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Monday, 26 September 2016

Aerospace and Defence Standards update

IAQG have finally announced the timetable for release and transition of the AS 91xx: 2016 Standards.

AS9100 :2016 Aerospace and Defence Standard released for publication in all sectors on
23 September 2016

AS9101:2016  QMS audit Standard, AS9110:2016  Maintenance QMS  and AS 9120:2016 Distributor QMS  to be released for publication in all sectors in October 2016.

It is important to note that any audit carried out from June 2017 must be to the 9100:2016, 9110:2016  or 9120 : 2016 standards.  That does make the timescale rather short.

Any organisation not transitioning to the 2016 standards by 15 September 2018 will no longer hold a valid certificate.

The revised Standards are based on the updated ISO 9001:2015 Standard and Annex SL (10 Section format) but with additional requirements.

Monday, 12 September 2016

A detailed look at the ISO 9001:2015 Quality Management Standard: Part 5

9. PERFORMANCE EVALUATION


MONITORING, MEASUREMENT, ANALYSIS AND EVALUATION


Details the requirement for the organisation to determine:

  • What needs to be monitored and measured;
  • The methods for monitoring, measurement, analysis and evaluation needed to ensure valid results;
  • When monitoring and measuring is performed;
  • When the results from monitoring and measurement are analysed and evaluated.
  • The organisation must evaluate the performance of the quality management system.

The organisation must retain documented information as evidence of the results.

CUSTOMER SATISFACTION


Details the requirement to monitor customers’ perception of the degree to which their needs and expectations have been fulfilled.  The organisation must determine the methods for obtaining, monitoring and reviewing this information.

The methods may include customer surveys, customer feedback on delivered products and services, meeting with customers, market share analysis, compliments, warranty claims and dealer reports.

ANALYSIS AND EVALUATION


Details the requirement for the organisation to analyse and evaluate appropriate data and information arising from monitoring and measurement. 

The results of analysis must be used to evaluate:

  • Conformity of products and services;
  • The degree of customer satisfaction;
  • The performance and effectiveness of the quality management system;
  • If planning has been implemented effectively;
  • The effectiveness of actions taken to address risks and opportunities;
  • The performance of external providers;
  • The need for improvements to the quality management system.

Methods to analyse data can include statistical techniques.

INTERNAL AUDIT


Details the requirements to conduct internal audits at planned intervals to provide information on whether the quality management system:

  • Conforms to:
    • The organisation’s own requirements for its quality management system;
    • The requirements of ISO 9001:2015;
  • Is effectively implemented and maintained.

The organisation must:

  • Plan, establish, implement and maintain an audit programme(s) including the frequency, methods, and responsibilities. Planning requirements and reporting, which must take into consideration the importance of processes concerned, changes affecting the organisation, and the results of previous audits;
  • Define the audit criteria and scope for each audit;
  • Select properly qualified auditors and conduct audits to ensure objectivity and impartiality of the audit process;
  • Ensure that the results of audits are reported to relevant management;
  • Take appropriate corrective actions without undue delay;
  • Retain documented information as evidence of the implementation of the audit programme and the audit results.

 

MANAGEMENT REVIEW


Details the requirement for the organisation to review the quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with strategic direction of the organisation.


MANAGEMENT REVIEW INPUTS


The management review must be planned and carried out taking into consideration:

  • The status of actions from previous management reviews;
  • Changes in external and internal issues that are relevant to the quality management system;
  • Information on the performance and effectiveness of the quality management system, including trends in:
    • Customer satisfaction and feedback from relevant interested parties;
    • The extent to which quality objectives have been met;
    • Process performance and conformity of products and services;
    • Nonconformities and corrective actions;
    • Monitoring and measurement results;
    • Audit results;
    • The performance of external providers;
  • The adequacy of resources;
  • The effectiveness of actions taken to address risks and opportunities;
  • Opportunities for improvement.

MANAGEMENT REVIEW OUTPUTS


The outputs of the management review must include decisions and actions related to:

  • Opportunities for improvement;
  • Any need for changes to the quality management system;
  • Resource needs;

The organisation must retain documented information as evidence of the results of management reviews.

10. IMPROVEMENT


GENERAL


Details of the requirements for the organisation to determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction.  These must include:

  • Improving products and services to meet requirements as well as to address future needs and expectations;
  • Correcting, preventing or reducing undesired effects;
  • Improving the performance and effectiveness of the quality management system;

NONCONFORMITY AND CORRECTIVE ACTION


Details the requirement for the organisation to action nonconformities, including any arising from complaints and must:

  • React to the nonconformity, and as applicable:
    • Take action to control and correct it;
    • Deal with the consequences;
  • Evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere by:
    • Reviewing and analysing the nonconformity;
    • Determining the cause of nonconformity;
    • Determining if similar nonconformities exist, or could possibly occur;
  • Implement any action needed;
  • Review the effectiveness of any corrective action taken;
  • Update risks and opportunities, determined during planning, if necessary;

Corrective actions must be appropriate to the effects of the nonconformities encountered.

The organisation must retain documented information as evidence of:

  • The nature of the nonconformities and any subsequent actions taken;
  • The results of corrective action.

CONTINUAL IMPROVEMENT


Details the requirement for the organisation to continually improve the suitability, adequacy and effectiveness of the quality management system.

The organisation must consider the results of analysis and evaluation, and the outputs from management reviews, to determine if there are needs or opportunities that must be addressed as part of continual improvement.


Once all this is put into place a formal assessment can take place.  Of course continued compliance is a must and will be checked by the Certification Body.

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