Iso 9000 [PDF]

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IS0-9000 (Quality Management System- QMS) Unit IV:Chapter 11: Quality Control: Importance of quality; Elements of quality; Organization for quality control; Quality assurance techniques; Documentation; Quality control circles; Total quality management; ISO – 9000.

1. About ISO:         

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International Organisation of Standardization Develops and Publishes standards Independent, Non Governmental International organization Has central Secretariat located in Geneva, Switzerland Derived from Greek ISOS meaning equal.Whatever the country, whatever the language, we are always ISO Facilitate –International coordination and unification of Industrial Standards Published 22598 International Standards and related Documents, Covering almost every industry, from technology to food safety, to agriculture and Healthcare It impact everyone,everywhere International Organization for standardization would have different acronyms in different languages(IOS in English, OIN-Organisation Internationale de normalisation- in French The ISO 9000 family of standards is the same across the globe even though they are called by different names. Each member country has their own entity authorized by ISO to manage the standards, but they are all the same exact ISO 9000 quality documents.

 ISO story began in 1946 when delegates from 25 countries met at the Institute of Civil Engineers in London and decided to create a new international organisation to facilitate internation coordination  On 23 February 1947 the new organization, ISO, officially began operations  over the years has established itself in the global economy having been adopted in over 178 countries with over one million registrations

2. About ISO 9001  There are several different documents in the ISO 9000 family of standards, but ISO 9001 is the only standard in the 9000 series that requires certification  ISO 9001 is the international standard for a quality management system (“QMS”).  In order to be certified to the ISO 9001 standard, a company must follow the requirements set forth in the ISO 9001 Standard.  The current version is ISO 9001:2015, which was published in September of 2015 (thus the: 2015).

 “ISO 9001 Certified” means an organization has met the requirements in ISO 9001, which defines an ISO 9001 Quality Management System (QMS).  ISO 9001 evaluates whether your Quality Management System is appropriate and effective, while forcing you to identify and implement improvements 3.About ISO 9001-Timeline ISO9001-1980- Technical Committee 176 formed IS9001-1987- First Edition ISO9001-1994- First Minor Revision ISO9001-2000- First Major Revision ISO9001-2008- Second Minor Revision ISO9001-2015-Second Major Revision

4. Salient Features of ISO 9001 a) It does NOT matter what size your organization is: 1 person or 1 million people.  ISO 9001 Implementation for Small Businesses b)

It does NOT matter what industry you are in (service or manufacturing) – it can be a restaurant, consultancy, manufacturing company, government entity, etc. There are other standards based upon ISO 9001 for a few specific industries.

c) It is NOT a standard for products. It does not define product quality.  This is a processbased standard: you use it to control your processes, then your end product should meet the desired results. d) It is NOT a personal Standard – a person cannot get certified to ISO 9001, instead an organization or company becomes certified. Individuals, however, CAN become an ISO 9001 Certified Lead Auditor after a 5 days training course.  This then allows them to audit other companies. e) There is no such thing as “ISO Certification” or “ISO 9000 Certification”, only ISO 9001 certification. f)

It is NOT a membership group – An organization cannot “join” ISO 9001. To become ISO 9001 certified, Any organization must i.

Follow the steps to implement an ISO 9001 quality management system.

ii.

Then a Certification Body (CB or Registrar) audits the performance of your organization against the latest version of the ISO 9001 Requirements. If you pass this audit, the Registrar issues an ISO 9001 Certificate demonstrating

that your organization is Registered to ISO 9001 for a three year period. ( Who is able to grant certification) iii.

Finally, the organization must be re-certified every three years in order to maintain their ISO 9001 certification status.

5.ISO 9000 VS. 9001 S.NO 1 2

ISO 9000 a series, or family, of quality management standards The ISO 9000 family of standards also contains an individual standard named ISO 9000

ISO 9001 a standard within the family ISO 9001 is the only standard within the ISO 9000 family to which organizations can certify is,

6.ISO 9000 Quality Management Principles

1. o o o o o o o 2. o o o o o o o 3. o o o o

Customer focus Understand the needs of existing and future customers Align organizational objectives with customer needs and expectations Meet customer requirements Measure customer satisfaction Manage customer relationships Aim to exceed customer expectations Learn more about the customer experience and customer satisfaction Leadership Establish a vision and direction for the organization Set challenging goals Model organizational values Establish trust Equip and empower employees Recognize employee contributions Learn more about leadership Engagement of people Ensure that people’s abilities are used and valued Make people accountable Enable participation in continual improvement Evaluate individual performance

Enable learning and knowledge sharing Enable open discussion of problems and constraints Learn more about employee involvement Process approach Manage activities as processes Measure the capability of activities Identify linkages between activities Prioritize improvement opportunities Deploy resources effectively Learn more about a process view of work and see process analysis

o o o 4. o o o o o o tools 5. o o o o o o 6. o o o o o 7. o o o o o o

Improvement Improve organizational performance and capabilities Align improvement activities Empower people to make improvements Measure improvement consistently Celebrate improvements Learn more about approaches to continual improvement Evidence-based decision making Ensure the accessibility of accurate and reliable data Use appropriate methods to analyze data Make decisions based on analysis Balance data analysis with practical experience See tools for decision making Relationship management Identify and select suppliers to manage costs, optimize resources, and create value Establish relationships considering both the short and long term Share expertise, resources, information, and plans with partners Collaborate on improvement and development activities Recognize supplier successes Learn more about supplier quality and see resources related to managing the supply chain

7.Benefits of ISO 9001:2015 quality management system  The 10 benefits of ISO 9001:2015 quality management system are: 1.

Increased Efficiency: The companies have done extensive researches on the processes they are following, how to maximize quality and efficiency before going through the ISO 9000 series Quality Management Standards certification process. Once they achieve certification, the processes are established. There are guidelines which can be easily followed by anyone, making it easy to provide training, transitions and even for troubleshooting purpose. 

2.

Increased Revenue: It has been observed that ISO QMS certified companies have shown improvements in the field of productivity, financial performance as compared to the uncertified ones.

3.

Employee Morale: The staff is more satisfied and motivated once there are defined roles and responsibilities, accountability of management, established training procedure and a well-defined picture of how the roles of the employees affect quality and overall success of the company.

4.

International Recognition: The International Organization for Standardization (ISO) is recognized worldwide as the authority on quality management.

5.

Factual Approach to Decision Making: The ISO9000 QMS standard sets out clear instructions regarding audits and process reviews. This helps in information gathering and decision making based on data.

6.

Supplier Relationships: ISO certification has been found beneficial regarding supplier relationships. The documentation and testing procedures help to ensure the quality of the raw materials used for production purpose. This also helps in properly evaluating a new supplier before changing suppliers. There is a procedure to check consistency with respect to how and where orders are placed.

7.

Documentation: Since the ISO QMS standard requires proper documentation of all processes, and changes made, errors or discrepancies, it helps mitigate problems, and provides stability. The staff is also more accountable. Documentation also guarantees that traceable records are available in case of non-compliant products or raw materials.

8.

Consistency: Since all processes are documented, there is a minimum scope of errors. Processes starting right from research and development, covering production, shipping is well documented. Even any small change in the process has to be documented ensuring that the changes are well planned and implemented in the best possible way to ensure maximum efficiency.

9.

Customer Satisfaction: Companies can gain the confidence of clients easily because the ISO is a universally accepted standard. ISO9001 QMS certification ensures efficiency, consistency and dedicated quality service by the companies thereby ensuring the satisfaction of the customers.

10.

Improvement Processes: The ISO 9000 QMS emphasizes on audit processes, management review and improved processes based on collected

data. Based on facts and using a system of documentation and analysis, improvements are carefully planned and implemented. This ensures that the best decisions are made for your company.

8.ISO 9000 family” or “ISO 9000 series

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The phrase “ISO 9000 family” or “ISO 9000 series” refers to a group of quality management standards which are process standards (not product standards).

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ISO 9000 Quality management systems – Fundamentals and Vocabulary, referenced in all ISO 9000 Standards.

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ISO 9001 Quality management systems – Requirements, contains the requirements an organization must comply with to become ISO 9001 certified.

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ISO 9002 – Guidelines for the application of ISO 9001:2015

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ISO 9004 – Managing for the sustained success of an organization, provides guidelines for sustaining QMS success through evaluation and performance improvement.