Prima Strategies

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ISO 9001:2015 Documentation and Implementation

COURSE DESCRIPTION

ISO 9001:2015 allows an organization flexibility in the way it chooses to document its quality management system (QMS). This enables each individual organization to determine the correct amount of documented information needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its QMS.

ISO 9001:2015 clause 4.4 Quality management systems and its processes requires an organization to “maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confident that the processes are being carried out as planned.”

An organization with an existing QMS should not need to rewrite all of its documented information in order to meet the requirements of ISO 9001:2015. This is particularly true if an organization has structured its QMS based on the way it effectively operates, using a process approach.  

This 2-day course will guide the organization to carry out some simplification and/or consolidation of existing documented information to ensure a smooth documentation transition from ISO 9001:2008 to ISO 9001:2015.

This course will include practical examples reflective of the organization’s documentation and implementation requirements to ease understanding of actual practices against compliance requirements as stated in ISO 9001:2015.

 

OBJECTIVES

At the end of this course, participants will acquire the knowledge to identify, document, implement and maintain the QMS documentation as required by ISO 9001:2015 and internal requirements.  They will be able to:

 

  1. Review and gain knowledge on the key changes within ISO 9001:2015
  2. Clarification of new structure, terminology and concepts
  3. Provide the necessary knowledge to the internal QMS representatives to enable them to correctly interpret ISO 9001:2015 documentation requirements and translate them into necessary documentation and practice.
  4. Begin the documentation transition from ISO 9001:2008 to ISO 9001:2015.
  5. Have better understanding on ISO 9001:2015 for Document Control and Record Control
  6. Perform gap analysis on current documentation and implementation practices (use of QMS numbering system and linkages to other levels of document) against ISO 9001;2015 requirements
  7. Create a document and record matrix with action items and timelines required to transition to ISO 9001:2015

 

TARGET AUDIENCE

This course is recommended for QMS Representatives and Document Controllers responsible to develop and ensure QMS documentation and implementation compliance to internal and ISO 9001:2015 requirements.

 

DURATION

2 Days

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