What documents do you need for your ISO 9001 management system?

What documents do you need for your ISO 9001 management system?

Is ISO 9001 on your agenda? Are you planning to expand your customer base? Do those potential new customers expect you to be accredited?

If the answer to any of these questions is yes, you may be considering using a template, pre-written document to help you meet the requirements of the standard.

It’s tempting to do this for three reasons. Speed, cost and ability to DIY.

When sales growth is a priority, you’ll want to get ISO 9001 in place as soon as you can. It’s quick to get hold of a system. In fact, you can download one immediately online. You’ll find ready written documentation online for as little as £149, and you can download some templates and start using them today.

However there are good reasons to take a longer-term view and avoid this approach.

You already have a management system

New customers are sometimes surprised to hear us say this, however you already have a management system. It’s what you’ve developed as you’ve grown your business. You don’t need a new system, you simply need to address any gaps between what you have and what you need for ISO 9001.

That doesn’t mean your system couldn’t be improved. With clients in engineering, maintenance and ecommerce and a background in construction and industrial services, our team brings experience and ideas to help solve the challenges you face.

However, introducing a manual without consultation can lead to your employees feeling they must be ‘doing it wrong’ when it couldn’t be further from the truth. Your employees and customers will tell you exactly how you can improve your business processes and results if only we provide them with the opportunity.

You already use ‘risk based thinking’

The standard says you should be using a Plan-Do-Check-Act approach with a focus on ‘risk-based thinking’. While it’s possible to lose sight of this in a corporate environment, this is already the mindset of successful entrepreneurs in small business.

What you’re likely to need help with is capturing those risks, opportunities and decisions.

This is particularly true for businesses controlled by one or two individuals. In a corporate environment you’ll have a board of directors to hold you accountable, and they’ll expect written reports. In a small business, chances are you’ll make decisions by talking in person, or if you’re the sole-decision maker, by talking with your partner or a trusted advisor. 

If you receive a customer complaint, you’ll speak to them directly, decide what needs to be done and why, and ask your employees to act accordingly. 

If something goes wrong, you’ll fix it, but you may not record what you did, and why.

When you change a design, you’ll do so for a reason – you may email your customer with an explanation, but it could be very difficult for you to track down that information for an audit.

(Incidentally, as your business grows, it’s great to be able to learn from your past experience and to share that knowledge with your growing team. ISO 9001 says this learning is part of your ‘organisational knowledge’.)

Your business is different from the next one

The great thing about ISO 9001:2015 is that it’s super-flexible – perfect for SMEs. 

It explicitly states that the extent of documented information will differ based on the size of your business, the type of work you do and how complex it is. You’re also expected to take into account the competence of your team.

We steer away from a one-size-fits-all approach because your business may:

  • be digital or still very paper-based
  • use cloud or on premise platforms
  • use standard office software (such as Microsoft Office 365 or Google Workspace) or a digital project management tool
  • work on an industry-specific or more generic platform
  • automate your workflow or rely on manual processes

Your customers may be:

  • business or consumers
  • placing high-value or low-value orders
  • in-person or e-commerce

Your sector may be:

  • highly regulated
  • have significant safety risks

The people in your business will also influence your approach. Do they spend their day at a desk, or should any admin tasks be done on their mobile? How comfortable are they with your IT platform?

Avoid making it too complicated

It’s easy to download a document and edit it for your business. But what if it’s too complicated? You may find:

  • Surplus document control information (e.g. you have everything you need on Sharepoint)
  • Word documents (when you prefer online forms or apps)
  • Lots of detail (when things are more straightforward)

You may overlook some of this complexity when you’re throwing resources at your project to gain ISO 9001. However it’s hard to maintain a complex system over the longer-term. It can be frustrating for your team, and expensive.

What do I need to do?

Most quality practitioners (including Wessex Commercial) will carry out a gap analysis for you. They’ll review what you’re already doing, and let you know what you need to do or change to meet ISO 9001 requirements. 

They can also document your management system in a Quality Manual, process map or training package. This helps your team understand how all of the processes interact, and why they’re important for your business and your accreditation. It also makes it easier for you to explain how things work to your auditor. 

Ready for the next step?

At Wessex Commercial, we’re ready to help you gain ISO 9001 certification. Get in touch today to book a free meeting, and let’s look at the steps you need to take to get accredited.

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