ISO 9000:2015ISO 9001:2015ISO 9004:2009ISO 22000

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Ayşegül Çandır-2013432091Miray Aksu-2012432005

Whatis ISO?

ISO, founded in 1947, is a worldwide federation of national standards bodies from some 100 countries, with one standards body representing each member country.

Member organizations collaborate in the development and promotion of international standards.

Whatis ISO?

The 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 organization ‘to facilitate the international coordination and unification of industrial standards’. In 1947 the new organization, ISO, officially began operations.

Today they have members from 162 countries and 788 technical bodies to take care of standards development. More than 135 people work full time for ISO’s Central Secretariat in Geneva, Switzerland.

ISO 9000 FAMILY

The standards provide guidance and tools for companies and organizations who want to ensure that their products and services continously meet customer’s requirements, and that quality is continously improved.

The ISO 9000 family addresses various aspects of quality management and contains some of ISO’s best known standards.

9000 FAMILY

ISO 9000

Quality management systems—Fundamentals and vocabulary

Essential background for the proper understanding and implementation of ISO 9001

ISO 9001

Quality management systems—Requirements

Requirements aimed primarily at giving confidence in the products and services an organization provides, thereby improving customer satisfaction

ISO 9004

Managing for the sustained success of an organization—A quality management approach

Guidance for organizations that choose to progress beyond ISO 9001 requirements to address a broader range of topics that can lead to continual improvement of the organization's overall performance

ISO 9000 describes fundamentals of quality management systems and specifies the terminology for quality management systems.

ISO 9001 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide products that fulfil customer and applicable regulatory requirements and aims to enhance customer satisfaction.

ISO 9004 provides guidelines that consider both the effectiveness and efficiency of the quality management system. The aim of this standard is improvement of the performance of the organization and satisfaction of customers and other interested parties.

The ISO 9000 family of standards

has been developed to assist organizations, of all types and sizes, to implement and operate effective (QMS) quality management systems.

ISO 9000:2015

This standard provides the fundamental concepts, principles and vocabulary for quality management systems (QMS) .

This International Standard is aimed to help the user to understand the fundamental concepts, principles and vocabulary of quality management, in order to be able to effectivelyand efficiently implement a QMS.

1.

ISO 9000:2015

The ISO 9000:2015 standards are based on seven quality management principles that senior management can apply for organizational improvement

ISO 9000:2015

ISO 9000 is a set of international standards on quality management and quality assurance developed to help companies effectively document the quality system elements to be implemented to maintain an efficient quality system.

They are not specific to any one industry and can be applied to organizations of any size.

ISO 9000 can help a company satisfy its customers, meet regulatory requirements, and achieve continual improvement. However, it should be considered to be a first step, the base level of a quality system, not a complete guarantee of quality.

ISO 9000:2015

1. Customer focus2. Leadership3. Engagement of people4. Process approach5. Improvement6. Evidence-based decision

making7. Relationship management

• No requirements

• Ideas useful in guiding organizations’ actions

• Used as a basis for developing ISO 9001

ISO 9000:2015

Principle 1 – Customer focusOrganizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.Principle 2 – LeadershipLeaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives.Principle 3 – Engagement of peoplePeople at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization's benefit.

ISO 9000:2015

Principle 4 – Process approachA desired result is achieved more efficiently when activities and related resources are managed as a process.Principle 5 – ImprovementImprovement of the organization's overall performance should be a permanent objective of the organization.Principle 6 – Evidence-based decision makingEffective decisions are based on the analysis of data and information.Principle 7 – Relationship managementAn organization and its external providers (suppliers, contractors, service providers) are interdependent and a mutually beneficial relationship enhances the ability of both to create value.

ISO 9000:2015

There are 13 different groupings of terms in the ISO standard:

1. Person or people

2. Organization

3. Activity

4. Process

5. System

6. Requirement

7. Result

8. Data, Information and Document

9. Customer

10. Characteristic

11. Determination

12. Action

13. Audit

ISO 9000:2015 ISO 9000:2015 describes principles of quality management

systems, which are universally applicable to the following:

a) organizations seeking advantage through the implementation of a quality management system; b) organizations seeking confidence from their suppliers that their product requirements will be satisfied; c) users of the products; d) those concerned with a mutual understanding of the terminology used in quality management (e.g. suppliers, customers, regulators); e) those internal or external to the organization who assess the quality management system or audit it for conformity with the requirements of ISO 9001 (e.g. auditors, regulators, certification/registration bodies); f) those internal or external to the organization who give advice or training on the quality management system appropriate to that organization; g) developers of related standards.

ISO 9000:2015

Individuals and organizations cannot be certified to ISO 9000 !

ISO 9001:2015

ISO 9001 is a standard that regulate

the requirements for a quality

management system. It helps

businesses and organizations to be

more efficient and improve

customer satisfaction.

2.

ISO 9001:2015

Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. It is the most popular standard in the ISO 9000 series and the only standard in the series to which organizations can certify.

ISO 9001 was first published in 1987 by the International Organization for Standardization (ISO), an international agency composed of the national standards bodies of more than 160 countries. The current version of ISO 9001 was released in September 2015.

2.

ISO 9001:2015

ISO 9001:2015 applies to any organization, regardless of size or industry.

More than one million organizations from more than 160 countries have applied the ISO 9001 standard requirements to their quality management systems (QMS).

BENEFITS OF 9001

ISO 9001 helps organizations ensure their customers consistently receive high quality products and services, which in turn brings many benefits,including satisfied customers, management, and employees.

organizations find that using the standard helps them:

I. Organize a QMSII. Create satisfied customers, management, and employeesIII. Continually improve

ISO 9001:2015

ISO 9001 is based on the plan-do-check-act methodology and provides a process-oriented approach to documenting and reviewing the structure, responsibilities, and procedures required to achieve effective quality management in an organization.

ISO 9001:2015

Specific sections of the standard contain information on topics such as:

Requirements for a quality management system, including documented information, planning and determining process interactions.

Responsibilities of management.

Management of resources, including human resources and an organization’s work environment.

Product realization, including the steps from design to delivery.

Measurement, analysis, and improvement of the QMS through activities like internal audits and corrective and preventive action.

Achieving ISO 9001 Certification

ISO 9001 is the only standard in the ISO 9000 series to which organizations can certify. Achieving certification means that an organization has demonstrated the following:

1. Follows the guidelines of the ISO 9001 standard2. Fulfills its own requirements3. Meets customer requirements and statutory and

regulatory requirements4. Maintains documentation

Achieving ISO 9001 Certification

Certification to the ISO 9001 standard can enhance an organization’s credibility by showing customers that its products and services meet expectations. In some instances or in some industries, certification is required or legally mandated.

The certification process includes implementing the requirements of ISO 9001:2015 and then completing a successful registrar’s audit confirming the organization meets those requirements.

This International Standard provides a wider focus on quality management than ISO 9001.

It addresses the needs and expectations of all relevant interested parties and provides guidance for the systematic and continual improvement of of the organization's overall performance.

ISO 9004:20093.

The sustained success of an organization is achieved by its ability to meet the needs and expectations of its customers and other interested parties, over the long term and in a balanced way.

Sustained success can be achieved by the effective management of the organization, through awareness of the organization's environment, by learning, and by the appropriate application of either improvements, or innovations, or both.

ISO 9004:20093.

ISO 9004 provides guidance on achieving sustainable success through quality management.

The European standard can be applied to all organizations across all sectors.

ISO 9004:2009

By meeting the needs and expectations of your customers.

By the effective management of your organization.

Through awareness of your organization’s environment.

By learning and improving.

How can sustained success be achieved with 9004?

ISO 9004 give you greater confidence in how you assess, maintain and improve it.

ISO 9004 outlines a systematic approach to continual improvement of your organization’s overall performance.

This includes best practice advice on quality strategy and policy, as well as managing resources and processes. The standard will guide you in monitoring and reviewing quality management and draw links with the ISO 9001 Quality Management System standard.

ISO 9004:2009

Organizations that want to implement ISO 9001.

Organizations that want to maintain ISO 9001.

Organizations that want to assess and improve quality management systems.

WHO SHOULD BUY 9004?

It provides the basis for a more holistic approach and for identifying system maturity levels which in turn can be used as a foundation for benchmarking and improvement identification.

BENEFITS OF ISO 9004

The standard is geared towards top management requirements with the generation of forward plans, strategies and policies to meet medium to long term goals.

Very much challenging the norm, it provides the basis for a more holistic approach and for identifying system maturity levels which in turn can be used as a foundation for benchmarking and improvement identification.

ISO 9004:2009 links with, and complements, all management system standards based on the Plan-Do-Check-Act (PDCA) approach.

It is consistent too with the LRQA methodology of engaging top management to establish the longer term view, linking ISO 9004 evaluation findings and comments to organisational strategies and objectives.

It also focuses on organisational risk, which also complements the LRQA Business Assurance and risk-based assessment approaches.

ISO 22000

ISO 22000 is an international standard that defines the requirements of a food safety management system covering all organizations in the food chain from “farm to fork”.

ISO 22000

ISO 22000 is a standard developed todealing with food safety. It involvesfollowing elements:

Interactive communication System management Prerequisite programs HACCP principles

ISO 22000

ISO 22000

ISO 22000 is a standard developed by the International Organization for Standardization dealing with food safety. It is a general derivative of ISO 9000.

Critical reviews of the above elements have been conducted by many scientists.

Communication along the food chain is essential to ensure that all relevant food safety hazards are identified and adequately controlled at each step within the food chain.

This implies communication between organizations both upstream and downstream in the food chain.

Communication with customers and suppliers about identified hazards and control measures will assist in clarifying customer and supplier requirements.

The most effective food safety systems are established, operated and updated within the framework of a structured management system.

This provides maximum benefit for the organization and interested parties. ISO 22000 has been aligned with ISO 9001 in order to enhance the compatibility of the two standards.

ISO 22000

ISO 22000 can be applied independently of other management system standards or integrated with existing management system requirements.

ISO 22000

ISO 22000 integrates the principles of the Hazard Analysis and Critical Control Point (HACCP) system and application steps developed by the Codex Alimentarius Commission.

ISO 22000 requires that all hazards that may be reasonably expected to occur in the food chain, including hazards that may be associated with the type of process and facilities used, are identifiedand assessed.

ISO 22000

ISO 22000 integrates the principles of the Hazard Analysis and Critical Control Point (HACCP) system and application steps developed by the Codex Alimentarius Commission.

By means of auditable requirements, it combines the HACCP plan with prerequisite programmes. Hazard analysis is the key to an effective food safety management system, since conducting a hazard analysis assists in organizing the knowledge required to establish an effective combination of control measures.

ISO 22000 requires that all hazards that may be reasonably expected to occur in the food chain, including hazards that may be associated with the type of process and facilities used, are identified and assessed.

Thus it provides the means to determine and document why certain identified hazards need to be controlled by a particular organization and why others need not.

ISO 22000

Introduce internationally recognized processes to your business.

Give suppliers and stakeholders confidence in your hazard controls.

Put these hazard controls in place across your supply chain.

Introduce transparency around accountability and responsibilities.

Continually improve and update your systems so it stays effective.

BENEFITS OF ISO 22000

REFERENCES

1. http://asq.org/learn-about-quality/iso-9000/overview/overview.html2. https://www.iso.org/standard/62085.html3. https://www.whittingtonassociates.com/2016/02/iso-90002015-terms/4. http://www.kascert.com/goster.aspx?metin_id=2655. https://www.iso.org/standard/45481.html6. https://www.excitant.co.uk/iso9000-2015-linking-to-strategic-direction/7. https://www.bsigroup.com/en-GB/iso-22000-food-safety/8. http://www.wcs.com.tr/iso22000_kalite_nedir.htm9. http://the9000store.com/what-are-iso-9000-standards/what-is-iso-9004/10. http://asq.org/learn-about-quality/iso-9000/iso-9001-2015/11. https://shop.bsigroup.com/ProductDetail/?pid=000000000030135851&_ga

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