ISO 9001 2015 - New requirements - Understanding the Context

There are many changes in the upcoming standard of ISO 9001:2015.The standard released as of now is DIS and likely to go undergo at least more round of change. The changes may not be very significant.  The first and major change is the Context of Organization. Let us to understand the requirements.

The clause 4 covers :  4 sub clauses :

1. Identification of Issues
2. Needs  and Expectations of interested parties
3. Determination of scope
4. Quality management processes

The entire system is based on the needs, issues, scope and processes. The information compiled here provides the basis for strategy, performance review and improvements.

1. Identification of Issues: The issues are significant points important to the organization . The points which are related to strategy are required to be identified. The issues are categorized as external, internal based on the control an organization has.

Internal--

Performance: Quality, Delivery.

Knowledge:  Product knowledge, patents

Values: team work, Integrity,

Culture:

 

External:

Market: Market share, Market size

Competitive: Features of competitors product

Technological: Infrastructure , work environment, Machines

Economical:  Pricing, costing

International: Currency rate , political stability

The requirement of the standard is to identify, monitor and review of  the issues.

The issues are referred in Management review, Risk and opportunities, quality policy, and top management commitment.

Though there is no specific requirement of documentation, but the issues can be coupled with risks identified , and opportunity.. A general introduction, or SWOT addressing  issues covering strategy  can be good way of representing the issues.

The link is as below:

Demonstration of consideration that  risks/ opportunities  are identified for the significant issues. Action plan on risk, opportunities, changes are availavble and reviewed  by management.

The requirements thus help the organization to get a more mature view.

1. Interested parties:
   The interested parties related to QMS can be: Customer, end user, Regulatory body, and employees, supplier, service provider,  management. The expectations  for each interested party are  different.
   Here again the needs are referred in the management review as inputs.

The idea is the management decisions are based on inputs from not only customers , but suppliers too.  The impact of this consideration can be more in on the organizations where end user, customers are different. Suppliers are 

 

1. Determination of scope:
   Though the requirement appears to be same , the details mentioned are with idea that , the processes , products, locations should be clearly defined. The boundary means the activities under control, and responsibility . There is no change in the exclusion with ref to the pervious standard.
2. System and processes:
   The change here is omission of the mention of quality manual, and that matter mention of requirement of documented procedure.
   However , the in order to prove the requirements related to establish, implement, maintain and improve the process, the organization can chose the way.
   The preferred way is still to have documents, macro/ micro flowcharts or cross linked matrix of can be an easy way.
   The new requirements are related to consideration to risk, opportunity, changes, and opportunity for improvement.
    
   Hence to summarize:
   The standard has brought together  following aspects in context.
    prevention as base.
    business situation or environment
   expectations from stake holders
   & processes
   Consideration is that management will have overview of needs, business environment, significant issues and current system.
   The aim is to have sustainable improvement and this clause now gives complete picture to the management for making decisions, look ahead , current scenario.
   The organization ideally should document

•  introduction in terms of the issues
• Levels of needs  from interested parties
• Processes and linkages
• Scope boundaries  
• 
  
  As an auditor , the understanding of context will streamline the audit focus, and will get initial knowledge on maturity of the system in the organization.