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Struggling with exemptions here are my initial thoughts; however, the more I review, the less I am convinced I am correct...looking for advice.
1.1 Clause 7.3.3 b and d: 3 Design and Development Outputs
PTI outputs of design and development cannot be provided in a form that enables verification against the design and development input and are not approved prior to release. Our design process is not appropriate for b and d of this clause. Specifically, Design and development outputs do not provide for:
b) appropriate information for purchasing, production and for service provision,
d) the characteristics the product that are essential for its safe and proper use.
1.2 Clause 7.3.5 Design and Development Verification
PTI does not perform verification in accordance with planned arrangements (see 7.3.1) to ensure the design and development outputs have met the design and development input requirements.
1.3 Clauses 7.5.1 and 7.5.2, Production and Service Provisions:
Each PTI product is developed specifically for the customer, and therefore these production and service provisions do not apply.
1.4 Clause 7.5.5, Preservation of Product:
Conformity of the PTI products cannot be impacted due to identification, handling, packaging, or storage.
1.5 Clause 7.6: Control of Monitoring and Measuring devices:
PTI does not manufacture or distribute any product therefore PTI does not utilize any measuring equipment for verification of conformity of product.
1.6 Applicability of all Other clauses of the ISO 9001:2000
All other standard apply to PTI operations, and have been addressed within the quality system.
1.1 Clause 7.3.3 b and d: 3 Design and Development Outputs
PTI outputs of design and development cannot be provided in a form that enables verification against the design and development input and are not approved prior to release. Our design process is not appropriate for b and d of this clause. Specifically, Design and development outputs do not provide for:
b) appropriate information for purchasing, production and for service provision,
d) the characteristics the product that are essential for its safe and proper use.
1.2 Clause 7.3.5 Design and Development Verification
PTI does not perform verification in accordance with planned arrangements (see 7.3.1) to ensure the design and development outputs have met the design and development input requirements.
1.3 Clauses 7.5.1 and 7.5.2, Production and Service Provisions:
Each PTI product is developed specifically for the customer, and therefore these production and service provisions do not apply.
1.4 Clause 7.5.5, Preservation of Product:
Conformity of the PTI products cannot be impacted due to identification, handling, packaging, or storage.
1.5 Clause 7.6: Control of Monitoring and Measuring devices:
PTI does not manufacture or distribute any product therefore PTI does not utilize any measuring equipment for verification of conformity of product.
1.6 Applicability of all Other clauses of the ISO 9001:2000
All other standard apply to PTI operations, and have been addressed within the quality system.