ISO 9001:2015; You Are 90% of the Way There

MessageThis Webinar is over
Date Sep 21, 2017
Time 12:00 PM EDT
Cost $179.00

The new structure of ISO 9001:2015 seems to be a major change, but there are only a handful of new features that require modification of existing ISO 9001:2008 systems. The processes of an ISO 9001:2008 system already meet most of the requirements of ISO 9001:2015, and there is no need to restructure the quality management system.
Among the biggest changes is clause 6.1, Actions to address risks and opportunities. It relates directly to 4.1, Context of the organization, and 4.2, Needs and expectations of interested parties. These concepts are hardly new, as organizational planners have actually considered the context of the organization (Strengths, Weaknesses, Opportunities, and Threats) for thousands of years. Needs and expectations mean simply a square deal for all organizational stakeholders, as delivered by Henry Ford with world-class success a century ago.
Why should you attend this webinar?
The deadline for the transition is September 2018, and prerequisites include an internal audit and a management review under the new standard prior to registration. A SIPOC conformity matrix can show, however, (1) how existing processes deploy the new standard's requirements and identify any gaps, and (2) the inputs, outputs, and handoffs between the processes. This relates emphatically to existing quality system processes, which may need modification but not an extensive revision to adapt them to the new standard. The SIPOC matrix meanwhile supports ISO 9001's process orientation. Processes can themselves be written to indicate inputs, outputs, and resources. 

Areas Covered in the Session:
  • Know how clause 6.1, Actions to address risks and opportunities, relates to 4.1, Context of the organization, and 4.2, Needs and expectations of interested parties. The latter clauses relate in turn to 4.3, the scope of the quality management system.
  • Registration to ISO 9001:2015 requires (1) an internal audit to the requirements of the new standard and (2) a management review meeting under the new standard.
  • Ensure that procedures identify clearly, "Who, what, when, how, where, and why?" to ensure identification of responsibilities, and also to ensure that those who carry out the procedure understand its purpose as well as the actual tasks.
    • This approach aligns with the job breakdown sheet from Training Within Industry (TWI).
    • Failure to assign specific responsibilities resulted in the death of a transplant patient due to a blood type mismatch. Everybody knew that the blood type of the organs had to match that of the recipient, but nobody had the specific responsibility to do it. "Who" is therefore extremely important.
  • Know how to cross-reference existing processes with ISO 9001 clauses in a conformity matrix to show how they deploy the requirements of the standard, and identify any gaps that must be addressed.
  • Use a SIPOC (Supplier, Input, Process, Output, Customer) matrix to illustrate in a simple format the handoffs between the processes of the quality management system.
    • These matrices are far more than checklists, as supporting detail can be added to spreadsheet cells while process identities can be hyperlinked to the controlled documents themselves. The SIPOC conformity matrix can, therefore, be the centerpiece of a simple quality manual that allows auditors and users to see the overall structure of the quality management system.
Who can Benefit:

Quality and management professionals who manage ISO 9001 systems and are involved in the transition to ISO 9001:2015

Contact Details:
Compliance Key
phone no: 717-208-8666 Ext: 100


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