Steps to become ISO 9001 certified

ISO 9001:2015

ISO 9001 sets out the criteria for a quality management system and can be used by any organization, large or small, regardless of its field of activity. There are more that one million companies and organizations in over 170 countries currently certified to the ISO 9001 standard.

The standard includes guidance and requirements that need to be implemented by organizations seeking certification, and maintained by organizations wanting to keep their certification. ISO 9001 is the most commonly recognized and most widely accepted version of the standards and is quickly becoming a "must have" to remain competitive in today's business environment.

ISO 9001 includes 10 sections and is based off of the Plan-Do-Check-Act cycle. Out of the 10 sections, only 7 of them contain auditable requirements. The basic concept is to make a plan, resource the plan, execute the plan, evaluate the results, and take appropriate action based upon the evaluation. If this cycle is consistently followed, the natural results will be excellent quality products, extraordinary customer service, and a healthy Quality Management System. 

How the PDCA cycle is represented in the standard:

  • Sections 4, 5, and 6 - The "planning" sections
  • Sections 7 and 8 - The "doing" sections
  • Section 9 - The "checking" section
  • Section 10 - The "acting" section

You can also break the standard down into the following 4 levels: 

  • Level 1 - Quality Manual, Policy, Objectives, and QMS Processes (Why we do what we do)
  • Level 2 - QMS Procedures (When we do what we do and who does it)
  • Level 3 - QMS Work Instructions, Forms, Matrices (How we do what we do)
  • Level 4 - QMS Records (Proof that we did what we said we would do)

Examples of ISO 9001 elements include:

  • Document & Record Control
  • Risk Management
  • Training & Awareness
  • Infrastructure & Work Environment
  • Leadership Commitment
  • Change Control
  • RFQ & Order Review
  • Production/Service Control
  • Inspection & Calibration
  • Controlling Nonconforming Product
  • Controlling Design & Development
  • Purchasing & Receiving
  • Supplier Approval & Evaluation
  • Data Analysis & Evaluation
  • Corrective Actions
  • Internal Audits
  • Management Reviews
  • Continuous Improvement