In my previous blogs I covered:
Step 1: ISO Publication and Beyond
Step 2: The High Level Structure
Step 3: Clauses 1, 2 and 3 – Scope, Normative References and Terms and Definitions
Step 4: Context of the Organization
Step 5: Leadership
Step 6: Planning
Step 7: Support
A quick reminder of the 10 Clauses of the High Level Structure- this blog covers Clause 8:
2. Normative References
3. Terms and references
4. Context of the organization
9. Performance evaluation
This Clause basically represents the production and operational control parts of the Standards- the ‘engine house’ of production (particularly for ISO 9001). It is probably best to discuss each separately, as, in a similar way to the existing ISO 9001 and ISO 14001, there are big differences in the content and detail for each.
ISO 14001:2015 is the easiest to discuss- it has two basic sub-clauses:
8.1 Operational planning and control
8.2 Emergency preparedness and response
These two are basically very similar to the existing 4.4.6 and 4.4.7 in ISO 14001:2004. Regarding the sub-clause 8.1, this is pretty similar, but with updates reflecting the more process-based approach and consideration of a life cycle perspective. There is clear content on the need to consider the life cycle perspective relating to design and development, procurement of products and services, communications with relevant external parties and downstream issues associated with transport, delivery, use, end-of-life and disposal. For sub-clause 8.2 on Emergency preparedness and response, it is very similar to the existing 4.4.7 in terms of response, planning, exercises and review.
For ISO 9001:2015, there are a number of sub-clauses added to the basic High Level Structure (HLS) sub-clause 8.1 of Operational planning and control:
8.1 Operational planning and control
8.2 Requirements for products and services
8.3 Design and development of products and services
8.4 Control of externally provided processes, products and services
8.5 Production and service provision
8.6 Release of products and services
8.7 Control of nonconforming outputs
So this clause really covers in the main what was covered under the ISO 9001:2008 Clause 7 Product realization- with some key additions and differences. I have summarized these below:
8.1 Operational planning and control: this is very clear about the importance of linking this clause to the critical elements of Clause 4.4 where the critical processes and their interactions are determined. There are also some additional requirements on control of changes (which are made more explicit now- but should be managed under any good management system!), and also on control over outsourced processes (previously covered under the purchasing clause of ISO 9001:2008).
8.2 Requirements for products and services: very similar to ISO 9001:2008 Clauses 7.2.1- 7.2.3 but now with some added content on communications relating to customer property and contingency actions.
8.3 Design and development of products and services: this follows much of the existing Clause 7.3, but with clearer structure and requirements around when a design and development process is required (8.3.1); for design and development planning consideration of needs from customers and from key documented information (which should be happening already!) (8.3.2); for design and development inputs a wider set of inputs including resource considerations and potential consequences of failures (8.3.3).
8.4 Control of externally provided processes, products and services: this sub-clause is now more holistic and wider in terms of referring to externally provided processes, products or services rather than the existing ISO 9001 clause on Purchasing. It also makes clear the criteria for applying the requirements.
8.5 Production and service provision: most of this sub-clause is very similar in content and intent to the existing requirements in ISO 9001:2008. The main change is with the two additional sub-sub-clauses 8.5.5 Post-Delivery Activities and 8.5.6 Control of Changes- these are mentioned in the existing standard, but these requirements are now much more clearly defined and specified.
8.6 Release of products and services: limited additional requirements.
8.7 Control of nonconforming outputs: limited additional requirements.
Overall ISO 9001:2015 has broadened the terminology and scope of the operations and production clause, whilst retaining much of the existing ISO 9001 content. The approach adopted is also aligned with the common process-based aspects of the High Level Structure (HLS), and covers more effectively the complete end-to-end production and service provision process.
In Step 9 I will look at the last two Clauses: Performance Evaluation and Improvement.
Contact us for support: Transition to the ISO 2015 revisions.
Do you have questions related to the ISO 9001:2015 & ISO 14001:2015 revisions? Post them in our LinkedIn group , and our auditors Doug Milne and Niall Pembery will get back to you.