Documented Information for ISO 9001:2015

As we move into the final months for transitioning to ISO 9001:2015, many companies are still asking themselves what documentation is required. Back with the 2008 release, most companies were comfortable with the six mandatory procedures that were expected of them as well as the need for a quality policy and manual. The update to 2015 has however removed the requirement for a quality manual and blurred the distinction between procedures and records.

With the new release, both documents and records are termed “documented information” and must be controlled and maintained. This is what will form the evidence required to show that you are conforming to the requirements of your quality management system.

Clause 4.4 of ISO 9001 requires your organization to maintain the documented information that is required to support the operation of your processes and to retain that information to be able to have confidence that those processes are being completed as planned.

So what is required by the standard?

The following is a clause-by-clause breakdown of what is required by the standard. However, some of these clauses can be excluded if the company does not perform the relevant processes:

Mandatory records:

• 7.1.5.1 – Monitoring and measuring equipment calibration records
• 7.2 – Records of training, skills, experience and qualifications
• 8.2.3.2 – Product/service requirements review records
• 8.3.2 – Record about design and development outputs review
• 8.3.3 – Records about design and development inputs
• 8.3.4 – Records of design and development controls
• 8.3.5 – Records of design and development outputs
• 8.3.6 – Design and development changes records
• 8.5.1 – Characteristics of product to be produced and service to be provided
• 8.5.3 – Records about customer property
• 8.5.6 – Production/service provision change control records
• 8.6 – Record of conformity of product/service with acceptance criteria
• 8.7.2 – Record of nonconforming outputs
• 9.1.1 – Monitoring and measurement results
• 9.2 – Internal audit program
• 9.2 – Results of internal audits
• 9.3 – Results of the management review
• 10.1 – Results of corrective actions

Other Mandatory Documents:

• 4.3 – Scope of the QMS
• 5.2 – Quality policy
• 6.2 – Quality objectives
• 8.4.1 – Criteria for evaluation and selection of suppliers

So what does this mean?

You should still tailor your quality management system to meet the requirements of your own business and all of the interested stakeholders. This can be done in any way that your organization sees fit; although a quality manual is still one of the easiest methods. As long as these processes and associated records can be shown to meet the requirements of ISO 9001:2015 effectively then that is fine. If not then the relevant action should be taken to ensure that all of the required clauses are covered.