Q: I am directing a ground floor implementation effort to become certified to the ISO 9001:2008 Quality management systems–Requirements. I work for a small manufacturing company (less than 20 employees). Is there a quality management system (QMS) or ISO template product that I could use to help guide this process? Something with generic formats and outlines that I could customize and populate with our information. Or do I need to create from scratch all QMS and ISO supporting documents? In practice, we currently have no documentation.
A: Please navigate these waters carefully. There are several “do it yourself” type packages out there. Unfortunately, many of them don’t go far enough to provide a functional system unless the end user already has a thorough working knowledge of quality management systems (QMS). Therefore, as a quality professional, I hesitate to recommend this approach.
In order to establish an ISO 9001:2008 QMS capable of obtaining third-party certification, you will need to prepare a quality manual, a quality policy, define your organizations quality objectives, develop the six required QMS procedures, which as a minimum include:
1. Control of documents
2. Control of records
3. Control of nonconforming product
4. Internal audits
5. Corrective actions
6. Preventive actions
The reference books from ASQ should contain some examples of the documents mentioned. Once these QMS documents are established, you will need to orient the organization to the requirements of the QMS, explain how each employee contributes to achieving the quality objectives, and ensure that the quality policy is communicated throughout the organization and is understood. An internal audit will also be required to assess the effectiveness of the QMS once it has been implemented.
A management review will be required to ensure that top management is aware of input items mentioned in ISO 9001:2008, clause 5.6.2 and that they take action as needed to ensure the effectiveness and continual improvement of the QMS. These items should be completed prior to scheduling your registrar’s onsite pre-assessment for certification. We wish you every success with your QMS project. Please contact us if you would like to discuss this matter in more detail or require any support.
ASQ Senior Member
Managing Director of Aston Technical Consulting Services
For more on this topic, please visit ASQ’s website.