The Complete Guide To ISO-Compliant Procedures For Your Organization

Introduction

Any management system is its operational core, which is the ISO-compliant procedures, that will close the gap between what an organization wants to accomplish, and how it will accomplish it. Regardless of the ISO 9001 (Quality), ISO 27001 (Information Security), or ISO 45001 (Safety) there needs to be business context, regulatory, and actual-day-to-day support of procedures, in addition to meeting the basic ISO requirements of documented information, control, traceability, and accessibility.

Getting Ready: Preparation And Planning

1. Identification of Purpose and Scope

There should be a definite purpose of why the process is necessary, and what area, activity, or dangers it involves, before putting pen to paper. This means:

• Assessing relevant ISO requirements and goals.
  
  
• Knowledge of the business process (input, output, internal/ external problem, and stakeholder).
  
  
• Boundary mapping What is included? Excluded? And what is the start and finish of this procedure?

Process Alignment: Not only ISO clauses, but procedures should be in line with the real business processes and context. This generates value in practice and sustainability. Risk and resource requirements are some of the aspects to consider in this alignment.

2. Collection of Information: Deep Dive and Cooperation

Data Collection Methods

• Collaborate with process owners/subject matter experts in order to have step-by-step activities captured.
  
  
• Explore all the angles using process mapping tools, flowcharts or using 5W1H approach (Who, What, Where, When, Why, How).
  
  
• Necessary documents, resources, competencies, controls and measurements.
  
  
• Determine regulatory, customer or stakeholder needs that affect the process.
  
  
• Tip: Interviews, and walkthroughs with the stakeholders helps enhance completeness and accuracy.

Reference and Benchmarking: Compare regulatory or industry standards with cross-reference and incorporate lessons learned on what was done in the last audit, incident or improvement project in order to enhance the relevance of the procedure.

3. Build Document Structure: Template and Layout

Basic Elements of ISO procedures.

An effective ISO procedure template will normally contain:

• Name and reference number/id
  
  
• Purpose and scope statement
  
  
• Definitions of key terms
  
  
• Roles and accountabilities of each step.
  
  
• Sequential (bulleted or numbered) step-by-step process.
  
  
• Allusions to the associated documentation/forms/records.
  
  
• Measurement, verification and monitoring criteria.
  
  
• Document control: revision history, version, author, approvals, effective date.
  
  
• Templates are clear and uniform facilitating readability, traceability and easier training. Be simple; do not use jargon.

4. Write the Procedure: Usability Writing

Writing Approach

• Be plain and simple (do not use ISO jargon unless necessary).
  
  
• Be simple yet thorough: all the steps must be made, but the unnecessary should be omitted.
  
  
• Apply the second person (you should...), or job/role (Production Supervisor will...).
  
  
• Make instructions sequential, logical and actionable.
  
  
• Indicate the point of decision making, safety check/records.
  
  
• Add decision points, exceptions and escalation paths where applicable.

Visual Aids Explain with flowcharts, diagrams or even video tutorials. Illustrations tend to clarify confusion and facilitate personnel comprehension.

5. Review, Approval, and Control

Peer and Management Review

• Get informed co-workers and owners of processes to endorse the draft- are all the steps sensible? Are responsibilities clear? Are risks covered?
  
  
• Integrate feedback; make the process feasible, regulatory, and not too complicated.
  
  
• Document Control and Approval.
  
  
• Make sure the end process is authorised by the manager in charge or authorised body.
  
  
• Add to the document control system: index, version, approval date, review cycle.
  
  
• Abandon the old versions and inform about changes.

6. Communication and Training

Rollout and Awareness

• Share the process with everyone involved in the institution- send via email, post on intranet / quality portal, or through team meetings.
  
  
• Give training when needed and take attendance.
  
  
• Communication of Change and Update.
  
  
• Make sure the staff is aware of the methods of communicating and accessing updated procedures. Recommend feedback systems to use to improve on a continuous basis.

7. Periodical Review and Monitoring

• Make review of the building process a part of the procedure, usually once a year or following major incidents.
  
  
• Seek user and manager responses to make modifications or adaptations to operational changes or audit results.
  
  
• Make sure the process is adherent, efficient and pertinent.

Related Topics

Procedures and Work Instructions.

1. Procedures: Indicate how to conduct business processes which may involve multiple roles/departments.
   
   
2. Work Instructions: The work instructions can be drilled down to single step often task-based instructions in a process. The hierarchical organization promotes clarity and control of operations.

Procedures Document Control

Strong document control systems safeguard the accuracy, versioning, access, and security in line with requirements of ISO documented information requirements. Much of the controls are automated through electronic document management systems.

Multi-Standard Systems Customization

Companies that have has several ISO certifications (e.g., ISO 9001 + ISO 14001 + ISO 27001) develop combined processes that support multiple standards at the same time. Compliance is made easy through cross-referencing of clauses, risks, and records.

Conclusion

The process of authoring a procedure that is in compliance with ISO is an art and a science, and it necessitates business acumen, clarity, regulatory savvy, and relevance to the operations of the business. Your planning, teamwork, drafting, reviewing, document control and constant communication will make you come up with procedures that will not only meet audit and regulatory requirements but will also make people smarter and safer in their work.