review the stage documents before release. 4.8) Design Validation: Follow design verification. Perform under defined operating conditions.
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Normally performed on final product. 4.9) Design Changes: Authorized personnel to identify document, review and approve design changes before implementation. 5) 5.1) DOCUMENTS AND DATA CONTROL: General: Ensure availability of latest versions of document and data such as standards, procedures, referenced materials etc. at the location of there use. Functional responsibilities for documents and data control are to be spelled out. Document and data can be maintained in hard copy or electronic media. 5.2) Document and Data Approval and Issue: Authorized personnel to review for adequacy and approve. Establish master list to identify revision status. Control to ensure that: Right document at right place. Obsolete documents are not issued or used. Identification of retained obsolete documents. 5.3) Document and Data Changes: Generally original and approving authority shall review and approve changes. If specifically designated, others can do it, provided they have access to all required information.
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Where practicable identify changes on document itself or an attachment. 6) 6.1) PURCHASING: General: Purpose is to ensure that product purchased meet specified requirements. 6.2) Evaluation of Sub-Contractors: Evaluate and select based on there ability to meet the requirements. Define the type and extent of controls exercised over subcontractor. Establish and maintain records of acceptable subcontractors. 6.3) Purchasing Data: Purchasing documents shall clearly describe the product ordered. 6.4) Verification of Purchased Product: to specify verification arrangements and methods of product release in the purchasing documents.
6.4.2) Customer Verification of Sub-Contracted Products : Customer has prerogative to verify at suppliers and sub-contractors premises that sub-contracted product conforms to specified requirements.
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7)
CONTROL OF CUSTOMER SUPPLIED PRODUCT: Control of verification, storage and maintenance of customer supplied product. Report loss of damage or rejection to customer and maintain record.
8)
PRODUCT IDENTIFICATION AND TRACE ABILITY: Identify product at all stages of receipts, production, delivery and installation. Providing unique identification of trace ability is a specified requirement.
9)
PROCESS CONTROL: Identify and plan production, installation and servicing processes. Carryout processes under controlled conditions. Carryout maintenance of equipment to ensure continued process capability. Specify requirements for qualification of process operations, equipment and personnel.
INSPECTION AND TESTING: General: Required inspection and testing to be detailed in the quality plan or procedure. Receiving, Inspection and Testing: Verification of incoming
material in accordance with quality plan and procedures before use. Positive recall procedure for urgent production purposes. 10.3) In Process Inspection and Testing:
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Verification of the process in accordance with quality plan. Focus on defect prevention methods-specification error, proofing, visual control, etc. 10.4) Final Inspection and Testing:
Carry out the final inspection & testing as per quality plan. Product not be dispatched until all inspection and test activities are satisfactorily completed and documentation authorized. 10.5) Inspection and test Records:
Record of inspection and test to be maintained. Records to identify authority responsible for product release. 11) 11.1) CONTROL OF INSPECTION AND MEASURING: General: Documented procedures to control calibrate and maintain inspection, measuring and test equipment including software. 11.2) Control Procedure:
Select appropriate procedure. Identify equipment that can affect product quality. Calibrate such equipment that can affect product. Indicate calibrate status. Maintain calibration records. Assess validity when equipments is found to be out of calibration. Ensure proper handling, storage and preservation of equipments.
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12)
INSPECTION AND TEST STATUS: Defining quality plan their stages at which the inspection and test status needs to be indicated. Indicate the status by suitable means.
13) 13.1)
CONTROL OF NON-CONFORMING PRODUCTS: General: Non-conforming product shall be prevented from unintended use or installations. Hence it has to be identified, documented, evaluated and segregated when practical and concerns functions notified.
13.2)
Rework Accept with or without repair Regard for alternate application Reject or scrap Obtain concession from customer when required contractually. Re-inspect repaired product as per quality plan.
14) 14.1)
CORRECTIVE AND PREVENTION ACTION: General: Documented procedures for corrective and preventive action.
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14.2)
Analyze quality records, audit records, concessions and Detect and analyze potential causes non-conformities. Decide on preventive action. Implement and ensure its effectiveness. Submit for management review. 15) HANDLING, STORAGE, PACKAGING, PRESERVATION AND DELIVERY: 15.1) General: Maintenance of procedures for safe handling, storage, packaging and delivery of products. 15.2) 15.3) Handling: Methods to prevent damage or deterioration. Storage:
Designated storage areas. Prevent damage or deterioration. Stipulate methods of receipt and dispatch to and from such areas. Inspect products at appropriate intervals to detect deterioration.
15.4)
Packaging:
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Material shipped to be labeled according to the customer requirements. 15.5) Preservation: Use of appropriate methods for preservation and segregation. 15.6) Delivery:
Protect product quality after final inspection and testing. If contractually required extend delivery to destination. 16) CONTROL OF QUALITY RECORDS: Identify quality records. Index the file. Store and maintain in a suitable environment to prevent damage, deterioration or loss. Determine detention period. 17) INTERNAL QUALITY AUDITS: Plan and schedule audits. Carryout as per plan by independent personnel. Record results of audit and notify auditor to take up timely corrective action.
18)
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19)
SERVICING: Establish procedures for performing, verifying and reporting that servicing meet specified requirements.
20) 20.1)
STATISTICAL TECHNIQUES: General: Identification of need. Identify appropriate statistical techniques for inspection, process control and other activities.
20.2) Procedures:
Establish
documented
procedures
for
PRODUCT CATOGORIES
ISO 9000 has categorized all possible products that can be supplied by any organization in to four generic categories:25
1. HARDWARE: Consisting of tangible, discrete products in to distinctive forms. Normally it is manufactured, constituted or fabricated parts. 2. SOFTWARE: An intellectual creation of information expressed through supporting medium. It may be in the form of concepts, transaction or procedures. 3. PROCCESED MATERIALS: Tangibles products generated by transforming raw material in to a desired state. The state of processed material can be liquid, gas, ingot, filament and sheet and its typically stored in drums, bags, tanks, cylinders, pipelines or rolls. 4. SERVICES: The results by activities at the interface between supplier and the customer and by supplier interval activities, to meet customer needs. ISO 9000 family of standards is applicable to all four generic product categories. The standard states that quality system requirements are essentially same for all generic product categories. However the terminology management system details and emphasis may differ.
1. Management commitment. 2. Defined responsibilities. 3. Complete written statement of Policy & object Objective Procedures & detailed instructions Control information 4. Regular internal audits of system 5. Assurance that employees have skills, qualification and training appropriate to their tasks.
principles because they can be used to improve organizational performance and achieve success. But how can you make sure that your organization applies these principles? The answer is to implement a quality management system that meets the ISO 9000 standard. If the organizations do so, then that organization will automatically apply these principles. This is because they permeate the new standard and will therefore be built in to any quality system that is based on this standard. If you want to improve the performance of your organization, you need to develop and implement an ISO 9001 quality management system that applies the eight principles listed below.
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1.
understand customer
Organizations
must
exceed
customer
2.
Provide leadership
Leaders purpose
must and
establish set
unity
of
the
direction
3.
Organizations
must
encourage
the
Organizations
must
help
people
to
4.
develop and use their abilities. Organizations are more efficient and effective when they use a process approach. Therefore:
Organizations
must
use
process
approach to manage activities related 5. Take a systems approach resources. Organizations are more efficient and effective when they use a systems approach. Therefore:
Organizations
must
use
systems
approach to manage their inter-related 6. Encourage continual processes. Organizations 29 are more efficient and effective when they continually try to improve.
appropriate model, assembling a steering committee, choosing a and (possibly) documenting process, implementing all new processes, and undergoing a third party audit by the registrar. Once certification is achieved, he company continuous to be audited by the registrar at regular intervals. After achieving ISO certification the benefits of process management by quality kick in. In fact, registration is just the first step on the path to continuous improvement. Organizations defect statistics low find to they can significantly locus. Their reduce the
potential for production errors or reworks. They are able to drive impressive streamlined processes enable reduced in-process testing and inspection, saving time and lowering costs. ISO 9000 makes continuous improvement a matter-of-fact process that delivers results to the bottom line. Companies that have been registered for several years will justify to the power and positive impact of ISO 9000 on their operations.
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procedures are written and what need to be written. 3. Develop time lines and goals for each department. 4. Start documenting, develop a standard format, revise existing procedures, create new ones, create the top-level quality manual. 5. Select a registrar. 6. Assign and train internal auditors, conduct at least one internal audit of the procedure. 7. Submit the manual for a best audit to registrar. 8. Undergo an audit by the registrar. 9. Receive an ISO 9000 certification or registration.
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2. Selection of ISO 9000 Standard: The selection of appropriate ISO 9000 standard may be organized on organization to organization. If company produces some product for which design/ development, production, installation and servicing
criterias are important then it should go for ISO 9000. If there is only production and installation involved then go for ISO 9000. If only inspection and testing is involved then ISO 9003 is the best option.
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If organization deals with management of services then 9004 is the best alternative.
3. Quality Manual: A company shall prepare quality policy manual which shall contain policies, procedures, work instruction and records. Policies: It have to be documented in a quality policy manual which describes what the company does to ensure that quality is maintained in each of these areas covered by clauses. Procedures: It describes how each process work is done. They demonstrate how policies are implemented. Work Instruction: Describing how specific work practices are done in detail and or a more local level than the procedures allow. In smaller organizations procedures and work instructions may be the same. Records: Records of work compiling of forms,
contracts, checklists etc. which need to be maintained and preserved wherever necessary. 4. Implementation of Quality System as per Manual: The job of management does not end with formulation, documentation, updating and correction in quality manual. But there real job starts after this: They have top educate grass root level employees about procedures and work instructed formulated. Take due care for this follow up.
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5. Internal Compliance Audit: In this step, company verifies and checks another documented systems and procedures are implemented in practice. This audit can be done by: Internal auditors. External auditors.
based
on
After doing internal compliance audit, company would know about discrepancies in implementation and would have ample time for its correction and updating. 7. Maintaining that system for sufficiently long to prove that system is stabilized: Frequent changes in systems are not advisable as it would waste unnecessary time on training and lead confusion at grass root level. 8. Verification and conformation by continuous internal auditing and assessment: Once systems are designed that does not mean that all products will be quality assured but due to frequent verification and audits they should be maintained and errors or non-conformances if any should be removed. 9. Selection of Certifying Agency: After selecting appropriate ISO 9000 standard and formulation and documentation of policy and quality manual
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company certificate.
should
invite
certifying
agencies
for
getting
10. Offering Quality Manual to that agency for adequacy audit. 11. Updating/Corrections/Improvements of quality manual based on adequacy audit report. 12. Fixing date of compliance auditing with certifying agency. 13. Compliance auditing with certifying agency. 14. Updating/Corrections/Improvements based on audit reports/ NCAPs (Non- conformance audit reports): According to ISO 8420 Non-conformity, refers to nonfulfillment of specified requirement. If any non-conformity is observed in system or quality manual than it should be corrected by taking proper action. 15. Verification/Certification certificate: and Registration Generally of the
process of registration is proceeded by a pre-assessment. The accreditation is requested to evaluate the state of readiness so that minor inadequacies can be attended to. Finally accreditation agency carries out an assessment and will advice an registrar.
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16. Maintaining the Quality System Maintaining quality system and continuing the internal auditing. It is never ending but continuous process. 17. Review audit at the intervals of six months by certifying agency: The organization needs to internalize the quality management system and every member has to fulfill his role in ensuring compliance, as certifying agency conducts audit at interval of six months. 18. Valid for three years: An ISO certificate is not a once-and-for-award; it must be renewed at regular intervals recommended by the certification body, usually around three years. 19. Adequacy audit and Compliance audit The assessor look for information to prove whether the system are adequate enough to meet ISO 9000 standards i.e. adequacy audit and to prove that systems are being followed i.e. compliance audit. 20. Adequate records as proof must be available.
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documented systems and procedures are being followed implemented in practice. This is either calendar led or event led. Both the audits are carried out in two stages. a) By Internal Auditors- who are trained to have a selfassessment and correction? There can be multiple internal audits before external audit. b) By External Auditors- mainly for certification purpose. These audits provide information to the management to know the status of the organization with respect to the quality system and to take appropriate corrective/improvement actions. For the discrepancies/ non-conformances mentioned in the audit reports.
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After the success of the ISO 9000 series of quality standards, the International Standards Organization published a comprehensive set of standards for environmental management. This series of standards is designed to cover the whole area of environmental issues for organizations in the global marketplace. ISO Secretary-General Alan Bryden: In a decade, ISO 14001 has become a globally relevant tool for managing the environmental impact of human activities. At the same time, ISO International Standards as a whole constitute a toolbox not only for the environmental integrity of the planet, but also for economic growth and social equity. In the globalization world, the environmental issues seem to be one of the most important topics. The pollution created in any manner such as air emission, effluent, land contamination, etc.,
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have several impacts to people throughout the world. Upon this pressure, the International Organization for Standardization has developed the environmental management standards which is known as the ISO 14000 Series. The ISO 14000 set of standards was created in 1996 and revised in 2004. The purpose of this standard is to help diverse
organizations protect the environmentto prevent pollutionand to improve their overall environmental performance. In other words, it is what an organization does to: Minimize harmful effects on the environment caused by its activities
Achieve Remove
continual uncertainty
improvement and
of
its
environmental by managing
performance
inconsistency
Give competitive advantage to avoid international trade barriers Help companies stay in compliance with regulatory
requirements
Improve overall performance. implement, assure itself maintain of its and improve an its environmental own stated management system
conformance
with
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seek certification of its environmental management system by an external third party organization make a self-determination of conformance
CONCEPT OF EMS
Briefly, the concepts of EMS are as follows: 1. Environmental Policy: Initially, the organizations top
management should have commitment and define the policy on EMS which is used for the direction of implementing and improving its EMS. 2. Planning: In order to achieve environmental policy, at least, the organization should:
Identify the environmental aspects of its activities and specify those which have significant impacts on the environment. Identify legal and other requirements to which the
organization involved.
Establish objectives and targets of its activities having impacts to environment. Establish environmental programmes for achieving its
objectives and targets. 3. Implementation: In order to achieve environmental planning, at least, the organization should:
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Communicate to the staffs at each level for the importance of conformance to the environmental policy; provide appropriate training to personnel performing the tasks to gain their knowledge and competence. Establish and control documentation relating to EMS. Control operations and activities to meet the specified objectives and targets. Identify potential accidents and emergency situations for preventing and mitigating the environmental impacts that may be associated with them and periodically test such procedures where practicable.
4.
Checking
and
Corrective
Action:
To
ensure
that
the
organization is performing in accordance with the stated EMS programmes, at least, the organization should:
Monitor and measure its operations and activities against the organizations plans. Identify non-conformance and take action to mitigate any impact caused. Record the on-going activities of the EMS. Conduct periodic EMS audits. Management Review: The organizations top management should review and continually improve its EMS, with the objective of improving its overall environmental performance.
5.
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foundation of the ISO 14000 group of international environmental management standards. An EMS can be registered as meeting the ISO 14001 EMS standard. Since the ISO 14001 EMS includes everyone in the Organization and all aspects of the Organization that affect the environment, it can improve an organization's environmental performance in many ways. This improved performance comes at a cost to the Organization, a cost that can be recovered by aggressively seeking benefits. Following are the benefits of implementing an EMS:
Managing organizations environment systematically. Obtaining better surroundings as well as providing protection to the potential emergency. Maintaining good public/community relation. Reducing environmental cost because of appropriate
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participate in environmental protection, the environmental management system considers all stakeholders, and there are processes to identify all environmental impacts. Proactive: It focuses on forward thinking and action instead of reacting to command and control policies. Systems Approach: system It across stresses all on improving of the
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GUIDE 14000 14010 14011 14012 14013 14015 14031 14032 14060
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48
STANDARD
DESCRIPTION
14000
14001
Environmental
Management
Systems
14010
14011
Guidelines for Environmental Auditing - Audit Procedures-Part 1: Auditing of Environmental Management Systems
14012
Guidelines
for
Environmental
Auditing
14013/15
14020/23 14024
Environmental Labeling Environmental Labeling - Practitioner Programs - Guiding Principles, Practices and Certification Procedures of Multiple Criteria Programs
14031/32
Guidelines Evaluation
on
Environmental
Performance
14040/43
An organization should focus on what needs to be done - it should ensure commitment to the EMS and define its policy.
An
organization
should
formulate
plan
to
fulfill
its
environmental policy.
For effective implementation, an organization should develop the capabilities and support mechanisms necessary to achieve its environmental policy, objectives and targets.
An organization should review and continually improve its environmental management system, with the objective of improving its overall environmental performance.
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52
53
54
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