1. Understanding the Requirements Qimpro Standards Organization
ISO 9001: 2000
Understanding the Requirements
Qimpro Standards Organization
April 2001

2. 1. Scope
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3. 1.1 General
Demonstrate ability to consistently provide product that meets customer and applicable regulatory requirements
Enhances customer satisfaction, achieve continual improvement and assurance of conformity to customer and applicable regulatory requirements
Product applies only to the product intended for, or required by, a customer.
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4. 1.2 Application
Requirements of the standard are generic - applicable to all organizations, regardless of type, size and product provided
Permissible exclusions possible – only for clause 7 (exclusions should not affect ability, or responsibility, to provide product that meets customer and applicable regulatory requirements).
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5. 2. Normative reference
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6. ISO 9000: 2000, Quality management systems – Fundamentals and vocabulary.
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7. 3. Terms and definitions
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8. Refer terms and definitions given in ISO 9000
Supplier, organization, customer
The term “organization” replaces the term “supplier” used in ISO 9001:1994, and refers to the unit to which this International Standard applies
The term “supplier” now replaces the term “subcontractor”
The term “product” also means “service”.
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9. 4. Quality management system
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10. 4.1 General requirements
Establish, document, implement and maintain a QMS
Continually improve effectiveness of QMS
Identify processes needed for QMS and their application across the organization
Determine the sequence and interaction of these processes
Determine criteria and methods needed to ensure that operation and control of these processes are effective
Cont…
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11. 4.1 General requirements (Cont…)
Ensure availability of resources and information necessary to support the operation and monitoring of these processes
Monitor, measure and analyze these processes, and
Implement actions necessary to achieve planned results and continual improvement of these processes.
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12. 4.1 General requirements (Cont…)
Organization is responsible for quality of outsourced process/material
Processes include processes for management activities, provision of resources, product realization and measurement.
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13. 4.2 Documentation requirements
4.2.1 General
Documented statements of a quality policy and quality objectives
A quality manual
Documented procedures required by the standard
Documents needed by the organization to ensure the effective planning, operation and control of its processes
Records required by the standard
Documented procedure - established, documented, implemented and maintained
Cont…
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14. 4.2.1 General (Cont…) Criteria for extent of the QMS documentation
Size of organization and type of activities
Complexity of processes and their interactions
Competence of personnel
Documentation can be in any form or type of medium – electronic is allowed.
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15. 4.2.2 Quality manual Quality manual includes:
Scope of QMS, including justification for exclusions
Documented procedures or reference to them
Description of interaction between processes of QMS.
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16. 4.2.3 Control of documents QMS documents must be controlled
Control includes
Approval of documents for adequacy prior to issue
Review and update
Ensure that changes and revision status is identified
Ensure that relevant versions are available at points of use
Ensure that documents remain legible and readily identifiable
Ensure that documents of external origin are identified controlled
Prevent use of obsolete documents
Documented procedure essential.
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17. 4.2.4 Control of records
Provide evidence of conformity to requirements and effective operation of QMS
Must be legible, readily identifiable and retrievable
Documented procedure essential - identification, storage, protection, retrieval, retention time and disposition of records.
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18. 5. Management responsibility
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19. 5.1 Management commitment
Evidence of commitment to development and implementation of QMS and continually improving its effectiveness by:
Communicating the importance of meeting customer and statutory/regulatory requirements
Establishing the quality policy and quality objectives
Conducting management reviews
Provide resources.
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20. 5.2 Customer focus
Top management must ensure that customer requirements are determined and met
Aim to enhance customer satisfaction.
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21. 5.3 Quality policy Top management must ensure that the quality policy:
Is appropriate to the purpose of the organization
Includes a commitment to comply with requirements and continual improvement
Provides a framework for establishing and reviewing quality objectives
Is communicated and understood within the organization
Is reviewed for continuing suitability.
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22. 5.4 Planning 5.4.1 Quality objectives
Top management must identify quality objectives
Must be measurable and consistent with the quality policy.
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23. 5.4.2 Quality management system planning
Top management shall ensure that:
QMS is planned to address in 4.1, and quality objectives
Integrity of the QMS is maintained when changes are planned and implemented.
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24. 5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
Top management must ensure that responsibilities and authorities are defined and communicated within the organization.
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25. 5.5.2 Management representative
Must be appointed
Member of management
Irrespective of other responsibilities, must have responsibility and authority that includes:
Ensuring that processes needed for QMS are established, implemented and maintained
Reporting to top management on performance of QMS
Ensuring the promotion of awareness of customer requirements throughout the organization.
Will liaison with external parties on matters relating to QMS.
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26. 5.5.3 Internal communication
Top management must ensure that communication processes are established to communicate effectiveness of QMS.
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27. 5.6 Management review 5.6.1 General
Top management must review QMS, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness
Review must include assessment of opportunities for improvement
Need for changes to QMS, including the quality policy and quality objectives must be reviewed
Records from management reviews must be maintained.
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28. 5.6.2 Review input Results of audits Customer feedback
Process performance and product conformity
Status of preventive and corrective actions
Follow-up actions from previous management reviews
Changes that could affect the quality management system
Recommendations for improvement.
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29. 5.6.3 Review output
Improvement in effectiveness of QMS and its processes
Improvement of the product related to customer requirements
Resource needs.
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30. 6. Resource management
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31. 6.1 Provision of resources
Implement and maintain the QMS and continually improve its effectiveness
To enhance customer satisfaction by meeting customer requirements.
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32. 6.2 Human resources 6.2.1 General
Personnel performing work affecting product quality must be competent
Competence includes appropriate education, training, skills and experience.
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33. 6.2.2 Competence, awareness and training
Determine the necessary competence for personnel performing work affecting product quality
Provide training or take other actions to satisfy these needs
Evaluate the effectiveness of the actions taken
Ensure that personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives
Maintain appropriate records of education, training, skills and experience.
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34. 6.3 Infrastructure
Determine, provide and maintain infrastructure needed to achieve conformity to product requirements
Building, workspace and associated utilities
Process equipment (both hardware and software)
Supporting services (such as transport or communication).
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35. 6.4 Work environment
Determine and manage the work environment needed to achieve conformity to product requirements.
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36. 7. Product realization
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37. 7.1 Planning of product realization
Plan and develop processes needed for product realization.
Planning of product realization must be consistent with requirements of other processes of QMS.
Determine quality objectives and requirements for the product
Determine the need to establish processes, documents, and provide resources
(Cont…)
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38. 7.1 Planning of product realization (Cont…)
Determine required verification, validation, monitoring, inspection and test activities and the criteria for product acceptance
Determine records needed to provide evidence that the realization processes and resulting product meet requirements.
The output of this planning must be in a form suitable for the organization’s method of operations.
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39. 7.2 Customer-related processes
7.2.1 Determination of requirements related to the product
Requirements specified by the customer, including the requirements for delivery and post-delivery activities
Requirements not stated by the customer but necessary for specified or intended use
Statutory and regulatory requirements related to the product
Any additional requirements determined by the organization.
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40. 7.2.2 Review of requirements related to the product
Review the requirements related to the product
Review must be conducted before commitment to supply
Ensure that product requirements are defined
Ensure that differences are resolved
Ensure that the organization has the ability to meet defined requirements
Records of the results of the review and actions must be maintained.
(Cont…)
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41. 7.2.2 Review of requirements related to the product (Cont…)
Where customer requirement is not documented, confirm the same before acceptance
Where product requirements are changed, amend documents and inform relevant personnel
In some situations, such as Internet sales, a formal review is impractical for each order.
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42. 7.2.3 Customer communication
Must determine and implement effective arrangements for communicating with customers
Product information
Enquiries, contracts or order handling, including amendments, and
Customer feedback, including customer complaints.
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43. 7.3 Design and development
7.3.1 Design and development planning
Must plan and control the design and development of product
Determine the design and development stages
Determine review, verification and validation at each stage
Determine responsibilities and authorities for design and development
Must manage the interfaces between different groups involved in design and development
Planning output must be updated as the design and development progresses.
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44. 7.3.2 Design and development inputs
Inputs relating to product requirements must be determined and records maintained
Functional and performance requirements
Applicable statutory and regulatory requirements
Where applicable, information derived from previous similar designs
Other requirements essential for design and development
Inputs must be reviewed for adequacy
Requirements must be complete, unambiguous and not in conflict with each other.
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45. 7.3.3 Design and development outputs
Outputs must be provided in a form that enables verification against inputs
Outputs must be approved prior to release
Meet the input requirements for design and development
Provide appropriate information for purchasing, production and for service provision
Contain or reference product acceptance criteria
Specify the characteristics of the product that are essential for its safe and proper use.
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46. 7.3.4 Design and development review
Systematic and at suitable stages and as planned
Evaluate the ability of the results to meet requirements
To identify any problems and propose necessary action
Participants must include representatives of functions concerned with the design and development
Records of the results of the reviews and any necessary actions must be maintained.
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47. 7.3.5 Design and development verification
Verification must be performed as planned
Ensure that outputs have met input requirements
Records of verification and any necessary actions must be maintained.
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48. 7.3.6 Design and development validation
Must be performed as planned
Ensure that resulting product is capable of meeting requirements for specified application / intended use
Validation must be completed prior to delivery or implementation
Records of results of validation and any necessary action must be maintained.
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49. 7.3.7 Control of design and development changes
Design and development changes must be identified and recorded
Changes must be reviewed, verified and validated, and approved before implementation
Review of changes must include evaluation of effect of changes on parts and product already delivered
Records of the results of the review of changes and any necessary actions must be maintained.
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50. 7.4 Purchasing 7.4.1 Purchasing process
Must ensure that purchased product conforms to specified purchase requirements
Type and extent of control on supplier and purchased product will depend on the effect of the purchased product on subsequent product realization or final product
Must evaluate and select suppliers based on their ability to supply product in accordance requirements
Cont…
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51. 7.4.1 Purchasing process (Cont…)
Criteria for selection, evaluation and re-evaluation must be established
Records of the results of evaluations and any necessary actions arising from the evaluation must be maintained.
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52. 7.4.2 Purchasing information
Must describe the product to be purchased
Requirements for approval of product, procedures, processes and equipment
Requirements for qualification of personnel
Quality management system requirements
Must ensure adequacy of specified purchase requirements prior to their communication to the supplier.
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53. 7.4.3 Verification of purchased product
Must establish inspection/other activities to ensure that purchased product meets purchase requirements
For self-certification/verification state intended verification arrangements and method of product release in the purchasing information.
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54. 7.5 Production and service provision
7.5.1 Control of production and service provision
Must plan and carry out production and service provision under controlled conditions
Information that describes the characteristics of the product
Work instructions
Use of suitable equipment
Use of monitoring and measuring devices
Implementation of monitoring and measurement
Implementation of release, delivery and post-delivery activities.
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55. 7.5.2 Validation of processes for production and service provision
Must validate any processes where output cannot be verified by subsequent monitoring/measurement.
Validation must demonstrate ability of these processes to achieve planned results
Defined criteria for review and approval of the processes
Cont…
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56. 7. 5. 2. Validation of processes for production
Validation of processes for production and service provision (Cont…)
Approval of equipment and qualification of personnel
Use of specific methods and procedures
Requirements for records
Revalidation.
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57. 7.5.3 Identification and traceability
Must identify product throughout product realization
Must identify product status with respect to monitoring and measurement requirements
Must control and record the unique identification of the product
In software, configuration management is used for identification and traceability.
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58. 7.5.4 Customer property
Provided for use or incorporation into the product
Must take care with customer property while it is under your control
Must identify, verify, protect and safeguard customer property
In case of loss, damage or unsuitability for use, inform customer and maintain records
Customer property includes intellectual property.
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59. 7.5.5 Preservation of product
Must preserve conformity of product during internal processing and delivery
Preservation includes identification, handling, packaging, storage and protection
Preservation must apply to the constituent parts of a product.
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60. 7.6 Control of monitoring and measuring devices
Must determine the monitoring and measurement requirements and devices
Needed to provide evidence of conformity of product to determined requirements
Measurement equipment must be calibrated or verified
Specific intervals, or prior to use, against standards traceable to international or national standards
Where no such standards exist, the basis used for calibration or verification must be recorded
Adjust or re-adjust
Cont…
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61. 7.6 Control of monitoring and measuring devices (cont…)
Identification to enable the calibration status to be determined
Safeguarded from adjustments that would invalidate the measurement result
Protected from damage and deterioration during handling, maintenance and storage
Must assess and record validity of the previous measuring results when the equipment is found not to conform to requirements
Cont…
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62. 7.6 Control of monitoring and measuring devices (cont…)
Must take action on the equipment and any product affected
Records of the results of calibration and verification must be maintained
When used for monitoring and measurement, computer software must be calibrated
ISO and ISO for guidance.
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63. 8. Measurement, analysis and improvement
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64. 8.1 General
Must plan and implement monitoring, measurement, analysis and improvement processes
Demonstrate conformity of the product
Ensure conformity of QMS
Continually improve the effectiveness of QMS.
Determine applicable methods, including statistical techniques, and the extent of their use.
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65. 8.2 Monitoring and measurement
8.2.1 Customer satisfaction
Must monitor information about customer perception w.r.t customer requirements
Determine methods for obtaining and using this information.
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66. 8.2.2 Internal audit Must conduct internal audits at planned intervals
Conformance of QMS to the planned arrangements
Conformance of QMS to the requirements of ISO 9001: 2000
Conformance of QMS to requirements of the organization
Effective implementation of QMS
Plan audits taking considering status and importance of processes and results of previous audits
Audit criteria, scope, frequency and methods must be defined
Cont…
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67. 8.2.2 Internal audit (Cont…)
Selection of auditors and conduct of audits must ensure objectivity and impartiality of the audit process
Auditors shall not audit their own work.
Documented procedure is a must
Auditee must ensure that actions are taken without undue delay
Follow-up activities must include verification of actions taken
ISO , ISO and ISO for guidance.
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68. 8.2.3 Monitoring and measurement of processes
Must monitor and measure QMS processes
Must demonstrate ability of the processes to achieve planned results
Initiate correction and corrective action to ensure conformity of the product.
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69. 8.2.4 Monitoring and measurement of product
Must monitor and measure characteristics of the product to verify that product requirements have been met
Must be done at stages of the product realization process as per plan
Evidence of conformity must be maintained
Records must indicate the person(s) authorizing release of product
Product release and service delivery shall not proceed until requirements are met
Waiver by relevant authority or customer.
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70. 8.3 Control of nonconforming product
Must ensure nonconforming is identified and controlled to prevent unintended use or delivery
Must establish a documented procedure
Take action to eliminate the detected nonconformity
Authorize use, release or acceptance under concession by a relevant authority or customer
Take action to preclude its original intended use or application
Records of non-conformities and any subsequent actions taken must be maintained
(Cont…)
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71. 8.3 Control of nonconforming product (Cont…)
After correction, the product must be re-verified to demonstrate conformity
If detected after delivery or use the organization must take action appropriate to the effects, or potential effects, of the nonconformity.
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72. 8.4 Analysis of data
Must determine, collect and analyze data to demonstrate suitability and effectiveness of QMS
Evaluate opportunities for continual improvement of effectiveness of QMS
Data can be generated from other relevant sources.
Analysis of customer satisfaction data
Analysis of conformity to product requirements
Analysis of characteristics and trends of processes and product including opportunities for preventive action
Analysis of information on suppliers.
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73. 8.5 Improvement 8.5.1 Continual improvement
Must improve effectiveness of QMS continually
Improvement traceable to quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.
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74. 8.5.2 Corrective action
Must take action to eliminate cause of non-conformities in order to prevent recurrence
Corrective actions must be appropriate to the effects of the non-conformities
Documented procedure must be established
Review non-conformities (including customer complaints)
Determine causes of non-conformities
Evaluate need for action to ensure that non-conformities do not recur
Determine and implement action needed
Records of results of action taken
Review corrective action taken.
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75. 8.5.3 Preventive action
Must take action to eliminate the causes of potential non-conformities to prevent occurrence. Preventive actions must be appropriate to the effects of potential problems
Documented procedure must be established
Determine potential non-conformities and their causes
Evaluate the need for action to prevent occurrence of non-conformities
Determine and implement action needed
Records of results of action taken
Review preventive action taken.
April 2001

76. Thank You standards@qimpro.com www.qimpro.com April 2001