As with anything in life, you can have as many goals as you like but if you don’t have a plan you’ll probably never achieve them. Wishful thinking is not enough.
One of the very first clauses in ISO 9001 advises us that the adoption of a quality management system is a strategic decision. Therefore, the quality objectives should be corporate objectives, not a set of goals that are the sole responsibility of the management representative (quality manager). They are the responsibility of the most senior managers in the organisation. In smaller businesses these are the business owners.
5 Management Responsibility
5.4.2 Quality Management System Planning
What does ISO 9001 Say?
The standard has little to say on the subject but it is important.
Top management shall ensure that:
a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and
b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.
Once you’ve set objectives, measures and targets it makes sense to develop plans. Objectives, measures and targets without the plans designed to achieve them are just wish lists.
Let’s break it down.
Top management shall ensure that:
a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives
The planning referred to in this clause is that required to meet your quality objectives and to ensure that your quality management system is effectively implemented and maintained (clause 4.1). This clause is not concerned with the planning you need to do to run a project, meet contractual obligations, or provide a product or service. That is address by the clause Product Realisation.
It is the responsibility of management to provide the direction, authorisation resources and reviews need for quality management system planning.
b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented
This clause refers to changes that affect the quality management system, not simply changes to the documentation. Your quality management system is based on the processes that exist in your organisation and because the purpose of a quality management system is to help an organisation satisfy customers, these systems are far reaching. Thus changes in your organisation such as in management, ownership, location, technology, products, services, customer base, and so forth will affect your quality management system. Changes must be carefully planned so as not to disrupt your organisation’s ability to effectively meet customer and other requirements.
How is this Demonstrated?
When changes occur in an organisation, planning requires more than just some updates to the organisation chart, procedures or other documents in the quality management system. Consideration must be given to the impact of the change on processes, people, products, raw materials, services, customers, etc. To ensure that these changes don’t have a detrimental impact on your organisation or your quality management system you could have a change management plan that:
- Determines the impact of the change on the process it directly affects as well as other connected processes.
- Identifies the impact of the change on the quality management system and what needs to change to maintain system effectiveness.
- Lists the actions required to effect the change, responsibilities and a timeline.
- Considers the resources required.
- Measures performance before, during and after the change.
Such planning in a large organisation may, if the change is significant, require a dedicated multi-disciplined team to manage the project. In a small organisation, or if the change is small, some one-on-one discussions may be enough. However, people’s ability to see the quality management system as something separate to the rest of the organisation never ceases to amaze me. In a well-designed and managed system that is fully supported by management, this shall pass. But I like to make sure that I am informed of changes that may affect the quality management system by including in management review meetings the item – are there any proposed changes to the organisation that will impact the Quality Management System? Recording what they are in the minutes demonstrates your awareness. How you deal with the change from here depends on its size and complexity and may necessitate some or all of the above actions.
Measures that demonstrate that planning has been effective include the achievement of quality objectives, improved customer satisfaction ratings, and a reduced number and seriousness of nonconformities.