Difference between ISO 9001:2015 Clauses 8.1 and 8.5.1
- Thread starter armani
- Start date
I think you're correct that in a general sense 8.1 includes 8.5.1. But 8.1 is much broader in scope. It covers planning for all of operations, including customer requirements, design, purchasing, etc. 8.5.1 only includes the production (and service) operations.
You could probably say there is a similar relationship between clauses 4.4 and 8.1. 4.4 covers planning for the entire QMS including leadership, resources, operations, supporting processes, etc. while 8.1 only covers the operational aspects of the system.
You could probably say there is a similar relationship between clauses 4.4 and 8.1. 4.4 covers planning for the entire QMS including leadership, resources, operations, supporting processes, etc. while 8.1 only covers the operational aspects of the system.
Randy
Super Moderator
It's (8.1) is a General requirements clause and 8.5.1 is a specific requirements clause....Meet what 8.5.1 requires and you automatically fulfill 8.1 requirments...You don't audit 8.1, you audit 8.5.1.
We've seen the exact same relationship for nearly 20 years now with 9001, 14001 and other documents that start with a (#).1 clause and have multiple (#.#.#) clauses. There's no secret here, no need for far fetched interpretation or anything els.
Quit making it complicated
We've seen the exact same relationship for nearly 20 years now with 9001, 14001 and other documents that start with a (#).1 clause and have multiple (#.#.#) clauses. There's no secret here, no need for far fetched interpretation or anything els.
Quit making it complicated
8.1, Operational planning and control, is production control planning. Determining how production will be controlled.
8.5.1, Control of production and service, is the application of the planning. It is production under controlled conditions. Controlled conditions are defined here. You confirm that production actually did take place under the conditions planned for in 8.1.
You audit BOTH.
8.5.1, Control of production and service, is the application of the planning. It is production under controlled conditions. Controlled conditions are defined here. You confirm that production actually did take place under the conditions planned for in 8.1.
You audit BOTH.
There is no part of the standard that you don't audit.
For 8.1 you audit production planning. The most common tool used for production planning is the Work Order / Traveler, or whatever that particular entity uses. Generation of the Work Order can start as early as the quote stage as many software packages are developed with that option. Sometimes it is generated at order entry, or as part of contract review. Sometimes it is generated at the start of production. It often also serves as a quality plan, where operational risk mitigation is applied.
Production planning often also handles shop scheduling and shop loading.
Big picture production planning, such as manpower needs and capital equipment needs are usually handled in a different manner, but are still part of production planning.
8.5.1 is where an auditor determines if the planning was followed to ensure that production takes place under controlled conditions.
You can't just audit one or the other.
For 8.1 you audit production planning. The most common tool used for production planning is the Work Order / Traveler, or whatever that particular entity uses. Generation of the Work Order can start as early as the quote stage as many software packages are developed with that option. Sometimes it is generated at order entry, or as part of contract review. Sometimes it is generated at the start of production. It often also serves as a quality plan, where operational risk mitigation is applied.
Production planning often also handles shop scheduling and shop loading.
Big picture production planning, such as manpower needs and capital equipment needs are usually handled in a different manner, but are still part of production planning.
8.5.1 is where an auditor determines if the planning was followed to ensure that production takes place under controlled conditions.
You can't just audit one or the other.
I see 8.1 as more like a list of things that need to be done for ALL of clause 8 (not just production). It contains brief statements of requirements which are expanded in other clauses. Yes you audit all clauses, but because they overlap you don't have to do it more than once.
You audit 8.1a and 8.2.2 at the same time.
You audit 8.1b.1 and 4.4.1c (and any process) at the same time.
You audit 8.1b.2 and 8.6 at the same time.
You audit 8.1c and 7.1 at the same time.
You audit 8.1d and 8.3.2, 8.3.4, 8.3.6, 8.4.2, 8.5, and 8.7 at the same time.
You audit 8.1e and 7.5 at the same time.
You audit 8.1a and 8.2.2 at the same time.
You audit 8.1b.1 and 4.4.1c (and any process) at the same time.
You audit 8.1b.2 and 8.6 at the same time.
You audit 8.1c and 7.1 at the same time.
You audit 8.1d and 8.3.2, 8.3.4, 8.3.6, 8.4.2, 8.5, and 8.7 at the same time.
You audit 8.1e and 7.5 at the same time.
Yes, you can audit some of the topics with other ones. That happens throughout the standard.
Each auditor will tend to develop their own methods and may combine things differently.
The main thing is that you need to audit each process. When you do you audit whatever parts of the standard are involved with that process. And you still need to make sure that all of the elements are audited that are in the scope of the audit.
Each auditor will tend to develop their own methods and may combine things differently.
The main thing is that you need to audit each process. When you do you audit whatever parts of the standard are involved with that process. And you still need to make sure that all of the elements are audited that are in the scope of the audit.
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