ISO documents typically include standards like ISO 9001 for Quality Management Systems, ISO 14001 for Environmental Management Systems, and ISO 45001 for Occupational Health and Safety Management Systems. These standards provide frameworks for organizations to manage their operations effectively and efficiently.
Here's a breakdown of the types of documents and records required for ISO certification:
1. Mandatory Documents (for all ISO standards):
- Quality Manual: A comprehensive document outlining the organization's quality management system, including policies, procedures, and work instructions.
- Quality Policy: A statement of the organization's commitment to quality, including objectives and strategies.
- Scope of the Quality Management System: Defines the boundaries of the QMS and what processes are included.
- Procedures and Work Instructions: Detailed step-by-step instructions for carrying out specific tasks and processes.
- Records of Training, Skills, Experience, and Qualifications: Evidence of employee competence and qualifications.
- Records of Monitoring and Measurement: Data collected from monitoring and measuring equipment and processes.
- Results of Management Reviews: Documentation of management reviews and any corrective actions taken.
- Records of Internal Audits: Documentation of internal audits and any findings.
- Records of Corrective Actions: Documentation of corrective actions taken to address non-conformances.
- Control of Documented Information: Procedures for managing documents, including their creation, review, approval, and distribution.
2. Specific Requirements for ISO 9001:
- Design and Development Controls: Procedures for managing the design and development of products and services.
- Control of Nonconforming Outputs: Procedures for managing non-conforming products or services.
- Identification and Traceability: Systems for identifying and tracking products or services.
- Performance Evaluation: Monitoring and analysis of performance metrics.
3. Specific Requirements for ISO 14001:
- Environmental Policy: A statement of the organization's commitment to environmental protection.
- Environmental Objectives: Goals related to environmental performance.
- Monitoring and Measurement of Environmental Performance: Data collected to track environmental performance.
4. Specific Requirements for ISO 45001:
- Occupational Health and Safety Policy: A statement of the organization's commitment to occupational health and safety.
- OH&S Objectives: Goals related to occupational health and safety.
- Monitoring and Measurement of OH&S Performance: Data collected to track OH&S performance.
Important Considerations:
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Document Control:
ISO standards require organizations to have a system for controlling their documents, ensuring that the latest version is always used.
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Record Retention:
Organizations must establish procedures for retaining records, ensuring that they are kept for a sufficient period of time.
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Tiered Documentation:
Some organizations structure their documentation into tiers, such as a Quality Manual, Procedures, and Work Instructions.