PROCEDURES
2.3.1 ISO 9000 implementation procedure
One can make the deduction that the decision to seek ISO 9000 certification by an organisation is voluntary judging by the studies on motivation for seeking Quality Management Systems certification (Kartha, 2004; Feng, Terziovski and Samson, 2008; Sampaio, et al., 2009).
The International Organisation for Standardisation outlines the steps to be taken if an organisation wishes to implement and maintain a Quality Management Systems based on ISO 9001, to be as follows:
Step 1:
Top management to be fully engaged.
This is so that they may define the motivation for implementing ISO 9001; define the quality policy in conjunction with the organisation’s mission, vision and values; and align the organisational objectives with related product or service objectives.
Step 2:
Key processes and the interactions need to meet quality objectives to be identified.
Step 3
Implement and manage the Quality Management System and its processes using the process management techniques.
Step 4
28 This can be achieved by identifying the ISO 9001 requirements, then mapping the ISO 9001 requirements with the organisation’s implemented Quality Management Systems. A gap analysis is then conducted in order to identify where the existing systems fulfil the ISO 9001 requirements and where they do not. Finally activities, procedures and controls needed, are to be included in the organisation’s Quality Management Systems.
Step 5
Implement the system, train company staff and verify effectiveness of organisation’s processes.
Step 6
Manage the Quality Management Systems.
Organisations should place emphasis on customer satisfaction, strive for continual improvement and consider implementing business excellence models in company operations (Anonymous, 2011a).
Once the Quality Management System is implemented according to the ISO 9001 requirements, organisations may seek to be “certified” to be regarded as to be conforming to ISO 9001. According to the ISO, certification is not any of ISO’s management system standard’s requirements, however organisations may choose to be certified.
Certification is defined by ISO as an issuance of written assurance (certificate) by an independent external body, that it had audited the organisation’s Quality Management Systems and verified that it conforms to the requirements specified in a particular standard (Anonymous, 2011a).
29 2.3.2 ISO/TS 16949 implementation procedure
For ISO/TS 16949, as in the section above, a number of steps have to be undertaken in order for an organisation to be ready to implement Quality Management Systems according to ISO/TS 16949.
Step 1
Create a process map and understand customer requirements
The first step includes studying one’s organisation in order to create a detailed process map. The developed process map should take into account activities from product development through to shipping the product to the customer. At this stage it is critical to understand the needs and expectations of the organisation’s customers, in order to align the processes with meeting these.
Step 2
Conduct a gap analysis
The organisation would need to conduct a gap analysis of the existing system, including the examination of the documentation structure behind the organisation’s Quality Management Systems. Using ISO/TS 16949 and ISO 9001 should provide the organisation with the correct criteria against which to measure their Quality Management Systems.
Step 3
Implement a Business Operating System (BOS)
This section includes identifying, grouping and rating customer and interested- party expectations with the view of aligning them with the organisation’s processes and metrics. Various tools can be used to link expectations to key processes and processes measurable that have to be measured and monitored in order to satisfy the requirements of ISO 9001. Business operating systems are also a good tool to use in order to achieve good Quality Management System planning.
30 Step 4
Implement Process Review Methodology (PRM)
Process review methodology is used to document and control Quality Management System processes. It uses the process map and the organisation’s documentation and applies process flows, process failure mode and effects analyses, and control plans to ensure that the documentation is effective and that the organisation’s Quality Management System processes are under control.
Not all the organisation’s processes need to be documented using process flows, but only those that require documentation to ensure the effective planning, operation and control of its processes. On the other hand, each process uses a process failure mode and effect analysis to document potential problems or failure modes and recommend actions to be taken.
A control plan is used at the process level for planning the kinds of controls needed to ensure that a process’s outputs meet the intended outcome of that process.
Lastly, the organisation would be required to implement ISO/TS 16949 with particular emphasis on customer satisfaction and the organisation’s processes. Business operating systems become an important method to use for organisations needing to be customer-focused (Kymal & Watkins, 2001).
The certification of an organisation to assure conformance of their Quality Management Systems to ISO/TS 16949 takes place via an external, accredited body (Anonymous, 2011). Typically, the initial certification is a two-stage process. The first stage, which is also known as a readiness review, is to confirm the organisation’s readiness for a certification audit or a second stage audit.
The assessor would typically review internal audit and management review records for the preceding 12 months against the ISO/TS 16949 requirements (at
31 least one full audit to comply with ISO/TS 16949 requirements). They would also review the customer and operational performance trends for the same time period. If the fundamental requirements have been met, then the assessor will confirm that the company is ready and confirm a date for a stage two assessment visit.
This audit’s aim is to confirm that the management system fully conforms to the requirements of ISO/TS 16949 in practice, and it is carried out within 90 days of the stage one review. If the assessor finds that the quality system conforms to ISO/TS 16949 requirements, then the organisation will be confirmed as ISO/TS 16949 certified (Anonymous, unknown).
2.3.3 Quality Systems Basics (QSB) implementation procedure
QSB is a mandatory, General Motors (GM) Quality Management System applicable to all GM suppliers world-wide. In case of a supplier who has never implemented QSB before, the following process is followed for initial QSB implementation.
The supplier acclimatises with QSB objectives, elements and requirements through the QSB training manual that is available electronically to both GM suppliers as well as GM employees. Then the supplier would be required to self - audit their processes using the QSB audit procedures which are also available electronically to both suppliers and GM employees.
The completed supplier process audit report should be sent to a responsible GM supplier quality engineer (SQE), who will evaluate it and schedule a customer- monitored audit. The GM SQE conducts the QSB audit at the supplier premises then allows the supplier time to correct any non-conformances, after which a final certification is scheduled and conducted.
32 The final audit, if successful, will lead to QSB certification. The certification is valid for three years and it is punctuated with yearly supplier self-audits, the reports of which are to be forwarded to the responsible GM SQE.
The stated objective of QSB is to assist suppliers to provide products of world- class quality standards through preventing major quality disruptions of the customer’s operations due to supplier fault, improving supplier delivery quality and reducing customer complaints. Additionally, QSB provides a system to communicate and document quality issues while instilling discipline in containing and solving quality issues (Anonymous, 2011).
The following section investigates the factors that influence organisations to embark on a process of certifying their Quality Management Systems.