Quality Management System: Implementation. Objectives. To provide information on implementation of a quality management system including: An implementation plan Quality manager Document and records Policies, processes and procedures Quality system essentials Quality policy statement
To provide information on implementation of a quality
management system including:
1. Get commitment from top management
2. Communicate your intent to all staff
3. Appoint a responsible individual (“quality manager”)
4. Review OLA requirements
5. Prepare an implementation plan
6. Prepare quality policy statement
7. Prepare quality manual: a compendium of policies*
8. Map processes as they are now *
9. Determine the gaps in processes and associated documentation
* Note: Steps 7 and 8 can be reversed
10. Prioritize the redesign of processes
11. Plan and document the new processes
12. Verify the new processes
13. Plan and document the associated procedures
14. Communicate and train staff
15. Implement the processes
16. Measure the effectiveness of the processes
17. If problems are identified, modify the processes and go back to step 11
Map the BASIC process:
Map the processes down to greater detail
Define the criteria for determining that the process is effective.
Ensure that there are adequate resources available to
implement the process
Train staff and implement the process.
All quality management system documents must have an
identification in the form of a header or footer that contains the
Purchasing and inventory
Documents and records
Investigation of non-conformities
Service and satisfaction
Facilities and safetyThe Quality System Essentials (QSE)
Which of the following statements is correct?
The correct answer to question 1 is b)
Processes do not include step-by-step instructions, these are PROCEDURES.
Which of the statements regarding procedure manuals is correct?
The answer to question 2 is a)
Laboratories have the latitude to write their manuals in keeping with their own unique situation and scope of practice. While GP2-A is an excellent resource for those looking for a template, we do not require every facility to revise their manuals to conform to it.
A suitable plan for continual improvement can be summarized as:
The answer to question 3 is c)
To be in compliance with OLA program requirements, each facility must designate a full-time “Quality Manager”
The correct answer to question 4 is b) FALSE
The responsibility for quality management must be assigned to an individual (quality manager or otherwise titled), but this can be either a full-time or part-time activity given in addition to other responsibilities.
Which of the following statements is incorrect?
The answer to question 5 is a).
OLA assesses the end result, not the manner in which a facility’s QMS was implemented.