21 checklist questions for a design manager from an IMS perspective

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Answering positively to all these questions does not assure total compliance to ISO 9001, ISO 14001 and/or AS/NZS 4801/OHSAS 18001 but it does pick up on some of the key aspects of an integrated management system.

1. Are design and development plans prepared for the design and for the development of product or service? (ISO 9001 7.3.1)

2. Are plans also prepared for the design of workplaces, work process, materials, plant and equipment? (AS/NZS 4801 4.4.6.2)

3. Do these design plans include the stages of the design and / or development, the review, verification and validation stages and the people who are responsible and have authority for design and development? (ISO 9001 7.3.1)

4. Are the design and development inputs recorded and do they include,

a)      The functional and performance requirements (ISO 9001 Clause 7.3.2)

b)      Applicable, legal , statutory and regulatory requirements (ISO 9001 Clause 7.3.2)(ISO 14001 Clause 4.3.2)(AS/NZS 4801 Clause 4.3.2)

c)       Information from similar designs whether by your organisation or other organisations (ISO 9001 Clause 7.3.2)

d)      The actual or potential environmental aspects and impacts (ISO 14001 Clause 4.3.1)

e)      The actual or potential hazards of the design or development. (AS/NZS 4801 Clause 4.4.6.2)

5. Have the people who are required to review the design and/ or development been identified and do they include, as applicable

a)      Suitable qualified and competent persons with regard to the functionality of the design and or development (ISO 9001 clause 7.3.2 & 6.2.2)

b)      People or representatives from interested parties (ISO 14001 Clause 4.3.3)

c)       Employees or employee representatives (AS/NZS 4801 4.4.3.1)

6. Do these reviews resolve issues and propose necessary actions, and are records of these design and development reviews maintained? (ISO 9001 Clause 7.3.4)

7. Are these design and development reviews conducted at the stages identified in the design plan? (ISO 9001 Clause 7.3.4)

8. Are design and development outputs produced in a suitable format that allows for verification against the design and development inputs? (ISO 9001 Clause 7.3.3)

9. Are the design and development outputs verified against the design and development inputs to ensure the requirements have been met? (ISO 9001 Clause 7.3.5)

10. Is the result of this verification recorded along with any actions that may be required? (ISO 9001 clause 7.3.5)

11. Have any identified hazards been risk assessed and do the controls identified use the hierarchy of control (AS/NZS 4801 Clause 4.4.6.4)

12. Has the environmental impact of the design and development been determined? (ISO 14001 Clause 4.3.1)

13. If the environmental impact of the design and development is determined to be significant have documented procedures been developed to control the use of the product or development where their absence could lead to deviation from your environmental policy, objectives or targets? (ISO 14001 Clause 4.4.6)

14. Do these documented procedures include the operating criteria? (ISO 14001 Clause 4.4.6)

15. Have any training needs been identified as a result of this design and development? (ISO 9001 clause 6.2.2.) (ISO 14001 4.4.2)(AS/NZS 4801 4.4.2)

16. If training needs have been identified, have competencies been developed for the correct use of the design and development? (AS/NZS 4801 clause 4.4.2)

17. Have these training needs and competencies been communicated to appropriate people such as,

a)      Employees and visitors

b)      Customers and users

c)       Persons working on behalf of the organisation

d)      Suppliers

18. Have all the actions identified through either design and development reviews or design and development verifications been appropriately addressed and closed?

19. Are design and development validations conducted to ensure the product / service is capable of meeting the requirements for the specified application or intended use? (ISO 9001 Clause 7.3.6)

20. When practicable have these design and development validations been conducted prior to delivery or implementation? (ISO 9001 Clause 7.3.6)

21. If it is not practicable to conduct design and development validations prior to delivery or use, are validations conducted after delivery or use? (ISO 9001 Clause 7.3.6)

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