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4.1.1 Exclusions
The majority of the standards clauses will be applicable but some might not. Either way, the manual must clearly
define which requirements from ISO 9001 (Section 7) have been excluded with a brief but detailed justification as to
their exclusion. Identify any ISO 9001:2008 requirements not applicable to your organizations activities and provide a
brief narrative justifying their exclusion from the scope of the quality management system.
An example of a justifiable exclusion might relate to the control of design and development, whereby, if a company
does not undertake design and development activities then the design and development clause would not be
applicable and can be excluded from the scope of the manual.
4.1.2 Justification
The justification for any exclusion and those considered not applicable must be clearly documented in the manual. If,
for example, design does not apply to the quality management system, the standard stipulates how a reduction in
scope of the standard should be justified and documented within the manual. All other potential exclusions within
Section 7 must be identified as not applicable or not applicable at this time with justification or explanation as to why
it does not apply. In addition, if an organization conducts these activities or is responsible by the customer to conduct
these activities, they must be part of the scope of certification. Design applies to product design; organizations cannot
exclude portions of design element.
This section includes the general requirements that must be met in order to establish, implement and continually
improve the effectiveness of a quality management system meeting the requirements of the standard. These
requirements are referenced to and/or further defined in subsequent clauses of the standard. Continual improvement
of the effectiveness of the quality management system may be reflected in a number of different areas. These
typically include:
Quality objectives
Management Reviews
If continual improvement has become a way of life for a company, it is unlikely that a demonstration of companywide
continual improvement will come from only a few sources. System deterioration would not necessarily lead to nonconformity if all actions were positive and the improvement path is still evident and logical. The system would be
questionable if the company did not recognize it or had not reacted to the issues appropriately.
It is the responsibility of the company to demonstrate improvement rather than the auditor to look for it. Accordingly,
it is a useful audit practice to ask management to identify any improvement initiatives taken since the previous visit,
and any planned for the future.
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Effect on quality
Economic risk
Competence of personnel
Complexity of processes
Customer Oriented Processes (COPS) which affect or interact with the customer:
Manufacturing/service
Design
Calibration
Maintenance
Finance/accounts
Human resources/training
Management Oriented Processes (MOPS) are formally conducted by the top management:
Management review
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Auditing
Data analysis
CAPA
Non-conformities
While defining processes however, this is not a requirement. The auditor must see evidence that the organization has
determined their processes and interactions. If your organization calls it a process, it must be monitored for
effectiveness in accordance with ISO 9001: 2008; clauses 4.1, 8.4 and 8.2.3.
Management
Orientated
Processes
Customer
Orientated
Processes
Support
Orientated
Processes
Assessment
Orientated
Processes
A process completed wholly or partially by a sister facility outside the scope of registration. Such as corporate
performing design, purchasing or customer related processes, this includes management activities i.e.
business planning, goal setting, resources, data analysis, budgeting, etc. This may include the entire element
or a subsection i.e. corporate completes supplier evaluation and re-evaluation of suppliers and the registered
site initiates purchase orders.
2.
A processes completed by an outside vendor or subcontractor such as heat treating, plating, calibration,
painting, powder coating, etc. These types of processes may be controlled by the purchasing process where a
formal contract or purchase order may be the controls. If this is the case, written documentation would be
the purchasing documentation and records however; these processes are required to be documented in the
quality manual.
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