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Judenah Marie Ade

on 30 September 2012

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Transcript of Cost

International Organization
for Standardization 1906 - International Electrotechnical
Commission (IEC) was established International standardization began in the electrotechnical field 1946 - delegates from 25 countries met
in London and decided to create
a new international organization To facilitate the international
coordination and unification
of industrial standards The objective? ISO (new organization) officially began operations on February 23, 1947 = ISO equal Business - International Standards are strategic tools
and guidelines to help companies tackle
some of the most demanding challenges
of modern business. ISO develops International Standards. Society - ISO has over 19 000 standards touching almost all aspects of daily life. Government - ISO standards draw on international expertise
and experience and are therefore a vital
resource for governments when developing regulations. Benefits from ISO Who are the members? Full Members Correspondent
Members Subcriber Members About ISO Standards!! provides requirements, specifications, guidelines or characteristics that can be used consistently to ensure that Standard
is a developed by group of experts, within technical committees (TCs) materials + products + services + processes fit for their purpose What do they develop? How? Publication
Stage Approval Stage Prepara-
tory Stage (cc) image by nuonsolarteam on Flickr Proposal
Stage Committee
Stage Enquiry Stage Key Principles in Standard Development respond to a need in the market based on global expert opinion developed through a multi-stakeholder process based on a consensus Certification to
ISO Standards - not obligatory but it adds
another level of confidence ISO/TC 176- responsible for the ISO 9000 family of standards for quality management and quality assurance. -answers the need for a basis for establishing effective and efficient quality management systems ISO 9000
SERIES provide guidance and tools for companies and organizations to ensure products and services meet customer’s requirements, and quality is consistently improved revised every 5 years to adapt to technological and market developments provides the fundamentals and vocabulary used in the entire ISO 9000 family of standards Summary of ISO 9001:2008 single standard ISO 9000 ISO 9001 ISO 9004 contains requirements and is often used for certification purposes referred as quality management system standards. discusses definitions and terminology used to clarify ISO 9001 and 9004 presents a set of guidelines presents a set of guidelines and is used
to achieve sustained
success ISO 9001, ISO 9004, ISO 13485, and AS9100 Process Approach Organizations seeking:
a.) advantage through the implementation of a quality
management system
b.) confidence from their suppliers that their product
requirements will be satisfied
c) Users of the products
d) others ISO 9001:2008 - Focuses on customer's needs
- The requirements cover everything
- Helps ensure that customers get the best.
- Checking that the system works is a vital part of ISO 9001:2008. Section 4.2.2 - develop quality manual •Overall requirements for the QMS and documentation
•Mgmt responsibility, focus, policy, planning and objectives
•Resource management and allocation
•Product realization and process management, and
•Measurement, monitoring, analysis and improvement. 5 Sections in implementing system -Quality policy's a formal statement from
-Quality policy is understood and followed
at all levels by all employees
-Business makes decisions about the quality system based on recorded data.

-Quality system is regularly audited and evaluated for conformance and effectiveness.
-Records show how and where raw materials and products were processed
-The business determines customer
requirements. -Business created systems for customer communication.
-Business plans stages in developing new products
-Business regularly reviews performance through internal
audits and meetings.
-Business deals with past and potential problems.
-The business documented procedures

-The business:
1. makes sure no one uses bad product,
2. determines what to do with bad product,
3. deals with the root cause of problems,
4. keeps records to improve the system. provides guidance to organizations to support
the achievement of sustained success by
a quality management approach ISO 9004:2009 ISO 19011 covers auditing of quality management systems and environmental management systems provides guidance on
the audit programmes the conduct of internal
or external audits and information on
auditor competence 1.Customer focused organisation
3.Involvement of people
4.Process approach 8 Quality Management Principles 5.System approach to management
6.Continual improvement
7.Factual approach to decision making
8.Mutually beneficial supplier relationships Benefits and Continual Improvements variation = efficiency = cost of quality Better products and services ISO 14000 series -applies to all businesses
-reduce environmental damage and industrial
-assist organizations manage the environmental effect of their business practices •ISO 14004 provides guidance on the development
and implementation of environmental management systems
•ISO 14010 provides general principles
of environmental auditing
•ISO 14011 provides specific guidance on
audit an environmental management system Other ISO 14000 Series •ISO 14011 provides specific guidance on
audit an environmental management system
•ISO 14012 provides guidance on qualification
criteria for environmental auditors and lead auditors
•ISO 14013/5 provides audit program review and assessment material. ISO14001 - most well known
- the only possible to be certified
by an external certification authority Characteristics of environmental tools
in ISO international Standards •Technically credible.
•Fulfill stakeholder needs.
•Facilitate the development of uniform requirements.
•Promote efficiencies
•Support regulatory compliance
•Enhance investor confidence ISO/Technical Committee 207 – 'Environmental management' - develops and maintains the
ISO 14000 family of Standards - established in 1993 - articulated at the 1992 United Nations Conference on Environment and Development in Rio de Janeiro Overview of the ISO 14000 Family of Standards ISO 14001 - most recognized framework for environmental management systems (EMS) Other environmental
management tools -ISO 14004 complements ISO 14001
-ISO 14031 provides guidance to organization
-. ISO 14020 series of standards addresses a range of different approaches to environmental labels and declarations -ISO 14064 parts 1, 2 and 3 are
international greenhouse gas (GHG) accounting and verification standards
-ISO 14065 complements ISO 14064
-ISO 14063, helps companies to make the
important link to external stakeholders Upcoming Standards ISO 14045, ISO 14051,ISO 14067 ISO 14069, ISO 14005, ISO 14006 ISO 14033, ISO 14066,ISO 14046 Companies seeking or using ISO Certification Environmental and
Economic Benefits •Reduced raw material/resource use
•Reduced energy consumption
•Improved process efficiency
•Reduced waste generation and disposal costs
•Utilization of recoverable resources. - provision by an independent body
of written assurance (a certificate) that
the product, service or system in
question meets specific requirements. Reasons for seeking ISO Certification formal recognition by an independent body,
generally known as an accreditation body,
which a certification body is capable
of carrying out certification. Accreditation "Becoming certified to the ISO
standard can open doors to
customers that are otherwise
closed to you.” Why seek
Certification? 1.Increased Efficiency
2.Increased Revenue
3.Employee Morale
4.International Recognition
5.Factual Approach to Decision Making 6.Supplier Relationships
9.Customer Satisfaction and Demands
10.European business
12.Improvement Processes Benefits of ISO 14001:2004 •Reduced cost of
waste management •Savings in consumption
of energy and materials •Lower distribution costs •Improved corporate image
among regulators, customers
and the public Benefits of ISO 9000 •Creates a more efficient, effective operation
•Increases customer satisfaction and retention
•Reduces audits
•Enhances marketing
•Improves employee motivation, awareness, and morale •Promotes international trade
•Increases profit
•Reduces waste and increases productivity
•Common tool for standardization Requirements for ISO Certification How to become
ISO Certified?? Quality system
must pass
an audit
performed by an
accredited ISO auditor. How can my
be ISO
Certified with Compliance
with ISO
9001 2000? To stay within the boundaries of this ISO standard and to be an ISO certified company, successful companies invest in the technology that is designed to automated processes associated with GxP, quality, compliance and document control. ISO does not perform
certification, only certification bodies.
And when choosing a certification
body it is a good idea to: •evaluate several certification bodies
•bear in mind that the cheapest
could be more costly in the long
run if its auditing is below standard How long will it take to
become ISO 9001 Certified? -You have to figure out how long it will take
to develop or upgrade your quality management system (QMS). Choosing
an ISO 9000
Product Defined Business Processes
-simple diagrams showing how work flows through your company and who is responsible for each step Quality Policy
-"quality slogan" issued by top management stating the company's commitment to meeting customer requirements and to continual improvement Quality Objectives and Performance Data
-Measurable targets for improvement and data to show current and past performance. Quality Manual
-general description of how your company operates
and how you meet ISO 9001 requirements 6) Administrative Procedures
-Document Control; Control of Records
Control of Nonconforming Product;
Internal Auditing; Corrective Action;
Preventive Action Additional Documentation (if needed)
-Specific procedures to ensure company processes meet your quality objectives Quality Records
-Historical records that demonstrate
compliance with company procedures
and the ISO 9001 standard Training
•Management responsibilities (for your managers)
•Job-specific training, as needed
•ISO awareness and understanding of the quality policy
•Understanding of the (6) administrative procedures
•Auditing skills (for your internal auditors) Supplier Tracking
-Data that demonstrates the
performance of your vendors and suppliers Calibration (if applicable)
-Scheduled inspection and adjustment
of any equipment used for inspections
and testing of your products Customer Feedback
-Tracking of customer complaints,
compliments and overall satisfaction Management Representative
-An assigned manager to coordinate your ISO program
' Management Review
-regular meeting of top management team to review the progress of ISO program and to initiate improvements as needed Internal Audit
-formal process by a team of employees trained to conduct an audit similar to the Registrar's audit Certification Audit
-The audit by the Registrar that leads to your formal certification
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