The following tips are designed to help employees at small and midsize businesses comply with ISO 9001 requirements. You may find these ISO 9001 tips useful during the ISO 9001 implementation phase or even later on as refreshing reminders.
Document control means that the right persons have the current version of the documents they need, while unauthorized persons are prevented from use.
We all handle many documents every day. These documents include forms that we fill out, instructions that we follow, invoices that we enter into the computer system, holiday schedules that we check for the next day off, rate sheets that we use to bill our customers, and many more.
An error on any of these documents could lead to problems. Using an outdated version could lead to problems. Not knowing if we have the latest version or not could lead to problems. Just imagine us setting up a production line to outdated specifications or making strategic decisions based on a wrong financial statement.
ISO 9001 gives us tools (also referred to as "requirements") that show us how to control our documents. Take a look into the ISO 9001 Quality and Procedures Manual for more information and simple instructions.
There are no “ISO 9001 documents” that need to be controlled, and “non ISO 9001 documents” that don't need control. The ISO 9001 system affects our entire company, and all business-related documents must be controlled. Only documents that don't have an impact on our products, services or company don't need to be controlled - all others need control. This means, basically, that any business-related document must be controlled, and our ISO 9001 manual explains how to do it.
However, how much control you apply really depends on the document.
The extent of your approval record, for example, may vary with the importance of the document (remember, documents are approved before they are published for use).
The Quality Policy, an important corporate policy document, shows the signatures of all executives.
Work instructions often just show a note in the footer indicating approval by the department manager.
Some documents don't even need any approval record: if the person who prepared a document is also responsible for its content (e.g., the Quality Manager prepares instructions for his auditors), a separate approval is superfluous.
On the other hand, identifying a document with a revision date, source and title is basic. It really should be done as a good habit for any document we create.
Please note that documents could be in any format: hardcopy or electronic. This means that, for example, the pages on the corporate internet need to be controlled.
Document control is the responsibility of all employees. It is important that all employees understand the purpose of document control and how to control our documents in accordance with ISO 9001.
Please be aware that if you copy a document or print one out from the Intranet and then distribute it, you are responsible for controlling its distribution! The original author won't know that you distributed copies of his documents, so the original author can't control your distribution.
ISO 9001 requires us to show on every document when it was created or last updated. Many of us may have thought to use our word processor's automatic date function for this, but... should we use the automatic date field on documents?
Generally not. If you enter the automatic date field into a document, the field will automatically be updated to always show the current date, no matter when you actually created or updated the document.
Example: For example, if you use the automatic date field in a fax and you save the fax on your computer for future reference, you won't be able to tell when you wrote the fax: when you open the fax on your computer, it will always show today's date.
Another Example: Another example is entering the automatic date field in the footer of a document that you frequently change and then print. You may have used the automatic date field as an easy way to see on your printouts when they were printed; your idea here probably was that the document with the latest date is the most current printout. However, you may make one printout today and another tomorrow without having made any changes to the document. Though both printouts are identical, they now show different dates. This will inevitably lead to confusion.
Document control requires us to show on any document when it was created or last updated. The automatic date field is not suitable for this. Therefore, as a general rule, don't use the automatic date field to identify revision status.
Yes, forms must be controlled as long as the form has an impact on our products, services or our company.
Blank forms are similar to work instructions as they guide the user to provide certain information. If the form is outdated or incomplete, the user will not be prompted to supply all the necessary information. It is, therefore, important to control blank forms like any other document. Refer to our quality procedures manual on how to meet this ISO 9001 requirement.
Once a form is filled out, however, it has become a record. At this point, we need to be concerned with filing, storage, archiving and eventually destruction. Our Record Retention Guide specifies how long records must be kept and how we can get rid of them (for example, do we need to shred them or is the recycle bin okay?).
Some auditors like to ask this question, so it is best to know that our ISO 9001 quality management system is documented through:
the Quality Procedures Manual, which also includes corporate policies and procedures affecting the entire company
Work instructions, which explain in detail how to perform a work process
Records, which serve as evidence of how we meet ISO 9001 requirements
Our ISO 9001 Quality Management Manual includes the corporate Quality Policy and all ISO 9001 Procedures! While most procedures affect only managers, every employee must be familiar with the Quality Policy and with the Document Control procedure. The Quality Policy contains the corporate strategy related to quality and customer satisfaction; all other ISO 9001 documents must follow this policy. The Document Control procedure shows how to issue documents, as well as how to use documents.
Management at each business unit or individual location needs to identify all key processes (or activities). The number of processes depends on how detailed you want to be. For the purpose of meeting ISO 9001:2015 requirements, about 10 key processes or less should be sufficient to describe the activities of the entire department, office or facility.
Once the key processes are identified, management needs to describe how the processes interact with each other. How to do this? A flowchart is ideal when identifying processes and their interaction.
Flowcharts are great ways to describe the interaction of processes. Flowcharts are often used to show how the key processes (also referred to as "activities") in an office or at a production facility work together; flowcharts are also often used to explain how to perform work, for example in work instructions and as part of procedures.
The following explains how to create and read flowcharts. Though there exist numerous flowchart shapes, the following shapes are sufficient for most flowcharts. Note the arrows which are used to connect the different shapes in the correct order.
This is the shape used to describe a process (or activity). In this example, the process is called “Check invoice”.
This is the shape used to describe a decision. A decision in a flowchart has usually two possible outcomes. In this example, the decision is “Is the invoice correct?” and the two possible outputs are “yes” and “no”.
Some decisions have several possible outcomes: the decision “From which supplier is the invoice?” could have either of the outcomes “Supplier A”, “Supplier B”, or “Supplier C”.
This shape describes a document. In this example, the document is called “Invoice”. See example below on how this shape is used.
Example on how to use all three shapes:
Microsoft Visio is an excellent program to create flowcharts; also Microsoft Word and PowerPoint can be used for some basic flowcharting.
Whichever tool you use, please keep it simple for the user. Some sophisticated shapes might make much sense to you, but most users will be confused as they won't understand the subtle differences.
ISO 9001 audits are typically more challenging for management than for workers. ISO 9001 is a quality MANAGEMENT system and provides many requirements on activities of managers and executives; in many cases, ISO 9001 directly affects how the company is managed.
All audits may cover any or all sections of the ISO 9001 quality management manual. As a general rule, almost all audits cover objectives, customer feedback, management reviews, internal audits (especially to verify if nonconformities from prior audits have been properly corrected), and corrective action. An extensive list of insider audit preparation tips is included with 9001Simplified's ISO 9001 Complete Package.
Implementing ISO 9001 is not a one-time benefit to our company. While we are utilizing our procedures and work instructions in daily business activities, we are not only benefiting from better quality and increased efficiency but we are also continually improving. In fact, the ISO 9001 requirements are designed to make us continually improve. This is a very important aspect because companies that don't continue to improve are soon overtaken by the competition.