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What is ISO 9001 | Quality Management | QMS

What is ISO 9001? What is a Quality Management System (QMS)? ISO 9001 explained & the steps to achieving compliance or certification.


ISO 9001 - Quality Management Systems (QMS)


What is ISO 9001?

ISO 9001 is the International Standard that specifies the requirements for a Quality Management System (QMS).

What is a Quality Management System (QMS)?

A QMS is a tool for achieving customer satisfaction. You can liken a QMS to your organisation’s road map for navigating the provision of products or services. This road map consists of processes, procedures, checklists and registers but can take any shape or form; paper, electronic, written, pictorial, flowchart.

What are the requirements of a Quality Management System (QMS)?

ISO 9001 does not specify what shape of form your QMS must take. The standard is written very broadly, enabling organisations to use a common sense approach when interpreting the standard’s requirements. There is no ‘one size fits all’ QMS. Using the road map analogy from above, a Melbourne road map is not a useful resource when navigating Sydney.

What are the requirements of ISO 9001?

Context of the Organisation: Who are we? You need to demonstrate that you understand who your organisation is. This is done by identifying risks & opportunities, needs & expectations of interested parties, your products & services and the process inputs & outputs to deliver those products & services. Your organisation’s SWOT analysis is a great starting point for understanding who you are.

Leadership: Where are we going? Top management needs to demonstrate leadership commitment to the QMS. Top Management must take responsibility for: establishing & communicating the quality policy & objectives, being focused on customer satisfaction, defining roles & responsibilities, providing adequate resources and promoting improvement. The Standard has no intention of tripping up Top Management for not knowing the micro detail of your QMS, but it does require the organisation’s leaders to know the way, go the way and show the way.

Planning: What’s the plan? You need to demonstrate planned actions to achieve your organisation’s quality objectives. You also need to show planned actions to address risks & opportunities along with your actions associated with planning for change. Your organisation’s strategic, business and or marketing plans are the perfect foundation.

Support: What’s keeping us upright? Competent people, infrastructure, environment, equipment and knowledge resources need to be determined, provided, reviewed and maintained to support the QMS. Your organisation’s training records, skills matrix and equipment maintenance schedules could be your starting point.

Operation: How are we related? You are required to understand the interacting processes within your organisation and plan & control those processes. This requirement covers customer communication, the design & development, requirements of a product or service, externally provided processes, products & services, production & release of the products or services, and control of non-conforming products or services. Essentially, these are all the activities necessary to provide products and or services to meet customer requirements. Simple flowcharts mapping each stage of your processes and the required controls are a useful tool to get you started.

Performance evaluation: How did we do? You will need to make your QMS accountable by measuring & monitoring performance. Think SMART: Specific, Measurable, Attainable, Realistic, Tangible when determining what needs to be measured & monitored, when & how to do so, and how to analyse & evaluate the results. These evaluations will need to include results from customer feedback, internal audits and management reviews. Your leadership team meetings or management meetings are the perfect forum to report performance evaluation.

Improvement: What could we do better? You need to identify opportunities for improvement and determine the actions to implement improvement. Improvements can include corrective action, process change, innovation and re-organisation. The suitability, adequacy and effectiveness of the QMS needs to be reviewed and improved continuously as the organisation develops and evolves over time. The QMS is not a set and forget tool. Referring to our road map analogy again, we would struggle to navigate our way around Melbourne today using a road map from 1920.

Who should consider compliance with ISO 9001?

All organisations regardless of size, industry or ownership structure can benefit from compliance with ISO 9001.

What are the benefits of ISO 9001?

• Drive growth, cut costs and increase profits

• Sharpen your organisation processes and increase efficiency

• Give your organisation a competitive edge & improve your marketing pitch

• Improve employee engagement

• Open up export markets for your goods and services

• Help you compete with bigger enterprises

• Improve your risk profile with financiers and insurers

• Enable you to compete for public and private tenders

How do we get started with ISO 9001?

ISO 9001 only has a handful of documents that it explicitly requires. The best way to get started is to conduct a review of your existing management tools (business plan, marketing plan, objectives & KPIs, processes, procedures, registers and forms) to assess how they satisfy the requirements of the Standard. Stay focused on the items that matter. Start with the bare minimum and build your QMS from there. Most importantly, make a visible note: ‘Quality Management does not equal mountains of paper & metrics.’

How do we attain ISO 9001 certification?

Certification is the written assurance (in the form of a certificate) from an independent body (Certification Body) that your organisation meets the requirements of the Standard. It stands to reason that assurance can only be provided once the Certification Body has reviewed your QMS in action. This is done in two stages. Stage 1 is a top level readiness assessment; it is used to gain knowledge of your organisation and review your organisation’s understanding of how your QMS meets the requirements of the Standard. Stage 2 is the evidence gathering audit; it is used to gather objective evidence that your QMS is complying with the standard and that you actually do what you say you are doing in your system.

Next steps

ISO Helper Consultants are Industry Experts in the Development, Implementation & Maintenance of user friendly Compliant Quality Management Systems. We can help you get started on your path to ISO 9001 compliance or certification by conducting a Quality Management Health Check of your organisation.


Specialising In: ISO 9001 | ISO 14001 |  ISO 45001 | OHSAS 18001 | AS/NZS 4801