This is a 52 week discussion of the proposed 2015 revision of ISO9001. We challenge you to follow us each week, and review your QMS from top to bottom with us. By year end 2015, you can have your QMS upgraded and ready for the 2015 revision!
4 Quality Management System
What is your definition of a QMS (Quality Management System)? According to Wikipedia, it is a “collection of business processes to achieve quality policy and quality objectives to meet customer requirements”.
Obviously, this should be well considered and clearly defined for any business as part of its business plan. It is also a key area that should be addressed at the very beginning of any quest for ISO9001 compliance or registration. So, let’s start at the beginning. This week is all about strategic planning. Start to put a face to your business by creating a profile which describes what your business does and how it does it.
If you are starting your QMS from scratch, spend the next week jotting down some thoughts about this. Next week, we will go through 4.1 General Requirements with a fine toothed comb to get you on your way to a successful construction (or review of your current QMS) that will be compliant to the proposed 2015 version of ISO9001.
LAST WEEK’S HOMEWORK – Keep yourself accountable!
Did you do get your copy of ISO9001:2015? Order from ISO.org
Did you review all the Terms and Definitions in the standard and evaluate whether these should be reviewed with your team? Did you get it done or put a plan in place?
THIS WEEK’S HOMEWORK – Keep up the good work!
Prepare for next week by getting ready to create a profile of your company and your QMS. Ask yourself the following. (We will begin putting this to paper next week).
1. Why does your business exist? What does it do?
2. What are your products or services?
3. Who are your customers?
4. What are the criteria, specifications of your products (services)? And what are your customer expectations?
5. How do you take your product (service) from start to finish? What processes are necessary to create your product (service) and deliver it to the customer?
6. Do you rely on suppliers to create your product? How will you manage them?
7. What level of performance do you expect? What are your objectives for these processes?
8. How will you measure your performance?
9. What will you do when you do/do not meet your objectives?
10. How will you continually challenge yourself to do better?
Work on these 10 questions this week and be ready with your answers. Next week, we will start reviewing our QMS. If your QMS is new, you’ll begin writing/framing your QMS. If you’re doing a review of an existing ISO9001 system, you’ll review your QMS for it’s compliance to section 4.1 of the standard.
I hope we can discuss the internal and external context of an organization which is in clause 4 of the new edition of QMS
Hello. What would you like to discuss? Do you have questions? Are you currently registered to ISO9001 or are you pursuing it?
Ok. What specifically would you like to talk about? Have you identified your organization’s internal and external context? I’d start by considering the external side first. Obviously, who is the customer and what do they want? Then, who else has an interest in your business? The community? Are there environmental concerns? Is your product “export controlled” so that it may have geopolitical impact? After all of those considerations are made, I would identify what processes are used to make the product or service.
In my business, design and construction (D&C), definition is subservient to purpose. “Why are we doing this” is more important than “let’s define it.” If the purpose makes sense, the definitions can follow. I humbly submit that the purpose of a QMS in D&C is to “free the team to design and build.”
@BrianPalmquist – I agree. “The Why” is usually overlooked.