QA-Z Consulting Specialists have provided information, aiming at demystifying the intent of ISO 9001:2000 for the newcomer and existing Quality Managers.
According to the Quality Standard ISO 9001:2000, documents required by the quality management system must be controlled.
One of the controls that need to be included in a procedure is that of approval of documents for adequacy prior to issue.
There is no set rule as to the application of this requirement for approval. This can be interpreted as the company implementing the control method determines fit to purpose.
A few simple methods used by organisations are as follows:
- A manually operated document approval system
- Approval recorded on the document
- Electronic control methods
One simple form can record specific details of each document created and revised within the establishment (master document inventory).
Headings include document name, creator, holders of the document, whether it is available as a printed document to all staff at points of use or electronic only, the current revision status and a signature of the approver to confirm that it has passed the checklist of requirements for creating or revising documentation each time this is done.
Another form can record changes made to the actual Quality manual which can be kept separate from the master document inventory or if not necessary, this can be included on the same inventory to save multiple paper filling.
Approval on document
Some organisations record the name of the approver in the document footer. While this is one idea and may be preferred by some organisations, it is better to write a position name - not a person’s name due to movement within the organisation and always better to minimise clutter on documentation.
This method also lends itself to laziness where documentation is updated without gaining the approval of the approver. This would be fine in cases where it is recorded perhaps in the Quality Manual that specific people automatically have the approval of the approver without needing to show document when revised. Some people create or revise a document, then email it through to the approver for approval.
In any case, it is important to either stamp or mark the document as being in the process of being revised or being a draft during the process from the point of updating and approval being granted. This eliminates the incorrect or premature use of documents prior to approval.
Some organisations adopt a system where a master copy can be printed off and the approver’s signature visible on the reverse side. Each time a document is updated, the approver signs the reverse side again before filing.
Electronic document management systems
Some organisations choose to minimise the quantity of forms and printed documentation and have moved toward having most documentation computerised. Some set up internal systems which are created on MS excel, and some invest in licenses for document management systems which also produce and store client information (records).
These document management systems are set up externally by the host provider and have a series of boxes and spaces to fill which then automatically produce a record containing inputted client information eliminating blank forms.
The system is an approved system and all changes notified to the host provider have already been approved prior to conducting the change. The approving of documents is then reduced to remaining documents such as Company Policies, Machine Instruction Manuals, Training Manuals, etc.
Auditors are quite adamant when it comes to appropriate and workably effective document control methods and may record evidence during an audit where the system for controlling documentation has lapsed or not been implemented effectively and/or utilised consistently.
Having proper internal and external documents under control can make the difference between having processes that are efficient and address all customer and organisational needs enabling the meeting of customer requirements consistently and having processes that constantly produce nonconformities (errors) throughout the organisation, costing valuable time and money.
If a system is out of control, the document and record control systems should be scrutinised.