In a Q&A session, TEC Transnational's managing director, Dr David Scrimshire talks about how the new ISO is likely to affect the revised AS9100 when it is issued in 2016.
Later this year, the ISO (International Organisation for Standardisation) is issuing an updated Quality Management System (QMS) standard, ISO 9001:2015. The AS9100, which is currently under revision, will incorporate the ISO's new structure and some of its requirements.
Q: How will the ISO 9001:2015 new structure affect AS9100?
What is particularly different about ISO 9001:2015 is that its new high level structure will be utilised in a variety of QMS standards, including AS9100. Previous Management System Standards (MSS) have differed in structure, terminology and requirements, and this has led to confusion and difficulties in implementation.
Adopting a generic management system with a common high level structure will introduce identical core text, common terminology and core definitions for use in all MSS, leading to enhanced compatibility across standards.
Individual MSS will add additional ‘discipline-specific' requirements as required, provided they do not affect harmonisation or contradict or undermine the intent of the high level structure. The AS9100 family of standards for aerospace and defence fall into this category. A major consequence will be the development of integrated management systems which will address multiple disciplines (e.g. quality, environmental, etc.).
Q: How might specific changes to the ISO impact on AS9100?
Based on the recently published ISO 9001:2014 draft International Standard, some of the key changes might include:
• Making risk-based thinking more explicit and incorporating it into requirements for establishing, implementing, maintaining and continually improving the QMS
• Organisations will need to determine the issues and requirements that can impact on the planning and development of the QMS
• The ‘process approach' will become an explicit requirement across all disciplines
• To remove the existing bias towards organisations dealing with physical commodities, the MSS adopts the term products and services
• The words ‘document' and ‘record' have both been replaced by ‘documented information', meaning that organisations can now decide on the nature and extent of their QMS documentation and documented information. But be careful – there are still over 30 mandatory requirements for documented information which can refer to traditional ‘documents' and ‘quality records'
• There is no ‘exclusions clause' as such, but the ‘scope requirement' must clearly state when a requirement cannot be applied. This takes the form of documented information clearly stating the organisation's products and services covered, with justification for any instance where a requirement cannot be applied
• Preventive action as a requirement has been replaced with ‘risk-based thinking' in order to understand risk in the context of the management system
• ‘Management Responsibility' now becomes ‘Leadership' so an organisation's top management is required to demonstrate its engagement in key QMS activities to help ensure that the QMS is embedded into routine business operations
• The phrase ‘externally provided products and services' replaces ‘purchasing' to underline the fact that the new standard is applicable to all suppliers – not just those that provide physical products
Q: Can you tell us anything specifically about the forthcoming AS9100 revision?
The 2016 revision of AS9100 will mandate that QMS continue to address customer, statutory and regulatory QMS requirements, and that actions are taken to ensure that processes achieve their planned results and strive for continual improvement. All processes must be fully described and senior management will still need to demonstrate customer focus by actively managing delivery and quality performance.
AS9100:2016 will demand that a specific member of the management team, who has unrestricted access to senior management, oversees the operation of the QMS. The monitoring and measuring resources (also known as inspection/rest equipment) must be calibrated and adjusted in an appropriate manner based on international/national standards. A register of this equipment must be maintained and individual items must be recalled when requiring calibration and/or checking.
There are many staffing aspects, including the competency of personnel being periodically reviewed, and personnel will need to be aware of how their work could be affected by factors such as social responsibility and ethics.
Documented information must include evidence of conformity to requirements and the effective operation of the QMS (i.e. audit results, etc.). Appropriate measures must be in place to prevent the inadvertent use of obsolete documents, and electronic documented information must be securely stored to prevent tampering and ensure that it can be retrieved when software or systems change.
The product design and development process must still be undertaken in a highly-structured manner, which includes verification and validation testing. A new requirement mandates that representatives in design and development review and reflect the stages being reviewed.
Requirements in the current AS9100 that require tight control of approved suppliers and routine monitoring of their performance carry forward and include the use of risk management and control of sub-tier providers.
All of the existing additional requirements in production and service revision are retained and have been revised to incorporate the new clause structure imposed by ISO 9001:2015. In many cases the additional aerospace industry requirements have been revised to improve clarity and to address the needs of all interested parties.
Q: What does this mean for aerospace businesses?
The issue of ISO 9001:2015 in September heralds the start of a three-year transitional period during which organisations will be able to implement the necessary changes to their QMS. The revised AS9100 will be issued in 2016. Organisations still using masses of narrative procedures should be investigating a process-based approach to QMS design embodying modern visual approaches.
Many existing ISO 9001 systems are failing to set quantitative quality objectives, which will be a must. These objectives must align with customer expectations. To support these ‘customer satisfaction metrics' it is mandatory to actively manage process-level key performance indicators.
Although there is a three-year transition period, it's never too soon to plan for change! And remember – as we've got this transition period, let's use it from the outset. Any companies trying to implement this in the last three months of the transition will either fall on their faces or have to throw money at the problem – both of which are painful.
Dr David Scrimshire is the managing director of TEC Transnational, an IRCA-approved and IAQG-certified training organisation. Its AS9100 courses and exams are recognised internationally.