What Are the Requirements for ISO 9001?

Your QMS is defined during this stage of strategic planning.

Clause 4: Context of the Organization

You must demonstrate that you understand your business’s place in the world.

• What you must do:
  • Use a SWOT or PESTLE analysis, for example, to determine which external and internal challenges are pertinent to your goal.
  • Determine the needs of your “interested parties” (such as clients, vendors, staff, and authorities).
  • Describe the areas of your business that your QMS covers.
  • Make a map of your main procedures and their relationships.

Clause 5: Leadership

Quality is everyone’s responsibility, but it needs to be led from the top, as this phrase makes clear.

• What you must do:
  • For the QMS, top management must show dedication and responsibility.
  • Create a formal quality policy, which is the “constitution” of your business.
  • Establish and disseminate positions, duties, and authority within the organization.

Clause 6: Planning

This is where your QMS should incorporate risk-based thinking.

• What you must do:
  • Determine the opportunities and dangers associated with your business’s procedures and context.
  • Make plans to deal with these opportunities and hazards.
  • “Reduce customer complaints by 10%” is an example of a measurable quality objective.
  • Make a plan for handling any modifications to your QMS.

Clause 7: Support

You have to demonstrate that you have the resources required to operate your QMS.

• What you must do:
  • Resources: Provide the appropriate workforce, workspace, and infrastructure (buildings, machinery, and IT).
  • Competence: Using education, training, or experience, make sure staff members are qualified for their positions.
  • Ensure that everyone understands the Quality Policy, their role in the QMS, and the consequences of noncompliance.
  • Communication: Arrange who will communicate both internally and externally, as well as what, when, and how.
  • Documented Information: Manage the records and documentation that your QMS needs.

DO: Executing the Plan (Clause 8)

This clause, which covers the daily tasks you perform to supply your product or service, is the biggest and most important one.

Clause 8: Operation

• What you must do:
  • Operational Planning: Arrange every stage required to develop your product or service, from inception to completion.
  • Communication with Customers: Establish explicit procedures for interacting with customers (e.g., contracts, feedback, complaints, and queries).
  • Development and Design: (If you design items) Establish a structured design process that covers inputs, controls, outputs, and change management.
  • Authority over Outside Providers: Oversee your contractors and suppliers to make sure their goods and services satisfy your needs.
  • Production & Service: Under regulated circumstances, manage your production and service procedures (e.g., using work instructions, quality checks).
  • Product Release: Make sure the product or service satisfies all requirements before sending it to the customer by implementing a clear “final check” procedure.
  • Nonconforming Outputs: Establish a procedure for locating, managing, and handling errors or subpar products.

CHECK: Measuring Performance (Clause 9)

You’ve made plans and carried them out. You now need to make sure everything is operating as it should.

Clause 9: Performance Evaluation

• What you must do:
  • Measurement and Monitoring: Choose what, how, and when to monitor (e.g., process performance, product quality).
  • Customer satisfaction: Keep a close eye on how successfully you’re fulfilling your clients’ needs (for example, by using surveys and feedback).
  • Internal Audit: To determine whether your QMS complies with your own policies and the ISO 9001 standard, conduct routine internal audits.
  • Management evaluate: To make sure the QMS is still appropriate, sufficient, and efficient, top management must formally evaluate it at predetermined times.

ACT: Making It Better (Clause 10)

This provision ensures that your QMS promotes genuine change and closes the loop.

Clause 10: Improvement

• What you must do:
  • Nonconformity & Corrective Action: You need a procedure in place to respond to nonconformities, identify the underlying reason, and take corrective action to keep them from happening again.
  • Continuous Improvement: To enhance your procedures, outputs, and the QMS itself, you must aggressively look for and seize chances.