Awareness to ISO 9001:2000
Be able to understand and interpret the requirements of the standard Planning to implement the requirements of the standard
Lectures and value added discussions on each topic. Workshops to enable delegates to increase their understanding regarding ISO 9001:2000 version and to experience Quality Management System implementation practices.
International Organization for Standardization
SA8 0 00
49 169 S O/T IS
ISO 9000:87 ISO 9000:94 ISO 9001:2000 BS5750 1979 AQAP1 (NATO) 1970’s MIL-STD-9858 (1940’s)
What is ISO?
International Organization for Standardization Develops standards do not certify companies Around 140 countries members Around 13000 standards produced Technical Committees are formed to produce standards TC 176 for ISO 9000 International Organization for Standardization Email: firstname.lastname@example.org Web: http://www.iso.ch http://www.bsi.org.uk/iso-tc176-sc2.
ISO 9000:2000 Family of Standards
ISO 9000:2000 Fundamentals and Vocabulary ISO 9001:2000 QMS Requirements ISO 9004:2000 Guidelines for Performance Improvement
ISO 10005:1995 Guidelines for Quality Plans ISO 10006:1997 Guidelines for Project Management ISO 10007:1995 Guidelines for Configuration Mgt ISO 10011-1, -2, -3 on Auditing ISO 10012-1 & -2, Quality Assurance for Measuring Eqpt. ISO 10013:1995 Guidelines for Quality manuals
ISO 9000:2000 Family of Standards
ISO/TR 10014:1998 Guidelines for managing economics of quality ISO 10015 Guidelines for Training ISO/TR 10017:1999 Guidelines on Statistical techniques
1. New Standard
ISO 9002 and 9003 dropped ISO 9001 modified
2. New Structure
20 clauses abandoned Now 8 sections
Quality Management System
A System of coordinated activities which is meant to “direct” and “control” an organization with regard to quality.
(satisfying your customer by managing your resources, through a standardized system)
Corrective & Preventive Actions
Production & Process Controls
Management Human Resource Controls Material, Equipment & Facility Controls
Records, Documents, & Change Controls
QUALITY MANAGEMENT PRINCIPLES
What are they?
The basic principles on which the ISO 9000:2000 standards are based
Principles of new Standard
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PRINCIPLE 1 CUSTOMER-FOCUSED ORGANISATION
Organization depend on their customers and therefore should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations.
PRINCIPLE 2 LEADERSHIP
Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives.
PRINCIPLE 3 INVOLVEMENT OF PEOPLE
People at all levels are the essence of an organisation and their full involvement enables their abilities to be used for the organisation’s benefit.
PRINCIPLE 4 PROCESS APPROACH
A desired result is achieved more efficiently when related resources and activities are managed as a process.
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.
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.
Any activity that takes “inputs” and converts them to “outputs”
The systematic identification and management of these activities and the interaction between activities.
Example - Purchasing Process
•• Demand for Demand for material material •• Item specs and Item specs and Date Date •• Supplier source Supplier source •• Suppliers Suppliers capability to capability to meet our meet our requirements requirements
Purchasing Purchasing Procedure Procedure
•Storage •Storage •Inspection and Testing •Inspection and Testing •Manufacturing •Manufacturing •Finance •Finance
Interactions to Interactions to
Outputs Outputs •• Receipt of Receipt of Material on right Material on right condition condition •• Right Quality Right Quality Right Quantity Right Quantity •• Right Time Right Time
Performance Measurements Performance Measurements •Delivery status – On-time, On spec, •Delivery status – On-time, On spec, etc etc •Supplier evaluation •Supplier evaluation
Process Approach Model
CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM
C U S T O M E R
R e q u i r e m e n t s
Management responsibility Resource management
U S T O M E R
Measurement, analysis and improvement
S a t i s f a c t i o n
•More emphasis on customer satisfaction •Commitment to comply with legal and statutory requirements •Need to review suitability of quality policy •Need to define quantified and measurable quality objective at different functions and levels •More emphasis on human resource management •Re-evaluation of suppliers on the basis of their performance •Analysis of data for continual improvement •Need to maintain suitable work environment •Term “Subcontractor” replaced with “Supplier” and “Supplier” replaced with “organization” •Exclusions defined
0 1 2 3 4 5 6 7 8 Introduction Scope Normative reference Terms and definitions Quality management system requirements Management responsibility Resource management Product realization Measurement, analysis and improvement
System Requirements / Structure of the Standard
4 Quality Management System 5 Management Responsibility 6 Resource Management 7 Product Realization 8 Measurement Analysis & improvement
General requirements (4.1) Documentation Requirements(4.2)
Management Commitment(5. 1) Customer focus (5.2) Quality policy(5.3) Planning(5.4)
Provision of resources(6.1)
Planning(7.1) Customer related processes(7.2 )
Design & development(7.3)
Monitoring & measurement(8.2)
Infrastructures(6.3 ) Work environment(6.4)
Control of NCP(8.3)
Analysis of data(8.4) Production & service provision(7.5)
Control of monitoring & measuring devices(7.6)
Responsibility, authority & communication( 5.5) Management Reviews (5.6)
0.4 Compatibility with other Management Systems
Standard is intended to be compatible with other management 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
Requirements may be excluded if not appropriate due to : nature of product customer requirements applicable regulatory requirements Exclusions must: Not affect ability to provide conforming product Be limited to clause 7
4 Quality Management System 4.1 General Requirements
Establish, document, implement, maintain and continually improve QMS in accordance with the standard.
4.2 General Requirements
To implement the QMS the Organization shall Identify and manage processes necessary for QMS Determine the sequence and interaction of processes Determine criteria and methods to ensure effective operation and control of the process 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 Documentation Requirements General
Extent Size and type of organization Complexity and interaction of processes Competence of personnel Note3 (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)
4.2 Documentation Requirements
4.2.2 Quality Manual The organization shall establish a Quality Manual that include: Scope of QMS Documented procedures or reference to them Description of interaction between the process of QMS
4.2 Documentation Requirements
4.2.3 Control of Documents Documents required by the QMS shall be controlled Approve, Review, Ensure current & relevant version, Identification of external origin documents, Prevent unintended use of obsolete documents. 4.2.4 Control of Quality Records Documented Procedure shall be established for identification, storage, protection, retrieval, retention time and disposition. Records shall be: Established and maintained to provide evidence. Legible, readily identifiable and retrievable.
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 Responsibility, authority and communication 5.5.1 Responsibility & authority 5.5.2 Management representative 5.5.3 Internal communication 5.6 Management Review 5.6.1 General 5.6.2 Review input 5.6.3 Review output
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
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
5.4 Planning 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 Planning 5.4.1 Quality Objectives (Cont)
Quality Objectives should be: • Specific • Measurable • Achievable • Realistic / Related • Time Bound
5.4.2 Quality Management System Planning
Identify and plan processes needed to achieve quality objectives
Plan the development of QMS Plan the implementation of QMS Plan the improvement of QMS
5.5 Responsibility, Authority and Communication
5.5.1 Responsibility and authority Functions and their interaction, responsibilities and authorities shall be defined and communicated to facilitate effective quality management
5.5.2 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
5.5.3 Internal Communication
Ensure communication between various levels and functions regarding the processes of the QMS and their effectiveness
5.6 Management Review 5.6.1 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 Records from Management Reviews shall be maintained (see 4.2.4).
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 Recommendations for improvement
5.6.3 Review Output
Output to include actions related to improvement of the effectiveness QMS and its processes improvement of product related to customer requirements resource needs
6 Resource Management
6.1 Provision of resourses 6.2 Human resources 6.2.1 General 6.2.2 Competence, awareness and training 6.3 Infrastructure 6.4 Work environment
6.1 Provision of Resources
The organization shall determine and determine the resources needed for : implement and maintain the QMS and continually improve its effectiveness. Enhance customer satisfaction by meeting customer requirements.
6.2 Human Resources 6.2.1 General
Those who have responsibilities defined in the QMS must be competent on the basis of appropriate education, training, skills and experience
6.2.2 Competency, Awareness and Training
Identify competency needs Provide required training Evaluate the effectiveness of training provided Ensure staff is aware of relevance and importance of their activities and contribution to achieving quality objectives Maintain appropriate records of education, training, qualification and experience
Identify, provide and maintain the infrastructure needed to achieve product conformity This shall include : Workspace & associated utilities Equipment, hardware and software Supporting services (transport or communication)
6.4 Work Environment
The organization shall determine and manage the work environment needed to achieve conformity to product requirements.
7 Product Realization
7.1 Planning of product 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 Product Realization
Sequence of process to achieve product Consistent with QMS and documented to suit method of operations Quality objectives and requirements for the product 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 Determination of requirements related to the product 7.2.2 Review of product requirements 7.2.3 Customer communication
7.2.1 Determination of requirements related to the product
Product requirements specified by the customer including requirements for delivery and post-delivery activities Requirements not specified but necessary for intended or specified use Obligations related to product, including regulatory and legal requirements any additional requirements determined by the organization
Review of requirements related to the product
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 Records of the results arising from the review shall be recorded.
7.2.3 Customer Communication
Identify and implement arrangements for communication with customers relating to: product information inquiry, contract or order handling, including amendments Customer feedback including complaints
7.3 Design & Development
7.3.1 Design & development planning 7.3.2 Design & development inputs 7.3.3 Design & development outputs 7.3.4 Design & development review 7.3.5 Design & development verification 7.3.6 Design & development validation 7.3.7 Control of design and development changes
7.4.1 7.4.2 7.4.3 Purchasing process Purchasing information Verification of purchased product
7.4.1 Purchasing Process
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 and re-evaluation of suppliers Results of evaluation and follow up actions must be recorded
7.4.2 Purchasing Information
Purchasing information shall describe the product to be purchased, including where appropriate: Requirements for approval of product,procedures, processes and equipment. Requirements for qualification of personnel. Quality management system requirements.
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.
7.5.1 7.5.2 7.5.3 7.5.4 7.5.5
Control of production and service provision Validation of processes for production and service provision Identification and traceability Customer Property Preservation of Product
7.5.1 Control of production and service provision
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 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
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
I can not remember
7.5.4 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 Customer Property tangible / intangible
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
7.6 Control of monitoring & measuring 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 General 8.2 Monitoring & Measurement
8.2.1 Customer satisfaction 8.2.2 Internal audit 8.2.3 Monitoring and measurement of processes 8.2.4 Monitoring and measurement of product
8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement 8.5.1 Continual improvement 8.5.2 Corrective action 8.5.3 Preventive action
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 Monitoring and Measurement 8.2.1 Customer Satisfaction
Organization shall monitor information on customer satisfaction and /or dissatisfaction 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 Product
Apply suitable methods for measurement and monitoring of those realization processes necessary to meet customer’s requirements.
8.2.3 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 5/01deliveryPmust not proceed until or AS OLD / H 19 SE have been allIFIED specified activities the D R VE completed unless otherwise approved by the customer
8.3 Control of Non conforming Product
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 Continual improvement
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
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 nonconformances and their causes Determining and ensuring implementation of preventive action needed Recording results of action taken
Situation Warranting Corrective Action
Identification of major non-conformance. Large number of minor non-conformities. The reoccurrence of a problem with a process or activity. Non-conformities observed during audits. Customer Complaints. Non-conforming deliveries from vendors.
Stages of Corrective & Preventive Action
REPORTING INVESTIGATION ACTION FOLLOWUP CLOSING
Transparency in working at all level Data availability : Hidden Factors are open Creates Accountability Planning & scheduling improved Rework & Rejection are known and being controlled Customer feedback through regular surveys Employees Participation enhanced Continuos Improvements Program launched Market Reputation