Where it all starts…ISO 9001:2015 Quality

This is where it all starts, ISO 9001:2015 Quality. A business without quality…well needs no explanation. 

As I sit here at my office desk, I begin to elegantly blow off the dust that covers the ISO 9001 Quality Manual, a bible of sorts filled with the holy grail of wisdom on how to run a quality business. It glimmers a golden fleck in the sunlight, leather bound, saddle stitch. A subtle build up of suspenseful music begins as I turn the first page. What a moment! 

…Okay well it probably hasn’t collected too much dust, last iteration was in 2015 and it’s online so really this scene isn’t something out of Hogwarts but I wanted to add a little creative flair. This is in fact what I initially envisioned when Jose first explained these standards. 

ISO 9001 is structured into 10 clauses (think of it like a chapter in a rulebook - each clause covers a different part of what a business needs to do to meet the standard.)

Clauses 1-3 are just introductory sections. The big juicy stuff starts at Clause 4 onwards. Let’s start there, don’t worry we are in this together (I’m a little nervous too). 

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Clause 4: Context of the organisation aka understanding your business & its needs.

From my understanding, in order to improve the quality of the business, we need to understand who you are as a business and what affects your ability to deliver quality services and/or products. This is like looking at the “big picture” assessment before diving into the nitty gritty details of your business. 

When we break this down, we identify four key things: 

• Internal and external factors that could impact your business.
• Determine interested parties; this might be customers, suppliers, regulators or employees.
• Define the scope of your Quality Management System (QMS) - what’s included in your business and what’s not?
• Set up your QMS processes to align with ISO 9001 requirements.

Now, this all seems straightforwardish but let’s face it, i’m not getting excited about this Clause yet. I don’t know what’s more dry…Clause 4 or the Sahara Desert.

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Super fun real world example incoming!

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Imagine you own “Glaze of Glory”, a boutique doughnut shop known for its outrageously delicious creations (I’m getting hungry thinking about this!). Before you can maintain top-tier doughnut quality, you need to understand what could impact your business. 

Identify internal & external factors

• Internal: Freshness of ingredients, consistency in recipes, staff training on making the perfect doughnut.
• External: Rising butter prices (tragic), food safety regulations, TikTok trends dictating wild new flavours (pickle-flavoured doughnut, anyone?).

Determine interested parties

• Customers (expect fluffy, delicious doughnuts every time).
• Suppliers (need to deliver top-quality flour, butter, and sprinkles).
• Employees (trained in doughnut artistry and proper hygiene).
• Regulators (making sure your kitchen isn’t a chaotic mess).

Define the scope of your QMS

• Covers ingredient sourcing, baking process, quality checks, and customer service - but not what happens when a customer leaves with their doughnut (if they drop it, not your fault that’s outside the scope of your management system).

Set up QMS processes

• Standardise recipes so every doughnut is *chef’s kiss*.
• Quality checks at every stage (burnt batch? Nope. But we’ll take it home anyway. Too much frosting? Impossible, but let’s check).
• Customer feedback system (is the new matcha-strawberry-glitter doughnut a hit or a disaster?).

By understanding these factors, Glaze of Glory can keep serving the best doughnuts in town, avoiding supply issues, staying compliant with food safety laws, and making sure every bite is pure bliss. 

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Moral of the story? 

Knowing your business inside out means you can deliver quality and where does this start? Clause 4 folks!

Ready to keep climbing the ISO mountain? Next up: Clause 5 – Leadership