Processes that may affect product quality should be documented. For example, an instruction on how to clean an office is not needed. However, an instruction on how to clean a clean room where company product is processed should be avaiable. If desired, document control system can also be utilized to keep other standard non-QMS documents, such as leave application form.
There must be a standalone procedure called "control of documents" to outline how the company controls documents.
Sometimes other management system also requires the same procedure. For example, OHSAS 18001 also requires a procedure on control of documents. OHSAS 18001 can utilize the control of documents procedure in the QMS without creating a new one.
To ensure that users will use those documents, documents published should be easily accessible and user-friendly.
ISO/TR 10013:2001 (Guidelines for QMS Documentation) can be referred to when setting up documentation.
Policies, procedures, fresh forms and filled forms are documents. Filled forms are a special type of document called record. All records are documents but not all documents are records.
Only forms that cannot be signed digitally (for example applicable users do not have computer) should be given the option of printing.
Documents of external origin may be kept by respective department. A master list is not mandatorily needed. Just ensure users are aware where to get the document and the document is the latest one. Example of such documents are customer standards, international standards, machine manual, law book, international shipping rules.
The company may have informational lists that are maintained manually by respective department for reporting purpose etc. The lists do not have to be controlled. The best practice is to state in the list itself on why the list is important and the department to maintain the list. For example, list of projects done by company is important to be used as reference for potential projects. The possible department to update this list is marketing.
All documents are to be in softcopy for easier retrieval and paper saving. Documented procedures can be in any medium, such as video, audio or text.
There must be only one location for access. No similar documents are to be put in another location. This is to avoid confusion among users and waste of time to update multiple locations.
Numbering format for the documents in the organization is to be set in the control of documents procedure. The format does not have to be long. For example P001 for procedure and F001 for form are already good enough.
A document must have a document number when it is to be used by more than one department. Some document types may not need a document number. Example are organization chart, technical drawing, informational list and documents of external origin. Usually quality manual and quality policy do not have a document number.
The document number of an obsolete document cannot be used for new document.
Newly proposed form can be marked for trial run for one user and see if there is feedback before assigning it with an official document number.
The first effective date should be stated on the document. By doing this, it is easier to know in the audit since when the form is auditable.
For forms, try minimize the number of signatures needed. Putting more signatures will slow down the process. Put only the mandatory signature. It is best if no signature is required but just name of employee(s).
The exact storage location of the document is stated in the document itself with clickable link. By doing this, users will be able to access the latest documents easily.
Record has retention period. For easy reference, the retention period should be stated in the form itself, for example in small font in the footer.
Users' department or designation should be stated in the document. By doing this, the company will easily know who should be using that document. This also enable easier communication if there is revision.
The department(s) that reviews any revision of the document and the department that approves the revision should be stated.
Detailed purpose of the document is to be stated, especially non-procedural documents such as list and form.
Write department's name instead of person's name as document owner so that document owner is not affected by personnel change.
Procedure may contain multiple sections. Sometimes when a section ends, there is not much space left at the bottom of the page to fit the entire next section. To make the procedure looks tidier, it is better to start the next section in the new page.
A sub-document can exist due to another document, for example a form is created due to a procedure. In this case, it is better to state the another document in the sub-document. In other words, the sub-document that is linked to should contain the document identification that is linked from. This is cross-referencing. This will let user refer on why and how to use the document.
It is acceptable to have date only for revision identification without count (e.g. rev 01, 02, 03).
Before creating any new document, review the existing documents first to avoid duplication. Thus it is important to have a document master list.
Communication of revised document is to include what has been revised. This will help cut down the time that users need to find out what has changed.
If a form is not used for three years (cycle of QMS recertification), have a meeting to see if it is still needed. If no, then put it as obsolete.
Each of the previous revisions must be kept. This is because someone may have documented reference (e.g. in project document) to the a certain clause number or row number the previous revision. However, previous revisions have to be clearly as obsolete in the documents themselves.
Users usually have first hand constructive idea about the document. Before releasing a revision, tell the related users that there will be revision and ask them if they also have any pending idea to propose. By doing this, related users will feel their importance and there will be no useful idea that is missed out.The reason of revision must be recorded so that in future the user can review before revision to avoid reverting to the same revision. The reason needs not to be stated in the document itself because users do not need that info. Solid reason and the person proposing the revision must be recorded in the document change database.