Companies often prepare far too many and unnecessary documents for ISO certification, especially for ISO 9001 certification. They mistakenly think that they have to document every detail of each of the processes in the firm, without realising that the details may be irrelevant to ISO 9001 certification. Indeed, there are only six procedures that must be documented for ISO certification in terms of the ISO 9001 standard.
You need to put together a Quality Manual, which will form the foundation of the Quality Management System (QMS) and which will clearly state your goals. To do this, you need to outline what the firm does and which parts of the standard you will not be doing. In addition, consider what procedures have been documented in governing the QMS of your firm. Consider how the processes combine, interact and integrate to make up the QMS. You will need to state the quality policy, goals and objectives, and may also want to include your firm’s vision and mission statements.
The main documents required for ISO 9001 certification are briefly discussed below, helping you to gain valuable insight into compliance regarding the standard:
Stipulate how documents are approved, updated and reviewed. State how you identify changes made in documents, and ensure that the latest and relevant documents are used instead of older, outdated and incorrect documents. You furthermore need to state how you ensure readability of the documents and how to address control over external documents entering the organisation’s system.
Document the procedures for maintaining, updating, storing and protecting records for easy retrieval when necessary, and when records must be destroyed. For this, you will clearly state the period and when you will not want to destroy records.
Internal Audit Process
Stipulate how your QMS is audited to ensure correct performance and optimal effectiveness. You need to indicate who does the planning and execution of the auditing process, and how the results are reported. In addition, you should stipulate how the audit records are stored and how corrective actions required are recorded and followed-up.
Control Over Non-conformances
Stipulate the controls that you have for non-conformances, the persons or roles responsible for such controls, and how you ensure that non-conforming products or services are not applied. Indicate which terms apply for non-conforming products – when can products be repaired? You should also indicate how products are verified after non-conformance and the audit trail in place for such processes.
Control Over Corrective Steps
Indicate how non-conformances are reviewed and indicate how you evaluate the need for corrective action, as well as the implementation of such actions. Stipulate how the actions taken are recorded.
Preventative Action Control
Record the process for corrective action regarding non-conformances and how such is applied in the prevention of non-conformances.
You will for instance, need to determine and indicate the information of the supplier when a purchase must be done, and show the procedure and person responsible for approval of a purchase. When it comes to design, you will want to indicate the person/role responsible for approval of a design before the actual design can be made, how control is exerted over changes of design and the approval thereof. In terms of production or service, you will want to indicate how the service is tracked from the placement of an order, right through to the completion of the said order, to ensure that the customer’s needs are met. Indicate how the equipment used for testing of products is controlled and which measurements you have in place to for such.
Why is Documentation as Part of a QMS so Important for ISO Certification?
Without proper and standardised documentation of the critical processes, you don’t have references against which you can measure consistency in quality. You will thus not be able to measure whether the employees understand the requirements and will not have a measurement of whether an action can be repeated with consistency. It is imperative to minimise the complexity of process documentation, in order to make actions repeatable and thus ensure consistency in quality and processes.
At WWISE, we provide you with a full range of services regarding ISO certification, including training, designing and implementing the QMS systems, audits and maintenance programmes. View our range of services and contact us for professional assistance to help you meet compliance requirements.