A detailed look at the ISO 9001:2015 Quality Management Standard: Part 2

ISO 9001 BY SECTION

4. CONTEXT OF THE ORGANISATION

 

Details the requirements for:

• UNDERSTANDING THE ORGANISATION AND ITS CONTEXT- the requirement for the organisation to consider a wide range of potential factors, both external and internal, that can impact on the management system, in terms of its structure, scope, implementation and operation, including:
  
  
  • Social;
  • Economic;
  • National;
  • Governance;
  • Technological;
  • Political;
  • Products and services

• UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES – The requirement to consider the needs of interested parties both internal and external, including, as appropriate:
  
  
  • Directors;
  • Employees;
  • Contractors;
  • Clients/Customers;
  • Suppliers;
  • Regulators;
  • Legislation;
  • Shareholders;
  • Neighbours;
  • Non-Government Organisations (NGO’s);
  • Parent Organisations.

The best way to demonstrate this is to have both the context and interested parties logged in a database, register or similar. This should include details of Legislation or Regulation to which the organisation must comply

• DETERNMINING THE SCOPE OF THE QUALITY MANAGEMENT SYSTEM – Now includes a requirement to consider both the Context and Interested parties along with the products or services being delivered.
  
  Naturally the scope must include a requirement to comply with the Quality Management Standard ISO 9001:2015.
  
  
• QUALITY MANAGEMENT SYSTEM AND ITS PROCESSES – The requirement to establish, implement, maintain and continually improve the management system, including the processes needed and their interactions in order to deliver the required products, services and performance required under the scope.
  
  The term processes (a set of interrelated activities which transforms inputs into outputs).
  
  Organisations need to address risks and opportunities (Section 6)
  
  Organisations will also need to demonstrate the resources needed, ensuring their availability.

5. LEADERSHIP

This clause used to be “management commitment” but now requires that top management engage more fully with the critical, aspects of the quality management system.

• LEADERSHIP AND COMMITMENT – The requirement that top management must demonstrate leadership and commitment to it. It is now a requirement that this top level oversight of the quality management system is a key component of the organisation and its core business processes and activities.
  
  The quality management system must be integrated into the organisation’s business processes.
  
  
• CUSTOMER FOCUS - A requirement to demonstrate leadership and commitment with respect to customer focus:
  
  
  • Fully determine market/customer needs and expectations.  This information then acts as an input to determining strategy, direction and facilities development of a management system capable of satisfying the targeted market or customer.
    
    An example could be:
  
  
  • Market surveys;
  • Customer/client meeting minutes;
  • Questionnaires;
  • Other areas of research.
    
    
  Customer/Client focus has been extended to include determination of risks and opportunities that affect conformity of products and services.
  
  This could be a S.W.O.T analysis (strengths, weaknesses opportunities and threats) or PESTLE (Political, Economic, Social, Technological, Legal and Environmental) or similar.
  
  

• QUALITY POLICY – The requirement for a quality policy establishing goals and commitments appropriate to the organisation & not simply a bland statement that could apply to any business.  The policy must be communicated to all employees and they need to understand the part that they have play in its deployment.  Additionally, the policy must be available to interested parties.  The policy is authorised by the most senior person in the organisation, CEO, MD, Senior Partner, etc.
  
  
• ORGANISATIONAL ROLES, RESPONSIBILITIES and AUTHORITIES – The requirement to ensure those involved are fully aware of their role. Top management must be identified as being responsible for ensuring that aspects of the system are properly assigned, communicated and understood.
  
  
• Top management must ensure that key responsibilities are defined. An organisation chart and job descriptions or procedures to identify responsibilities and authorities.
  
  Unlike previous versions of this standard the specific role of Management Representative is not used.  The activities of the role however, are now referenced within the core structure of the organisation, including top management.