Quality management requirements in the aerospace industry are continually evolving, so to make sure you're not caught off guard, LRQA has put together some information to help you keep abreast of the changes.
All AS/EN 9104 assessments carried out by LRQA are now done against the AS/EN 9104-001:2013 version for which LRQA received accreditation back in July 2013.
Now assessed annually, all clients for AS/EN 9104 will have had their certificates reissued to show that certification has been performed in accordance with the requirements of the 2013 version.
- Certificate structure type - Your assessor will evaluate your site locations and value streams to agree with you a current certificate structure, i.e.: Single site, Multiple site, Campus, Sevel sites, Complex.
- Surveillance visit duration - Based on the certificate structure type and employee numbers your audit duration will be calculated based on the new requirements. Your surveillance programme will now be based on an annual programme, but the audit duration per visit may have increased. This allows your assessor more time to evaluate both the conformance and effectiveness of your system.
- Other audit requirements - Your purchasing process will now become part of the annual audit process and shift auditing will be included during the initial assessments and at the 3-year certificate renewal visit.
Your certificate will stipulate that you have been assessed in accordance with the requirements of AS/EN 9104-001:2013.
AS/EN 9110 Revision B
In conjunction with scheduled surveillance visits, all assessment to AS/EN 9110 is now to Revision B following the transition period. The main driver behind the revision was to address the needs of the European Aviation Safety Agency requirements and to achieve AS/EN 9110 recognition by other National Aviation Authority arrangements.
AS/EN 9101 Revision E
Further to the update at last year’s event, IAQG published the expected Revision E update to AS/EN 9101.
The IAQG’s team for 9101 included members representing the Americas, Europe and Asia-Pacific sectors from 6 different countries and 9 IAQG,. There was also an involvement and representation from 5 leading certification bodies.
The revision was deemed necessary for a number of reasons, not least of which was the issue of revisions to ISO/IEC 17021:2011, 19011:2011 and the release of 9104-1:2012 since the previous version had been issued.
Other factors included feedback from aerospace auditor transition training, stakeholder feedback, lots of questions arising over the old version plus even some requirements being lost in the appendix instructions.
General changes include: specific call out of ISO/IEC 17021 clauses, incorporation of AS/EN 9104-1:2012 requirements, ‘Methodologies’ being renamed ’Approaches’, ‘should’ becoming ‘shall’ and some changes and general improvements to the QMS Process Matrix, NCR and Audit Reports.
Also, Appendices are now being referred to as Forms.
Recording objective evidence requirement still remains but the actual Objective Evidence Record has now been removed as the process should now be captured within the new PEAR for clause 7 and updated QMS Process Matrix Report for other clauses.
PEAR changes include the report now being broken down into four sections: Process Details, Process Results, Process Realisation and Process Effectiveness. This revised PEAR form will enable process conformance and effectiveness to be evaluated and systematically reported.
The revisions affects all clients currently certificated to AS/EN 9100 and AS/EN 9120, as well as those seeking certification to those standards.
IAQG has revised its expectations related to how certification bodies conduct and report the results of AS 9101 assessments.
All assessments performed after July 2014 have had to be done in accordance with AS/EN 9101:2014 (Revision E).
Revision F is already in draft
The next version of the AS 9100 standard is due to be released in 2016 and will:
- Incorporate changes made by ISO/TC 176 to the embedded ISO 9001 requirements (ISO liaison organised to collaborate with the IAQG 9100 team and to obtain consideration for IAQG requirement
- Consider aviation, space and defence stakeholders’ needs identified since the last revision (web survey performed in 2013
- Consider clarifications to 9100 series requests issued by IAQG since the last revision (requirements clarified or notes added)
Key Changes (from ISO 9001:2015)
- High level structure (HLS) Terminology
- Risk-based thinking
- Process approach strengthened and more explicit with integration of the QMS into organisation’s business processes
- Concept of preventive action now addressed throughout the standard by risk identification and mitigation
- Emphasis on change management Introduction of knowledge management
- Clearer understanding of the organization’s context
- Aligning QMS policy and objectives with the strategy of the organisation
- Explicit performance evaluation requirements
- Greater flexibility with documentation
- More compatible with services
AS/EN 9100:2016 Key Changes
- Product Safety added in carefully selected areas and consistent with 9110
- Human Factors added as a consideration in Nonconformity / Corrective Action
- Risk merged current 9100 requirements with the new ISO requirements and emphasis on Risks in Operations
- The current requirements absorbed into Risk & Opportunities and Non-conformance & corrective action clauses, 9100 additions reinforce prevention
- Counterfeit Products enhanced in carefully select areas and limited new requirements
- Configuration Management clarified and improved considerably to address stakeholder needs
- Product Realization & Planning clarified and enhanced planning throughout the standard
- Post Delivery Support merged current 9100 requirements with the new ISO requirements
- Project Management & Work Transfer combined with Operation Planning clause to address user interpretation issues
- Design Development and Supplier Management gap analysis - ISO text has been added back in a few places to meet the IAQG needs
- Quality Manual note added pointing to the requirements that make up a Quality Manual or the equivalent
- Management Representative requirement added back in for QMS oversight
AS/EN 9101 Revision F
While Revision E was only released last year, Revision F is already currently in draft.
It is being further revised to incorporate the requirements for accredited certification bodies introduced by ISO 17021-1:2015. The 2016 changes to AS/EN 9100-series of standards and inputs received from interested parties have also been incorporated
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