9 Steps Toward a ISO 9001 Management System.

A Quality Management System is simply a Business Management System and ISO 9001:2015 can be a small business guide to implementing best practices. Your business objectives and a risk-based approach in managing your business processes – is at the core of an ISO 9001 compliant Quality Management System.

Clause 4.4.1 of the ISO 9001:2015 standard states that “The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interaction, in accordance with the requirements of this International Standard.”
Clause 4.4.1 a-h provide a checklist for establishing and managing your Business Management System based on key processes-
But, these items need to be re-ordered to provide a step-by-step guide. Below are those steps re-ordered and rewritten in plain English.

1. The organization shall determine the processes needed for the business.
2. Assign process owners.
3. Determine the order and interactions for each process.
4. Determine inputs and outputs for each process.
5. Integrate risk-based actions into the processes considering outputs from strategic planning such as strengths, weaknesses, opportunities, and threats (SWOT) and Program Evaluation & Review Technique (PERT).
6. Determine metrics for process performance- consider inputs, outputs, who, where, when, and how.
7. Determine the resources needed and ensure their availability.
8. Audit (evaluate per the standard) these processes.
9. Improve the processes and business management system as needed at planned review/audit cycles. The Management Review, Internal Audits, and the Corrective Action process will identify systemic issues for process change. This is a continuous improvement approach to business management.

For your company – you already have business processes in place. The above steps can provide a guide or a checklist to be sure that you’ve integrated continuous improvement mechanisms, and it applies to all your critical business processes. This, along with your company objectives and recognition of customers and stakeholders, is the basis of an ISO 9001:2015 Quality Management System.