One reaction may be that the quality manual is unnecessary. The ISO9001 2015 version does not make a company throw away what is working for them (the procedures and documents). The new standard might not have procedures, but still an auditor will require the proper documents to see if a company is ready for certification.
A documented procedure in the 2008 and previous versions was a general list of what a company would do given certain circumstances. For example, if a product sent to a supplier for processing does not conform to requirements when it arrives back in house then the controls necessary for that supplier may need to change to reflect the changing quality of the product. A documented procedure for the example would be the actions taken to place necessary controls on the supplier.
It was basically understood that if a procedure was needed then the quality manual would say it. A fundamental principle of: we say we are going to do this, we produce documents that said we did this step, and in reality we did do the particular step.Say-Do-Document was the continuum.
Document procedures were used in the first place as a place to monitor change, make potentially good changes to the system, hold information, show a list of what competency requirements are, and information to interested parties.
Documented procedures sounds like such a good way to put everything down in writing and make sure that all processes are left-right-left.
What are the reasons for documented procedures to be taken out of the standard? A general emphasis of not needing such a detailed orientation on document creation (many companies do not need the detailed procedures to do their processes effectively) was a bit too explanatory of every single detail. A larger scope general standard was needed to open the path for more industries to follow the ISO9001 2015 standard.
Why the Change:
– Industries Change
– ISO’s ability to be in more industries
– Simplify Language (in many different languages)
– Ability to be used with multiple standards
– Follow Annex SL
The new paradigm Plan-Do-Check-Act, will be replacing the Say-Do-Document as a quality management technique for some procedures. Plan can help create specific objectives to be achieved. Do are the steps needed for implementation. Check are the processes as to their changes and amount. Act are the necessary steps for corrective/preventative actions to improve a process.
See the discussion related to this topic in LinkedIn.
We at K & S Quality Associates strive to bring understanding about the changes in the new ISO9001 2015 revision. The next series of blogs will be focused on some of the common questions asked of the new revision and general revision timeline that might alleviate some concerns. If you are interested in ISO auditor training or services please email email@example.com.