After reading this article you will learn about:- 1. Introduction to ISO-9000 2. History and Origin of the ISO-9000 3. Advantages 4. Effectiveness 5. Quality System Standards 6. Set of Standards 7. Quality Management Principles 8. Requirements 9. ISO-9001:2008 Version.
Introduction to ISO-9000:
ISO-9000 refers to a set of standards and is the only available internationally accepted standard for quality management system in the world. It is rapidly becoming the most important quality standard and hundreds of thousands companies in over 100 countries have already adopted it.
ISO-9000 is applicable to all types of organisations in manufacturing or service sectors. It is a documentation oriented system which allows complete freedom on selection and use of process and framing of operating procedures and work instructions.
This is a widely recognised quality management tool and meets the quality requirements of every kind of products or services. Production of consistently good quality product or service is very important for customer confidence and higher positioning of buyer perception. Every conscious company who wants to survive and grow, have either adopted this standard or in the process of adopting it.
A properly established quality management system will help to reduce cost, improve quality, develop confidence and a good image in the minds of customers and public. This requires consistent implementation, careful auditing and total commitment of the whole organisation.
ISO-9000 set of standards are “generic management system standards”. This means that the same standards can be applied:
i. To any organisation, large or small, whatever its product;
ii. Including whether its “product” is actually a service;
iii. In any sector of activity; and
iv. Whether it is a business enterprise a public administration, or a government department.
The “ISO-9000 quality management system” adopting organisations fulfill:
i. The customer’s quality requirements;
ii. Applicable regulatory requirements;
iii. Enhance customer satisfaction; and
iv. Achieve continual improvement of its performance.
Many companies require their suppliers to adopt ISO-9000 and get registered. Registered companies find that their market opportunities have increased as it ensures a sound quality management system.
Registered companies had reduction in customer complaints, significant reductions in operating costs and increased demand for their products and services. Other benefits can include better working conditions, increased market share, and increased profits.
History and Origin of the ISO-9000:
After issuing several inspection system documents in the 1950’s the U.S. military later integrated them into a set of requirements documents and issued them in December 1963 with the names of Inspection System Requirements and Quality Programme Requirements. Thereafter, documents issued were on standard clauses in procurement, contracts, required control over final inspection and testing; and then on Calibration System Requirements.
Similarly, Canadian series of standards were issued, in four levels, in the mid 1970’s and the British standard was issued, in three levels, in 1979 as quality management systems.
In the meantime, in December 1979 the United States issued Generic Guidelines for quality systems. This was a menu of quality management elements, and each organisation could choose the elements they felt were helpful, allowing them for almost infinite degree of tailoring.
Since different standards for different countries were creating problems to international trade, necessity was felt for developing internationally recognised quality management standards.
The ISO Technical Committee (TC-176) was therefore constituted, which had its first meeting in 1980, and issued its first standard ISO 8402 regarding “Quality System-Vocabulary”. Thereafter, in 1987, they issued ISO-9001, 9002, 9003 and 9004. There standards were later on revised in 1994, and then extensively revised in the year 2000.
Advantages of ISO-9000:
It is widely acknowledged that proper quality management improves business, often having a positive effect on investment, market share, sales, sales growth, sales margins, competitive advantage and avoidance of litigation. The quality principles in ISO-9000:2000 are also sound, and ISO-9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive.
Implementing ISO often gives the following advantages:
1. Creates a more efficient, effective operation.
2. Increase customer satisfaction and relation.
3. Reduces audits.
4. Improves marketing.
5. Improves employee motivation, awareness and morale.
6. Promotes international trade.
7. Increases profit.
8. Reduces waste and increases productivity.
9. Common tools for standardization.
Effectiveness of ISO-9000:
Effectiveness of ISO system being implemented depends on a number of factors, the most significant of which are:
1. Commitment of Senior Management to Monitor, Control and Improve Quality:
Organizations that implement an ISO system without this desire and commitment often take the cheapest road to get a certificate and ignore problem areas uncovered in the audits.
2. How Well the ISO System Integrates into Current Business Practices:
Many organizations that implement ISO try to make their system fit into a ready-made quality manual instead of creating a manual that documents existing practices and only adds new processes to meet the ISO standard when necessary.
3. How Well the ISO System Focuses on Improving the Customer Experience:
The broadest definition of quality is “Whatever the customer perceives good quality to be.” This means that a company doesn’t necessarily have to make a product that never fails; some customers will have a higher tolerance for product failures if they always receive shipments on time or have a positive experience in some other dimension of customer service.
An ISO system should take into account all processes that deal with three stakeholders (customers, suppliers and organization); only then will a company be able to sustain improvements in the customer’s experience.
4. How Well the Auditor Finds and Communicates Areas of Improvement:
Many auditors simply rely on submitting reports that indicate compliance or non- compliance or noncompliance with the appropriate section of the standard. Auditors that can clearly identify and communicate areas of improvement in language and terms executive management understands facilitate action on improving initiatives by the companies they audit.
When management doesn’t understand why they were non-compliant and the business implications associated with noncompliance, they simply ignore the reports and focus on what they do understand.
Quality System Standards of ISO-9000:1994:
With increased focus on quality issues worldwide, the international organisation for standardization (ISO) brought out 6 standards. One on standards terminology (ISO 8402) and 5 standards (known as ISO 9000 series). This series of standards establish requirements with which company’s Quality Management System can be installed, operated and also evaluated both in-house and independently by third parties. The ISO 9000 series of standards serve as a basis for ensuring quality to all providers of goods and services.
ISO 8402 Quality system — Vocabulary
ISO 9000 Quality systems — Guidelines for selection and use of standards on quality systems.
ISO 9001 Quality systems — Models for quality assurance in design/development, production, installation and servicing.
ISO 9002 Quality systems — Model for quality assurance in production and installation.
ISO 9003 Quality systems — Model for quality assurance in final inspection and test.
ISO 9004 Quality Management and quality system elements — Guidelines.
Areas Covered in I.S.O. 9000:1994:
1. I.S.O. 9000 provides the guidelines for selection and use of the quality standards.
2. I.S.O. 9001 is a quality system model for quality assurance in design/development, production, installation and servicing. This is most exhaustive standard. The engineering organisations, where the manufacturing capabilities are based on in-house designs have to work for ISO 9001 certification.
Manufacturers of:
(a) Household goods like TV, refrigerator etc.
(b) Perishable consumer goods like tooth-paste etc.
Which have both servicing and design/development have to work towards ISO 9001.
3. I.S.O. 9002 provides a model for quality assurance only in production and installation. It does not cover areas of design/development and servicing. ISO 9002 also looks at internal quality audits. Steel plants, departmental stores, hospitals, chemical plants etc., where the designing and servicing do not constitute the key activities, may prefer ISO 9002.
4. I.S.O. 9003 deals only with quality systems related to final inspection and testing.
5. I.S.O. 9004 provides guideline for quality management and quality system elements.
In addition to the I.S.O. 9000 series, I.S.O. 8402 deals with vocabulary used in the ISO 9000 series.
Certification:
It is the mechanism by which a customer can have confidence in a company and is most effective when carried out by a national certification body. In Europe, already both large and small purchasing organisations place great importance upon the ability of their suppliers to demonstrate that they are operating effective quality system which meet the fact that the company operates a quality system complying with the standard allows the purchaser to have increased confidence in the quality of the product concerned with the supply of product. Assessment and registration of a quality management system to ISO 9000 series is done by a third party.
Set of Standards for ISO-9000: 2000:
ISO-9000: 2000 includes three quality standards:
ISO-9000: 2000, ISO-9001: 2000 AND ISO-9004: 2000.
In these standards ISO-9001: 2000 presents requirements, while ISO-9000: 2000 and ISO-9004: 2000 presents guidelines, All of these are process standards (not product standards). The certificate is awarded to an organisation in respect of compliance of standards ISO-9001: 2000.
Following standards make up the ISO 9000: 2000 family:
From the above it is clear that, in order to develop a quality management system, you are required to only meet the requirements specified by ISO-9001: 2000. You can consult the ISO- 9000: 2000 and ISO-9004: 2000 guidelines only when you need clarification.
Your quality management system must simply meet requirements as specified in ISO-9001: 2000. When your quality system has been fully developed and implemented, you carry out assessment to ensure that you met every signal. ISO-9001: 2000 requirement. When you are ready, ask an external auditor to audit the effectiveness of your quality management system.
If your auditors find that you have introduced and implemented the ISCI-9001: 2000 standards, they will certify that your quality system had met ISO’s requirements. They will then issue an official certificate to you and will record your achievement in their registry. You can then announce to the world that the quality of your products and services is managed, controlled, and assured by a registered ISO-9001: 2000 Quality Management System.
Quality Management Principles of ISO-9000: 2000 Standards:
ISO-9000: 2000 standards are based on eight quality management principles. ISO chose these principles because they can be used to improve organisational performance and achieve success. These principles can be used by senior management as a framework to guide their organisation towards improved performance.
The eight quality management principles as given in the ISO-9000: 2000, Quality management system-Fundamentals and vocabulary; and in ISO-9004-2000, Quality management systems-Guidelines for performance improvements are:
Principle 1: Focus on Your Customers:
Organisations depend on their customers.
Therefore:
i. Organisations must understand customer needs.
ii. Organisations must meet customer requirements.
iii. Organisations must exceed customer expectations.
Principle 2: Provide Leadership:
Organisations rely on leaders.
Therefore:
i. Leaders must establish a unity of purpose and set the direction the organisation should take.
ii. Leaders must create an environment that encourages people to achieve the organisations objectives.
Principle 3: Involvement of People:
People at all levels are the essence of an organisation and therefore:
i. Organisations must encourage the involvement of people at all levels.
ii. Organisations must help people to develop and use their abilities.
Principle 4: Use a Process Approach:
Organisations are more efficient and effective when they use a process approach.
Therefore:
i. Organisations must use a process approach to manage activities and related resources.
Principle 5: Take a System Approach:
Organisations are more efficient and effective when they use a systems approach.
Therefore:
i. Organisations must identify inter-related processes and treat them as a system.
ii. Organisations must use a systems approach to manage their inter-related processes.
Principle 6: Encourage Continual Improvement:
Organisations are more efficient and effective when they continually try to improve.
Therefore:
i. Organisations must make a permanent commitment to continually improve their overall performance.
Principle 7: Get the Facts Before Taking a Decision:
Organisations perform better when their decisions are based on facts.
Therefore:
i. Organisations must base decisions on the analysis of factual information and data.
Principle 8: Mutually Beneficial Supplier Relationship:
Organisations depend on their suppliers help them create value.
Therefore:
i. Organisations must maintain a mutually beneficial relationship with their suppliers.
Requirements of ISO-9001: 2000:
ISO-9001: 2000 is the standard intended for quality management system assessment and registration. This apply uniformly to organisations of any size or description. ISO presents its requirements in section 4 to 8 of ISO-9001: 2000 standard.
Broad features of these sections and requirements there of which have to be built in the documentation and then implemented are given hereunder:
Section 4: Systematic Requirements:
Establish your quality system. Your organisation needs to document and use a quality system. Then, there is a need to continually improve it.
For this, the organisation must:
i. Identify Key processes to meet customer requirements.
ii. Establish the order of these processes and how they fit together.
iii. Establish how you will control these processes.
iv. Make resources available to support these processes.
v. Measure these processes to not only ensure that they do what you wanted to about that you plan for them to improve.
vi. Where any process has been out soured, it must be ensured that control over them is retained.
vii. Implement your quality management system.
viii. Manage and monitor process performance.
ix. Improve the quality management system.
Documentation Requirements:
i. Develop documents that reflect what organisation does.
ii. Develop documents to implement quality system including quality policy and objectives.
iii. Document procedures.
iv. Describe as to how processes interact.
v. Prepare Quality Manual including the scope of quality system.
vi. Approve documents before their distribution.
vii. Provide the correct version of documents at points of use.
viii. Review and re-approve documents whenever they are updated.
ix. Monitor documents that come from external sources,
x. Quality records (working forms/registers or other records) are used and kept to prove the system is functioning properly.
xi. Develop a procedure to control records.
Section 5: Management Requirements:
Management Commitment:
Top management should support the Quality Management System and should involve in its continual improvement.
i. Promote the importance of quality.
ii. Promote the need to meet customer requirements, regulatory requirements, and statutory requirements.
iii. Develop a quality management system.
iv. Establish quality policies.
v. Ensure quality objectives are established.
vi. Provide quality resources.
vii. Implement quality management systems.
viii. Perform quality management reviews.
ix. Improve quality management system.
Customer Focus:
i. Understand and identify customer requirements.
ii. Meet customer’s requirements.
iii. Enhance customer satisfaction.
Establish a Quality Policy:
i. Define the organisation’s quality policy and ensure that it serves the organisations purpose.
ii. Ensure that it emphasises the need to meet requirement.
iii. Ensure that it facilitates the development of quality objectives.
iv. Ensure that it makes a commitment to continuous improvement.
v. Review the policy to ensure that it is still suitable.
Quality Planning:
i. Formulate quality objectives by ensuring that objectives are set for functional areas.
ii. Ensure that objectives support the quality policy.
iii. Ensure that objectives are measurable.
iv. Plan the development and implementation of quality management system.
v. Plan the improvement of quality management system.
Control the Quality System:
i. Define and communicate responsibilities and authorities.
ii. Appoint management representative who should oversee the quality management system and report the status regularly.
iii. Ensure sufficient communication processes are established.
Management Review:
i. Evaluate the performance of quality system and whether it should be improved.
ii. Inputs to management review shall include: results of audits; customer feedback; process performance and product conformity; any preventive and corrective actions; previous actions and their outcomes and recommendations for improvements.
iii. Generate actions to improve quality system and products.
Section 6: Resource Requirements:
Provision of Resources:
i. Provide resources needed for implementing the quality management system (QMS) and make sure that customer requirements are being met.
Providing Human Resources:
i. Provide competent personnel for which ensure that they have the right experience, education, training and skills.
ii. Maintain a record of competence.
Providing Infrastructure:
i. Provide and maintain the infrastructure needed to achieve product/service conformity to requirements.
Providing Work Environment:
i. Identify needed work environment.
ii. Manage needed work environment.
Section 7: Realisation Requirements:
Planning of Product Realisation:
i. Plan and develop processes needed to realise (make/generate) the product in line with QMS.
ii. Develop methods to control quality during product realisation.
Customer Related Processes:
i. Identify customer requirements and other requirements imposed by external agencies (including statutory requirements) and the requirements that organisation wishes to meet.
ii. Review customers product requirement before you agree to sell it.
iii. Handle any changed requirements.
iv. Communicate with customers by developing a process control communications with customers and implement it.
Product Design and Development:
i. Define your product design and development stages.
ii. Clarify design and development responsibilities and authorities.
iii. Manage interaction between design and development groups.
iv. Update design and development plans as changes occur.
v. Define design and development inputs.
vi. Create product design and development inputs.
vii. Approve design and development outputs prior to release.
viii. Use design and development output to control product quality.
ix. Carry out design and development reviews.
x. Perform design and development verifications.
xi. Conduct design and development validations.
xii. Manage design and development changes.
Control Purchasing Function:
i. Control purchasing process-For this ensure that suppliers as well as purchased product meet requirements.
ii. Describe the products which are being purchased.
iii. Specify the requirements that must be met.
iv. Verify purchased products at suppliers premises and also at your own premises.
Control Production and Service Activities:
i. Control production and service provisions i.e., processes information’s, instructions, equipment, measurements and other activities.
ii. Validate production and service provision i.e., proves that processes, personnel and equipment can produce planned outputs.
iii. Identity and track the products i.e. establish and maintain the Intently of the products and their status.
iv. Protect the property (drawings, data, personnel, environment etc.) supplied by the customers.
v. Preserve the products and components during internal processing as well as during final delivery.
Control of Monitoring and Measuring Devices:
i. Calibrate the equipment and verify them at specified intervals or prior to use against any relevant standards.
ii. Calibration must be adjusted as necessary.
iii. It must be identified to establish when the equipment will require recalibration.
iv. Calibrated equipment must be stored and used in such a way as to prevent its misalignment.
Section 8: Remedial Requirements:
Perform Remedial Processes:
i. Plan and implement remedial processes to demonstrate that a process is capable of producing desired results.
ii. Use remedial processes to improve QMS.
Monitor and Measure Quality:
i. Monitor and measure customer satisfaction.
ii. Plan and perform regular internal audits.
iii. Monitor and measure quality processes.
iv. Take action when processes fail to achieve planned results.
v. Monitor and measure product/service characteristics.
vi. Keep a record of product/service monitoring and measuring activities.
Control Non-Conforming Products:
i. Ensure that products/services/processes not conforming to requirements/plans are suitably identified and controlled to prevent misuse.
ii. Controls and responsibilities must be identified within a documented procedure.
iii. Re-verify non-conforming products that were corrected, meet the requirements.
iv. Maintain records of such products and describe the actions taken to deal with nonconformities.
Analyse Quality Information/data:
i. Demonstrate the effectiveness of the quality system and then evaluate where continual improvement can be achieved. Standard indicators are usually; customer satisfaction; conformance to requirements; characteristics and trends of processes and products; and supplier performance.
Make Quality Improvements:
i. Improve quality management system through the use of quality policy, objectives, audits, analysis of data, corrective and preventive actions and management review.
ii. Corrective action be taken after analysing cause of problems and a documented procedure be written to this effect.
iii. Record the results that corrective actions achieve.
iv. Examine the effectiveness of corrective actions.
v. Develop preventive actions to eliminate potential problems. For this a documented procedure should be established.
ISO-9001:2008 Version:
ISO-9001:2008 basically narrates ISC)-9000:2000. The 2008 version only introduces clarifications to the requirements of ISO-9001:2000 and some changes intended to improve consistency with ISO-14001:2004. There were no new requirements.
This fourth edition (first edition ISO-9000:1987 version, second edition ISO-9000:1994 version, third edition ISO-9000:2000 version, fourth edition ISO-9000:2008 version) cancels and replaces the third edition, which has been amended to clarify points in the text and to enhance compatibility with ISO-14001:2004.
This version states that the design and implementation of an organization’s quality management system is influenced by:
(a) Its organizational environment, changes in that environment and the risks associated with that environment,
(b) Its varying needs,
(c) Its particular objectives,
(d) The products provided,
(e) The process employed, and
(f) Its size and organizational structure.
It is not the idea of this standard to imply uniformity in the structure of quality management systems or uniformity of documentation.
This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system to enhance customer satisfaction by meeting customer requirements.
According to this new version, ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customers, statuary and regulatory requirements. The type and extent of control to be applied to the outsourced processes shall be defined within the quality management system.
This new version also defines the term ‘work environment’ which relates to those conditions under which work is performed including physical, environmental and other factors (such as noise, temperature, humidity, lighting or weather).
This version also includes the post-delivery activities under the heading “customer-related processes” which include actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.