ISO Records and Registers Every Organization Should Maintain: Risk Register, Audits & Management Reviews

by Poorva Dange

Introduction

Records are not paperwork, they are in fact, the documentation that completes the circle between policy, procedure and actual performance. In contrast to documents (where plans and instructions are contained), the ISO records and registers recorded actions taken, decisions made and the outcome of monitoring, measurement and improvements. These records require proper management, retention, and traceability that are essential in certification, efficiency in operations, and organizational sustainability.

ISO Records and Registers Every Organization Should Maintain: Risk Register, Audits & Management Reviews

Basic Web Core Records And Roles

1. Risk Register

Purpose: Risk Register A risk register is a well-designed list of known risks, risk analysis, risk control, risk remainder, and risk owners, and monitoring. It offers an active perspective of the risk situation in the organization, strategic threats to operational risks.

Contents:

  • Special risk identification codes or numbers.

  • Background of every risk (business, safety, information security, etc.)

  • Impact rating and likelihood rating.

  • Risk owner and stakeholders

  • Mitigation/control actions

  • Status (open, closed, pending)

  • Date of assessment and reviews

  • Residual risk analysis

Importance: The risk register helps auditors and managers to ensure the proactive, systematic approach to risk management, the key to such standards as ISO 9001, ISO 27001, and ISO 45001.

2. Training Records

Purpose: Training records are some of the records that give verifiable evidence on the competency, qualification and awareness of the employees. They follow who, when and with what outcome attended what training and are certain that the workforce of the organization is prepared to undertake work and adhere to the ISO requirements.

Contents:

  • Identity of the employees (name, position, department).

  • Time of training, kind of training and subject matter of training.

  • Trainer or provider name

  • Test or assessment results

  • Renewal, Certificate and qualification.

  • Awareness evidence (e.g. sign-off sheets)

Importance: The compliance is inspected by the internal and external auditors, which discourage the risk of the unqualified staff and encourages the constant skills and safety practices enhancement.

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3. Audit Reports

Purpose: Both internal and external audits find, observe, identify nonconformities, and make recommendations and later corrective actions that are captured in audit reports. They play a key role in the presentation of review, verification, and improvement in accordance with ISO Plan-Do-Check-Act cycle.

Contents:

  • Audit scope, objectives and date.

  • Name and independence statement of auditors.

  • Audited process or department.

  • Evidence and observations made.

  • Improvement techniques observed or noted.

  • Actions agreed and taken correctively.

  • Status of the audit closure The audit closure was started but not completed.

Importance: Audit reports evidence that the organization systems are assessed systematically in terms of effectiveness, compliance and the continuous improvement-prerequisites of ISO certification and operational excellence.

4. Management Review Minutes

Purpose: The management review minutes can be defined as the official document of periodical leadership gatherings to examine the effectiveness of the management system, overview the goals, deliberate the risks, audit findings, and make decisions.

Contents:

  • Date, time, and attendees

  • Summary of discussion and points in the agenda.

  • Performance review of QMS/ISMS/EMS.

  • Objectives, risks, and nonconformities analysis.

  • Resource requirements and improvement activities.

  • Decisions, assignments and deadlines.

Importance: These records are audited by certification auditors to ensure the management is fully engaged and responsible towards the direction and enhancements of the system.

Regulatory Requirements And Best Practices Of ISO Records

1. Identification: All the records/registers should be distinctly identified and all titles, dates and references should be well made to facilitate easy access.

2. Storage: Physical and digital documents must be stored in a manner that their destruction, loss, or damage is minimized or prevented to the greatest possible extent. Take into account access control and contingency plans.  Use of the system is controlled by a policy defining password protection of a certain strength.  

3. Access and protection: Access to modifications of records is to be restricted and kept under control access to modification prevented in the interest of accountability to modifications that are unauthorized and to control records of access to the record.  

4. Retention:  Retention periods must be defined to the standard legal requirements.

Example: 10-15 years of medical device records according to ISO 13485). And do not destroy records until their period of retention is expired; a written retention policy is needed.

5. Retrieval and Disposition: The records should be easily accessible to audit or regulatory inspection. In case it is allowed to be discarded, make sure it is done securely and irreversibly through a formal process.

The Way Records Help In ISO Certification

Records are obligatory in all major ISO requirements not only to demonstrate that the planned activities took place, but also to facilitate learning, accountability, and transparency. Examples of the records required per standard include:

ISO 9001 (Quality): Management review, results of audit, release of product/service, Calibration results, training, nonconformance and corrective action.

ISO 27001 (Information security): The risk assessment, access logs, incident logs, audit results, employee training. There are Safety, Incident Investigation Reports, Safety Training, Risk Registers, Health and Awards Meetings, and Corrective Actions.

ISO 14001 (Environment): Environmental aspects register, environmental compliance audit, incident report, performance measurement.

Records management is a necessary system that can pass audits and ensure long-term certification.

Conclusion

The actual evidence of system operation, compliance and improvement are in the ISO records and registers; risk register, training register, audit report and management review minutes. Effective records management is known to guarantee accountability, resiliency, audit preparedness, and promote informed decision-making and continuous improvement.

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