CHAPTER 4: REQUIREMENTS OF ISO 9001:2015
The Standard comprises ten clauses (eleven if you include the introduction – Clause 0), of which seven (Clauses 4–10) specify the requirements for a QMS. Clause 0 provides context for the Standard, including some guidance on how the PDCA cycle (Plan-Do-Check-Act) may be adopted and the principles of quality management. Clauses 1–3 describe the application of the Standard, the reference material that is essential in understanding and applying the standard, terms and definitions, and so on. The requirements are followed by a pair of annexes (A and B), which are informative (they provide additional information) rather than normative (indispensable for the application of the document, such as ISO 9000: effectively mandated reading!).
In many cases, the requirements of the Standard will already be met through existing processes. Checking and confirming which requirements are met can be a valuable process before beginning your implementation project, and can be achieved with a gap analysis.6
Although this book does not describe an implementation path or methodology, the commentary that follows will be useful for implementers to make sure that some of the finer details have been identified and met.
For organisations seeking assistance with their first ISO 9001 implementation, consultants can provide a range of services. Regardless of the level of service, the organisation can take advantage of a consultant’s expertise to develop knowledge and skills relevant to the management system and thereby simplifying ongoing compliance.
Plan-Do-Check-Act
Subclause 0.3.2 describes the PDCA cycle, which is a recommended but not prescribed method of implementing, maintaining and continually improving an ISO 9001-compliant QMS.
Rather than just describing the methodology behind PDCA – which is widely understood – the Standard also provides a diagram to show how it works in relation to ISO 9001. This depicts the cycle as the operation of each of the clauses, with key inputs and outputs. It demonstrates that the cycle is not only applicable to the QMS, but also to product and service provision in general.
6 A gap analysis checks the requirements against your current state. A gap analysis tool can be used to streamline this process by posing a set of questions that can be answered with a yes/no/qualified yes. These tools allow the organisation to quickly identify where work needs to be done.