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Archive for ISO9001:2015

Section 5 Leadership:

ISO9001:2015 Refers to the top management of an organization as Leadership. This is significant. Leadership according to section 5.1.1 must have established organizational strategy and ensure that the company policy and objectives support the company strategic direction. ISO9001:2008 required the policy to be communicated and understood within the organization. ISO9001:2015 requires that the established policy is also applied or lived within the organization. Objective evidence must exist that the company policy is alive and applied. Requiring solid and active leadership that develops and communicates strategy as well as ensuring the effectiveness of each process output is a new dimension in the auditable process.

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Understanding the context of the organization

This week let’s discuss the requirement for “Understanding the context of the organization”

Context of the organization is defined in ISO9001:2015 as the Business environment. The combination of the internal and external factors and conditions that can have an effect on an organization’s approach to its products, services and investments and interested parties.

Let’s consider two kinds of business and what the internal and external factors may be that can have an effect on the organization’s approach.

Number One Widget Makers sells widgets to manufacturing companies. The widgets are used to make automated processing equipment.   The internal environment is quite stable / static with few changing environmental forces. Externally, there aren’t many competitors and new technologies are not being found. Thus, there is little activity from outside groups that might influence the organization.

Compare Number One Widget Makers to Social Media Marketing, an Internet marketing start up that faces an active environment with quickly changing regulations and new competitors who are constantly entering the market. Customers require the latest technology and are continually changing their preferences. The internal and external factors are many that affect the approach Social Media Marketing takes on its services.

These two companies have very different organizational environments both internally and externally. Number One Widget Makers’ leadership is results and deadline driven, distant, and not as concerned with employee morale. Social Media Marketing’s leadership style is very hands-on depending on a lot of creativity, ingenuity, and imagination in solving organizational problems. Their managers are concerned about employee morale and welfare and try to make their employees feel valued and important.

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What is changing in ISO9001 with the 2015 Revision?

I thought it would be a good idea to talk about the upcoming changes to ISO9001.   For the next few blogs, I will discuss things that I noticed when reviewing the DIS level of the revision. Please comment on things that you noticed and also what you think is going to change in the 3rd party auditing. Let me know if you agree or disagree with my thoughts.

The 2009 requirements for a QMS were contained in sections 4, 5, 6, 7 and 8; they are now contained in sections 4, 5, 6, 7, 8, 9, and 10. I will highlight below thing things that caught my eye as being new requirements or terminology.

Section Context of the Organization:

  • Understanding the context of the organization is required
  • Understanding the needs and expectations of the interested parties is required

Section 5 Leadership:

  • Leadership – New Term
  • Requires Top management shall demonstrate leadership and commitment with respect to the quality management system

Section 6 Planning for the Quality Management System

  • More definition for setting and monitoring objectives
  • Tighter controls required when changes are made to the QMS

Section 7 Support

  • New section for The Environment for the Operation of the Processes
  • Requirement to monitor and measure resources and having organizational knowledge

Section 8 Operation

  • Very similar to section 7 of the 2009 revision
  • Seems to be more emphasis on post-delivery activities

Section 9 Performance Evaluation

  • This section is similar to section 8 of the 2009 revision
  • Allows the organization to determine the aspects that need to be monitored to ensure structure, control and accountability

Section 10 Improvement

  • Covers non conformity and corrective action
  • Preventive action has been removed but the activity is covered in the new subsection in section 6 on Risk.

Next blog, I am going talk specifically about section 4. There are some pretty significant things that need to be discussed and understood. Can’t wait to share and hear what you think.

 

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