ISO 16106 pdf download – Packaging – Transport packages fordangerous goods Dangerous goodspackagings, intermediate bulk containers(IBCs) and large packagings — Guidelines for the application of lso 9001.
4 Quality management system
The management system requirements of ISO 9001:2000. Clause 4 apply.
Documentation specified in ISO 9001:2000, 42.4 should be kept dunng the assumed lifetime of packangs. IBCs and large packagings or for live years. whichever is longer.
5 Management responsibility
The management system requirements of ISO 9001:2000. Clause 5 apply.
NOTE Documentation c be subject to audit by the conetent authority
6 Resource management
The management system requirements of ISO 9001:2000. Clause 6 apply.
7 Product realization
7.1 Planning of product realization
The management system requirements of ISO 9001:2000. 7,1 apply.
The product specifications for packaging and IBCs should conform to Annex A and Annex B.
NOTE Arwiex A and Annex B are extracted from ISO 161042003. Annex G and ISO 16467:2003. Annex C. respectively.
7.2 Customer-related processes
The management system requirements of ISO 9001:2000. 7.2 apply.
7.3 Design and development
The management system requirements of ISO 9001:2000. 7.3 apply.
For the design validation process, specified In ISO 9001:2000. 7.3.6. reference should be made to tile official design validation process (design tWe testing and approval procedure) wh.ch is completed by the allocation of the UN marking, as required in 6.1.3,6.5.2 and 6.6.3 of the UN Model Regulations.
7.4 Purchasing
The management system requirements of ISO 9001:2000. 7.4 apply.
Purchased products should conform to customer requirements and tile approved design type specification. Verification of conformity by certificates of conformity in accordance with ISOIIEC 17050.2 or any other documentation providing the same level of confidence, or. where those are not provided with the delivery, by tests, should be based on the criteria given in C.1.
The conformity of components with the approved design type specification should be verified in accordance
Note 1 the minimum specification data given In Annex A and Annex B.
7.5 Production and service provision
7.5.1 Control of production and service provision
The management system requirements of ISO 9001:2000, 7.5.1 apply.
After any change in process parameters, visual inspection should be carried out to ensure that the changes do not impair or change the specified design type criteria.
NOTE Changes in process parameters can change the design characteristics and require retesting in accordance with 61,5, 654 and 66,5 of the UN Model Regulabons
7.5.2 Validation of processes for production and service provision
Manufacturing processes should be validated using the control parameters given in C.2.
The design type test and approval procedure is also required as validation of the manufacturing process and
the equipment, personnel and procedures involved.
7.5.3 Identification and traceability
The management system requirements of ISO 9001:2000, 7.5.3 apply
7.5.4 Customer property
The management system requirements of ISO 9001:2000, 7.5.4 apply
7.5.5 Preservation of product
The management system requirements of ISO 9001:2000, 7.5.5 apply
7.6 Control of monitoring and measuring devices
The management system requirements of ISO 9001:2000, 7.6 apply.
8 Measurement, analysis and improvement
8.1 General
The management system requirements of ISO 9001 :2000, 8.1 apply.
8.2 Monitoring and measurement
The management system requirements ISO 9001:2000, 8.2 apply.
Monitoring of production should be based on visual or computer-aided automated monitoring of the manufacturing process to identify any need for adjustment to the function of machines and installations.
At initial production, first samples should be checked for conformity with the design type specifications as described in Annex A and Annex B. Where applicable. conformity of the following should be verified:
dimensions;
masses;
Conformity with the approved performance levels of packaging, lBC and large packaging design types shouldbe verified periodically as specified in a test plan or procedure (including frequency and acceptance limits) toconfirm the continuing ability of the manufacturing process to satisfy its intended purpose.
NOTE 1 See 6.1.5,6.5.4 and 6.6.5 of the UN Model Regulations for the relevant regulatory requirements.NOTE2 See Annex D for examples of typical frequencies for the verification of conformity.
Performance test conditions should be specified.For the execution of the performance tests listed in C.4 andC.5, the design type performance test requirements should be met.
NOTE3 For the purpose of production monitoring, the test conditions may differ from the design type test requirementsand may be restricted to comparisons with previous test results.
NOTE4 The monitoring and measurement of product can also be used to demonstrate compliance with 6.1.5.1.3,6.5.1.6.7 and 6.6.5.1.3 of the UN Model Regulations.For this purpose, performance tests at random may be performed onproduction samples at intervals agreed with the competent authority.
8.3Control of nonconforming product
The management system requirements of ISo 9001:2000,8.3 apply.
lf controls have previously shown nonconformities during production, appropriate measures, such as finalinspection of the complete lot, or performance testing at a higher frequency, should be carried out in contextwith corrective/preventive actions.
NOTE Corrective actions can be subject to the agreement of the competent authority.
ISO 16106 pdf download – Packaging – Transport packages fordangerous goods Dangerous goodspackagings, intermediate bulk containers(IBCs) and large packagings — Guidelines for the application of lso 9001
