ISO 9000 ISO 9000 SERIES

What do you need to know about ISO 9000?

What are the ISO 9000 Series Standards? What are the elements of the Standards? Why is ISO 9000 so important? What is quality system registration? Ten steps to ISO 9000 registration

ISO 9000

What are ISO 9000 Standards?

Who created the standards?

International Organization for Standardization - Geneva ISO tech committee - TC 176 started in 1979 Standards created in 1987

ISO 9000 Standards

Define the required elements of an effective quality management system Can be applied to any company Adopted by the United States as the ANSI/ASQC Q90 series.

Revised 2000 wider applicability

To eliminate country to country differences To eliminate terminology confusion To increase quality awareness

ISO 9000

ISO 9000

How did ISO get started?

ISO Organization
General Assembly
Policy Development Committees Technical Management Board Technical Advisory Groups Technical Committees Technical Committees Technical Committees Technical Committees

1906 - International Electro-technical Commission 1926 - International Federation of the National Standardizing Associations (ISA) 1946 London - delegates from 25 countries decided to create a new international organization "the object of which would be to facilitate the international coordination and unification of industrial standards 1947 - ISO began to officially function 1951 - The first ISO standard was published
"Standard reference temperature for industrial length measurement".
ISO 9000

Council

ISO 9000

What has ISO Accomplished?

ISO 9000:2000 Consists of 3 Areas

ISO 9000:2000 Quality Management Systems: fundamentals and vocabulary ISO 9001:2000 Quality Management Systems Requirements (required for certification) Management responsibility Resource management Product/service realization

ISO 9000 which provides a framework for quality management and quality assurance ISO 14000 series provides a similar framework for environmental management Internationally standardized freight containers Standardized paper sizes. Automobile control symbols ISO international codes for country names, currencies and languages

Measurement, analysis, improvement

ISO 9004-2000 Quality Management Systems Guidelines for performance improvement

ISO 9000

ISO 9000 Family of Standards

What are the elements of the standards?

Management responsibility Resource management Quality System Contract Review Design Control Document Control Purchasing Purchaser-Supplied Product Product Identification and Traceability Process Control

ISO 8402 - QA and Quality management vocabulary ISO 9000-2 - Generic guidelines for applying ISO 9001, ISO 9002, and ISO 9003 ISO 9000-3 - Guidelines for applying ISO 9001 to the development, supply, and maintenance of software ISO 9000-4 Application for dependability management ISO 9004-2 Guidelines for services ISO 9004-3 Guidelines for processed material ISO 9004-4 Guidelines for quality improvement ISO 9004-5 Guidelines for quality plans ISO 9004-6 Guidelines for configuration management

Inspection and Testing Inspection, Measuring and Test Equipment Inspection and Test Status Control of Nonconforming product Corrective Action Quality Records Internal Quality Audit Training Servicing Statistical Techniques
ISO 9000

ISO 9000

Element Standard: Management Responsibility

Element Standard: Process Control

Management must have a written policy statement of their commitment to quality. This policy must be communicated to and understood by all employees. Management must clearly define qualityrelated organizational responsibilities and interrelationships. A management representative must be assigned to oversee the implementation and continuous improvement of the quality system. Senior management must continually review the system.
ISO 9000

The company must identify all processes that directly affect the quality of the product or service and ensure that these processes are carried out under controlled conditions, including:
Formal approval of process design and equipment. Documented work instructions. Development of quality plans describing how the process is to be monitored. A suitable working environment. Documented quality criteria.
ISO 9000

Why is ISO 9000 important?

Why adopt ISO 9000?

To comply with customers who require ISO 9000 To sell in the European Union market To compete in domestic markets To improve the quality system To minimize repetitive auditing by similar and different customers To improve subcontractors performance

ISO 9000

European Union directive

ISO 9000 certification required by suppliers of Regulated Products
health, safety, and the environment

EC has strict corporate liability legislation protecting consumers

Globalization impact

ISO 9000

Third party registration

ASQC
Accreditors (RAB in US)

Ten Steps to ISO Registration

10. Registration! 9. Final assessment by registrar 8. Take corrective actions 7. Pre-assessment by registrar 6. Submit quality manual for approval

Registrars

5. Perform self-analysis audit 4. Select a third-party registrar and apply 3. Develop and implement the quality system

Supplier Companies
ISO 9000

2. Select the appropriate standard 1. Set the registration objective

ISO 9000

Six Essential Elements of a Successful Registration Effort

Senior Management Commitment to the Effort Appropriate ISO 9000 Training An Effective Management Review Process Documentation of the Quality System An Effective Internal Auditing System An Effective Corrective Action Process

ISO 9001:2008 and ISO 9004:2009

Managing for the sustained success of an organization

ISO 9000

ISO 9000

ISO 9001:2008 Update

Impact on Organization: No new requirements Certification of conformity to ISO 9001:2008 and/or national equivalents shall only be issued after official publication of ISO 9001:2008 (which should take place before the end of 2008) and after a routine surveillance or recertification audit against ISO 9001:2008. Validity of certifications to ISO 9001:2000 One year after publication of ISO 9001:2008 all accredited certifications issued (new certifications or re-certifications) shall be to ISO 9001:2008. Twenty four months after publication by ISO of ISO 9001:2008, any existing certification issued to ISO 9001:2000 shall not be valid

ISO 9001:2008 Changes

Changes: Table of content sub closes included (i.e. 4.2.1) Annex A ISO 9001:2008 vs. ISO 14001:2004 Introduction 0.1 General added organizations environment as a factor for implementing QMS 0.3 Relationship with ISO 9004 not a consistent pair any more 0.4 Compatibility with other standards replaced the word aligned with ISO 14001, with the words due consideration

ISO 9001:2008 Changes

Changes: 1 Scope Note 1: term product applies to the product intended for, or required by, the customer or the product realization process Note 2: Statutory and regulatory requirements may be expressed as legal requirements 2 Normative Reference Referencing ISO 9000:2005 QMS Fundamentals and Vocabulary 3 Terms and Definition Removed the clarification about word organization vs. supplier
ISO 9000

ISO 9001:2008 Changes

Changes: 4 QMS 4.1 Note 1: definition of processes includes processes for analysis and improvement 4.1 Note 2 and 3: Clarification of Outsourced Processes 5 Management Responsibility no changes 6 Resources 6.2.1 Note: Conformity may be affected directly or indirectly by personnel performing any task 6.2.2 c): instead of evaluate actions taken, new wording is ensure that the necessary competence has been achieved 6.4 Note: Clarification of the work environment conditions under which the work is performed including physical, environmental and other factors
ISO 9000

ISO 9001:2008 Changes

Changes: 7 Product Realization 7.2.1 Note: Clarification of Post Delivery activities 7.3.1 Note: Clarification of design review vs. verification vs. validation 7.3.3 Note: Design output information may include preservation 7.6 Note: Clarification of the confirmation of the software ability 8 Measurement, analysis and improvement 8.2.1 Note: Monitoring customer perception examples 8.2.2 Note: Reference to ISO 19011 for Guidance 8.2.3 Note: Extent of Monitoring processes to be based on their impact on customer and QMS performance

Management System Integration

ISO 9001:2008
0.4 Compatibility with other management systems This International Standard (ISO 9000:2008) has been developed with due consideration to ISO 14001:2004 in order to enhance the compatibility of the two standards for the benefit of the user community. This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, financial management or risk management. However This International Standard enables an organization to align or integrate its own QMS with related management system requirements.

ISO 9004:2009
Sustainability - Defined
Definition sustained success: result of the ability of the organization to achieve and maintain its objectives in the long term ISO 9004:2009: The sustained success of an organization is demonstrated by its ability to satisfy needs and expectations of its customers and other interested parties over the long term and in a balanced way.

Sustainability - Defined
Definition organizations environment is a combination of external and internal factors and conditions that can affect the achievement of an organizations objectives, and its behaviour towards interested parties. ISO 9004:2009: provides wider focus on quality management then ISO 9001; it addresses the needs and expectations of all interested parties and their satisfaction
ISO 9000

ISO 9000
ADVANTAGES
Increased marketability Reduced operational expenses Better management control Increased customer satisfaction Improved internal communication Improved customer service Reduction of product-liability risks Attractiveness to investors

DISADVANTAGES
Owners and managers do not have an adequate understanding of the ISO 9000 certification process or of the quality standards themselves Funding for establishing the quality system is inadequate Heavy emphasis on documentation Length of the process

ISO 9000