ISO 9001 quality management systems; understanding QMS fundamentals.

Processes and documented procedures are the heart of a quality management system.

Quality Management System

Process Features of a QMS

Quality management system processes.

Both ISO 9001 and ISO 13485 emphasize a process approach. This process is the conversion of inputs into outputs to create something of value. As an example, every worker in an assembly line follows a process and each output becomes an input for the next worker. Other inputs may include materials, instructions, resources, tools, etc.

At the end of the day, an ISO 9001 or ISO 13485 quality management system should implement processes for the following capabilities:

  • Control over design, purchasing, production & distribution
  • Management of waste & defective product
  • Control over label & packaging processes
  • Documentation & record control
  • Customer & employee feedback
  • Management reviews
  • Training
  • Handling & storage procedures
  • Identification & traceability of materials
  • Equipment maintenance
  • Measuring & monitoring
  • Communication
  • Resource acquisition & application
  • Servicing & installation procedures
  • Statutory / regulatory requirements (if applicable)
  • Enforcing quality objectives
  • Implementing corrective & preventive actions
  • Protecting sensitive data
  • Internal audits
  • Continuous improvement to the QMS

For information or help building an ISO certified QMS, feel free to contact us with your questions. DoMETRIQ is committed to driving ISO approved quality projects to put our clients ahead of the curve.

Documented Procedures

Documented procedures required for ISO 9001 quality management systems.

A documented procedure describes a process using text, images or flowcharts. Both QMS standards (ISO 9001 & ISO 13485) require documented procedures* for the following elements of your QMS:

  1. Control of documents
  2. Control of records
  3. Internal audits
  4. Control of non-conforming product
  5. Corrective actions
  6. Preventive actions

*ISO 13485 expands this list to include documenting, implementing and maintaining:

  1. Requirements
  2. Activities
  3. Special arrangements

Process Dissection

Turtle Diagrams are popular tools for dissecting a process. They are commonly used by ISO auditors to visualize the procedures in an operation during an audit. Components of the model include:

  • Process inputs
  • Process outputs
  • Equipment & materials
  • Personnel & qualifications
  • Procedural descriptions & methods
  • Performance metrics

To get a better understanding of your QMS, try mapping each process using this simple diagram. It's a great tool demystifying your system.

Turtle Diagram for ISO 9001 quality management.

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ISO 9001 Tools

The following tools are designed for beginners to implement ISO 9001 on their own.

  • This guide offers high level instructions for becoming ISO 9001 certified. Request a free copy.
  • Should be Empty: