chapter 2 - overview of iso 9001 2000
DESCRIPTION
An Overview of ISO9001:2000 Quality Management SystemTRANSCRIPT
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Chapter 2 Overview of ISO 9001:2000
Chapter 2Overview of
ISO 9001:2000
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Chapter 2 Overview of ISO 9001:2000
� 0.1 General
� Strategic decision - adoption of QMS
� QMS design & implementation is organisation specific
� Standard can be used by internal & external parties to assess the ability to meet customer, regulatory and organisation’s own requirements
� QMS requirements are complementary to technical requirements forproduct
� NOTES are for guidance or clarification only
0 Introduction
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Chapter 2 Overview of ISO 9001:2000
0.2 Process approach
• Process approach to quality management encouraged
• Introduces & explains the process model as conceptual presentation of QMS requirements specified
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Chapter 2 Overview of ISO 9001:2000
Plan
Do
Verify
Correct
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Chapter 2 Overview of ISO 9001:2000
Processes
ProcessActivities
+Resources
InputInput OutputOutput
ControlsControls(e.g.procedure(e.g.procedure) )
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Chapter 2 Overview of ISO 9001:2000
Processes - understand interactions
ProcessA
ProcessD
ProcessB
ProcessC
InputOutputControls
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Chapter 2 Overview of ISO 9001:2000
CUSTOMERS
CUSTOMERS
Management responsibility
Resourcemanagement
Measurement, analysis,improvement
ProductProductrealisation
Continual Improvement of theQuality Management System
Requirements
Satisfaction
InputOutput
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Chapter 2 Overview of ISO 9001:2000
0.3 Relationship with ISO 9004
� ISO 9001 & ISO 9004 - consistent pair
� Designed to complement each other
� Can be used as stand alone
� Different scope - similar structure
� ISO 9001 can apply for certification or contractual purposes andfocuses on effectiveness
� ISO 9004 aims on improving performance and efficiency
� ISO 9004 not an implementation guidance
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Chapter 2 Overview of ISO 9001:2000
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 systems such as EMS, OHSM, or financial management
• Integration of management systems is possible
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Chapter 2 Overview of ISO 9001:2000
1 Scope (1.1 General)
� Standard specifies QMS requirements for use to:
• demonstrate organisation’s ability to consistently provide product meeting customer & applicable regulatory requirements
• enhance customer’s satisfaction through effective application of the system including processes for its continual improvement and assurance of conformity to customer and applicable regulatory requirements
NOTE:
Product = product intended for or required by customer
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Chapter 2 Overview of ISO 9001:2000
1.2 Application
� Requirements are generic
� Requirement may be excluded if cannot be applied due to the nature of organisation and its product
� Exclusions must:
• Not affect ability or responsibility to provide conforming product
• Be limited to clause 7
(Cl. 4.2.2: “details of & justification for any exclusion” to be included in the quality manual”)
� Conformity to ISO 9001 may not be stated if exclusions go beyondabove
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Chapter 2 Overview of ISO 9001:2000
2 Normative reference
�Amendments or revisions of cited standard do not apply
�Users encouraged to use most recent revision
�ISO 9000 : 2000 Quality Management Systems -Fundamentals and Vocabulary.
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Chapter 2 Overview of ISO 9001:2000
• ISO 9000 : 2000 applies
• New supply chain terminology
Supplier
Organisation
Customer
3 Terms and definitions
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Chapter 2 Overview of ISO 9001:2000
3 Terms and definitions
Product = Result of processProduct = Result of process
Note: four generic product categories:� hardware� software� services� processed materials
ISO 9000:2000
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Chapter 2 Overview of ISO 9001:2000
4.1 General requirements4.1 General requirements
Establish, document, implement and maintain a QMS andcontinually improve its effectiveness in accordance with the standard
4 Quality management system
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� Identify the processes necessary for QMS
�Determine the sequence and interaction of processes
�Determine criteria & methods to ensure effective operation & control of the processes
�Ensure availability of resources and information needed to support the operation & monitoring of the processes
�Measure, monitor and analyse processes
� Implement actions necessary to achieve planned results & continual improvement
4.1 General Requirements
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Chapter 2 Overview of ISO 9001:2000
� Manage the processes in accordance with the standard
� Ensure control of outsourced processes affecting product conformity
� Identify control of outsourced processes within the QMS
Note: Processes needed for QMS include processes for management activity, provision of resources, product realisation and measurement.
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Chapter 2 Overview of ISO 9001:2000
4.2 Documentation requirements
4.2.1 General
QMS documentation must include:
� Quality Policy
� Quality Objectives
� Documented procedures required by standard
� Documents required by organisation to ensure effective planning, operation & control processes
� Records required by the standard
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Chapter 2 Overview of ISO 9001:2000
Note 1 Term documented procedure means that it must be established, documented, implemented and maintained
Note 2 Extend of documentation may differ due to
• Size & type of organisation
• Complexity & interaction of processes
• Competence of personnel
Note 3 Documentation may be in any type of media (now note 15)
4.2.1 General
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4.2.2 Quality manual
Quality manual must include as minimum:
� The scope of QMS including details of, and justification for, and exclusions (See 1.2)
� Documented procedures or reference thereto
� Description of the interaction between the processes of the QMS
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4.2.3 Control of documents
Documented procedures to:
� approve documents prior to issue
� review, update as necessary and re-approve documents
� to identify the changes and the current revision status of documents
� to ensure documents remain legible, readily identifiable
� ensure relevant versions of applicable documents are available at points of use
� ensure that documents of external origin are identified and distribution controlled
� obsolete documents are prevented from unintended use and identified if kept for any reason
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Chapter 2 Overview of ISO 9001:2000
4.2.4 Control of records
�Records must be established and maintained
�Records must be legible, readily identifiable and retrievable.
�Documented procedure for control of identification, storage, retrieval, retention time and disposition of quality records.
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Chapter 2 Overview of ISO 9001:2000
CUSTOMERS
CUSTOMERS
Management responsibility
Resourcemanagement
Measurement, analysis,improvement
ProductProductrealisation
Continual Improvement of theQuality Management System
Requirements
Satisfaction
InputOutput
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Chapter 2 Overview of ISO 9001:2000
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.4.1 Quality objectives
5.4.2 QMS planning
5 Management responsibility
5.5 Responsibility, authority and communication
5.5.1 Responsibility & authority
5.5.2 Management representative
5.5.3 Internal communication
5.6 Management review5.6.1 General
5.6.2 Review input
5.6.3 Review output
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Chapter 2 Overview of ISO 9001:2000
5.1 Management commitment
Provide evidence of commitment to the development implementation and improvement of QMS by:• communicating the importance of meeting customer and statutory
and regulatory requirements
• establishing quality policy & objectives
• management reviews
• provision of resources
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Chapter 2 Overview of ISO 9001:2000
5.2 Customer focus Determine customerrequirements
Meet requirements
Customer satisfaction
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Chapter 2 Overview of ISO 9001:2000
5.3 Quality policy
a) appropriate to the purpose of the organisation
b) commitment to comply with requirements & continually improve the effectiveness of the QMS
c) framework for establishing & reviewing quality objectives
d) communicated and understood within the organisation
e) is reviewed for continuing suitability
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Chapter 2 Overview of ISO 9001:2000
5.4.1 Quality objectives
�establish quality objectives at relevant functions and levels
�objectives must be measurable & consistent with the quality policy
� include those needed to meet requirements for product {see 7.1 (a)}
�documented {see 4.2.1 (a)}
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5.4.2 Quality management system planning
�planning of the QMS is carried out in order to meet requirements given in 4.1, as well as the quality objectives
�the integrity of the QMS integrity must be maintained when changes are planned and implemented
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5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
Responsibilities and authorities shall be
defined and communicated within the organisation.
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Chapter 2 Overview of ISO 9001:2000
5.5.2 Management Representative
Member of the management who has responsibility and authority that includes
• ensuring that processes needed for the QMS are established, implemented and maintained
• reporting on performance of QMS including needs for improvement
• ensuring the promotion of awareness of customer needs & requirements
Note: Responsibility may include liaison with external parties in relation to QMS
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Chapter 2 Overview of ISO 9001:2000
5.5.3 Internal communication
Ensure appropriate communication within the organisation regarding the processes of the QMS and their effectiveness.
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Chapter 2 Overview of ISO 9001:2000
5.6 Management Review
5.6.1 General
Review of the QMS by top management at planned intervals to:
• ensure QMS suitability, adequacy & effectiveness
• assess opportunities for improvement
• evaluate the need for changes to QMS including policy & objectives
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5.6.2 Review input
Review performance and improvement opportunities related to:
» audit results
» customer feedback
» process performance & product conformity
» status of preventive and corrective actions
» follow up actions from earlier reviews
» changes that could affect the QMS
» recommendations for improvement
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5.6.3 Review output
Output to include actions related to:
� improvement of the effectiveness of the QMS and its processes
� improvement of product
� resource needs
Results of management review must be recorded
Note changes to 4.1.3Role of management review significantly enhancedImpact: significant
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Chapter 2 Overview of ISO 9001:2000
CUSTOMERS
CUSTOMERS
Management responsibility
Resourcemanagement
Measurement, analysis,improvement
ProductProductrealisation
Continual Improvement of theQuality Management System
Requirements
Satisfaction
InputOutput
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Chapter 2 Overview of ISO 9001:2000
6 Resource Management
6.1 Provision of resources
6.2 Human resources
6.2.1 General
6.2.2 Competence, awareness and training
6.3 Infrastructure
6.4 Work environment
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Chapter 2 Overview of ISO 9001:2000
6.1 Provision of resources
Determine & provide the resources needed to:
�implement, maintain the QMS and continually improve its effectiveness
�enhance customer satisfaction
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6.2 Human Resources
6.2.1 General
Personnel performing work affecting product quality must be competent on the basis of appropriate education, training, skills and experience.
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Competence considerations:
� Future demands
� Anticipated management and workforce succession needs
� Changes in the processes and equipment
� Individual competencies needed
� Statutory and regulatory requirements, standards, directives, etc.
(ISO 9004 :2000)
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6.2.2 Competence, awareness and training
�Determine the necessary competence
�Provide training or take other action to satisfy those needs
�Evaluate the effectiveness of actions taken
�Ensure staff are aware of relevance and importance of their activities and contribution to achieving objectives
�Maintain appropriate records of education, training, skills and experience
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Awareness
�The vision for future
�Policy & objectives
�Organisational change & development
� Improvement activities
�Creativity
� Innovation
� Impact on society
� Introductory programmes
�Refreshers
(ISO 9004 :2000)
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Chapter 2 Overview of ISO 9001:2000
6.3 Infrastructure
Identify, provide & maintain the infrastructure needed to achieve product conformity. Infrastructure includes, as applicable:
• buildings, workspace & associated facilities
• equipment (hardware & software)
• supporting services
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Chapter 2 Overview of ISO 9001:2000
6.4 Work environment
Determine and manage the work environment needed to achieve product conformity
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6.4 Work environmentHuman Factors
�creative work methods�opportunities for greater involvement of people
�safety rules and guidance
�ergonomics
�special facilities for people
�social interaction
(ISO 9004 :2000)
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Chapter 2 Overview of ISO 9001:2000
6.4 Work environment
Physical factors
�Heat
�Noise
�Light
�Hygiene
�Humidity
�Cleanliness
�Vibration
�Pollution
�Air flow
(ISO 9004 :2000)
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Chapter 2 Overview of ISO 9001:2000
CUSTOMERS
CUSTOMERS
Management responsibility
Resourcemanagement
Measurement, analysis,improvement
ProductProductrealisation
Continual Improvement of theQuality Management System
Requirements
Satisfaction
InputOutput
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Chapter 2 Overview of ISO 9001:2000
7 Product realisation
7.1 Planning of product realisation
7.2 Customer related processes
7.3 Design & development
7.4 Purchasing
7.5 Production & service provision
7.6 Control of measuring & monitoring devices
Note: exclusionswithin this clauseare allowed
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7.1 Planning of product realisation
Planning must determine as appropriate:
�quality objectives and requirements for the product
� the need for processes, documentation, resources specific to theproduct
� verification and validation activities & acceptance criteria
� records
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7.2 Customer related processes
7.2.1 Determination of requirements related to product
7.2.2 Review of requirements related to product
7.2.3 Customer communication
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Chapter 2 Overview of ISO 9001:2000
7.2.1 Determination of requirements related to product
Organisation must determine:
� requirements specified by the customer including delivery & post delivery activities
� requirements not specified but necessary for specified or intended use, where known
� statutory and regulatory requirements related to product,
� any additional requirements
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Chapter 2 Overview of ISO 9001:2000
7.2.2 Review requirements related to the product
Review identified requirements before commitment to supply product and ensure that:
• product requirements are defined
• differences between tender & contract are resolved
• organisation has ability to meet the requirements
Record the results
Documentation to be amended in case of changes & personnel made aware
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7.2.3 Customer communication
Determine and implement effective arrangements for communication with customers relating to :
• product information
• enquiry, contract & order handling including amendments
• customer feedback including complaints
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7.3 Design & development
7.3.1 Design & development planning (4.4.1, 4.4.2 & 4.4.3)
7.3.2 Design & development inputs (4.4.4)
7.3.3 Design & development outputs (4.4.5)
7.3.4 Design & development review (4.4.6)
7.3.5 Design & development verification (4.4.7)
7.3.6 Design & development validation (4.4.8)
7.3.7 Control of design & development changes (4.4.9)
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Chapter 2 Overview of ISO 9001:2000
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 & authorities for D&D
�Interfaces between groups must be managed
�Planning to be updated as the D&D progresses
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Chapter 2 Overview of ISO 9001:2000
7.3.2 Design & development inputs
�Determine & record product requirements including:• functional & performance requirements
• applicable statutory and regulatory requirements
• information from previous similar designs
• any other essential requirements
�Review input for adequacy
�Requirements must be complete, unambiguous and not in conflict with each other
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7.3.3 Design & development outputs
�D&D output in a form allowing verification
�D&D output must
• meet the input requirements
• provide information for purchasing, production or service provision
• contain or reference acceptance criteria
• define characteristics essential for proper & safe use
�Approve output prior to release
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7.3.4 Design & development review
�At suitable stages systematic reviews of D&D to:
• evaluate the ability to meet requirements
• identify problems and propose follow up
� Involve all functions concerned
�Record the results and any necessary actions
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7.3.5 Design & development verification
�Verify D&D to ensure that output meets the input requirements
�Record the results of verification and necessary actions
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Chapter 2 Overview of ISO 9001:2000
7.3.6 Design & development validation
� Perform D&D validation to confirm that product is capable of meeting the requirements for the specified or intended use, where known
� Whenever applicable to be completed prior to delivery
� Results of validation and necessary actions must be recorded
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Chapter 2 Overview of ISO 9001:2000
7.3.7 Control of design and development changes
�Design & development changes must be identified and records maintained
�Changes must be reviewed, verified and validated as appropriate and approved before implementation
�Record results of review of changes and any necessary actions
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Chapter 2 Overview of ISO 9001:2000
7.4 Purchasing
7.4.1 Purchasing process
7.4.2 Purchasing information
7.4.3 Verification of purchased product
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Chapter 2 Overview of ISO 9001:2000
7.4.1 Purchasing process
�Ensure that purchased product meets requirements
�Type & extend of control depends on effect purchased product may have on product realisation or the final product
�Evaluate and selects suppliers based on their ability to supply conforming product
�Establish criteria for selection, evaluation and re-evaluation of suppliers
�Results of evaluation and any necessary actions must be recorded
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Chapter 2 Overview of ISO 9001:2000
7.4.2 Purchasing information
Purchasing information must describe the product to be purchasedincluding where appropriate:
• requirements for approval of product, procedures, processes and equipment
• requirements for qualification of personnel
• quality management system requirements
Ensure adequacy of specified purchase requirements prior to their communication to supplier
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Chapter 2 Overview of ISO 9001:2000
7.4.3 Verification of purchased product
Establish & implement inspection or other activities needed to ensure purchased product conformity
Where organisation or its customer propose verification at supplier’s premises, organisation must specify in purchasing information:
• verification arrangements
• method of product release
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Chapter 2 Overview of ISO 9001:2000
7.5 Production and service provision
7.5.1 Control of production and service provision
7.5.2 Validation of processes for production and service provision
7.5.3 Identification & traceability
7.5.4 Customer property
7.5.5 Preservation of product
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Chapter 2 Overview of ISO 9001:2000
7.5.1 Control of production and service provisionPlan and carry out production & service provision under controlled conditions. Controlled conditions include as applicable:
a) availability of information describing product characteristics
b) availability of work instructions, as necessary
c) the use of suitable equipment
d) availability & use of measuring & monitoring devices
e) implementation of monitoring and measurement
f) the implementation of release, delivery and post delivery activities
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Chapter 2 Overview of ISO 9001:2000
7.5.2 Validation of processes
Processes where outcome is not verified and/or where deficiencies may become apparent after delivery must be validated to demonstrate ability to achieve planned results
Arrangements must be established for these processes including, as applicable:�criteria for review and approval of the process�approval of equipment�qualification of personnel�use of defined methods & procedures�requirements for records�re-validation
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Chapter 2 Overview of ISO 9001:2000
7.5.2 Validation of processes
Considerations:
�High value products
�Where deficiency will only be apparent when product is in use
�Where process can not be repeated
�Where product verification is not possible
(ISO 9004:2000)
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Chapter 2 Overview of ISO 9001:2000
7.5.2 Validation of processes
Examples of risk assessment:
» FMEA
» Fault tree analysis
» Relationship diagrams
» Reliability prediction
» Simulation techniques
(ISO 9004:2000)
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Chapter 2 Overview of ISO 9001:2000
7.5.3 Identification and traceability
�Where appropriate identify product by suitable means throughout realisation
� Identify status with respect to measurement & monitoring requirements
�Where traceability is required control & record unique identification of product
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Chapter 2 Overview of ISO 9001:2000
7.5.4 Customer property
�Care for customer’s property while it is under organisation’s control or being used by organisation
� Identification, verification, protection & safeguarding customer property provided for use or incorporation
�Any customer property that is lost, damaged or found unsuitable must recorded & reported to customer
Note: Customer property includes intellectual property
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Chapter 2 Overview of ISO 9001:2000
7.5.5 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 a product
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Chapter 2 Overview of ISO 9001:2000
7.6 Control of monitoring & measuring devices
� Determine monitoring and measurements to be made & measurement & monitoring devices needed to provide evidence of conformity of product
� Ensure measuring and monitoring is carried out consistently with monitoring and measurement requirements
� Suitability of measuring/monitoring software must be confirmed prior to use
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Chapter 2 Overview of ISO 9001:2000
7.6 Control of monitoring & measuring devices� Calibrate or verify measuring and monitoring devices (MMD) at specified
intervals or prior to use against international or national standards. Where no such standard exist record the basis
� Adjust or re-adjust as necessary
� Identify to enable the determination of calibration status
� Safeguard MMD from adjustments invalidating calibration
� Protect MMD from damage or deterioration during handling, maintenance& storage
� record results of calibration
� assess and record validity of previous results when device found to be out of calibration
Note: See ISO 10012 for guidance
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Chapter 2 Overview of ISO 9001:2000
CUSTOMERS
CUSTOMERS
Management responsibility
Resourcemanagement
Measurement, analysis,improvement
ProductProductrealisation
Continual Improvement of theQuality Management System
Requirements
Satisfaction
InputOutput
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Chapter 2 Overview of ISO 9001:2000
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 & measurement of processes
8.2.4 Monitoring & 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
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Chapter 2 Overview of ISO 9001:2000
8.1 General
Plan & implement measurement, monitoring analysis and improvement processes needed to:
�demonstrate conformity of the product
�ensure conformity of QMS
�continually improve the effectiveness of the QMS
This includes determination of applicable methods, including statistical techniques, and the extent of their use
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Chapter 2 Overview of ISO 9001:2000
8.2.1 Customer satisfaction
� Organisation shall monitor information related to customer perception as to whether the organisation has met customer requirements.
� The methods for obtaining and using this information must be determined
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Chapter 2 Overview of ISO 9001:2000
8.2.2 Internal audit
Conduct internal audits at planned intervals to determine if :� QMS conforms to the planned arrangements, requirements of the
standard and organisation’s requirements
� QMS is effectively implemented & maintained
Plan the audit programme considering:� status and importance of the processes and the areas
� results of previous audits
Define audit criteria, scope, frequency & methodologies
Select auditors to ensure objectivity and impartiality.
Auditor must not audit own work.
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Chapter 2 Overview of ISO 9001:2000
8.2.2 Internal audit�The documented procedure must cover:
• responsibilities & requirements for planning and conducting audits
• reporting results and maintaining records
�Corrective actions without undue delay
�Follow up to verify actions taken & report verification results
Note:See ISO 10011 for guidance
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Chapter 2 Overview of ISO 9001:2000
8.2.3 Monitoring and measurement of processes
� Apply suitable methods for monitoring and, where applicable, measurement of QMS processes
� These methods shall demonstrate the ability of the processes to achieve planned results
� Where planned results are not achieved corrections and corrective actions must be taken to ensure conformity of the product
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Chapter 2 Overview of ISO 9001:2000
8.2.4 Monitoring and measurement of product
�Monitor & measure product characteristics to verify conformity at appropriate stages of realisation processes in accordance with planned arrangements
�Evidence of conformity with the acceptance criteria must be maintained. Records must indicate the person(s) authorising release of the product
�Release or delivery must not proceed until all the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority, and where applicableby the customer
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Chapter 2 Overview of ISO 9001:2000
8.3 Control of nonconforming product
� Nonconforming product must be identified and controlled to prevent unintended use or delivery
� Documented procedure to define controls, responsibility and authority
� When non conformance detected after delivery take appropriate action
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Chapter 2 Overview of ISO 9001:2000
8.3 Control of nonconforming product
� Organisation must deal with nonconforming product by one or more of the following ways:
• action to eliminate detected nonconformity
• concession
• preclude original intended use or application
� When the nonconforming product is corrected it must be re-verified to demonstrate conformity
� Records of the nature of nonconformity and any subsequent actionincluding concessions must be maintained
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Chapter 2 Overview of ISO 9001:2000
8.4 Analysis of data
�Determine, collect & analyse appropriate data to demonstrate thesuitability and effectiveness of QMS and to evaluate where continual improvement of the QMS can be made
�Data from measurement & monitoring & other relevant sources
�Analyse data to provide info on:• customer satisfaction
• conformity to product requirements
• process, product characteristics and their trends including opportunities for preventive action
• suppliers
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Chapter 2 Overview of ISO 9001:2000
CUSTOMERS
CUSTOMERS
Management responsibility
Resourcemanagement
Measurement, analysis,improvement
ProductProductrealisation
Continual Improvement of theQuality Management System
Requirements
Satisfaction
InputOutput
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Chapter 2 Overview of ISO 9001:2000
8.5 Improvement
8.5.1 Continual improvement
Organisation shall continually improve the effectiveness of the QMS through use of:
• quality policy
• quality objectives
• audit results
• analysis of data
• corrective actions
• preventive actions
• management review
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Chapter 2 Overview of ISO 9001:2000
Continual Improvement
SPCBenchmarkingQuality Circles
Risk AssessmentTeamwork for Quality
Quality Function Deployment
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Chapter 2 Overview of ISO 9001:2000
Continual Improvement
Problem Solving TechniquesProblem Solving Techniques
� Cause & effect diagram
� Pareto analysis
� Flowcharting
� Brain storming
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Chapter 2 Overview of ISO 9001:2000
8.5.2 Corrective action
Organisation shall take actions to eliminate the causes of nonconformities to prevent recurrence.
Corrective actions appropriate to the impact of the problem
Documented procedure shall define requirements for:• reviewing nonconformities (including customer complaints)
• determining the causes of nonconformities
• Evaluating the need for corrective action
• determining & implementing action needed
• recording results of action taken
• reviewing corrective action taken
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Chapter 2 Overview of ISO 9001:2000
8.5.3 Preventive action
Organisation shall determine action to eliminate the causes of potential nonconformances to prevent occurrence.
Actions appropriate to the impact of the potential problem
Documented procedure must define the requirements for
• determining potential nonconformances & their causes
• evaluating the need for preventive action
• determining and implementing action needed
• recording the results of action taken
• reviewing preventive action taken