Introduction to ISO 9001The ISO 9001 Quality Management Standard is intended to be generic and applicable to all organisations, no matter the size or industry. This is because it is a process standard, not a service or product standard.
ISO 9001 gives the requirements for what the organisation must do to manage processes affecting quality of its products and services. It does this through the creation of a Quality Management System.
‘Quality Management’ refers to all aspects of delivery of the service required by a client, as well as compliance to applicable regulations. The standard asks what the organisations does to enhance client satisfaction and to continually improve performance, which is checked on an ongoing basis through Surveillance Audits.
Having been refined over a number of years by a consensus of experts across various industries and sectors, ISO 9001 is an international, up-to-date model for organisations to follow. By systemising the way of doing things, ISO 9001 makes clear who is responsible for doing what, when, how, why and where.
The Quality Management SystemA Quality Management System (QMS), the heart of the ISO 9001 standard, is the way your organisation directs and control those activities related either directly or indirectly to meeting client requirements. Broadly speaking, it consists of your organisation’s structure together with the planning, processes, resources and documentation that you use to achieve your quality objectives, meet your customers’ requirements and to continually improve.
What you need in placeThe standard requires you to have certain documented procedures. They must meet the requirements as described in the following 6 clauses as mentioned in the standard:
- (clause 4.2.3) Control of documents
- (clause 4.2.4) Control of records
- (clause 8.2.2) Internal audit
- (clause 8.3) Control of nonconforming product
- (clause 8.5.2) Corrective action
- (clause 8.5.3) Preventative action
The Quality Manual, which includes the Quality Policy, is a document which states the organisation’s intentions for operating their QMS and defines the scope of what it covers. It will also point out what it doesn’t cover, such as activities outside of your control. The manual will contain documented policies which are mapped with the requirements of the ISO 9001 standard. They must include:
- How management expects company operations to function
- Who is responsible to implement these expectations
- Where and when the policies are applicable within the organisation
- What interdependencies exist between functions and processes
The format of the Quality Manual is not defined; most organisations start work on a template initially to get the ball rolling. The intention isn’t for ISO 9001 to impose something completely new; even if you are just at the start, the likelihood is that your organisation already has an effective system, it may be it is simply informal and not documented.
Moving towards certificationAs you implement the QMS, ensure that you properly identify what kind of training different members of your staff require. For those directly involved in creating documentation, training to Internal Auditor status would be a benefit. For those less involved, simple internal training may be all that is required.
With the ISO 9001 QMS being all about continual improvement, it is important that you monitor and measure the operation of the QMS. Conduct internal audits and focus on the end goal: customer satisfaction.
Once your QMS is established and effective, you are then ready for certification to take place. You can find more about this process in our Routes to Certification article.
First StepsIf you think you are now ready to take the leap, purchasing a copy of the standard itself will reveal the full requirements in order to achieve certification.
Quality Management resourcesSee all resources to support ISO 9001 Quality Management.
ISO 9001 Client manual (PDF)
ISO 9001 Implementation guide (PDF)
ISO 9001 Self-assessment checklist (PDF)
Guide to assessing your management system (PDF)
View all ISO 9001 resources