ISO 9001 Standards Requirements – Design and Development

ISO 9001 Standards Requirements – Design and Development

Design and Development Planning
Plan and control the product design and development. This planning must determine the:
Stages of design and development
Appropriate review, verification, and validation activities for each stage
Responsibility and authority for design and development
The interfaces between the different involved groups must be managed to ensure effective communication and the clear assignment of responsibility. Update, as appropriate, the planning output during design and development.
NOTE: Design and development review, verification, and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as deemed suitable for the product and the organization.

Design and Development Inputs
Determine product requirement inputs and maintain records. The inputs must include:
Functional and performance requirements
Applicable statutory and regulatory requirements
Applicable information derived from similar designs
Requirements essential for design and development
Review these inputs for adequacy. Resolve any incomplete, ambiguous, or conflicting requirements.

Design and Development Outputs
Document the outputs of the design and development process in a form suitable for verification against the inputs to the process. The outputs must:
Meet design and development input requirements
Provide information for purchasing, production, and service
Contain or reference product acceptance criteria
Define essential characteristics for safe and proper use
Be approved before their release

Design and Development Review
Perform systematic reviews of design and development at suitable stages in accordance with planned arrangements to:
Evaluate the ability of the results to meet requirements
Identify problems and propose any necessary actions
The reviews must include representatives of the functions concerned with the stage being reviewed. Maintain the results of reviews and subsequent follow-up actions.

Design and Development Verification
Perform design and development verification in accordance with planned arrangements to ensure the output meets the design and development input requirements. Maintain the results of the verification and subsequent follow-up actions.

Design and Development Validation
Perform validation in accordance with planned arrangements to confirm the resulting product is capable of meeting the requirements for its specified application or intended use, where known. When practical, complete the validation before delivery or implementation of the product. Maintain the results of the validation and subsequent follow-up actions.

Control of Design and Development Changes
Identify design and development changes and maintain records. Review, verify, and validate (as appropriate) the changes and approve them before implementation. Evaluate the changes in terms of their effect on constituent parts and products already delivered. Maintain the results of the change review and subsequent follow-up actions.

ISO 9000 Standards – Design and development

ISO 9000 Standards – Design and development

Planning the design and development of a product means determining the design objectives and the design strategy, the design stages, timescales, costs, resources and responsibilities needed to accomplish
them. Sometimes the activity of design itself is considered to be a planning activity but what is being planned is not the design but the product.

The purpose of planning is to determine the provisions needed to achieve an objective. In most cases, these objectives include not only a requirement for a new or modified product but also requirements governing the costs and product introduction timescales (Quality, Cost and Delivery or QCD). Remove these constraints and planning becomes less important but there are few situations when cost and time is not a constraint. It is therefore necessary to work out in advance whether the objective can be achieved within the budget and timescale. One problem with design is that it is often a journey into the unknown and the cost and time it will take cannot always be predicted. It may
in fact result in disaster and either a complete reassessment of the design objective or the technology of the design solution. This has been proven time and again with major international projects such as Concorde, the Channel Tunnel and the International Space Station. Without a best guess these projects would not get off (or under!) the ground and so planning is vital firstly to get the funding and secondly to define the known and unknown so that risks can be assessed and quantified.

Design and development plans need to identify the activities to be performed, by whom they will be perform and when they should commence and be complete. One good technique is to use a network chart (often called a PERT chart), which links all the activities together. Alternatively a bar chart may be adequate. There does need to be some narrative in addition as charts in isolation rarely conveys everything required.

Design and development is not complete until the design has been proven as meeting the design requirements, so in drawing up a design and development plan you will need to cover the planning of design verification and validation activities. The plans should identify as a minimum:
- The design requirements
- The design and development programme showing activities against time
- The work packages and names of those who will execute them (Work
packages are the parcels of work that are to be handed out either internally or to suppliers)
- The work breakdown structure showing the relationship between all the parcels of work
- The reviews to be held for authorizing work to proceed from stage to
stage
- The resources in terms of finance, manpower and facilities
- The risks to success and the plans to minimize them
- The controls that will be exercised to keep the design on course
Planning for all phases at once can be difficult as information for subsequent phases will not be available until earlier phases have been completed. So, your design and development plans may consist of separate documents, one for each phase and each containing some detail of the plans you have made for subsequent phases.
Your design and development plans may also need to be subdivided into
plans for special aspects of the design such as reliability plans, safety plans, electromagnetic compatibility plans, configuration management plans. With simple designs there may be only one person carrying out the design activities. As the design and development plan needs to identify all design and development activities, even in this situation you will need to identify who carries out the design, who will review the design and who will verify the design. The same person may perform both the design and the design verification activities, however, it is good practice to allocate design verification to another person or organization because it will reveal problems overlooked by the designer. On larger design projects you may need to employ staff of various disciplines such as mechanical engineers, electronic engineers, reliability engineers etc. The responsibilities of all these people or groups need to be identified and a useful way of parcelling up the work is to use work packages that list all the activities to be performed by a particular group. If you subcontract any of the design activities, the supplier’s plans need to be integrated with your plans and your plan should identify which activities are the supplier’s responsibility. While purchasing is dealt with in clause 7.4 of the standard, the requirements also apply to design activities.

ISO 9000 Standards – Design and development

Planning the design and development of a product means determining the design objectives and the design strategy, the design stages, timescales, costs, resources and responsibilities needed to accomplish
them. Sometimes the activity of design itself is considered to be a planning activity but what is being planned is not the design but the product.

The purpose of planning is to determine the provisions needed to achieve an objective. In most cases, these objectives include not only a requirement for a new or modified product but also requirements governing the costs and product introduction timescales (Quality, Cost and Delivery or QCD). Remove these constraints and planning becomes less important but there are few situations when cost and time is not a constraint. It is therefore necessary to work out in advance whether the objective can be achieved within the budget and timescale. One problem with design is that it is often a journey into the unknown and the cost and time it will take cannot always be predicted. It may
in fact result in disaster and either a complete reassessment of the design objective or the technology of the design solution. This has been proven time and again with major international projects such as Concorde, the Channel Tunnel and the International Space Station. Without a best guess these projects would not get off (or under!) the ground and so planning is vital firstly to get the funding and secondly to define the known and unknown so that risks can be assessed and quantified.

Design and development plans need to identify the activities to be performed, by whom they will be perform and when they should commence and be complete. One good technique is to use a network chart (often called a PERT chart), which links all the activities together. Alternatively a bar chart may be adequate. There does need to be some narrative in addition as charts in isolation rarely conveys everything required.

Design and development is not complete until the design has been proven as meeting the design requirements, so in drawing up a design and development plan you will need to cover the planning of design verification and validation activities. The plans should identify as a minimum:
- The design requirements
- The design and development programme showing activities against time
- The work packages and names of those who will execute them (Work
packages are the parcels of work that are to be handed out either internally or to suppliers)
- The work breakdown structure showing the relationship between all the parcels of work
- The reviews to be held for authorizing work to proceed from stage to
stage
- The resources in terms of finance, manpower and facilities
- The risks to success and the plans to minimize them
- The controls that will be exercised to keep the design on course
Planning for all phases at once can be difficult as information for subsequent phases will not be available until earlier phases have been completed. So, your design and development plans may consist of separate documents, one for each phase and each containing some detail of the plans you have made for subsequent phases.
Your design and development plans may also need to be subdivided into
plans for special aspects of the design such as reliability plans, safety plans, electromagnetic compatibility plans, configuration management plans. With simple designs there may be only one person carrying out the design activities. As the design and development plan needs to identify all design and development activities, even in this situation you will need to identify who carries out the design, who will review the design and who will verify the design. The same person may perform both the design and the design verification activities, however, it is good practice to allocate design verification to another person or organization because it will reveal problems overlooked by the designer. On larger design projects you may need to employ staff of various disciplines such as mechanical engineers, electronic engineers, reliability engineers etc. The responsibilities of all these people or groups need to be identified and a useful way of parcelling up the work is to use work packages that list all the activities to be performed by a particular group. If you subcontract any of the design activities, the supplier’s plans need to be integrated with your plans and your plan should identify which activities are the supplier’s responsibility. While purchasing is dealt with in clause 7.4 of the standard, the requirements also apply to design activities.

ISO 9000 Standards – Design and development

Planning the design and development of a product means determining the design objectives and the design strategy, the design stages, timescales, costs, resources and responsibilities needed to accomplish
them. Sometimes the activity of design itself is considered to be a planning activity but what is being planned is not the design but the product.

The purpose of planning is to determine the provisions needed to achieve an objective. In most cases, these objectives include not only a requirement for a new or modified product but also requirements governing the costs and product introduction timescales (Quality, Cost and Delivery or QCD). Remove these constraints and planning becomes less important but there are few situations when cost and time is not a constraint. It is therefore necessary to work out in advance whether the objective can be achieved within the budget and timescale. One problem with design is that it is often a journey into the unknown and the cost and time it will take cannot always be predicted. It may
in fact result in disaster and either a complete reassessment of the design objective or the technology of the design solution. This has been proven time and again with major international projects such as Concorde, the Channel Tunnel and the International Space Station. Without a best guess these projects would not get off (or under!) the ground and so planning is vital firstly to get the funding and secondly to define the known and unknown so that risks can be assessed and quantified.

Design and development plans need to identify the activities to be performed, by whom they will be perform and when they should commence and be complete. One good technique is to use a network chart (often called a PERT chart), which links all the activities together. Alternatively a bar chart may be adequate. There does need to be some narrative in addition as charts in isolation rarely conveys everything required.

Design and development is not complete until the design has been proven as meeting the design requirements, so in drawing up a design and development plan you will need to cover the planning of design verification and validation activities. The plans should identify as a minimum:
- The design requirements
- The design and development programme showing activities against time
- The work packages and names of those who will execute them (Work
packages are the parcels of work that are to be handed out either internally or to suppliers)
- The work breakdown structure showing the relationship between all the parcels of work
- The reviews to be held for authorizing work to proceed from stage to
stage
- The resources in terms of finance, manpower and facilities
- The risks to success and the plans to minimize them
- The controls that will be exercised to keep the design on course
Planning for all phases at once can be difficult as information for subsequent phases will not be available until earlier phases have been completed. So, your design and development plans may consist of separate documents, one for each phase and each containing some detail of the plans you have made for subsequent phases.
Your design and development plans may also need to be subdivided into
plans for special aspects of the design such as reliability plans, safety plans, electromagnetic compatibility plans, configuration management plans. With simple designs there may be only one person carrying out the design activities. As the design and development plan needs to identify all design and development activities, even in this situation you will need to identify who carries out the design, who will review the design and who will verify the design. The same person may perform both the design and the design verification activities, however, it is good practice to allocate design verification to another person or organization because it will reveal problems overlooked by the designer. On larger design projects you may need to employ staff of various disciplines such as mechanical engineers, electronic engineers, reliability engineers etc. The responsibilities of all these people or groups need to be identified and a useful way of parcelling up the work is to use work packages that list all the activities to be performed by a particular group. If you subcontract any of the design activities, the supplier’s plans need to be integrated with your plans and your plan should identify which activities are the supplier’s responsibility. While purchasing is dealt with in clause 7.4 of the standard, the requirements also apply to design activities.

ISO 9000 Standards – Design and development

Planning the design and development of a product means determining the design objectives and the design strategy, the design stages, timescales, costs, resources and responsibilities needed to accomplish
them. Sometimes the activity of design itself is considered to be a planning activity but what is being planned is not the design but the product.

The purpose of planning is to determine the provisions needed to achieve an objective. In most cases, these objectives include not only a requirement for a new or modified product but also requirements governing the costs and product introduction timescales (Quality, Cost and Delivery or QCD). Remove these constraints and planning becomes less important but there are few situations when cost and time is not a constraint. It is therefore necessary to work out in advance whether the objective can be achieved within the budget and timescale. One problem with design is that it is often a journey into the unknown and the cost and time it will take cannot always be predicted. It may
in fact result in disaster and either a complete reassessment of the design objective or the technology of the design solution. This has been proven time and again with major international projects such as Concorde, the Channel Tunnel and the International Space Station. Without a best guess these projects would not get off (or under!) the ground and so planning is vital firstly to get the funding and secondly to define the known and unknown so that risks can be assessed and quantified.

Design and development plans need to identify the activities to be performed, by whom they will be perform and when they should commence and be complete. One good technique is to use a network chart (often called a PERT chart), which links all the activities together. Alternatively a bar chart may be adequate. There does need to be some narrative in addition as charts in isolation rarely conveys everything required.

Design and development is not complete until the design has been proven as meeting the design requirements, so in drawing up a design and development plan you will need to cover the planning of design verification and validation activities. The plans should identify as a minimum:
- The design requirements
- The design and development programme showing activities against time
- The work packages and names of those who will execute them (Work
packages are the parcels of work that are to be handed out either internally or to suppliers)
- The work breakdown structure showing the relationship between all the parcels of work
- The reviews to be held for authorizing work to proceed from stage to
stage
- The resources in terms of finance, manpower and facilities
- The risks to success and the plans to minimize them
- The controls that will be exercised to keep the design on course
Planning for all phases at once can be difficult as information for subsequent phases will not be available until earlier phases have been completed. So, your design and development plans may consist of separate documents, one for each phase and each containing some detail of the plans you have made for subsequent phases.
Your design and development plans may also need to be subdivided into
plans for special aspects of the design such as reliability plans, safety plans, electromagnetic compatibility plans, configuration management plans. With simple designs there may be only one person carrying out the design activities. As the design and development plan needs to identify all design and development activities, even in this situation you will need to identify who carries out the design, who will review the design and who will verify the design. The same person may perform both the design and the design verification activities, however, it is good practice to allocate design verification to another person or organization because it will reveal problems overlooked by the designer. On larger design projects you may need to employ staff of various disciplines such as mechanical engineers, electronic engineers, reliability engineers etc. The responsibilities of all these people or groups need to be identified and a useful way of parcelling up the work is to use work packages that list all the activities to be performed by a particular group. If you subcontract any of the design activities, the supplier’s plans need to be integrated with your plans and your plan should identify which activities are the supplier’s responsibility. While purchasing is dealt with in clause 7.4 of the standard, the requirements also apply to design activities.

ISO 9000 Standards – Design and development

Planning the design and development of a product means determining the design objectives and the design strategy, the design stages, timescales, costs, resources and responsibilities needed to accomplish
them. Sometimes the activity of design itself is considered to be a planning activity but what is being planned is not the design but the product.

The purpose of planning is to determine the provisions needed to achieve an objective. In most cases, these objectives include not only a requirement for a new or modified product but also requirements governing the costs and product introduction timescales (Quality, Cost and Delivery or QCD). Remove these constraints and planning becomes less important but there are few situations when cost and time is not a constraint. It is therefore necessary to work out in advance whether the objective can be achieved within the budget and timescale. One problem with design is that it is often a journey into the unknown and the cost and time it will take cannot always be predicted. It may
in fact result in disaster and either a complete reassessment of the design objective or the technology of the design solution. This has been proven time and again with major international projects such as Concorde, the Channel Tunnel and the International Space Station. Without a best guess these projects would not get off (or under!) the ground and so planning is vital firstly to get the funding and secondly to define the known and unknown so that risks can be assessed and quantified.

Design and development plans need to identify the activities to be performed, by whom they will be perform and when they should commence and be complete. One good technique is to use a network chart (often called a PERT chart), which links all the activities together. Alternatively a bar chart may be adequate. There does need to be some narrative in addition as charts in isolation rarely conveys everything required.

Design and development is not complete until the design has been proven as meeting the design requirements, so in drawing up a design and development plan you will need to cover the planning of design verification and validation activities. The plans should identify as a minimum:
- The design requirements
- The design and development programme showing activities against time
- The work packages and names of those who will execute them (Work
packages are the parcels of work that are to be handed out either internally or to suppliers)
- The work breakdown structure showing the relationship between all the parcels of work
- The reviews to be held for authorizing work to proceed from stage to
stage
- The resources in terms of finance, manpower and facilities
- The risks to success and the plans to minimize them
- The controls that will be exercised to keep the design on course
Planning for all phases at once can be difficult as information for subsequent phases will not be available until earlier phases have been completed. So, your design and development plans may consist of separate documents, one for each phase and each containing some detail of the plans you have made for subsequent phases.
Your design and development plans may also need to be subdivided into
plans for special aspects of the design such as reliability plans, safety plans, electromagnetic compatibility plans, configuration management plans. With simple designs there may be only one person carrying out the design activities. As the design and development plan needs to identify all design and development activities, even in this situation you will need to identify who carries out the design, who will review the design and who will verify the design. The same person may perform both the design and the design verification activities, however, it is good practice to allocate design verification to another person or organization because it will reveal problems overlooked by the designer. On larger design projects you may need to employ staff of various disciplines such as mechanical engineers, electronic engineers, reliability engineers etc. The responsibilities of all these people or groups need to be identified and a useful way of parcelling up the work is to use work packages that list all the activities to be performed by a particular group. If you subcontract any of the design activities, the supplier’s plans need to be integrated with your plans and your plan should identify which activities are the supplier’s responsibility. While purchasing is dealt with in clause 7.4 of the standard, the requirements also apply to design activities.

ISO 9000 Standards – Design and development

Planning the design and development of a product means determining the design objectives and the design strategy, the design stages, timescales, costs, resources and responsibilities needed to accomplish
them. Sometimes the activity of design itself is considered to be a planning activity but what is being planned is not the design but the product.

The purpose of planning is to determine the provisions needed to achieve an objective. In most cases, these objectives include not only a requirement for a new or modified product but also requirements governing the costs and product introduction timescales (Quality, Cost and Delivery or QCD). Remove these constraints and planning becomes less important but there are few situations when cost and time is not a constraint. It is therefore necessary to work out in advance whether the objective can be achieved within the budget and timescale. One problem with design is that it is often a journey into the unknown and the cost and time it will take cannot always be predicted. It may
in fact result in disaster and either a complete reassessment of the design objective or the technology of the design solution. This has been proven time and again with major international projects such as Concorde, the Channel Tunnel and the International Space Station. Without a best guess these projects would not get off (or under!) the ground and so planning is vital firstly to get the funding and secondly to define the known and unknown so that risks can be assessed and quantified.

Design and development plans need to identify the activities to be performed, by whom they will be perform and when they should commence and be complete. One good technique is to use a network chart (often called a PERT chart), which links all the activities together. Alternatively a bar chart may be adequate. There does need to be some narrative in addition as charts in isolation rarely conveys everything required.

Design and development is not complete until the design has been proven as meeting the design requirements, so in drawing up a design and development plan you will need to cover the planning of design verification and validation activities. The plans should identify as a minimum:
- The design requirements
- The design and development programme showing activities against time
- The work packages and names of those who will execute them (Work
packages are the parcels of work that are to be handed out either internally or to suppliers)
- The work breakdown structure showing the relationship between all the parcels of work
- The reviews to be held for authorizing work to proceed from stage to
stage
- The resources in terms of finance, manpower and facilities
- The risks to success and the plans to minimize them
- The controls that will be exercised to keep the design on course
Planning for all phases at once can be difficult as information for subsequent phases will not be available until earlier phases have been completed. So, your design and development plans may consist of separate documents, one for each phase and each containing some detail of the plans you have made for subsequent phases.
Your design and development plans may also need to be subdivided into
plans for special aspects of the design such as reliability plans, safety plans, electromagnetic compatibility plans, configuration management plans. With simple designs there may be only one person carrying out the design activities. As the design and development plan needs to identify all design and development activities, even in this situation you will need to identify who carries out the design, who will review the design and who will verify the design. The same person may perform both the design and the design verification activities, however, it is good practice to allocate design verification to another person or organization because it will reveal problems overlooked by the designer. On larger design projects you may need to employ staff of various disciplines such as mechanical engineers, electronic engineers, reliability engineers etc. The responsibilities of all these people or groups need to be identified and a useful way of parcelling up the work is to use work packages that list all the activities to be performed by a particular group. If you subcontract any of the design activities, the supplier’s plans need to be integrated with your plans and your plan should identify which activities are the supplier’s responsibility. While purchasing is dealt with in clause 7.4 of the standard, the requirements also apply to design activities.

ISO 9000 Standards – Design and development

Planning the design and development of a product means determining the design objectives and the design strategy, the design stages, timescales, costs, resources and responsibilities needed to accomplish
them. Sometimes the activity of design itself is considered to be a planning activity but what is being planned is not the design but the product.

The purpose of planning is to determine the provisions needed to achieve an objective. In most cases, these objectives include not only a requirement for a new or modified product but also requirements governing the costs and product introduction timescales (Quality, Cost and Delivery or QCD). Remove these constraints and planning becomes less important but there are few situations when cost and time is not a constraint. It is therefore necessary to work out in advance whether the objective can be achieved within the budget and timescale. One problem with design is that it is often a journey into the unknown and the cost and time it will take cannot always be predicted. It may
in fact result in disaster and either a complete reassessment of the design objective or the technology of the design solution. This has been proven time and again with major international projects such as Concorde, the Channel Tunnel and the International Space Station. Without a best guess these projects would not get off (or under!) the ground and so planning is vital firstly to get the funding and secondly to define the known and unknown so that risks can be assessed and quantified.

Design and development plans need to identify the activities to be performed, by whom they will be perform and when they should commence and be complete. One good technique is to use a network chart (often called a PERT chart), which links all the activities together. Alternatively a bar chart may be adequate. There does need to be some narrative in addition as charts in isolation rarely conveys everything required.

Design and development is not complete until the design has been proven as meeting the design requirements, so in drawing up a design and development plan you will need to cover the planning of design verification and validation activities. The plans should identify as a minimum:
- The design requirements
- The design and development programme showing activities against time
- The work packages and names of those who will execute them (Work
packages are the parcels of work that are to be handed out either internally or to suppliers)
- The work breakdown structure showing the relationship between all the parcels of work
- The reviews to be held for authorizing work to proceed from stage to
stage
- The resources in terms of finance, manpower and facilities
- The risks to success and the plans to minimize them
- The controls that will be exercised to keep the design on course
Planning for all phases at once can be difficult as information for subsequent phases will not be available until earlier phases have been completed. So, your design and development plans may consist of separate documents, one for each phase and each containing some detail of the plans you have made for subsequent phases.
Your design and development plans may also need to be subdivided into
plans for special aspects of the design such as reliability plans, safety plans, electromagnetic compatibility plans, configuration management plans. With simple designs there may be only one person carrying out the design activities. As the design and development plan needs to identify all design and development activities, even in this situation you will need to identify who carries out the design, who will review the design and who will verify the design. The same person may perform both the design and the design verification activities, however, it is good practice to allocate design verification to another person or organization because it will reveal problems overlooked by the designer. On larger design projects you may need to employ staff of various disciplines such as mechanical engineers, electronic engineers, reliability engineers etc. The responsibilities of all these people or groups need to be identified and a useful way of parcelling up the work is to use work packages that list all the activities to be performed by a particular group. If you subcontract any of the design activities, the supplier’s plans need to be integrated with your plans and your plan should identify which activities are the supplier’s responsibility. While purchasing is dealt with in clause 7.4 of the standard, the requirements also apply to design activities.

ISO 9000 Standards – Design and development

Planning the design and development of a product means determining the design objectives and the design strategy, the design stages, timescales, costs, resources and responsibilities needed to accomplish
them. Sometimes the activity of design itself is considered to be a planning activity but what is being planned is not the design but the product.

The purpose of planning is to determine the provisions needed to achieve an objective. In most cases, these objectives include not only a requirement for a new or modified product but also requirements governing the costs and product introduction timescales (Quality, Cost and Delivery or QCD). Remove these constraints and planning becomes less important but there are few situations when cost and time is not a constraint. It is therefore necessary to work out in advance whether the objective can be achieved within the budget and timescale. One problem with design is that it is often a journey into the unknown and the cost and time it will take cannot always be predicted. It may
in fact result in disaster and either a complete reassessment of the design objective or the technology of the design solution. This has been proven time and again with major international projects such as Concorde, the Channel Tunnel and the International Space Station. Without a best guess these projects would not get off (or under!) the ground and so planning is vital firstly to get the funding and secondly to define the known and unknown so that risks can be assessed and quantified.

Design and development plans need to identify the activities to be performed, by whom they will be perform and when they should commence and be complete. One good technique is to use a network chart (often called a PERT chart), which links all the activities together. Alternatively a bar chart may be adequate. There does need to be some narrative in addition as charts in isolation rarely conveys everything required.

Design and development is not complete until the design has been proven as meeting the design requirements, so in drawing up a design and development plan you will need to cover the planning of design verification and validation activities. The plans should identify as a minimum:
- The design requirements
- The design and development programme showing activities against time
- The work packages and names of those who will execute them (Work
packages are the parcels of work that are to be handed out either internally or to suppliers)
- The work breakdown structure showing the relationship between all the parcels of work
- The reviews to be held for authorizing work to proceed from stage to
stage
- The resources in terms of finance, manpower and facilities
- The risks to success and the plans to minimize them
- The controls that will be exercised to keep the design on course
Planning for all phases at once can be difficult as information for subsequent phases will not be available until earlier phases have been completed. So, your design and development plans may consist of separate documents, one for each phase and each containing some detail of the plans you have made for subsequent phases.
Your design and development plans may also need to be subdivided into
plans for special aspects of the design such as reliability plans, safety plans, electromagnetic compatibility plans, configuration management plans. With simple designs there may be only one person carrying out the design activities. As the design and development plan needs to identify all design and development activities, even in this situation you will need to identify who carries out the design, who will review the design and who will verify the design. The same person may perform both the design and the design verification activities, however, it is good practice to allocate design verification to another person or organization because it will reveal problems overlooked by the designer. On larger design projects you may need to employ staff of various disciplines such as mechanical engineers, electronic engineers, reliability engineers etc. The responsibilities of all these people or groups need to be identified and a useful way of parcelling up the work is to use work packages that list all the activities to be performed by a particular group. If you subcontract any of the design activities, the supplier’s plans need to be integrated with your plans and your plan should identify which activities are the supplier’s responsibility. While purchasing is dealt with in clause 7.4 of the standard, the requirements also apply to design activities.

ISO 9000 Standards – Design and development

Planning the design and development of a product means determining the design objectives and the design strategy, the design stages, timescales, costs, resources and responsibilities needed to accomplish
them. Sometimes the activity of design itself is considered to be a planning activity but what is being planned is not the design but the product.

The purpose of planning is to determine the provisions needed to achieve an objective. In most cases, these objectives include not only a requirement for a new or modified product but also requirements governing the costs and product introduction timescales (Quality, Cost and Delivery or QCD). Remove these constraints and planning becomes less important but there are few situations when cost and time is not a constraint. It is therefore necessary to work out in advance whether the objective can be achieved within the budget and timescale. One problem with design is that it is often a journey into the unknown and the cost and time it will take cannot always be predicted. It may
in fact result in disaster and either a complete reassessment of the design objective or the technology of the design solution. This has been proven time and again with major international projects such as Concorde, the Channel Tunnel and the International Space Station. Without a best guess these projects would not get off (or under!) the ground and so planning is vital firstly to get the funding and secondly to define the known and unknown so that risks can be assessed and quantified.

Design and development plans need to identify the activities to be performed, by whom they will be perform and when they should commence and be complete. One good technique is to use a network chart (often called a PERT chart), which links all the activities together. Alternatively a bar chart may be adequate. There does need to be some narrative in addition as charts in isolation rarely conveys everything required.

Design and development is not complete until the design has been proven as meeting the design requirements, so in drawing up a design and development plan you will need to cover the planning of design verification and validation activities. The plans should identify as a minimum:
- The design requirements
- The design and development programme showing activities against time
- The work packages and names of those who will execute them (Work
packages are the parcels of work that are to be handed out either internally or to suppliers)
- The work breakdown structure showing the relationship between all the parcels of work
- The reviews to be held for authorizing work to proceed from stage to
stage
- The resources in terms of finance, manpower and facilities
- The risks to success and the plans to minimize them
- The controls that will be exercised to keep the design on course
Planning for all phases at once can be difficult as information for subsequent phases will not be available until earlier phases have been completed. So, your design and development plans may consist of separate documents, one for each phase and each containing some detail of the plans you have made for subsequent phases.
Your design and development plans may also need to be subdivided into
plans for special aspects of the design such as reliability plans, safety plans, electromagnetic compatibility plans, configuration management plans. With simple designs there may be only one person carrying out the design activities. As the design and development plan needs to identify all design and development activities, even in this situation you will need to identify who carries out the design, who will review the design and who will verify the design. The same person may perform both the design and the design verification activities, however, it is good practice to allocate design verification to another person or organization because it will reveal problems overlooked by the designer. On larger design projects you may need to employ staff of various disciplines such as mechanical engineers, electronic engineers, reliability engineers etc. The responsibilities of all these people or groups need to be identified and a useful way of parcelling up the work is to use work packages that list all the activities to be performed by a particular group. If you subcontract any of the design activities, the supplier’s plans need to be integrated with your plans and your plan should identify which activities are the supplier’s responsibility. While purchasing is dealt with in clause 7.4 of the standard, the requirements also apply to design activities.

ISO 9000 Standards – Design and development

Planning the design and development of a product means determining the design objectives and the design strategy, the design stages, timescales, costs, resources and responsibilities needed to accomplish
them. Sometimes the activity of design itself is considered to be a planning activity but what is being planned is not the design but the product.

The purpose of planning is to determine the provisions needed to achieve an objective. In most cases, these objectives include not only a requirement for a new or modified product but also requirements governing the costs and product introduction timescales (Quality, Cost and Delivery or QCD). Remove these constraints and planning becomes less important but there are few situations when cost and time is not a constraint. It is therefore necessary to work out in advance whether the objective can be achieved within the budget and timescale. One problem with design is that it is often a journey into the unknown and the cost and time it will take cannot always be predicted. It may
in fact result in disaster and either a complete reassessment of the design objective or the technology of the design solution. This has been proven time and again with major international projects such as Concorde, the Channel Tunnel and the International Space Station. Without a best guess these projects would not get off (or under!) the ground and so planning is vital firstly to get the funding and secondly to define the known and unknown so that risks can be assessed and quantified.

Design and development plans need to identify the activities to be performed, by whom they will be perform and when they should commence and be complete. One good technique is to use a network chart (often called a PERT chart), which links all the activities together. Alternatively a bar chart may be adequate. There does need to be some narrative in addition as charts in isolation rarely conveys everything required.

Design and development is not complete until the design has been proven as meeting the design requirements, so in drawing up a design and development plan you will need to cover the planning of design verification and validation activities. The plans should identify as a minimum:
- The design requirements
- The design and development programme showing activities against time
- The work packages and names of those who will execute them (Work
packages are the parcels of work that are to be handed out either internally or to suppliers)
- The work breakdown structure showing the relationship between all the parcels of work
- The reviews to be held for authorizing work to proceed from stage to
stage
- The resources in terms of finance, manpower and facilities
- The risks to success and the plans to minimize them
- The controls that will be exercised to keep the design on course
Planning for all phases at once can be difficult as information for subsequent phases will not be available until earlier phases have been completed. So, your design and development plans may consist of separate documents, one for each phase and each containing some detail of the plans you have made for subsequent phases.
Your design and development plans may also need to be subdivided into
plans for special aspects of the design such as reliability plans, safety plans, electromagnetic compatibility plans, configuration management plans. With simple designs there may be only one person carrying out the design activities. As the design and development plan needs to identify all design and development activities, even in this situation you will need to identify who carries out the design, who will review the design and who will verify the design. The same person may perform both the design and the design verification activities, however, it is good practice to allocate design verification to another person or organization because it will reveal problems overlooked by the designer. On larger design projects you may need to employ staff of various disciplines such as mechanical engineers, electronic engineers, reliability engineers etc. The responsibilities of all these people or groups need to be identified and a useful way of parcelling up the work is to use work packages that list all the activities to be performed by a particular group. If you subcontract any of the design activities, the supplier’s plans need to be integrated with your plans and your plan should identify which activities are the supplier’s responsibility. While purchasing is dealt with in clause 7.4 of the standard, the requirements also apply to design activities.