Adapt to the organization’s purpose and environment and support its strategic direction

Provide a framework for goals

Includes commitment to meet applicable requirements

Includes a commitment to continuous improvement

obtain and maintain documentation

internal communication

When appropriate, relevant parties can obtain

consistent with policy

measurable

Applicable requirements

Relevant to product and service qualifications and enhanced customer satisfaction

what to do

What resources are needed

Who is responsible

when to complete

How to evaluate

buildings and related facilities

Equipment, including hardware and software

transportation resources

information and communication technology

Social factors (non-discrimination, stability, non-confrontation)

Psychological factors (stress reduction, excessive fatigue

Physical factors (temperature, humidity, hygiene, noise)

7.1.5.1 Ensure that the resources provided are suitable for the specific type of monitoring and measurement activities carried out and are maintained

7.1.5.2 When measurement traceability is the basis for trusting the validity of measurement results, the equipment should

should be maintained and updated (information used and shared to achieve organizational goals)

create

renew

Documented information requirements

activities to control documented information

1) Process: eg: work instructions, process requirements

2) Receipt of products and services: eg: acceptance outline, inspection specifications

1) Make sure that the process has been carried out according to the plan

2) Confirm that products and services meet requirements

Provide information about products and services

Process inquiries, contracts or orders, including changes

Obtain customer feedback and complaints

Dispose of or take control of customer property

Specific requirements for developing emergency measures

a) Requirements of laws and regulations, and requirements considered necessary by the organization

b) The products and services provided meet the stated requirements

Customer-specified requirements, including requirements for delivery and post-delivery activities

The customer has a request that is necessary for the specified purpose or the intended use of the book, although it is not expressly stated.

Requirements specified by the organization

Legal and regulatory requirements applicable to products and services

Contract or order requirements that are inconsistent with previously stated requirements (the organization shall ensure that contract or order requirements that are inconsistent with previously stated requirements have been resolved)

Keep documented information: (1) review results; (2) new requirements for products and services

Ensure relevant documented information is revised

Ensure relevant personnel are aware of the changed master requirements

Consider: the nature, duration and complexity of design and development activities

Required process stages, including applicable design and development reviews

Required design and development review and validation activities 4

Responsibilities and authorities involved in the design and development process

Required internal and external resources

Control requirements for interfaces between process participants

The need for customers and users to participate in the design and development process

Requirements for subsequent product and service provision

The level of control over the design and development process expected by customers and interested parties

Documented information required to demonstrate that design and development requirements have been met

Functional and performance requirements

Information derived from previous similar design and development activities

Legal and regulatory requirements

A standard or industry standard that the organization is committed to implementing

Potential failure consequences due to the nature of products and services

Conflicts should be resolved

Keep written information: design brief

Ensure that the results to be obtained are specified

Implement review activities to evaluate the ability of design and development results to meet requirements

Implement verification activities to ensure that design and development outputs meet input requirements (validation)

Implement validation activities to ensure that released products and services meet specified use requirements or intended uses (validation)

Take necessary measures to address issues identified during the review, verification, and validation processes

Meet the input requirements

Meet the needs of subsequent product and service delivery processes

Include or reference monitoring and measurement requirements and, where appropriate, acceptance criteria

Specifies the characteristics of products and services that are necessary for their intended purpose, safety and proper provision

Retained cost information: drawings, plans

design development changes

Review results