Pre-audit and gap analysis
We assess the current state against the ISO 9001 requirements and show what already works and what is missing.
ISO 9001
Building and certifying an ISO 9001 quality management system
We build or tidy up a quality management system that meets ISO 9001 requirements and is tied into your product development, production, suppliers and day-to-day management. From the pre-audit and process mapping to the certification audit.
Who it is for
Who this service is for
- Companies whose client, supply chain or public tender requires ISO 9001 certification
- Growing manufacturing and technology companies moving from product development to series production
- Organisations that hold a certificate but whose system has turned into paperwork
- Companies that already have ISO 27001 and want to add ISO 9001 to the same system
What is included
What the service includes
Process mapping
We describe the core processes as your company runs them: owners, inputs, outputs and metrics.
Risks and objectives
We tie risk management and quality objectives to the business goals, so they do not become a separate spreadsheet nobody opens.
Supplier management
A procedure for selecting, evaluating and qualifying suppliers that fits your risks and volumes.
Documentation and automation
Only what is needed. Where possible we use your existing tools and automation to reduce manual administration.
Internal audit and management review
The standard requires both. We carry out the internal audit and prepare the management review with proposals for decisions.
Process
How we work
Kick-off and scope
We agree which products, services, sites and processes fall under the system.
Pre-audit
We review existing processes, documents and practice and record every gap together with its impact.
Roadmap
You get a concrete action plan with owners and deadlines – in language management understands.
Implementation
Processes, metrics, supplier management and documentation, done together with your team.
Internal audit and management review
We check whether the system works and fix the gaps before the auditor finds them.
Certification audit
The certification body's stage 1 and stage 2 audit, where we stand beside you and help with the follow-up actions.
Outcome
What you end up with
- A quality management system that meets ISO 9001
- Mapped processes with owners and metrics
- Quality objectives linked to business goals
- A supplier evaluation and qualification procedure
- Internal audit report and management review minutes
- A clear picture of where you stand in relation to the certification audit
FAQ
Frequently asked questions
How long does ISO 9001 preparation take?
It depends on the size of the company, the scope and how many processes are already in place. Preparation typically takes between a few months and about a year. Within the first few weeks, the pre-audit shows how much work is needed in your case.
Do you issue the certificate as well?
No. The certificate is issued by an independent accredited certification body. To keep things independent, we never audit a system we helped build. Our audit experience benefits you in a different way: we know exactly what the auditor looks at.
Can ISO 9001 and ISO 27001 be combined?
Yes. Both standards share a common structure, so leadership, risks, document control, internal audit and management review can be shared. If you already have one, you are not starting from zero with the other – and one integrated system is cheaper to maintain than two separate ones.
Is ISO 9001 suitable for a small company?
Yes. The standard scales, and a small company's system is simply smaller and simpler. What matters is that it fits your products, clients and risks.
Is your ISO 9001 project realistic?
Get in touch and we will talk through your scope, timeline and what is already in place. Afterwards you will have a clear picture of how much work lies ahead.
See also
Related services
ISO 14001 environmental management system
Building an environmental management system and preparing for certification.
Read more →Head of Quality as a service
An experienced Head of Quality part-time – for growing technology and manufacturing companies.
Read more →ISO 27001 consulting
Preparing your company for the ISO 27001 audit.
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