ISO 9001:2015 Clause 4 – “Context of the Organization”
This is a valuable requirement to spend some time on. The better we understand our ‘Context’, the stronger Management System we will design. It will result in more resilience for our organization.
This clause requires that we identify what kids of external and internal issues exist that will affect our ‘…ability to achieve intended results…’. We need to become aware of our ‘purpose’ as an organization and consider how our business strategy supports our purpose. These opening words also are a glimpse into ‘Auditing 2.0’ where we’ll see our Registrar’s auditors looking at results more than a line-by-line audit of each procedure. Our Internal Auditors will have to learn this skill as well.
By examining our ‘Context’ we will keep the needs and expectations of our ‘relevant interested parties’ (4.2) in focus. Context includes issues like trends that may affect us and our ‘interested parties’, our strategies, our policies and our resources (competence, for one), including any outsourcing we do.
We can plan how produce our goods and deliver our services, within our ‘Scope’ (4.3). As before, we’ll list any clauses that are not applicable here.
You’ll find more explanation this time on the application of the ‘process approach’ (0.3, 4.4) and a requirement to ‘…evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results…’ (4.4.1 g)/
You can see how this supports the idea of the new ISO 9001 standard becoming a strategic consideration and how it is pushing its way into the Boardroom. Clause 4 gets us to consider quality in context of all elements of the organization, not just the manufacturing and delivery process.
Next post: Clause 5 – Leadership