Quality Manual: The ISO9001 Quality Management System first requires a Quality Manual to be written. This document is the backbone of the Management System, and is where you announce your intentions. What does your company do, and are there any parts of the ISO9001 standard that you are not doing (such as Design)? What documented procedures have you created to govern the Quality Management System? How do your company processes, both documented and not documented, interact to form your Quality system? This is often the document where the company records the Quality Policy and Objectives, and sometimes adds the company’s Mission and/or Vision Statement. Learn more in this article: Writing a short Quality Manual.
Along with this manual, there are requirements for documented procedures. As stated above, there are only six required documented procedures in the ISO9001 standard. These are:
Control of Documents: How do you approve, update and re-approve your documents? When a document is changed, how do you identify changes and make sure that people who need the current document have it and stop using older documents? How do you make sure the documents can be read and how do you control documents that come from outside of your organization for use?
Control of Records: How do you maintain your records that show your product is acceptable to use, including how you identify, store and protect the records so that they can be retrieved as necessary, for the correct amount of time, and destroyed when no longer needed – but not before?
Internal Audit: How do you audit your Quality Management System to make sure that it is performing as planned and is effective? Who is responsible for planning and carrying out the audits? How do you report results and what records are kept? How do you follow up on Corrective Actions noted in Audits?
Control of Non-Conforming Products: What