Title

Make an action plan following the report of the external audit and monitor its implementation

Why

Nonconformities identified in the external audit (see previous activity) need to be solved/corrected in order to prepare for accreditation.

What

Once the audit report is completed it is submitted to the laboratory management. The laboratory management has to develop a SMART action plan to ensure the timely correcting/solving of nonconformities identified during the audit.

How & who

Laboratory Manager:

  1. When the audit report is received from the external mock auditors, discuss the nonconformities with the laboratory staff in a weekly staff meeting. Think together about possible solutions for solving/correcting the nonconformities. Note that it may also be possible that you decide to do nothing with a nonconformity indicated by the auditors if you have good reasons why you do something differently. It is however important in this case that you have to be able to show that the quality remains controlled and assured.
  2. Correct the nonconformities identified in the external mock audit following the same procedure as for internal audit (use the SOP developed in phase 3):
    • Draft a SMART action plan for correcting/solving all the nonconformities identified in the audit
    • Formulate corrective actions for each nonconformity and, if possible, formulate preventive actions that prevent the same nonconformity from occurring again in the future. If necessary and applicable, implement control steps to check if the nonconformity still reoccurs.
    • Discuss the action plan in a weekly staff meeting and inform the staff members of the action points that were assigned to them specifically.
    • Give the action plan, together with the report, to the Quality Officer who has to monitor its timely and correct implementation.
    • Once all the action points have been completed, sign and date the action plan for completion. The Quality Officer will subsequently archive the report and action plan.
  3. After completing this activity your laboratory is ready to apply for accreditation: select an accreditation body that is member of the International Laboratory Accreditation Cooperation and is accredited itself according to ISO 17011:2004 Conformity assessment - General requirements for accreditation bodies accrediting conformity assessment bodies.
  4. Apply for accreditation at the selected accreditation body.


Quality Officer:

  1. Once the Laboratory Manager has written and presented the action plan following the external mock audit report he will give it to you. Start monitoring timely implementation of the action plan following the same procedure as for internal auditing (use the SOP developed in phase 3).
  2. Once all the action points have been implemented completely, give the action plan to the Laboratory Manager who must sign and date the action plan for completion.
  3. Once signed and dated by the Laboratory Manager, archive the action plan together with the report in a new folder entitled "External Audits".

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This activity belongs to the QSE Assessment

 

ISO15189:2007: 4.10.1 4.11.1 4.12.1
ISO15189:2012: 4.10 4.11 4.12
ISO15190:2003: