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Understanding ISO 9001:2015

5.3  Organizational roles, responsibilities and authorities   

Before we begin, let’s clarify some definitions: 

Role:  is the defined or expected behavior associated with a particular position, function or status in an organization. 

Responsibility : The duty, obligation and accountability for the performance of assigned duties, tasks and activities. 

Authority : The power or right to control, command, issue orders, make decisions, assign resources, delegate, and ensure compliance to company policies and practices. 

Accountability  means taking responsibility for and accepting the consequences of your actions in achieving results and proving it to others (see our discussion under clause 5.1.1a). 

Top management must establish the organizational framework necessary to deploy the QMS. It must define the structure, hierarchy and lines of reporting. Additionally, (perhaps, through the assistance of the Human Resources function), it must ensure that the duties, roles, responsibilities and authority of all personnel are defined and communicated. All personnel must be clear on their duties, responsibilities and authority in meeting customer and regulatory requirements. 

Although this version of the ISO 9001 standard does not specifically require any documentation, clause 4.4.2 does require that to the extent necessary, the organization must maintain documents and records to support the QMS.

Organization charts, job descriptions, procedures, work instructions, responsibility matrices, etc, are typically some of the many ways that top management may use to define and document its organizational framework and associated duties, roles, responsibilities and authority  

These must be communicated and deployed, as applicable, throughout the organization. Orientation packages; quality and operator manuals, appointment postings; sign-off on job descriptions; job training on procedures and work instructions, etc, are some of the many ways to accomplish this. 

The organization structure and lines of reporting; responsibility and authority of managerial functions and departments must be established by top management (business planning) and the responsibilities and authorities for the rest of the organization may be established by the HR function working with various process owners and department heads. Again, this would depend on the size, complexity and culture of the organization. 

The specific QMS activities themselves that top management must assign responsibilities and authorities for are covered in detail in other parts of this ISO 9001 standard. In this clause, we are only concerned with top management’s role in assigning them. 

In the 2008 version of this standard, the Management Representative (MR) was assigned specific responsibilities and authority for overseeing the implementation, maintenance and improvement of the QMS and reporting on QMS performance to top management. This MR function could be assigned to any individual at the managerial level who had a reasonable grasp of the ISO 9001 standard and people skills in promoting and implementing the QMS.

In this version there is no such requirement. The expectation is that some companies will continue to maintain the MR function, while others may choose to reassign the responsibility for the various QMS activities indicated by clause 5.3a-e.

This article is an extract from my eCourse “Understanding ISO 9001:2015”. The rest of the article discusses in detail clause 5.3.a-e and the action items needed to address these requirements. 

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Understanding ISO 9001:2008