Basic Mandatory Documents for ISO 9001:2015

Before we proceed, please take note that we are talking about the 2015 version here.

I had to point that out because there are mandatory documents in the 2008 version that are no longer required in the 2015 version.

For example, in the old version, the standard strictly requires to keep a quality manual. If you want to confirm, refer to clause 4.2.2 of ISO 9001:2008.

The 2015 version does not mention that you should have a quality manual.

Let’s list down the basic mandatory documents in each clause.

Basic!

It means that you can have the option to have more than what the standard requires.

Clause 4. Context of the Organization

  • Scope of the Quality Management System (4..3)

Clause 5. Leadership

  • Quality Policy (5.2)

Clause 6. Planning

  • Document on Quality Objectives (6.2)

Clause 7. Support

  • Record on the Evidence of fitness for purpose of the monitoring and measurement resources or verification/calibration evidence (7.1.5)

Clause 8. Operation

  • Document and Record on the Operational planning and control (8.1)
  • Record on the Requirements for products and services (8.2)
  • Record on the Design and development of products (8.3)
  • Record on the Control of outsourced processes, products or services (8.4)
  • Record on Identification and traceability of product (8.5)
  • Record of Property belonging to customers or external customers (8.5)
  • Record on Control of changes (8.5)
  • Record on the Release of products and services

Clause 9. Performance Evaluation

  • Record on the evaluation of QMS performance (9.1)
  • Record on the Internal Audit / Audit Report (9.2)
  • Record on the Management Review / Minutes of Meeting (9.3)

Clause 10. Improvement

  • Record on the nonconformity and corrective action (10.2)

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s