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List of Mandatory Documents for ISO 9001

Author: Mark Hammar

Many companies go overboard with documentation in the belief that they need to document every single process that is in place in their organization, without realizing that this is not necessary to meet the requirements of the ISO 9001 standard. In the standard, only six documented procedures are needed, with any remaining procedure documentation at the discretion of the company (under certain guidelines). So, you may ask, “What should I document?”

What documentation does the ISO 9001 Standard Require?

Quality Manual: The ISO 9001 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 ISO 9001 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 ISO 9001 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 controls are in place, and who is responsible, to make sure that a non-conforming product is not used? Are there terms that can be put in place to allow the use of non-conforming product such as Rework, Repair or Acceptance by Customer? How do you ensure that a corrected product is re-verified, and what records are kept of the process?

Corrective Actions: How do you review non-conformities, determine causes, and evaluate the need for actions to correct them? How do you implement the necessary actions, review that the actions were effective, and keep records of the actions taken?

Preventive Actions: How do you apply the same process used for Corrective Actions to non-conformities that are identified before they occur?

At a minimum, these are the documented procedures that are necessary to meet the requirements and are all that is needed to document a simple Quality Management System. However, there is often a need to provide written documents for more. The trick is in knowing what else your company needs to document (see also Deciding which procedures to document in QMS).

What are other common Documented Procedures?

At this point you do not need to capture any other processes in documented procedures if you can prove that no mistakes will be made by not doing so. There are several procedures that are often documented in order to ensure that there is easy access to some important information to govern that process. Some examples are:

Purchasing: What information is needed for a supplier, and who is responsible for generating it? Who needs to approve various levels of expense (you may not want a buyer to be responsible for committing the company to pay for large purchases without other approvals)? How do you decide on the standard requirements to place on your suppliers, and how do you approve and control these suppliers?

Design: This is often turned into a documented procedure in order to capture what gates and reviews are required to ensure a good design every time. Where do all of your requirements come from? Who can approve a design to proceed? How do you control your design changes, and who can approve a change to the design?

Production/Service: For complicated products or services, it is easy to see why the process would be documented. How do you control the flow of parts and documentation to your production area for use? How do you track your service from customer order to completion to ensure customer requirements are met? How do you ensure that product status can be identified, such as what has or has not been tested? How do you track customer acceptance of your service?

Monitoring and Measurement: How do you control the equipment you use to test that your product meets the requirements and is fit for use? How do you manage measurement equipment brought in by employees (such as machinist’s tools that are owned by the machinist)?

The importance of documentation in the QMS

Documentation in the Quality Management System is important to ensure that critical processes, where you need to make sure that all employees consistently do the same thing, are understood and repeatable. In order to make this work, it is wise to have these processes as uncomplicated as possible and presented in the simplest manner to make them easy to understand. Often, using a graphical flow chart can suffice to relay all the relevant information quickly and easily. The less complicated the process documentation, the easier it will be to ensure that all employees can deliver repeatable, quality outcomes for the processes. In the long run, the old adage is often right: “The simpler, the better.”

Click here to download a free white paper  Mandatory Documentation Required by ISO 9001:2008.

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Iciar Gallo
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