2. An Overview of the International Quality Management Standard
To insert your company logo on this slide
From the Insert Menu
Select “Picture”
Locate your logo file
Click OK
To resize the logo
Click anywhere inside the logo. The boxes that appear outside the logo are known as “resize handles.”
Use these to resize the object.
If you hold down the shift key before using the resize handles, you will maintain the proportions of the object you wish to resize.
An Overview of the International Quality Management Standard
ISO 9001:2008
Isocert Solutions.com
America

3. PURPOSE OF THIS SEMINAR
To introduce the ISO 9001:2008 standard
To discuss the implications on an Organization
To discuss a strategy for implementation
Isocert Solutions ©
Rev D 2014
America

4. What does ISO mean?
It is commonly believed that it is an acronym for International Standards Organization.
This is false
ISO is the Greek word for equal
The aim of ISO is to equalize the basic structure and vocabulary of businesses worldwide.
With todays global sourcing of materials and components it is critical for producers of products and services to be “speaking the same language”
Isocert Solutions ©
Rev D 2014
America

5. ISO 9001:2008 History of ISO 9001 Focus Isocert Solutions © Rev D 2014
America

6. ISO 9001:2008 Current Revision was published in November 2008
Contains no new requirements to the previous 2000 version
It is called an amendment because it only adds clarifications to the prior revision
It does however, change the name from Quality Management Standard to Business Standard
Isocert Solutions ©
Rev D 2014
America

7. ISO 9001:2008 (con’t)
Focus is on conformity and demonstration of customer satisfaction
Isocert Solutions ©
Rev D 2014
America

8. The 8 Quality Principles
ISO 9001:2008 uses the 8 Quality Principles as the fundamental foundation for a Business Management System: 1: Customer focus 2: Management 3: Involvement of people 4: Process approach
Continued next page
Isocert Solutions ©
Rev D 2014
America

9. The 8 Quality Principles (con’t)
5: Systems approach to management
6: Continual improvement
7: Factual approach to decision making
8: Mutually beneficial supplier relationships
Isocert Solutions ©
Rev D 2014
America

10. ISO 9001:2008 The Business standard emphasizes: defining requirements
verifying achievement of requirements
measuring customer satisfaction
having objectives for all relevant functions
analysis of process data related to business results
Continued next page
Isocert Solutions ©
Rev D 2014
America

11. ISO 9001:2008 (con’t) determining the effectiveness of training
the continuous improvement cycle
management’s role in monitoring quality
Isocert Solutions ©
Rev D 2014
America

12. A Process Approach ISO 9001:2008 uses a process approach
A process is any activity that converts inputs to outputs
Almost all activities and operations involved in making a product or providing a service are processes
Isocert Solutions ©
Rev D 2014
America

13. Process Approach (con’t)
BUSINESS MANAGEMENT SYSTEM
CONTINUAL IMPROVEMENT
Management
Requirements
responsibility S a t i s f c o n C C u u
Measurement , s
Resource s
analysis , t
management t
improvement o o m m e e
Product r
Input
Output r (
and /
or service )
Product /
realization
Service
Isocert Solutions ©
Rev D 2014
America

14. Business Management Systems
To implement a business management system the organization must:
Determine the needs and expectations of customer
Establish quality policy and business objectives
Define necessary processes and responsibilities
Establish the measures for process effectiveness
Determine current effectiveness of processes
Search for process improvement opportunities
Prioritize improvements for optimum results
Isocert Solutions ©
Rev D 2014
America

15. Business Management Systems
Plan strategies, processes and resources
Implement the plan
Monitor the effects of the improvements
Assess the results against expected outcomes
Review activities to identify follow-up actions
Isocert Solutions ©
Rev D 2014
America

16. Benefits of a Business Management System
Some of the benefits of an effective business management system are:
It creates confidence in processes and products
Provides a basis for continual improvement
Leads to customer satisfaction and mutual success
Isocert Solutions ©
Rev D 2014
America

17. Business System Documentation
Isocert Solutions ©
Rev D 2014
America

18. Extent of Documentation
Range and details of a company's documentation depend upon:
Size and type of organization
complexity of products and processes
customer and regulatory requirements
industry standards and codes
education, experience, and training of personnel
workforce stability
past quality problems
Isocert Solutions ©
Rev D 2014
America

19. ISO 9001:2008 Comprised of the following 8 clauses: 1. Scope
2. Normative references (part of the requirements)
3. Terms and definitions
4. Quality management system
5. Management responsibility
6. Resource management
7. Product (and/or service) realization
8. Measurement, analysis & improvement
Isocert Solutions ©
Rev D 2014
America

20. PDCA improvement cycle
Plan
Management responsibility - everything flows from Management who define the requirements for the system
Resource management - from these requirements the resources will be identified and management must ensure they are provided and applied within the system Do
Product (and/or service) realization - the necessary processes are established and carried out
Isocert Solutions ©
Rev D 2014
America

21. PDCA improvement cycle
Check
Measurement, analysis and improvement - processes and products will be monitored and measured against policies, objectives and requirements for the product and results/opportunity for improvement reported
Act
Measurement, analysis and improvement - acting upon data reported in the check cycle, improvement actions can be taken - directly, or as an output of the Management Review process
Isocert Solutions ©
Rev D 2014
America

22. Business Management System
General requirements - Must define processes to be managed (including out-sourced processes - which can include design, training, calibration, maintenance, etc.); determine the sequence and interaction of these processes; determine the criteria and methods needed to ensure these processes are effective; and take actions to improve these processes
Documentation requirements Documentation requirements less prescriptive; however, at a minimum must include a quality manual and the six required subjects to be documented
Isocert Solutions ©
Rev D 2014
America

23. Documentation Requirements
The following 6 subjects (at a minimum) are required to be included in documented procedures:
Document Control
Control of Records
Internal Audits
Control of Nonconforming Product
Corrective Action
Preventive Action
Isocert Solutions ©
Rev D 2014
America

24. Management Responsibility
Management commitment - top management must:
Demonstrate commitment to development and implementation of their business system and continually improve its effectiveness
Customer focus - customer requirements must be met with the aim of enhancing customer satisfaction, including “perception” and must be measured and reported
Isocert Solutions ©
Rev D 2014
America

25. Management Responsibility
Management commitment - top management must:
Quality policy - establish a quality policy that:
includes commitment to meeting requirements and continual improvement of the effectiveness of the business management system
provides a framework for establishing/reviewing measurable business objectives; and, quality policy must be periodically reviewed for continuing suitability
Isocert Solutions ©
Rev D 2014

26. Management Responsibility
Planning - establish measurable business objectives at relevant functions and levels in the organization needed to meet product requirements and identify and plan business system processes
Responsibility, authority and communication - management representative must promote awareness of customer requirements throughout the organization; internal communications regarding the effectiveness of the business system must be established
Isocert Solutions ©
Rev D 2014
America

27. Management Responsibility
Management review - a review of the entire business management system, presented to top management on a regular basis. Including evaluating the need for changes to the business management system (including policy and objectives) by reviewing specified inputs (improvement opportunities) and reporting specified outputs (related management actions and resource needs)
Isocert Solutions ©
Rev D 2014
America

28. Resource Management
Provision of resources - determine and provide resources needed to implement and improve the BMS, meet the requirements (customer, statutory and regulatory) and address customer satisfaction
Human resources - determine needed competencies, evaluate effectiveness of actions taken to satisfy competency needs; and ensure employees are aware of the importance of their activities and how they contribute to achieving business objectives
Infrastructure and Work Environment - determine and manage the infrastructure (buildings, workspace, utilities, equipment and support services), as well as the work environment needed to achieve product conformance
Isocert Solutions ©
Rev D 2014
America

29. Product Realization
Planning of product realization - determine measurable business and quality objectives for contracts, projects and products
Customer-related processes - define the processes for communicating with the customer with regards to product information; inquiries, contracts or order handling, and customer feedback, including complaints
Design and development resources - design output to show validation of requirements and to include appropriate information for purchasing, production and for service provision
Isocert Solutions ©
Rev D 2014
America

30. Product Realization
Purchasing - use of only approved suppliers, establish criteria for supplier evaluation and selection, and periodic re-evaluation. Validation of all purchased materials and products
Production and service provision - all production and service operations are carried out under controlled conditions, including adequate instructions available at the work center
Control of measuring and monitoring devices - all devices used to measure product must be calibrated including validation of software used to verify product requirements
Isocert Solutions ©
Rev D 2014
America

31. Measurement, analysis and improvement
General - plan and implement monitoring, measurement, analysis and improvement of processes
Monitoring and measurement - must measure and monitor customer satisfaction (note: customer satisfaction is any information relating to the customer’s “perception” of the organization’s ability to meet customer requirements); internal auditors must be objective and impartial. Processes used to manage the business management system must be measured/monitored to the degree necessary to demonstrate they achieved planned results
Isocert Solutions ©
Rev D 2014
America

32. Measurement, analysis and improvement
Control of nonconforming product - NO nonconforming product can be unintentionally incorporated into end product
Analysis of data -analyze data to determine the business system effectiveness and to provide information on customer satisfaction, supplier performance, product conformance, and process/product characteristics and trends used to identify opportunities for preventive action
Improvement - must improve effectiveness of the business management system (note: accomplished through the use of quality policy, objectives, audit results, analysis of data, corrective and preventive actions, and management review)
Isocert Solutions ©
Rev D 2014
America

33. What does this mean to you?
Developing a Business Management System designed to comply with ISO provides every member of your organization with the opportunities and tools to make your company more successful.
This allows for growth and an enhanced work environment, with this comes ownership on every level and enhanced morale
Isocert Solutions ©
Rev D 2014

34. The last word
ISO 9001:2008 describes what is required for a successful company in todays environment.
What is does not do is tell you HOW to do it
Creativity, innovation and teamwork in a Business Management Systems is essential
Isocert Solutions ©
Rev D 2014

35. certificate of Completion
AWARDED TO
[NAME]
For Introduction to Quality Management System
Standard ISO 9001:2008
Awarded this ___ day of __________, 20__
Presenter Name and Title
Isocert Solutions
Rev D 2014

36. For more information visit our website Isocertsolutions.com
We are a full service provider of products and services to support Quality Assurance in any industry.
Isocert Solutions ©
Rev D 2014