Saturday, November 26, 2011

Plan internal audits

ISO 9001:2008 clause 8.2.2 "Internal Audits" says that an audit programme shall be planned, taking into consideration:

  • status and importance of the processes and areas to be audited,
  • results of previous audits.
It means that established internal audit schedule is not "fixed", it can be updated according to the needs of an organization. 
The best way to identify which processes and areas require more attention and help is to measure your processes using established measurement methods and criteria.
Review internal audit schedule for the purpose of identifying audits to be performed first, establishing sequence and frequency of audits, fine tuning audit areas, objectives and criteria. Issues which may cause changes in current internal audit schedule/plan and listed but not limited to:
  • Negative trends in process performance
  • Process slow down due to poor communication
  • Needs in resources, applied new resources
  • Performed training
  • New product/service
  • Increased number of nonconformities and required corrective actions
  • Critical issues as result of previous audit.
Some internal audits may be repeated to verify that corrective actions has taken place to eliminate any critical issues identified during previous audits.

Review and update internal audit program/schedule during company management meeting. This will add visibility to internal audits results, appreciation of the efforts of internal auditors, as well as allow company management team to utilize internal audit program to solve problems and mitigate risks in the future.
 



Friday, November 18, 2011

Create internal audit schedule.

OK, lets start with simply stating what ISO 9001:2008 requires for internal audit.

Clause 8.2.2  "Internal Audit" of ISO 9001:2008 requires that:


"The organization shall conduct internal audits at planned intervals to determine whether the quality
management system 
a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to
the quality management system requirements established by the organization, and
b) is effectively implemented and maintained.


An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. The selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.

A documented procedure shall be established to define the responsibilities and requirements for planning and
conducting audits, establishing records and reporting results.


Records of the audits and their results shall be maintained (see 4.2.4).


The management responsible for the area being audited shall ensure that any necessary corrections and
corrective actions are taken without undue delay to eliminate detected nonconformities and their causes.


Follow-up activities shall include the verification of the actions taken and the reporting of verification results
(see 8.5.2)."


At the very beginning of clause 8.2.2 we read, that internal audits shall be conducted at planned intervals. Therefore:

  • Step 1: write internal audit schedule. Start with listing your processes and process owners.
  • Step 2: define how often audits will be performed. Examples: "at least one audit per month". As you see, ISO 9001 does not require any particular frequency.
  • Step 3: outline audit objective for each process. It can be as general as "compliance with ISO requirements", or as specific as "Check implementation of new working instructions in production shop".
  • Step 4: Define audit scope for each process in the schedule. You may want to audit the full process for the first time. Or further down the road, you may focus your internal audit on certain areas of the process. Examples: Process: Purchasing, scope: vendors selection and evaluation; or Process: Sales, scope: communication of feedback from the customers."
  • Step 5: choose dates for internal audits and assign auditors
  • Step 6: don't forget to communicate internal audit schedule within your organization, at least with management team.
Your first internal audit schedule is ready! Please send me an email or visit my web site www.almallc.com if you want to have schedule template.  
I am planning to write these posts weekly. Next time I will wright about complying with above ISO 9001 requirement "An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits."