ISO 9001 Basics Lesson #6 – Clause 10: Improvement

The video below offers an explanation of Clause 10. Watch the video and use your pdf workbook to follow along with different action steps to help you document how your organization meets each requirement.

Below is a short summary of each of the subclauses that are discussed at length in the video.

Three pillars of ISO 9001 are:

  1. Customer Focus
  2. The Process Approach and
  3. Continual Improvement

Clause 10.1 General
The organization has to demonstrate that it has improved the effectiveness of the management system (appears 11 times in this Standard):

  • Improve products or services
  • Correct, prevent or reduce ‘unwanted results’
  • Improve the effectiveness of the management system

Clause 10.2 Non-conformances and Corrective Actions – “Non-conformances are nuggets of gold”

Sources for ideas for system improvements:

Sources of Opportunities for Improvement (OFIs) or Non-conformances (NCs)

Find your nuggets of gold here:

  • Customers (Internal and External)
    It costs 7 to 10 times as much money to find a new customer as it does to keep an existing customer
  • Audits (Internal and External)
  • Metrics (choose any measurement methods that bring you value)
  • Management ReviewThe ‘non-conformance and corrective action’ requirement has been around since 1982. Risk based thinking and analysis helps you prevent occurrence of problems. Corrective Action helps you prevent recurrence of problems.Cause analysis helps you get to the root of a problem to decide on a ‘corrective action’ that will prevent recurrence of the ‘unwanted result’. Consider using the Ishikawa Fish Bone to help you determine the reason why the problem occurred. Next, decide on a ‘corrective action’ and implement it. Then follow up to see if the corrective action worked.Assess your risk analysis activities to see if you may have been able to avoid the problem. To encourage people to bring non-conformances to the table, change one question: Change the ‘Who messed up?’ question to “What was the weakness in our system that allowed this to happen?’ People will be more willing to suggest improvements.
    Corrective action = prevent recurrence of the problem that occurred. Use some form of ‘Root Cause Analysis’ (like the Ishikawa fishbone mentioned above) to determine the cause, implement a corrective action and prevent the issue from happening again.
  • Clause 10.3 Continual ImprovementMaking the system better makes an organization more profitable, keeps employees longer, makes Stakeholders happier (Shareholders, Regulatory bodies) – benefits all around.Describe what your organization does to meet these requirements: