Common ISO Documentation Requirements Every Organization Should Know

Introduction

The ISO management system approach is based on documentation. Regardless of the ISO 9001 ISO 27001 ISO 45001, or any other standard, organizations should keep and manage critical documents and records to demonstrate conformity, provide effective operations and promote constant improvement. The knowledge of such universal requirements will make the implementation to be very effective, audits to be successful, and compliance long term.

Concept Of Documented Information In ISO

In a 2015 structure named Annex SL, the structure developed a harmonized way of documenting the ISO standards. The concept of documented information has been modified to mean both documents (plans, policies, guides) and records (evidence of activities and results). These are the typical demands of any ISO management systems.

Policies

Any system must have a core policy, like Quality Policy (ISO 9001), Information Security Policy (ISO 27001), or Safety Policy (ISO 45001). These reports articulate intent in organizations, commitment by leadership and coherence with the standard involved.

Objectives

The standards demand that organizations establish, record, and track goals that are pertinent to the policy, including quality goals (ISO 9001), security goals (ISO 27001), and OHS goals (ISO 45001).

System Scope

Organizations need to specify and draft the scope of management systems that they are using- such as limits, applicability and processes that the certification process will cover.

Procedures And Processes

All ISO standards anticipate documented processes of major operations:

1. Document and record control.
   
   
2. Internal audits
   
   
3. Corrective and preventive action.
   
   
4. Operation planning and control.
   
   
5. Assessment of suppliers and supplier control.
   
   
6. Risk evaluation and incident reporting (in particular, in ISO 27001 and ISO 45001)

Records

The organizations are required to keep records as a measure that:

1. The processes are implemented according to plan.
   
   
2. Resources (people, surveillance devices) are of the right kind.
   
   
3. Training and competency are upheld.
   
   
4. The needs of the products and services are evaluated.
   
   
5. The design and developments are controlled.
   
   
6. Corrective actions and nonconformities are solved.
   

Documented Information That Is Mandatory In Major ISO Standards

The following are an outline of the core documents and records as mandated by standard and everywhere:

1. ISO 9001 (Quality) Quality Policy

• Scope of the QMS
• Quality Objectives
• Supplier evaluation criteria.
• Procedures (where necessary) documented.
• Training, calibration, audits, management reviews, corrective actions Records.

2. ISO 27001 (Information Security) Information Security Policy

• Scope of the ISMS
• Security goals and risk treatment strategy.
• Statement of Applicability
• Procedures of incident response.
• Acceptable use and asset inventory policies.
• Log and event records

3. Occupational Health and Safety ISO 45001 OHS Policy

• The scope of OH&S management system.
• Procedures of risk assessment and incident investigation.
• Recording monitoring and measurement.
• Record of corrective and preventive action.
• History of consultation and involvement.

4. ISO 14001 (Environment) Environmental Policy

• Scope and boundaries of EMS
• Aspect and impact registers
• Procedures of operational control.
• Emergency preparedness documentation records.
• Indication of adherence to requirements.
  

Rationales of Documentation Requirements

The requirements of ISO documentation can be used in various ways:

• Standardization and consistency of processes.
  
  
• Indications of agreement in audits.
  
  
• Training and onboarding assistance.
  
  
• Communication and knowledge retention facilitation.
  
  
• Prerequisite to continuous improvement and rectification.
  

Information documented should be:

• Approved prior to issue
• Stored and revised in case of any change.
• Available to the concerned staff.
• Safeguarded against accidental damage or destruction.
• Holding periods of a given time.

Document Control: Basic Requirements

Any standards of ISO demand that good document control systems are in place to ensure integrity and accuracy:

• Receiving approval of the documents by the authorized personnel.
  
  
• Version controls (dates, authorship) and revision version controls (unique ID)
  
  
• Restrictions to access and distribution.
  
  
• Retention and disposition policies.
  
  
• Training and notification of change on updated documents.

Good document control strategy means that only current, relevant and approved versions are utilized in operations.

Organizing The ISO Documentation

The ISO documentation is usually hierarchical:

• Policies: Statement of intent at the top level.
  
  
• Manuals: It is optional, but typical as a summary guide.
  
  
• Core process Procedures: Step by step instructions.
  
  
• Work Instructions: In-depth operational instructions, usually of duties or jobs.
  
  
• Forms and Templates: This is completed as records or evidence.
  
  
• Records: Evidence that processes have been implemented and goals met.
  

Related Topics

1. Continual Improvement: Any standard focuses on documentation in order to facilitate Plan-Do-Check-Act (PDCA) cycles. The revision and the update of documentation assist with the corrective measures and improvement efforts following audits and reviews.

2. Training and Competence Records: It is mandatory to keep the documentation to demonstrate staff competence, training, and qualifications through standards. Training records are often demanded as evidence by auditors.

3. Outsourced Process Control and Supplier: The compliance of manufacturing and service industries is based on documents and records concerning evaluation, selection, and monitoring of suppliers and outsourced processes.

4. Audit Records and Management Reviews: The use of internal audit schedules, reports, nonconformity logs and management review minutes is universally required in order to show system effectiveness and continuous improvement.

5. Risk Management Documentation: The ISO 27001 and ISO 45001 standards give much emphasis on the risk assessment and record of risk treatment but almost all ISO standards today have incorporated the concept of risk-based thinking in their documents.

Conclusion

The ISO documentation requirements form the basis of consistent, efficient and continuous improvement management systems. Although the document and record types and purposes can differ, by standards, central requirements, such as policies, objectives, system scope, operations procedures, records, and document control, are provided across all the ISO structures. Organizations should make sure that their documented information is well structured, controlled and maintained to assure of the same performance, auditability and sustainability.