ISO 9001 – Design and Development – Part 2

8.3.3 Design and Development Inputs

Design inputs serve as the basis for product development. The inputs for design and development processes and activities must be determined in order to ensure their availability to those processes and activities.

Determine the Essential Requirements for Design and Development

The inputs serve as essential requirements necessary for the progress of design and development. Those requirements must all be defined as corresponding to the purposeof the product or service. The inputs should be determined according to the planned activities of the design and development processes and the intended use of the product. The main concept of defining one’s design and development inputs is simple: the inputs must relate to the product’s intended use, functional performance, and quality and regulatory requirements. Within the design and development of inputs requirements, the organization must refer to the issues that will be discussed in this chapter. The inputs may be derived from

• Development of prototypes
• Need to modify earlier developments
• Request for changes
• Problems or failures with earlier versions
• Failure to comply with the acceptability criteria
• New customer requirements
• An iterative development

Inputs Relevant to the Intended Use and Performance

The organization shall determine product requirements for performance, functionality,and intended use in order to allow the identification of all necessary design and development inputs. The objective here is to ensure that the product will acquire all its expected features and functionalities. The intended use of the product or service refers to its purpose, operation, and utilization and relates to user expectations. Intended use refers to information and outputs derived from market surveys or research, risk-based thinking outputs, customer requirements, and a review of requirements related to the product. The definition shall refer to situations where it is inadvisable to use the product or provide the service. Let us review some aspects of the functional and performance requirements:

• Physical characteristics of the product such as plans, sizes, dimensions, diagrams, drawings, samples, and prototypes. The definition shall refer to tolerances and limits.
• Requirements for handling and behavior with the product and specifications of aspects such as packaging, storage, labeling, operation, handling, and maintenance requirements; anything that might affect the quality of the product or its intended use must be reviewed during the development stages.
• Definition regarding the operating environment of the product or the environment in which the service shall be provided. If the product is to operate under a controlled temperature, the design and development activities must take that into consideration. This requirement is also valid when a software must be installed and there are technical specifications for installation.
• Interface with other products where the product is to be combined or installed with other products or pieces of equipment and/or accessories; this shall be referred to as inputs to design and development.
• Service requirement shall be taken into account. When it is already known that the product will require service activities in the long run, it will be reviewed in the design and development activities so that certain characteristics of the product may be planned appropriately.
• Compatibility of the product’s components shall be considered when the product is constructed or assembled from various components and materials; it is necessary to examine the materials used in order to ensure that the different components compete or match one another and the risk of contamination, error, or failure is prevented.
• The organization will specify any safety requirements that are needed to serve as inputs for the development and which may affect the design of the product and its characteristics and intended use.
• Appropriate considerations to the integration of environmental protection aspects shall be delivered as inputs to design and development as and when they are applicable.

8.3.5 Design and Development Outputs

The outputs of design and development shall demonstrate that the activities were carried out in accordance with the plan through a traceability to the design and development inputs. In other words, the outputs will allow adequate evaluation of conformance to design input requirements. Design and development outputs shall be documented, reviewed, and approved before release.

Definition of Design and Development Outputs

Design and development outputs are the results of design and development activities, and they represent the specifications for the product or the service:

• Characteristics of the product or service
• Specifications for the realization (manufacturing of a product or provision of a service)
• Monitoring and measuring activities to ensure conformity to the product or service
• Acceptance criteria for expected outputs of the realization activities

It must be clear to the design and development team which outputs are required, in which form and format, and what are the expected details. This definition of the outputs  shall assist in controlling all the expected outputs that were accepted after each design and development activity and will allow traceability to the inputs. In the next paragraphs, I will go into details.

Acceptance Criteria

One output of the design and development activities shall be the acceptance criteria for the product. The acceptance criteria are used as a basis for comparison or as a reference point against which the product can be compared, evaluated, and then released or rejected. A good example is the determination of quality specifications or characteristics of a product. These characteristics are to demonstrate the features of a product or a service such as measurements of the product, performance or functionality, and tolerances and limits. These acceptance criteria shall be used during the realization of the product in order to determine the quality of the product and eventually enable the release of the product. The acceptance criteria shall demonstrate traceability to the design and development inputs. For example, one of the inputs is customer expectations of the product— a specific feature. The acceptance criteria shall include an examination that this feature exists and answers the expectations.

Activities Necessary for the Realization of the Product or Service

One of the main purposes of the design and development outputs is to prescribe the necessary requirements and activities necessary for the realization of the product:

• To demonstrate how the organization’s QMS applies to the realization of the product
• To demonstrate how realization activities may meet customer specifications
• To demonstrate how realization activities may meet regulatory specifications
• To describe how resources shall be used during the realization processes including reference to responsibilities and authorities
• To describe the controls that shall be applied on the realization processes
• To describe how risks shall be addressed during the realization processes
• To describe which documented information shall be maintained during the realization processes: used documentation and expected records

++++++++++++++++

ISO 9001 – Design and Development Review

The ISO 9001 requires a method for reviewing the design and the development. The goal is to create a reporting method regarding the progress of the development according to the organization’s requirements, goals or schedules. The design and development review must deal with the next points:

• Definitions of issues that must be reviewed during the development review. The intention here is to focus on certain issues that are relevant and has significant importance to the design and the development.
• Timeframes for the review.
• The type of the review; samplings, demonstrations, examinations, tours to any kind of facilities. It will be define according to the nature of the product.
• The functional parties are involved during the development review. It is required to define who is responsible of conducting the review and who shall participate.
• The preparations that must be taken in place before the review; schedules, objectives, required documentation etc.
• It is required to define the outputs to be produced after the review: meetings summaries, reviews, tasks, etc.
• Where nonconformities are revealed during the design and development review, you must introduce them into a controlled process with the objective to eliminate them. This process may a corrective action process. You are not required to define a specific process for the matter. You may include it in your normal corrective action process.

The most classic design and development review that we know may be defined as a periodic meeting, where a responsible party reviews the development, for example. The logic requirement is not to proceed to the next development stage before all the nonconformities, and disclosures are dealt and closed. But it’s not a standard requirement. The ISO 9001 Standard requires that records of the design and development review are to kept – that means that the review must be documented. These records will be evidence that the review took place and its results are satisfying. These records will be defined as quality records and will be included in your records control procedure. This is not a recommendation but a standard requirement.

ISO 9001 – Design and Development Verification

Verification is an action to ensure that activities were performed as necessary.  During the design and development the verification may test whether all the required design and development activities were performed under defined conditions, for example. You are required to define a method to verify the development. The intention is to ensure that the design and the development are appropriate to the inputs requirements. Verifications can occur as samplings, demonstrations, analysis, or simulations. This requirement may be conducted along with the design and development review. Only verified outputs should be preceded to the next developing step. This requirement will ensure the organization that the development is preceding according to the definition. The ISO 9001 Standard requires that records and evidence of the design and development review are kept – that means that the verification must be recorded. These records must be defined as quality records will be included in your records control procedure. This is not a recommendation but a requirement.
I certainly mentioned it before: it is not easy to develop under the ISO 9001 Standard requirements… As always I am suggesting solutions that might make your life just a bit easier. The next site offers a tool for design and development according to the ISO 9001 Standard requirements: QualityManualTemplates.com.

ISO 9001 – Design and Development Validation

Validation is an action to ensure that results are as expected. During the design and development the validation may test whether results of the activities are according to the specifications. You are required to define a method to validate that the product was developed according to the requirements: customers’ requirements, legal requirements, marketing requirement etc. The organization must review the products functionalities to see that they are as expected. For example, if the organization is developing software that would work on a windows operation system environment, one of the tests (or more than one) would have to run the software on a computer with windows installed. First time on windows XP, second time on windows vista and third time windows 7 OS. The ISO 9001 Standard require that you define these tests in advance. The validation activities must be performed in an identical environment to that where the product will function or perform later after released. In order to achieve this requirement, the organization must define the test and examinations for the product before releasing it. Where it is not applicable for any reason, the organization must decide how the product could be measured in order to validate the development as much as identical to intent environment. The ISO 9001 Standard requires that records of the design and development review are kept – that means that the validation must be recorded and supported with evidence. The evidence will prove that the results are satisfying. These records must be defined as quality records and will be included in your records control procedure. This is not a recommendation but a requirement.

ISO 9001 – Control over Changes on the Design and the Development

Any requirement for a change in the design and development shall be recorded, identified reviewed and approved.  The documentation may appear as a configuration management (only a suggestion). A change may occur all along the development cycle; the requirements, the test requirements, the required outputs etc. Therefore it is required to carefully review the change .While carrying out the changes it is required to examine:

• whether the change unwillingly affects any other component on the product,
• whether there is an operational influence of the change over the product,
• whether there is an functional influence of the change over the product,
• if other products were already delivered to the customer, how shall the changes affect these products

Records of the evaluation shall be kept and submitted to the records control process. The records shall include the activities required after approving the change.  You are required to provide evidence for the activities mentioned above. Actually you are not required to maintain a documented procedure but only to present documentation or specification of all the requirements.

Confusing isn’t it? We know. But the main principle is a preliminary planning and control over the process. Just like most of the ISO 9001 Standard requirements. Once you get the hold of it, you understand that these requirements are logic.

This webpage contains only a fragment of the chapter 8 – Operation from the book: ISO 9001: 2015 – A Complete Guide to Quality Management Systems published by:

 Share This