One of things I find in most audits are process deficiencies with the organization’s QMS (Quality Management System) documents. I usually find obsolete documents in circulation and/or documents that are not controlled. What happens is that the organization sometimes does not realize the difference between the types of documents or the levels or where employees have posted documents.

Let us first discuss levels of documented information:

The Quality Manual describes your processes within your QMS on how the organization meets the requirements of the standard (in this case, ISO9001:2015). Procedures are documented information that outline specific work processes, such as: Sales, Purchasing, and Production. Work Instructions are documented information that give step by step directions on how a task should be done. Forms are documented information used to make a record completing all or part of the process described in your Quality Manual, Procedure, and/or Work Instruction.
 

We will examine the process of entering a room, for example. A procedure would identify the what the person has to do. It might say I open the door to the room and walk inside. A work instruction would be step by step to enter the room. I get up from my chair. I walk over to the door. I grab the knob. I turn the knob. I push the door forward. I walk into the room.

One of the best practice for ensuring obsolete documents are not kept in circulation is to ensure employees do not keep copies at their work stations. If an employee needs access to it then identify its distribution. The best practice is to have a controlled documented register of all your documents to ensure current status and location.

For more tips on ISO, please click here.

Roles (Section 5.3) of the ISO standard is key to your QMS (Quality Management System). If your roles are not identified, then it can have an adverse effect throughout your organization. It can cause confusion among employees and who their immediate supervisor is. My clients often tell me that well there are many roles that an employee may fulfill. That is fine, but they have to be consistent and defined.

If an employee performs the role of a General Manager and Inspector, then these two roles need to be listed in your organization. The best practice is an organization chart that lists all positions and departments. If an employee only performs the role of the General Manager and Inspector, but his or her business card identifies the role of Sales Manager, then this is an issue. If the Sales Manager position is listed on the organization chart, then it is not.

The next step is responsibilities and authorities for each role (organization chart or other means) defined within the organization. What is required of an employee performing the Inspector role? What is required of an employee performing the General Manager role? You must define what are all their responsibilities. Within the responsibilities you have to define what types of authority that role has.

The best practice is the organization chart and job descriptions for each role on the organization. This will also cover the requirements of Section 7.2 of the ISO Standard if filled out correctly.

The Quality Policy is the foundation for your QMS (Quality Management System) and its processes.  It derives from PDCA (Plan, Do, Check, Act), risk-based thinking, and opportunities for improvement. It provides the framework for your QMS quality objectives. It should be concise and easy for the whole organization to understand.

The Quality Policy has to be compatible with the context of the organization. It shall be established (Plan), implemented (Do) and maintained (Check, Act). It shall be maintained as documented information. The documented Quality Policy must have a commitment to satisfy applicable requirements, and must include a commitment to continual improvement of the QMS. The Quality Policy has to be available (including to interested parties), communicated, understood, applied and within the organization. Everyone in the organization must be aware of the Quality Policy.

The word shall in the standard (ISO9001;2015) is a must requirement. Auditors look for the where the documented Quality Policy is available, how it applies with the organization, and what means to the employee. There are several steps in achieving ISO certification. The Quality Policy is one of the requirements that must be fulfilled within the organization.

Examples of Quality Policy:

Steps for Certification:

1. QMS Documented Information.
2. QMS Implementation.
3. QMS Internal Audit.
4. QMS Continuous Improvement and Management Review.
5. Registrar Certification

The same principles apply with other systems, such as EMS (Environmental Management System), and IMS (Integrated Management System). There is additional work and time involved in the project.

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