ISO 9001 Requirements
ISO 9001 Requirements Clause 5.2 Quality policy
Developing a QMS must be a strategic business decision and therefore top management must provide the necessary direction and leadership, including establishing the quality policy and objectives.
The quality policy is the organization’s expression of its strategic direction and commitment to quality. It is typically expressed in the form of commitments to meet or improve various business goals that add value to its purpose and overall strategic direction.
It is top management’s vision on quality management for the organization. It provides the organization with focused direction, i.e. high level goals and objectives for quality management with regard to its products, services and operations.
As ISO 9001 expands its scope towards becoming more of a overall business standard, rather than just a quality management standard, organizations are integrating its policies for quality management with its other business policies such as business growth; sales and marketing product or manufacturing technology; culture; values; workforce competence; innovation; business flexibility, etc.
Because of this expanded scope, the quality policy may be called by other names such as its charter, statement of excellence, mission statement, business vision, etc.
Your quality policy must also be consistent with the scope of your QMS (see our discussion of clause 1- scope).
If the scope of your QMS activities does not include product design and development, and you take on a contract or project which includes product design and development; this would be inconsistent with your quality policy commitment of ‘meeting customer requirements’, as your QMS does not include that activity.
Can you outsource the design and development work and still take on the contract or project? Sure you can, but not under the umbrella of the ISO 9001 QMS. You must make it clear to your customer that design and development is not within your QMS scope and get their written waiver, if the work was required to be done under ISO 9001 QMS.
The quality policy must be appropriate to the purpose and context of the organization and support its strategic direction. First we should briefly clarify some terms used in the standard.
Purpose: The purpose of an organization answers the question of why it exists. What does it do that benefits or adds value to society? For example an advertising company’s purpose could be ‘We enhance your image and visibility”. A recruitment company’s purpose could be – ‘We help people achieve their ambitions’.
Context of the organization: The meaning of this is covered in detail in our discussion of clause 4.1
Strategic direction: is the path defined by the vision, mission, specific strategies that lead to the achievement of the goals and objectives of an organization.
Fit the purpose – if you’re a recruitment firm, one of your quality policies would likely be a commitment to thoroughly whet all potential applicants before presenting them to employers. A bank would commit to maintaining the confidentiality of all customer information.
If your strategic direction is to outsource all manufacturing activities as many organizations do these days, your quality policy may include a commitment to transition from producing products and services internally to outsourcing them.
If your organization has identified contextual factors (external or internal) that may have an impact on the QMS, the quality policy may need to incorporate policies dealing with these factors, e.g. using leading edge technology as a competitive resource; using social media and the internet to grow the business; recognizing changing demographics and culture to maintain and improve the work environment, etc. (Also see discussion under 5.1.1b)
This article is an extract from my eCourse “Understanding ISO 9001:2015”. The rest of the article discusses in detail clause 5.2.1 and 5.2.2 and the action items needed to address these requirements.