ISO 2015 in Plain English: Documented Information
This is another change that, at first glance, looks like an improvement that will eliminate a lot of the current documents required by ISO 2008. However, as with the quality manual, there may be very little you choose to remove from your QMS.
ISO 2015 has replaced “Documented Procedures” & “Records” with “Documented Information”. This is one of the few changes of the new standard that I believe was better the old way. The distinction between the two was very clear in the past: A documented procedure was any SOP, work instruction, flowchart, etc. that contained information on “how to do something”. A quality record was any form, checklist, log, etc. that had user information entered on it. A procedure was how to do something; a record was proof something had been done, plain and simple.
In 2015, the only requirements for Documents are: 
- Scope of the QMS
- Quality policy
- Quality objectives
- Criteria for evaluation and selection of suppliers
The requirement for Records really hasn’t changed:
- Calibration records
- Training/skills/experience and qualifications
- Product/service requirements review records
- Characteristics of product/service
- Customer property
- Change control
- Conformity of product/service with acceptance criteria
- Nonconforming outputs
- Monitoring and measurement results
- Internal audit program & Audits
- Management review
- Results of corrective actions
However, I would argue that a company cannot train to, nor guarantee consistency in, a process without having some type of a procedure. So my advice to all of my clients is not to start deleting procedures just because the standard says you can. As with most things ISO, common sense needs to prevail here.
Contact me to see how I can help you simplify your QMS Documentation while still doing what’s in the best interest of your business.
920-841-3478
Steve@TheRightApproachConsulting.com