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•Understand the back ground for third edition of standard
•Understand the process and system approach to quality management system
•Be able to understand and interpret the requirements of the standard
Course Introduction
•Presentation
•Discussions
•Q & A
Revision Process




Why Change ?
Why Change
•The normal revision cycle 5/7 years
•Evolving user and customer needs - ever changing
•Adoption of Process oriented management
•Emphasis on meeting the needs of customers and interested parties
•ISO 9000:1994 - Manufacturing based terminology
•Compatibility with other management systems
•Simplicity and ease of understanding
•Implementing the system should ensure continual improvement


ISO 9000:2000 Current Schedule
What’s New
•Familiar 20 elements are gone but are identifiable
•New structure is process based and more generic
•Clearly based on Plan-Do-Check-Act
•Alignment with ISO 14000

New definition of Quality
“Ability of complete set of realized, inherent characteristics of a product, system or process to fulfil requirements.”

(ISO/DIS 9000:2000)

REPLACEMENTS / REVISIONS
•ISO 9001:2000
Replaces ISO 9001:1994, ISO 9002 and ISO 9003
•ISO 9004:2000
Replaces ISO 9004-1
•ISO 9000:2000
Replaces ISO 8402 and ISO 9000-1
•ISO 19011:2000
Replaces ISO 10011 parts 1, 2 & 3 and ISO 14010, 14011 and 14012
IAF-ISO/TC 176
•Accredited certificates shall not be granted until publication of ISO 9001:2000
•Certification bodies may begin to assess against DIS/FDIS
•Certificates issued to ISO 9001/2/3 shall be valid for no longer than 3 years from publication of Year 2000 edition
ISO 9000 series Development
Relationship with ISO 9004
•Designed to be used together
•Can be used as stand alone
•Different scope -Similar structure
•ISO 9004 aims on further improving process


Quality Management Principles
HCustomer focused organization
HLeadership
HInvolvement of people
HProcess approach
HSystem approach
HContinual Improvement
HMutually beneficial Supplier relationship





QUALITY MANAGEMENT PRINCIPLES
QUALITY MANAGEMENT PRINCIPLES
QUALITY MANAGEMENT PRINCIPLES
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•PRINCIPLE 5 - SYSTEM APPROACH TO MANAGEMENT
•Identifying, understanding and managing a system of interrelated processes for a given objective improves the organization’s effectiveness and efficiency

•PRINCIPLE 6 - CONTINUAL IMPROVEMENT
•Continual improvement should be a permanent objective of the organization

QUALITY MANAGEMENT PRINCIPLES
•PRINCIPLE 7 - FACTUAL APPROACH TO DECISION MAKING
•Effective decisions are based on the analysis of data and information

•PRINCIPLE 8 - MUTUAL BENEFICIAL SUPPLIER RELATIONSHIPS
•An organization and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value

Foreword
•ISO 9002 and ISO 9003 incorporated in ISO 9001 and will be withdrawn.
•Users of ISO 9002/9003 may use ISO 9001:2000 by excluding certain requirements.

0 Introduction01 General
•To address customer satisfaction by meeting customer and applicable regulatory requirements
•Standard can be used for external/internal parties to audit
•QMS requirements are complementary to technical requirements for product
0.2 Process Approach
•Process approach to quality management encouraged
•Introduces and explain the process model as conceptual presentation of QMS requirements specified
0.3 Relationship with ISO 9004
•ISO 9001 and ISO 9004 as consistent pair
•Designed to be used together
•Can be used as stand alone
•Different scope-similar structure
•ISO 9004 aims on improving performance
•ISO 9004 not an implementation guidance
0.4 Compatibility with other Management Systems
•Standard is intended to be compatible with other systems
•It is aligned with ISO 14000 to enhance compatibility
•Standard does not include requirements for other management system such as EMS, OHSM or Financial management
1 Scope (1.1 General)
•Standard specifies QMS requirements for use to
–demonstrate organization’s ability to consistently provide products meeting customer and applicable regulatory requirements
–Address customer’s satisfaction through effective application of the system including processes, prevention of non-conformity and continual improvement (Note this requires evaluation of customer perception)
–Standard is generic
–Intended to be applied entirely but certain exclusions are allowed (See 1.2)


1.2 Permissible Exclusions
•Requirements may be excluded if not appropriate due to :
–nature of product
–customer
–applicable regulatory requirements
•Exclusions must:
–Not affect ability to provide conforming product
•Be limited to clause 7
2 Normative Reference
•Replica of present clause 2
•Users encouraged to use most recent revisions
•ISO 8402:1994 replaced by ISO 9000:2000, Quality management systems-Fundamentals and vocabulary
3 Terms and Definitions
•ISO 9000 : 2000 applies
•New supply chain terminology


Supplier ----> Organization ----> Customer
3 Terms and Definitions
•Product = Result of process
•Note : Four generic product categories
–hardware
–software
–services
–processed materials
The Structure
•0 Introduction
•1 Scope
•2 Normative reference
•3 Terms and definitions
•4 Quality management system requirements
•5 Management responsibility
•6 Resource management
•7 Product and/or service realization
•8 Measurement, analysis and improvement
4 Quality Management System4.1 General Requirements
•Establish, document, implement, maintain and continually improve QMS in accordance with the standard. (Similar to clause 4.2.1 first paragraph ISO 9001:1994)
4.1 General Requirements
•To implement the QMS the Organization shall
–Identify and manage processes necessary for QMS and their application throughput the organization.
–Determine the sequence and interaction of processes
–Determine criteria and methods to ensure effective operation and control of the process

4.1 General Requirements
–Ensure availability of information needed to support the operation and monitoring of processes
– Measure, monitor, analyze processes and act as necessary to achieve planned results and continual improvements
–Manage the process in accordance with the standard

4.2 General Documentation Requirements
•Extent
•Size and type of organization
•Complexity and interaction of processes
•Competence of personnel

•Note2 (Documentation may be in any type of media)
•To Include
•Documented procedures required by standard
•Documents required by organization to ensure effective operation and control process

•Note 1 (Where the term “documented procedure” appears)
5 Management Responsibility
•5.1 Management Commitment
•5.2 Customer Focus
•5.3 Quality policy
•5.4 Planning
•5.4.1Quality objectives
•5.4.2 Quality Planning
•5.5 Administration
•5.5.1 General
•5.5.2 Responsibility & authority
•5.5.3 Management representative
•5.5.4 Internal Communication
•5.5.5 Quality Manual
•5.5.6 Control of Documents
•5.5.7 Control of Quality record
•5.6 Management Review

5.1 Management Commitment
•Provide evidence of commitment to the development and improvement of QMS by:
–Communicating the importance of meeting customer and legal/regulatory requirements.
–Establishing quality policy and objectives.
–Management Reviews
–Provision of resources.
5.2 Customer Focus
•Top Management shall ensure that customer needs & expectations are determined, converted into requirements & fulfilled with the aim of achieving customer satisfaction
•Note - consider obligation related to product, including legal/regulatory requirements
5.3 Quality Policy
•Appropriate to the purpose of organization.
•Commitment to meeting requirements and continual improvements
•Frame work for establishing and reviewing quality objectives
•Communicated and understood at appropriate levels
•Is reviewed for continuing suitability
•Quality policy must be controlled (See 5.5.6)
5.4.1 Quality Objectives
•Establish quality objectives at relevant functions and levels
•Objectives must be measurable and consistent with the quality policy including the commitment to continual improvement
•Include those needed to meet requirements for product
5.4.2 Quality Planning
•Identify and plan processes needed to achieve quality objectives
•The out put of planning must be documented
•Planning must ensure control of change and maintenance of QMS integrity during this change
5.4.2 Quality Planning
•Planning must cover
–Processes required in QMS, considering any permissible exclusions (1.2)
–Resources needed
–Continual improvement of organization
5.5 Administration5.5.1 General
Clause 5.5.2 to 5.5.7 describe administration of the QMS
5.5.2 Responsibility and Authority
•Functions and their interaction, responsibilities and authorities shall be defined and communicated to facilitate effective quality management
5.5.3 Management Representative
•Member of the management who has responsibility and authority for
–ensuring that processes of the QMS are established and maintained
–Reporting on performance of QMS including needs for improvement
–Promoting awareness of customer needs and requirements
•Note: Responsibilities may include liaison with external parties in relation to QMS
5.5.4 Internal Communication
•Ensure communication between various levels and functions regarding the processes of the QMS and their effectiveness
5.5.5 Quality Manual
•Quality manual must include as a minimum:
–The scope of QMS including details of and justification for, any exclusions (See 1.2)
–Description of the sequence and interaction of the processes included in the QMS
–Documented procedures or reference thereto
5.5.6 Control of Documents
•Approve documents prior to issue
•Review, update as necessary and re approve documents
•To identify the current revision status of documents
•Documents remain legible, readily identifiable and retrievable
•Ensure relevant version of applicable documents are available at point of use
•Ensure that documents of external origin are identified and distribution controlled
•Obsolete documents are prevented from unintended use
5.5.7 Control of records
•Documented procedures for identification, storage, retrieval, protection, retention time and disposition of quality records
5.6 Management Review5.6.1 General
•Review of QMS by top management at planned interval to;
–ensure QMS suitability, adequacy and effectiveness
–Evaluate the need for changes to QMS including policy and objectives
5.6.2 Review Input
•Review performance and improvement opportunities related to:
–Audit results
–Customer feedback
–Process performance and product conformance
–Status of preventive and corrective actions
–Follow up actions from earlier reviews
–Change that could affect the QMS
5.6.3 Review output
•Output to include actions related to
–improvement of QMS and its process
–improvement of product
–resources needs
•Results of management reviews must be recorded.
6 Resource management
•6.1 Provision of resourses
•6.2 Human resources
•6.2.1 Assignment of personnel
•6.2.2 Training, awareness and competency
•6.3 Facilities
•6.4 Work environment
6.1 Provision of Resources
•Determine and provide in timely manner resources needed to implement and improve the processes of the QMS and to address customer satisfaction
6.2 Human Resources6.2.1 Assignment of Personnel
•Those who have responsibilities defined in the QMS must be competent on the basis of applicable education, training, skills and experience
6.2.2 Training, Awareness and Competency
•Identify competency needs
•Provide required training
•Evaluate the effectiveness of training provided
•Ensure staff aware of relevance and importance of their activities and contribution to achieving objectives
•Maintain appropriate records of education, training, qualification and experience
Awareness
•the vision for future
•policy and objectives
•organizational change and development
•improvement activities
•creativity
•innovation
•impact on society
•introductory programs
•refreshers
6.3 Facilities
•Identify, provide and maintain the facilities needed to achieve product conformity
• This shall include :

–Workspace & associated facilities
–Equipment, hardware and software
–Supporting services
6.4 Work Environment
•Identify and manage human and physical factors of the work environment needed to achieve product conformity

6.4 Work EnvironmentHuman factors
•Creative work methods
•Opportunities for greater involvement of people
•Safety rules and guidance
•Motivation
6.4 Work EnvironmentPhysical factors
•Heat
•Noise
•Light
•Hygiene
•Humidity
•Cleanliness
•Vibration
•Pollution
•Air flow
7 Product Realization
•7.1 Planning of realization
•7.2 Customer related processes
•7.3 Design & development
•7.4 Purchasing
•7.5 Production & service operation
•7.6 Control of measuring & monitoring devices
7.1 Planning of Realization Processes
•Sequence of process to achieve product
•Consistent with QMS and documented to suit method of operations
•Quality objectives for the product, project or contract
•The need for processes, documentation, resources and facilities specific to the product
•Verification and validation activities and acceptance criteria
•Records
7.2 Customer Related Processes
•7.2.1 Identification of customer requirements
•7.2.2 Review of product requirements
•7.2.3 Customer communication
7.2.1 Identification of Customer Requirements
•Product requirements specified by the customer including availability, delivery and support
•Requirements not specified but necessary for intended or specified use
•Obligations related to product, including regulatory and legal requirements
7.2.2 Review of Product Requirements
•Review identified requirements and ensure before commitment to supply product that;
–Product requirements are defined
–For verbal orders requirements are confirmed
–Difference between tender and contract are resolved
–Organization has ability to meet the requirements

7.2.3 Customer Communication
•Identify and implement arrangements for communication with customers relating to:
–product information
–inquiry contract and order handling including amendments
–Customer feedback including complaints
7.3 Design & Development
•7.3.1 Design & development planning
•7.3.2 Design & development input
•7.3.3 Design & development output
•7.3.4 Design & development review
•7.3.5 Design & development verification
•7.3.6 Design & development validation
•7.3.7 Control of changes

7.3.1 Design & Development Planning
•Plan & control D&D of the product
•Planning to include:
–D&D stages
–required review, verification and validation activities
–responsibilities and authorities for D&D
–interfaces between groups must be managed
–Planning to be updated as the D &D progresses
7.3.2 Design & Development Input
•Define & document product requirements including
–functional and performance requirements
–applicable regulatory and legal requirements
–information from previous similar designs
–any other essential requirements
•Review input for adequacy
•Review for adequacy and resolve any ambiguous, incomplete or conflicting requirements
7.3.3 Design & Development Output
•Document D&D output allowing verification
•D&D output must meet the input requirement
•Provide information for production or device operations
•Contain or refer acceptance criteria
•Define characteristics essential for proper and safe use
•Appropriate output documents prior to release
7.3.4 Design & Development Review
•At suitable stages review D&D to;
–evaluate the ability to fulfil requirements
–identify problems and propose follow up
•Involve all functions concerned
•Record the results and follow up actions
7.3.5 Design & Development Verification
•Verify D & D to ensure that out put meets the input requirements
•Record the results of verification and subsequent follow up actions
7.3.6 Design & Development Validation
•Perform D & D validation to confirm that product is capable of meeting the requirements for intended use
•Whenever applicable to be done prior to delivery
•Where it is impractical partial validation shall be done to the maximum extend applicable
•Results of validation and follow up actions must be recorded
7.3.7 Control of Changes
•Design and development changes must be identified, documented and controlled including:
–evaluation of the effect on the constituent parts and delivered products
–Verification and validation of changes as appropriate
–Approval before implementation.
•Record results of review of changes and follow up actions
7.4 Purchasing
•7.4.1 Purchasing control
•7.4.2 Purchasing information
•7.4.3 Verification of purchased product
7.4.1 Purchasing Control
•Control purchasing process to ensure that purchased product meets requirements
•Type & extend of control depends on effect purchased product may have on realization processes and their output
•Selects suppliers based on their ability to supply conforming product
•Define criteria for selection and periodic evaluation of suppliers
•Results of evaluation and follow up actions must be recorded
7.4.2 Purchasing Information
•Purchasing documents must contain information describing product ordered including where appropriate:
–requirements for approval or qualification of product, procedure, processes, equipment and personnel
•Quality management system requirements
•Ensure adequacy of specified requirements contained in purchasing documents prior to their release
7.4.3 Verification of Purchased Product
•Identify and implement activities needed to verify purchased product
•Where organization or its customer purpose verification at supplier premises, organization must specify in purchasing information:
–verification arrangements
–method of product release.
7.5 Production & Service Operations
•7.5.1 Operations control
•7.5.2 Identification & traceability
•7.5.3 Customer property
•7.5.4 Preservation of product
•7.5.5 Validation of processes
7.5.1Operatrions Control
Control production & services operations through:
•Availability of information specifying product characteristics
•Work instructions available where necessary
•Use and maintenance of suitable equipment
•Availability & use measuring and monitoring devices
•Implementation of monitoring activities
•Implementation of defined processes for release, delivery and post delivery activities
7.5.2 Identification & Traceability
•Where appropriate identify product through all stages of operations
•Identify status with respect to measurement & monitoring requirements
•Where traceability is required control & record unique identification of product
7.5.3 Customer Property
•Care for customer’s property being under organization’s control or being used by organization
•Identification, verification, protection & maintenance of customer property provided for use or incorporation
•Any customer property that is lost, damaged or found un- suitable must be recorded & reported to customer
7.5.4 Preservation of Product
•Preserve conformity of product during internal processing and final delivery to intended destination
•Include identification, handling, packaging, storage and protection
•This applies to constituent parts of product
7.5.5 Validation of Processes
Validation arrangements must be defined and must include as applicable
–qualification of the process
–qualification of equipment and personnel
–use of defined methodologies & procedure
–requirements for record
–re-valuation
7.6 Control of measuring & monitoring devices
•Calibrate & adjust measuring and monitoring devices at specified intervals as prior to use
•Traceability to international or national standards. Where no such standard exist record the basis
•Safeguard MMD from adjustments invalidating calibration
•Protect MMD from damage or deterioration during handling, maintenance or storage
•Record results of calibration
•Assess validity of previous results when devices found to be out of calibration
8 Measurement, Analysis and Improvement
•8.1 Planning
•8.2 Measurement/ monitoring
•8.2.1 Customer satisfaction
•8.2.2 Internal audit
•8.2.3 Measurement & monitoring processes
•8.2.4 Measurement and monitoring of product
•8.3 Control of non-conformity
•8.4 Analysis of data
•8.5 Improvement
•8.5.1 Planning for continual improvement
•8.5.2 Corrective action
•8.5.3 Preventive action
Measurement
•Principal source of information for factual decision taking
•Shows level of achievement
•Review the measurements periodically
•Analyze data
Measurement
•Quality indicators
•Financial measures
•Bench marking
•Self assessment
8.1 Planning
•Define, plan & implement measurement and monitoring activities needed to assure conformance and achieve improvement
•This include determination of the need and use of applicable methodologies and statistical techniques
8.2.1 Customer Satisfaction
•Organization shall monitor information on customer satisfaction and /or dis-satisfaction
•The methodologies for obtaining and utilizing such information must be determined

8.2.2 Internal Audit
•Conduct periodic internal audit to determine if QMS:
–Conforms to the requirements of the standard
–Has been effectively implemented & maintained
•Plan the audit program considering:
–Status and importance of the activity
–results of previous audits
•Define audit scope, frequency and methodologies performed by personnel not performing audited work
8.2.2 Internal Audit
•The documented procedure must cover:
–Responsibilities & authorities for conducting audits
–Ensuring independence
–Recording results and reporting to management
–Timely corrective actions
–Follow up to verify & report implementation of verification results
8.2.3 Measurement and Monitoring of Processes
•Apply suitable methods for measurement and monitoring of those realization processes necessary to meet customer’s requirements.
•These shall confirm the continuing ability of each process to satisfy its intended purpose.
8.2.4 Measurement and Monitoring of Product
•Measure & monitor product characteristics to verify conformance at appropriate stages of realization processes
•Evidence of conformity with the acceptance criteria must be documented, records must indicate the authority responsible for release of product
•Release or delivery must not proceed until all the specified activities have been completed unless otherwise approved by the customer
8.3 Control of Non conformity
•Documented procedures for control of non conforming product to prevent unintended use or delivery
•Non conforming product shall be corrected
•Re-verify after correction
•If non-conformance detected after delivery take appropriate action
•It is often required that the proposed rectification be reported for concession to the customer, the end user, regulatory or other body
8.4 Analysis of Data
•Collect & analyze data, determine suitability and effectiveness of QMS and to identify improvements that can be made
•Data from measurement & monitoring & other related sources
•Analyze data provide info on:
–Customer satisfaction and/or dissatisfaction
–Conformance to customer requirement
–Process, product characteristics and their trends
–Suppliers
8.5 Improvement
•8.5.1 Planning for Continual Improvement
•The organization must plan and manage processes necessary for continual improvement of the QMS
•Facilitate continual improvement using:
–quality policy
–objectives
–audit results
–analysis of data
–corrective actions
–preventive actions
•Management Review
8.5.2 Corrective Action
•Organization must take corrective action to eliminate the causes of non-conformance to prevent recurrence
•Action appropriate to the impact of problem
•Documented procedures shall define requirements for:
–identifying non conformities
–determine the causes
–evaluating the need for corrective action
–determine corrective action needed and implemented
–Recording results of action
8.5.3 Preventive Action
•Organization must identify preventive action to eliminate the causes of potential non conformances to prevent occurrences
•Actions appropriate to the impact of potential problem
•Documented procedures must define the requirements for
–Identification of potential non-conformances and their causes
–Determining and ensuring implementation of preventive action needed
–Recording results of action taken
Benefits of ISO 9000:Rev 2000
•Make continuous improvement visible
•Help client improve efficiency & reduce cost
•Make organization more customer focused
•Make organization more employee focused
•Ensure that QMS make a positive contribution to the management process
Thank You