What is ISO Documentation?

ISO makes documents with required standards, specifications, guidelines or characteristics. These can consistently be used by companies and ensure that materials, products, processes and services are suitable for their purpose.

Mandatory documents and records required by ISO 9001:2015

Here are the documents you need to produce if you want to be compliant with ISO 9001:2015. (Please note that some of the documents will not be mandatory if the company does not perform relevant processes.):

• Scope of the QMS (clause 4.3)
• Quality policy (clause 5.2)
• Quality objectives (clause 6.2)
• Criteria for evaluation and selection of suppliers (clause 8.4.1)

  • Monitoring and measuring equipment calibration records* (clause 7.1.5.1)
  • Records of training, skills, experience and qualifications (clause 7.2)
  • Product/service requirements review records (clause 8.2.3.2)
  • Record about design and development outputs review* (clause 8.3.2)
  • Records about design and development inputs* (clause 8.3.3)
  • Records of design and development controls* (clause 8.3.4)
  • Records of design and development outputs *(clause 8.3.5)
  • Design and development changes records* (clause 8.3.6)
  • Characteristics of product to be produced and service to be provided (clause 8.5.1)
  • Records about customer property (clause 8.5.3)
  • Production/service provision change control records (clause 8.5.6)
  • Record of conformity of product/service with acceptance criteria (clause 8.6)
  • Record of nonconforming outputs (clause 8.7.2)
  • Monitoring and measurement results (clause 9.1.1)
  • Internal audit program (clause 9.2)
  • Results of internal audits (clause 9.2)
  • Results of the management review (clause 9.3)
  • Results of corrective actions (clause 10.1)

Here are the documents you need to produce if you want to be compliant with ISO 14001: 2015 (Environmental Management System).

  • Scope of the EMS (clause 4.3)
  • Environmental Policy (clause 5.2)
  • Risk and Opportunities to be Addressed and Processes Needed (clause 6.1.1)
  • Criteria for Evaluation of Significant Environmental Aspects (clause 6.1.2)
  • Environmental Aspects with Associated Environmental Impacts (clause 6.1.2)
  • Significant Environmental Aspects (clause 6.1.2)
  • Compliance Obligations Document (clause 6.1.3)
  • Environmental Objectives and Plans for Achieving Them (clause 6.2)
  • Operational Control (clause 8.1)
  • Emergency Preparedness and Response (clause 8.2)

And here are the mandatory records if you want to be compliant with ISO 14001:

  • Records of Training, Skills, Experience and Qualifications (clause 7.2)
  • Evidence of Communication (clause 7.4)
  • Monitoring and Measurement Results (clause 9.1.1)
  • Evidence of the Compliance Evaluation Result(s) (clause 9.1.2)
  • Internal Audit Program (clause 9.2)
  • Results of Internal Audits (clause 9.2)
  • Results of the Management Review (clause 9.3)
  • Results of Corrective Actions (clause 10.2)

Here are the documents you need to produce if you want to be compliant with ISO 45001:

  • Scope of the OH&S management system (clause 4.3)
  • OH&S policy (clause 5.2)
  • Responsibilities and authorities within OH&SMS (clause 5.3)
  • OH&S process for addressing risks and opportunities (clause 6.1.1)
  • Methodology and criteria for assessment of OH&S risks (clause 6.1.2.2)
  • OH&S objectives and plans for achieving them (clause 6.2.2)
  • Emergency preparedness and response process (clause 8.2)

And, here are the mandatory records:

  • OH&S risks and opportunities and actions for addressing them (clause 6.1.1)
  • Legal and other requirements (clause 6.1.3)
  • Evidence of competence (clause 7.2)
  • Evidence of communications (clause 7.4.1)
  • Plans for responding to potential emergency situations (clause 8.2)
  • Results on monitoring, measurements, analysis and performance evaluation (clause 9.1.1)
  • Maintenance, calibration or verification of monitoring equipment (clause 9.1.1)
  • Compliance evaluation results (clause 9.1.2)
  • Internal audit program (clause 9.2.2)
  • Internal audit report (clause 9.2.2)
  • Results of management review (clause 9.3)
  • Nature of incidents or nonconformities and any subsequent action taken (clause 10.2)
  • Results of any action and corrective action, including their effectiveness (clause 10.2)
  • Evidence of the results of continual improvement (clause 10.3)