7. Product Creation

7.1 Planning of product creation

The organization shall [hidepost = 3] to plan and develop the processes needed for product creation.

Planning processes of creation must be consistent with the requirements of other processes of the QMS (sm.4.1).

Planning to create a product, the organization must determine whether, taking into account the following:

a) quality objectives and product requirements,

b) need in development processes and documents, to provide resources specific to the product

a) the required verification activities, approval, monitoring, measurement, inspection and test, which are characteristic of the product, and product acceptance criteria,

g) records confirming that the process of creating and finished product meet requirements (see 4.2.4).

Output of such planning should be in a form appropriate mode of functioning

the organization.

NOTE 1 Document describing the processes of the QMS (including the product creation process) and resources used for a specific product, project or contract can be presented as a quality plan.

NOTE 2 Organization can [/ hidepost] apply the requirements of § 7.3 to the development process of product creation.

7.2 The processes associated with the consumer

7.2.1 Definition requirements to Product

The organization shall determine:

a) The requirements specified customer, including the requirements of the delivery and aftercare,

b) requirements that are not specified by the customer but necessary for specified or intended use, if it is determined

c) set and legislative requirements relating to product, and

g) any [Hidepost = 3], additional requirements needed by the organization.

NOTE: After-sales service includes, for example, warranty service, contractual obligations to repair and ancillary services such as: re- use waste or destruction [/ hidepost] (burial)

7.2.2 Review of product requirements

The organization shall review the requirements related to the product.

Such an analysis should be conducted prior to the organization of obligations to deliver the product to the consumer (eg, prior to the filing of tenders, contracts or taking orders, making changes to contracts or orders) and shall ensure that:

a) product requirements are defined,

b) contract requirements or order different from those set forth above, settled, and

a) organization capable of fulfilling these requirements.

The results of the review and actions must be documented (see 4.2.4).

If the consumer did not provide documented requirements, customer requirements should be confirmed by the organization prior to their adoption.

If the product requirements are changed, the organization must ensure that appropriate documentation has been changed, and the staff was aware of the changed requirements.

NOTE In some cases, such as Internet sales, a formal review is impractical for each order. Then the analysis may include information such as catalogs, or advertising.

7.2.3 Relationship with customers

The organization shall determine and implement effective communication with consumers

about:

a) information about a product,

b) review inquiries, contracts or orders, including amendments thereto, and

c) customer feedback, including complaints of consumers.

7.3 Design and development

7.3.1 Design and Development

The organization shall [hidepost = 3] to plan and manage product design and development.

When planning the design and development of the organization shall determine:

a) stages of design and development

b) analysis, review and approval, which correspond to each stage of the design and development, and

a) responsibility and authority for the design and development.

The organization shall manage the interfaces between the various groups involved in the design and development to ensure effective communication and clear assignment of responsibilities.

Expected output should be updated on as execution work on the design and development.

NOTE: The analysis, verification and validation in the design and development have individual goals. They can be conducted and documented in separate or in any combination as suitable for production and organization

7.3.2 Design and development

The input data relating to product requirements shall be identified and documented (See 4.2.4). These should include:

a) functional and operational requirements

b) applicable statutory and regulatory requirements,

a) applicable information obtained during the implementation of similar previous projects, and

g) other requirements essential for design and development.

These inputs shall be reviewed, for adequacy. Requirements should be

complete, unambiguous and consistent.

7.3.3 The outputs of design and development

The outputs of design and development shall be provided in a form suitable for comparison with the input data and must be approved before release.

The outputs of design and development should be:

a) match the input data design and development

b) provide appropriate information for purchasing, production and service

a) contain or reference product acceptance criteria, and

d) determine the product characteristics that are essential for its safe and proper use.

NOTE Information for production and service provision may include instructions for the preservation of the product.

7.3.4 Project and development

At appropriate stages, systematic reviews should be carried out design and development, in accordance with planned arrangements (sm.7.3.1) to:

a) assess the ability of the results of the design and development conform to the requirements

b) to determine all problems and propose necessary actions.

This analysis should include representatives whose activities are relevant to the analyzed stages of design and development. The results of the review and actions must be documented (Sm.4.2.4).

7.3.5 Test Design and Development

The inspection must be performed in accordance with planned arrangements (see 7.3.1) to ensure that the output of design and development meet the input requirements. The results of inspections and subsequent actions should be documented (see 4.2.4).

7.3.6 Approval of Design and Development

Approval of the design and development must be carried out in accordance with planned activities (Sm.7.3.1), to assure compliance with the final product provided (prospective) application, if known. On opportunities approval must be completed prior to delivery or performance of the product. The results and subsequent approval of additional actions should be documented (see 4.2.4).

7.3.7 Management of changes in the design and development

Changes in the design and development should be identified and documented. Changes must be reviewed, verified and approved in accordance with established rules, and approved before implementation. Analysis of changes in the design and development should include an assessment of the impact of changes in the already delivered products and components.

Results of the analysis of changes and any necessary actions shall be documented (see 4.2.4).

7.4 Purchasing

7.4.1 The procurement process

The organization shall ensure that purchased product meets specified purchase requirements specified. The type and extent of control applicable to the supplier and the purchased products should depend on the impact of purchased product on subsequent product or create the final product.

The organization shall evaluate and select suppliers based on their ability to deliver product in accordance with the requirements of the organization. Should be set criteria for selection, evaluation and re-evaluation. The results of the assessment and any necessary actions arising from the evaluation should be documented (see 4.2.4).

7.4.2 Information on Procurement

Information on the purchase should describe the purchased product, including, if applicable:

a) requirements for approval product, procedures, processes and equipment,

b) requirements to qualifications personnel, and

a) quality management system requirements.

The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.

7.4.3 Testing of the product purchased

The organization shall establish and implement a monitoring or other actions necessary to ensure that purchased product meets specified purchase requirements specified.

If the organization or its customer intends to fulfill [/ hidepost] of verification within the provider organization must determine the appropriate measures to verify and release the product in the way of information on procurement.

7.5 Implementation of the manufacturing and services

7.5.1 Management processes production and delivery of services

The organization shall plan and carry out production and provide services under controlled conditions. Controlled conditions shall include, if applicable:

a) availability of information that describes the characteristics of the product

b) availability of work instructions, if necessary,

a) use of appropriate equipment

g) presence and use equipment for monitoring and measuring

e) introduction of monitoring and measurement, and

e) The introduction of the issue, delivery and maintenance after delivery.

7.5.2 Validation processes manufacturing and services

The organization must certify all of the processes of production and services, where the final result can not be verified by subsequent monitoring or measurement, and as a result, defects can be detected only after using the product, or service provision.

Certification must demonstrate the ability of these processes to achieve planned results.

The organization shall establish requirements for these processes, including, if applicable:

a) defined criteria for review and approval processes

b) certification equipment and staff

a) use of special techniques and procedures

g) requirements to management records (Sm.4.2.4), and

e) recertified.

7.5.3 Identification and traceability

If necessary, the organization must identify the product by suitable means throughout

its creation.

The organization shall identify the product status with respect to the monitoring requirements and measurements for its creation.

Where traceability is a requirement that the organization should monitor the individual identification of the product and support record (Sm.4.2.4).

NOTE In some industries, configuration management is a tool for identification and traceability.

7.5.4 Customer property

The organization shall preserve the property consumer while it is under the control of an organization or used by the organization. The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or rendered inoperable, the organization shall report to the customer and to document it (see 4.2.4).

NOTE Customer property can include intellectual property, or personal data.

7.5.5 Preservation of product

The organization should keep the product in the domestic service and delivery to the specified destination in order to ensure compliance. If applicable, preservation shall include identification, product handling, packaging, storage and protection. Preservation shall apply to the constituent parts of the product.

7.6 Control of monitoring equipment and measurements

The organization should determine what monitoring and measurement should be conducted, and what kind of equipment for monitoring and measuring devices needed to provide evidence of product conformity to specified requirements.

The organization shall establish processes to ensure that monitoring and measurement can be performed and executed in a manner that is consistent with the requirements for monitoring and measurement.

If you want to [hidepost = 3] to provide reliable results, measuring equipment shall:

a) be calibrated and / or believed at specified intervals or prior to use according to measurement standards that are traceable to international or national measurement standards, in the absence of such standards the basis used for calibration or verification shall be documented,

b) configured or reconfigured if necessary,

c) be marked for the determination of the calibration

g) be protected by regulation, which will lead to invalid results,

e) be protected from damage and breakage during handling, maintenance and storage.

In addition, the organization must evaluate and document the reliability of previous measurements, if found that the equipment does not meet the requirements. The organization shall take appropriate action with respect to this equipment and all products to which it affected.

Results of calibration (verification) and testing should be documented (see 4.2.4).

Should be confirmed by the ability of the software used to monitor and

measurements, perform identified the problem. It should be undertaken prior to use and re-confirmed, if necessary.

NOTE: Confirmation of the ability of software to perform its function usually includes an inspection and configuration management to maintain it [/ hidepost] fitness for use.