Introduction to ISO 9001:2000

Outline ISO 9000 is the most successful standard in ISO history and is accepted world-wide Over 500,000 registrations world-wide with registrants in over 150 countries from all continents Being applied in a wide variety of organizations Over 40 “sectors” or industry classifications - led by: electrical/optical equipment, metal products, construction, machinery, wholesale/retail trade - but growing in acceptance by many others, including: engineering, information technology, health/social work, utilities, transportation, public administration, education, other services.

ISO 9000:2000 is based on Eight Quality Management Principles 1-Customer Focus 2-Leadership 3-Involvement of People 4-Process Approach 5-System Approach 6-Continual Improvement 7-Factual Approach to Decision Making 8-Mutually Beneficial Supplier Relationships

1- Customer Focus Organizations depend on their customers and therefore should: understand current and future customer needs, meet customer requirements, and strive to exceed customer expectations.

2- Leadership Leaders should: establish unity of purpose and direction of the organization, and create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.

3- Involvement of People People at all levels are the essence of an organization, and their full involvement enables their abilities to be used for the organization’s benefit.

4- Process Approach Organizations need to do more than simply monitor process outputs, (typically through inspection activities) they must also control all process inputs, (people, facilities/equipment, material and methods) Process Approach(contd) and, they must establish appropriate controls over the transformation activities (if desired results are to be achieved consistently and efficiently)

What is a Process? Activity that transforms input into output Resources: People Facilities/Equipment Material Methods Results: Products Services Performance

How is a Process Managed? Monitor & Measure the Process make sure the inputs are right, the transformation activities consistently work, and the desired results are achieved, then - improve the process as needed Activity Input Output Right Resources: Qualified People Right Facilities/Equipment Correct Materials Proven Methods Desired Results: Quality Products Quality Services Customer Satisfaction

How is a Process Measured? Efficient No Waste Effective Desired Results Achieved Activity Input Output Right Resources: Qualified People Right Facilities/Equipment Correct Materials Proven Methods Desired Results: Quality Products Quality Services Customer Satisfaction

5-System Approach Organizations must understand a system is a set of interrelated processes, and the output of one process is the input to one or more subsequent processes, so ... It is critical to manage the “white space” (or interface) between processes to ensure that the overall system is effective

6-Continual Improvement Continual improvement of the organization’s overall performance should be a permanent objective: Improvement must be a planned activity if the organization desires to improve overall performance and capabilities.

The QMS must be used for continuous improvement ... Improve Process through PDCA Cycle Results Baseline Performance Plan Do Act Check Measure/Monitor Results Against Objectives - Improve Process and Change QMS as Needed to Achieve and Sustain Desired Results QMS Improvement Objective

7- Factual Approach to Decision Making Effective decisions are: based on the analysis of data and information.

8- Mutually Beneficial Supplier Relationships An organization and its suppliers are truly inter-dependent, and a mutually beneficial relationship enhances the ability of both to create value.

Role of ISO 9000:2000 Defines quality management principles terms and definitions fundamentals: - systems approach - process approach - continual improvement ISO 9000:2000 is a “normative reference” (i.e. part of the requirements)

Role of ISO 9001:2000 Specifies quality system requirements: for achieving customer satisfaction applicable to entire enterprise note: “permissible exclusions” (like design) are limited to requirements within Clause 7 - Product Realization, and your registrar must verify they are not part of your business

Role of ISO 9004:2000 Provides guidelines for performance improvement, based on quality management principles and approaches defined in ISO 9000, and continual improvement of the quality management system itself note: however, ISO 9004 is NOT intended as a guideline for implementing or assessing implementation of ISO 9001 requirements

ISO 9001 and ISO 9004 are the “Consistent Pair” 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

ISO 9001:2000 implements the PDCA improvement cycle Plan Clause 5. Management responsibility - everything flows from Management who define the requirements for the system Clause 6. Resource management - from these requirements the resources will be identified and management must ensure they are provided and applied within the system Do Clause 7. Product (and/or service) realization - the necessary process are established and carried out

ISO 9001:2000 implements the PDCA improvement cycle Check Clause 8. 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 Clause 8. 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 (Clause 5.6)

Clause 4 - Quality management system 4.1 General requirements - New: must define processes to be managed (including out-sourced processes - which typically include design, training, calibration, heat treat, 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 4.2 Documentation requirements - New: documentation requirements less prescriptive; however, at a minimum must include a quality manual and the following six documented procedures: Control of Documents (Clause 4.2.3), Control of Quality Records (Clause 4.2.4), Internal Audits (Clause 8.2.2), Control of Nonconforming Product (Clause 8.3), Corrective Action (Clause 8.5.2), and Preventive Action (Clause 8.5.3).

Clause 5 - Management responsibility 5.1 Management commitment - New: top management must demonstrate commitment to development and implementation of the quality system and continually improving its effectiveness 5.2 Customer focus - New: customer requirements (identified per Clause 7.2.1) must be met with the aim of enhancing customer satisfaction (a “perception” that must be measured per Clause 8.2.1) 5.3 Quality policy - New: quality policy must include commitment to meeting requirements and continual improvement of the effectiveness of the QMS, provide a framework for establishing/reviewing measurable quality objectives; and, quality policy must be periodically reviewed for continuing suitability

Clause 5 - Management responsibility 5.4 Planning - New: establish measurable quality objectives at relevant functions and levels in the organization needed to meet product requirements (identified per Clause 7.1 a); and identify and plan quality system processes (identified per Clause 4.1) 5.5 Responsibility, authority and communication - New: management representative must promote awareness of customer requirements throughout the organization; internal communications regarding the effectiveness of the quality system must be established

Clause 5 - Management responsibility 5.6 Management review - New: evaluate the need for changes to the quality system (including policy and objectives) by reviewing specified inputs (improvement opportunities) and reporting specified outputs (related management actions and resource needs)

Clause 6 - Resource management 6.1 Provision of resources - New: determine and provide resources needed to implement and improve the QMS and address customer satisfaction 6.2 Human resources - New: 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 quality objectives 6.3 Infrastructure and 6.4 Work Environment - New: determine and manage the infrastructure (buildings, workspace, utilities, equipment and support services), as well as the work environment needed to achieve product conformance

Clause 7 - Product realization 7.1 Planning of product realization - New: determine measurable quality objectives for contracts, projects and products 7.2 Customer-related processes - New: define the processes for communicating with the customer with regards to product information; inquiries, contracts or order handling, and customer feedback, including complaints 7.3 Design and development resources - New: design output to include appropriate information for purchasing, production and for service provision

Clause 7 - Product realization 7.4 Purchasing - New: establish criteria for supplier evaluation and selection, and periodic re-evaluation 7.5 Production and service provision - New: Nothing, essentially the same as requirements contained in Elements 4.7, 4.8, 4.9, 4.15, and 4.19 of ISO 9001:1994 7.6 Control of measuring and monitoring devices - New: validate software used to verify product

Clause 8 - Measurement, analysis and improvement 8.1 General - New: plan and implement monitoring, measurement, analysis and improvement processes 8.2 Monitoring and measurement - New: 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 now be objective and impartial (vice “independent); and processes used to manage the quality system must be measured/monitored to the degree necessary to demonstrate they achieved planned results

Clause 8 - Measurement, analysis and improvement 8.3 Control of nonconforming product - New: Nothing, essentially the same as requirements contained in Clause 4.13 of ISO 9001:1994) 8.4 Analysis of data - New: analyze data to determine quality 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 8.5 Improvement - New: must improve effectiveness of the quality management system (note: accomplish through the use of quality policy, objectives, audit results, analysis of data, corrective/preventive actions, and management review)

ISO 9000:2000 standards released December 2000 The final International Standard (IS) was released 15 December 2000 and is available now

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