7. Creating a product

7.1 Planning of product realization

The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of other processes, quality management system (see 4.1).

When planning a production organization should, as appropriate (as applicable), set the following:

a) quality objectives and product requirements;

b) the need to establish processes, documents and provide resources for specific products;

c) required for specific products work on verification, validation, monitoring, inspection and testing, and product acceptance criteria;

d) records needed to provide evidence that the processes of creating products and the resulting product meet requirements (see 4.2.4).

Output (results) of this planning should be presented in a form acceptable to the organization adopted the methods of work.

Note 1. The document describes the process for quality management system (including processes for product creation) and the resources to be applied to a specific product, project or contract, can be regarded as a quality plan.

Note 2. The organization can also apply the requirements contained in section 7.3, the development process of creating products.

7.2 The processes associated with the consumer

7.2.1 Determination of requirements related to the product

The organization shall determine:

a) requirements specified by the customer, including requirements for delivery and post-delivery activities

b) requirements not stated by the customer but necessary for specified or intended use of the product, if known;

c) statutory and regulatory requirements related to the product, as well as

g) Any additional requirements determined by the organization.

7.2.2 Review of requirements related to the product

The organization shall review the requirements related to the product. This analysis should be performed before the organization will be bound to supply products to the consumer (for example, to participate in tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders), and must provide assurance that:

a) product requirements are defined

b) the differences between the requirements of contracts or orders previously made ​​by the requirements are eliminated, and that

c) organization able to meet the requirements.

Shall be maintained recording the results of the analysis and actions arising from this analysis (see 4.2.4).

In cases where the customer provides no documented requirements, the organization must obtain confirmation of these claims by the consumer prior to their adoption.

When changing product requirements an organization must ensure that relevant documents are amended, and the staff is concerned, was aware of the changed requirements.

Note. In some situations, such as selling over the Internet, a formal review of each order is almost impossible. Instead, the analysis may relate to the relevant information on products, such as catalogs or promotional materials.

7.2.3 Communication with customers

The organization shall determine and implement effective arrangements for communicating with consumers about:

a) Product information

b) implementation of inquiries, contracts or order handling, including amendments, as well as

c) customer feedback, including customer complaints.

7.3 Design and development

7.3.1 Design and Development

The organization shall plan the design and development of products and manage them.

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

a) The design and development stage;

b) relevant to each stage of the design and development review, verification and validation, as well as

c) responsibilities and authorities for design and development.

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

Planning output shall, as appropriate, to update the course design and development.

7.3.2 Design and development

Inputs relating to product requirements shall be determined, and the recording of this be maintained (see 4.2.4).

These inputs shall include:

a) functional and operational requirements;

b) applicable statutory and regulatory requirements;

c) information obtained from previous similar projects (where applicable), and

g) other requirements essential for design and development.

These inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not contradictory.

7.3.3 The outputs of design and development

The outputs of design and development shall be provided in the form, making it possible to verify them with respect to input data for the design and development, and must be formalized prior to their release.

The outputs of design and development should be:

a) meet the input requirements for design and development;

b) provide appropriate information for purchasing, production and service;

c) contain criteria for product acceptance or links to them, as well as

g) establish the characteristics of products are essential for its safe and proper use.

7.3.4 Design and development

At appropriate stages in accordance with planned arrangements (see 7.3.1) should be the results of systematic reviews of design and development to:

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

b) identify any problems and propose necessary actions.

Participants in such reviews shall include representatives of functions (activities) as it relates to a test (s) of the stage (s) design and development. Shall be maintained recording the results of the analysis and any necessary actions (see 4.2.4).

7.3.5 Design and development verification

In accordance with planned arrangements (see 7.3.1) verification should be carried out to ensure that the output of the design and development consistent with the input requirements for design and development. Shall be maintained recording the results of the verification and any necessary actions (see 4.2.4).

7.3.6 Design and development validation

In accordance with planned arrangements (see 7.3.1) should be validated design and development to ensure that the resulting products were able to meet the requirements in respect of its application or intended use (if known).

In all cases where practicable (feasible), validation shall be completed prior to delivery or implementation of products.

Shall be maintained recording the results of validation and any necessary actions (see 4.2.4).

7.3.7 Control of design changes and development

Design and development changes shall be identified and records of this be maintained. Changes must be reviewed, verified and validated as appropriate and approved before they are made. Analysis of changes in design and development should include an assessment of the impact of changes on constituent parts and product already delivered.

Shall be maintained recording the results of analysis of changes and any necessary actions (see 4.2.4)

7.4 Purchasing

7.4.1 The procurement process

The organization shall ensure that purchased product meets specified purchase requirements. The type and amount of control applied to the supplier and the purchased product, must depend on its effect on the subsequent creation of products or finished products.

The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the requirements of the organization. Should be set criteria for selection, evaluation and reassessment of suppliers. Shall be maintained recording the assessment of any necessary actions arising from the evaluation (see 4.2.4).

7.4.2 Purchasing information

Purchasing information shall describe the products to be purchased, including where appropriate:

a) requirements applicable to the approval (approval) of product, procedures, processes and equipment supplier;

b) requirements for qualification of personnel provider, as well as

a) requirements for quality management system vendor.

The organization shall ensure the adequacy of its purchase requirements prior to their posts by the supplier.

7.4.3 Verification of purchased product

The organization shall establish and implement the inspection or other activities necessary to ensure that purchased product meets specified purchase requirements.

If the organization or its customer intend to perform verification at the supplier, the organization must state that the activities of verification and the method of production of information on procurement.

7.5 Production of products and services

7.5.1 Control of production of goods and provision of services

The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, where applicable:

a) availability of information describing the nature of the product;

b) the presence (if necessary) work instructions;

c) use appropriate (suitable) equipment;

g) the availability and use of devices for measuring and monitoring;

d) monitoring and measurement, as well as

e) the activity to produce a product, its delivery and post-delivery activities.

7.5.2 Validation of processes for production and delivery of services

The organization shall validate (confirm, approve) all production processes and services, the results of which can not be verified by subsequent monitoring or measurement. To include all the processes, deficiencies become apparent only after the products began to be used or service provided.

Validation shall demonstrate the ability of these processes to achieve planned results.

For these processes, the organization must develop measures including, where applicable:

a) defined criteria for review and approval (admissibility) processes;

b) approval (recognition of eligibility) equipment and staff;

c) use of specific (designed specifically for these processes) methods and procedures;

d) requirements for records (see 4.2.4)

e) perevalidatsiyu processes.

7.5.3 Identification and traceability

Organization, where appropriate, should be all over a product to identify its appropriate means.

The organization shall identify the product status with respect to requirements for monitoring and measuring devices.

In cases where traceability is a specified requirement, the organization must manage the unique (no entanglement) identification of the product and to maintain and keep records of this (see 4.2.4).

Note. In some industries, identification and traceability are maintained by configuration management.

7.5.4 Customer property

The organization shall exercise care with customer property in cases where it is managed by an organization or used by it. The organization shall identify, verify, protect from damage and protect customer property provided for use by the organization or for incorporation into the product. In case of loss of any customer property is damaged or finding that the property has become unfit for use, this should be communicated to the consumer, and must be maintained on this record (see 4.2.4).

Note. Customer property can include intellectual property.

7.5.5 Preservation of product

The organization shall preserve the conformity of product to determined requirements during internal processing and delivery of the required destination. This preservation shall include identification, proper handling of product, its packaging, storage and protection from damage.

Preservation shall also apply to the component parts of products.

7.6 Control of monitoring and measuring

The organization shall establish a monitoring and measurement of what should take place, and to identify a device for monitoring and measuring devices needed to provide evidence of conformity to product requirements (see 7.2.1).

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

Where necessary to ensure valid (with force) results, measuring equipment shall be:

a) calibrated or verified for a set period of time or before use by the standards of measurement, having a correlation with national or international standards of measurement, if such standards exist, should be fixed, the basis used for calibration or verification;

b) set (adjusted), or, if necessary, re-configured;

a) be identified in such a way that allows to determine calibration status (status of equipment in relation to the facts and calibration or verification);

d) safeguarded from adjustments that would make the results of measurements of void (unenforceable);

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

In addition, the organization shall assess and record the validity of (force) the results of measurements made ​​earlier, if it is found that the equipment for measuring and monitoring is inadequate. The organization shall take appropriate action in relation to equipment and all measured with the help of its products. Shall be maintained recording the results of calibration and verification (see 4.2.4).

If during the monitoring and measuring the degree of conformity to the requirements of use of computer software, and their ability to satisfy the intended application shall be confirmed. This should be done before the application software, and, if necessary, confirmation should be repeated.

Note. Guidance on this issue can be found in ISO 10012-1 and ISO 10012-2.

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