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CHAPTER 1, CHAPTER 2 ISO 9000, 1.2 Application, Resource Management,…

- - - - Provides essential definitions and concepts
      - Useful for understanding terminology
      - Foundation for the entire ISO 9000 family
  - - - Applicable to any organization
      - Focus on customer satisfaction and continual improvement
      - Sets criteria for a quality management system (QMS)
      - The only certifiable standard in the series
  - - - Goes beyond ISO 9001
      - Focuses on long-term performance and stakeholder satisfaction
      - Provides a self-assessment tool for continuous improvement
  - - - Offers guidance on internal and external audits
      - Covers audit principles, managing audit programs, and conducting audits
      - Useful for organizations implementing or managing audits of QMS
- - - - Specifies requirements for a quality management system (QMS).
      - Aims to enhance customer satisfaction by meeting customer and regulatory requirements.
  - - - Identify needed processes and their application.
      - Determine sequence and interaction of processes.
      - Ensure availability of resources and information.
      - Monitor, measure, and analyze processes.
      - Implement actions to achieve planned results and continual improvement.
    - - 4.2.1 General: QMS documentation includes
        
        Quality policy and objectives.
        
        Quality manual.
        
        Documented procedures and records.
        
        Documents required for effective planning and operation.
      - 4.2.2 Quality Manual
        
        Includes scope of QMS, details of exclusions, documented procedures, and description of process interactions.
      - 4.2.3 Control of Documents
        
        Documents must be reviewed, updated, and approved.
        
        Current versions must be available.
        
        Obsolete documents must be controlled.
      - 4.2.4 Control of Records
        
        Records provide evidence of conformity and effective operation.
        
        Must be controlled, protected, and retrievable.
  - - - Communicate importance of meeting requirements.
      - Establish quality policy and objectives.
      - Conduct management reviews.
      - Ensure availability of resources.
    - - Ensure customer requirements are determined and met to enhance satisfaction.
    - - Appropriate to the organization’s purpose.
      - Commitment to continual improvement.
      - Framework for quality objectives.
      - Communicated and understood within the organization.
    - - 5.4.1 Quality Objectives
        
        Measurable, consistent with policy, and applied across relevant functions.
      - 5.4.2 QMS Planning
        
        Ensure QMS meets requirements and changes are managed.
    - - 5.5.1 Responsibility and Authority
        
        Defined and communicated.
      - 5.5.2 Management Representative
        
        Oversees QMS, reports performance, promotes awareness.
      - 5.5.3 Internal Communication
        
        Ensures effective internal communication processes.
    - - 5.6.1 General
        
        Review QMS for suitability, adequacy, and effectiveness.
      - 5.6.2 Review Input
        
        Includes audit results, customer feedback, performance, preventive actions, etc.
      - 5.6.3 Review Output
        
        Includes decisions on improvements and resource needs.
  - - - 7.2 Customer-related Processes
        
        7.2.1 Determination of Requirements Related to the Product
        
        Determine requirements specified by the customer, including the requirements for delivery and post-delivery activities
        
        7.2.2 Review of Requirements Related to the Product
        
        Review requirements related to the product
        
        7.2.3 Customer Communication
        
        Determine and implement effective arrangements for communicating with customers in relation to product information, enquiries, contracts, customer feedback and complaints
        
        7.3 Design & Development
        
        7.3.1 Design & Development Planning
        
        Plan and control design and development of product
        
        7.3.2 Design & Development Inputs
        
        Inputw relating to product requirements shall be determined and records maintained such a functional and performance requirements, applicable statutory and regulatory requirements
        
        7.3.3 Design & Development Outputs
        
        Shall be provided in a form that enables verification against the design and development input shall be approved prior to release
        
        7.3.4 Design & Development Review
        
        To evaluate the ability of results of design and development to meet requirements and
        
        To identify any problems and propose necessary actions
        
        7.3.5 Design & Development Verification
        
        Shall be performed in accordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirements
        
        7.3.6 Design & Development Validation
        
        To ensure that the resulting product is capable of meeting the requirements for the specified application or intended use where known
        
        7.4 Purchasing
        
        7.4.1 Purchasing Processs
        
        Ensure that purchased product conforms to specified purchase requirements
        
        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
        
        7.4.3 Verification of Purchased Product
        
        Establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements
        
        7.5 Production and Service Provision
        
        7.5.1 Control of Production & Service Provision
        
        Shall plan and carry out production and service provision under controlled conditions
        
        7.5.2 Validation Processes for Production & Service Provision
        
        Validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring measurement
        
        7.5.3 Identification & Traceability
        
        Identify the product by suitable means throughout product realisation
        
        7.5.4 Customer Property
        
        Shall exercise care with customer property while it is under the organisation's control or being used by the organisation
        
        7.5.5 Preservation of Product
        
        Preserve the conformity of product during internal processing and delivery to the intended destination
        
        7.6 Control of Monitoring & Measuring Devices
        
        Determine the monitoring and measurement to be under taken and the monitoring and measuring devices needed to provide evidence of conformity of product to determine requirements
        
        7.3.7 Control of Design and Development Changes
        
        Changes shall be reviewed, verified and validated as appropriate and approved before implementation
      - Plan and develop the processes needed for product realization
- - - - Monitor information relating to customer perception whether has met customer requirements
    - - Should be conducted to determine the qms conforms to the planned arrangement and is effectively implemented and maintained
    - - Methods shall demonstrate the ability of the processes to achieve planned results
    - - Monitor and measure the characteristic of the product to verify that product requirements have been met
  - - - Improve the effectiveness of qms through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review
    - - Take action to eliminate the cause of nonconformities in order to prevent recurrence
    - - Determine action to eliminate the cause of potential nonconformities in order to prevent their occurrence