The Power of the ISO 9001 Checklist
When making any purchase decision, a major concern is the quality of the product. It is vital to know whether a supplier or contractor is capable of delivering a product that will meet customer expectations. It is not always possible to opt for pre-dispatch inspection; also, the pre-assessment of a supplier’s quality capabilities may incur extra cost. This is especially true in the case of overseas suppliers. To overcome this uncertainty; many organizations operate universally accepted quality assurance system such as ISO 9001 where inspection checklists are commonly used to demonstrate and communicate evidence of conformity.
Why use a Checklist?
In general, a simple checklist is an ideal tool that helps to identify missed activities while performing a task and often, the success of a task relies on a task-oriented checklist. In fact, for any process to operate smoothly and to yield benefits to product quality; the process requires a comprehensive checklist covering a pre-determined set of requirements.
A common fallacy exists that becoming ISO 9001 certified is a complex task and that the implementation of a quality management system distracts from the every day running of a business. An ISO 9001 checklist makes implementing a quality management system a much more simple process since the ISO 9001 checklist doubles as a gap analysis tool.
Preparing the ISO 9001 Checklist
It is always preferable to prepare the ISO 9001 checklist yourself since you will get better understanding of how the requirements apply your business processes. Some requirements of ISO 9001 may not be applicable to your organization, such as clauses from section 7 – Product Realisation, can therefore be excluded from the ISO 9001 checklist. Ensure that all applicable requirements are covered by the ISO 9001 checklist by:
- Identifying the relevant requirements from ISO 9001:2008.
- Converting each requirement into question, e.g. ‘does the organization have a documented quality policy?’ (Clause 4.2.1a)
- Gathering evidence to validate ‘yes’ answers.
- Taking action to remedy ‘no’ answers in order to fill a compliance gap.
This method of preparing the ISO 9001 checklist and subsequent interrogation of the quality management system is very similar to the method undertaken by certification body auditors when assessing an organization’s compliance to the standard.
What Records are Required?
According to ISO 9001:2008; there are 21 different records that are required to be maintained for various clauses throughout the standard. The checklist of these records should be included in the main ISO 9001 checklist for ease of reference during audits. Include any other records necessary to demonstrate process conformance. When referring to records within the ISO 9001 checklist, it is essential to note document title or document number of each record to avoid confusion later.
Download a free internal audit checklist example courtesy of ISO 9001 Checklist:
The ISO 9001 checklist and gap analysis tool is ideal for organizations that require a quick and affordable approach to assessing compliance with the requirements of ISO 9001. It provides an invaluable framework for internal auditors.