ISO 16106:2020 pdf free.Transport packages for dangerous goods一Dangerous goods packagings,
intermediate bulk containers (IBCs) and large packagings – Guidelines for the application of ISO 9001.
4 Context of the organization
4.1 Understanding the organization and its context
The organization should determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.
The organization should monitor and review information about these external and internal issues. NOTE 1 Issues can include positive and negative factors or conditions for consideration.
NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local.
NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.
4.2 Understanding the needs and expectations of interested parties
Due to their effect, or potential effect, on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization should determine:
a) the interested parties that are relevant to the quality management system;
b) the requirements of these interested parties that are relevant to the quality management system.
The organization should monitor and review information about these interested parties and their relevant requirements.
4.3 Determining the scope of the quality management system
The organization should determine the boundaries and applicability of the quality management system to establish its scope.
When determining this scope, the organization should consider:
a) the external and internal issues referred to in 4J
b) the requirements of relevant interested parties referred to in 4.2;
c) the products and services of the organization.
The organization should apply all the requirements of this document if they are applicable within the determined scope of its quality management system.
The scope of the organization’s quality management system should be available and be maintained as documented information. The scope should state the types of products and services covered, and provide justification for any requirement of this document that the organization determines is not applicable to the scope of its quality management system.
Conformity to this document may only be claimed if the requirements determined as not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.
4.4 Quality management system and its processes
4.4.1 The organization should establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this document.
The organization should determine the processes needed for the quality management system and their application throughout the organization, and should:
a) determine the inputs required and the outputs expected from these processes;
b) determine the sequence and interaction of these processes;
c) determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes;
d) determine the resources needed for these processes and ensure their availability;
e) assign the responsibilities and authorities for these processes;
1) address the risks and opportunities as determined in accordance with the requirements ofj;
g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;
h) improve the processes and the quality management system.
4.4.2 To the extent necessary, the organization should:
a) maintain documented information to support the operation of its processes;
b) retain documented information to have confidence that the processes are being carried out as
planned.ISO 16106 pdf download.