Like all other things in life, the ISO 9001 Standard takes the design and the development very seriously. A massive specific chapter was dedicated to the issue (chapter 7.3). We will go further and reveal that even us (!!!) once (!!!) had failed a certification audit only because of this issue. It is not easy to comply with the entire requirements.

The ISO 9001 Standard knows exactly where the organization might fail during the development processes, and so, assists the organization dealing with the development. Development processes are very complex. Everybody knows that development means lots of money: Scientist's hours in labs, Programmers working long hours in front of the computer zipping high quality coffee, complicated diagrams performed on a expensive software, prototypes manufactured and being sent across oceans - all this occurrences require resources and the bottom line - they cost money. Many times the development fails for various reasons and good ideas are kept aside. It happens all the time. But The ISO 9001 Standard will assure that your development reaches its zenith and would do its best to minimize costs.
The development requires the organization's employees to handle many different parameters: customers' requirements, budget requirements, schedules requirements, management breathing down their necks and trying to make a living among all…

The ISO 9001 Standard's bottom line is: determine a method for your development and follow it. The main goal is to eliminate problems as much as possible. The tactic is to examine whether the development is preceded according to the requirements and according to the prior planning. We would review the requirements.

THE PLANNING OF THE DESIGN AND THE DEVELOPPEMENT

The design and the development must be planned in order to eliminate problems as much as possible. The idea is to define the required mile stones of the design and the development processes. Therefore, the organization must set requirements for the development as a method.
The method for design development should regard the next issues:

• Mile stones during the development process: the stages that the organization must follow through, while performing any kind of design and development. Your organization is required to describe what the development activities are. It is required to define what is expected at the end of any activity – the outputs.
• Definition of responsibilities and authorities during the design and development processes. Very similar to organizational definitions.
• The method shall include where time frames, schedules, objectives and resources are decided and documented. The specifications must refer to purchasing of any kind, as well.
• The method must allow identification of any requirements for the development: Standards requirements, technical requirements, safety requirements, customers' requirement or regulatory requirements.
• The method shall include how the organization verifies and validates that the development proceeds according to the defined requirements and who are the responsibility parties. The planning must allow an effective control over the design and the development.
• The planning must also include specifications of internal or external interfaces and information sharing. When there are different plans from different parties within the organization or outside the organization – the plans must be related to each other.
• Reference to similar and/or prior developments performed in the organization (when one was performed). This information may assist the organizations in the various steps.
• Risks – you are required to define a method to identify risks before and during the development processes. The method shall refer, to any kind of problems that might arise during the development. The method shall define who is responsible for any risk or problem occurred; a department or a specific function. 

The method must be documented but it is not required to document it as a procedure. We will explain it later…

DESIGN AND DEVELOPEMENT INPUTS

The ISO 9001 requires defining which inputs are required to carry out the development. The inputs should be determined according to the design and development activities. For example which employees are required or what information is required for every step of the development. Within inputs we may encounter:

• Employees - engineers, scientists, programmers, lab technicians, etc.
• Certain documentations with information required: customers' orders, marketing specifications, diagrams etc. Any documentation that relates to the design and the development.
• Working tools and work environment of any kind - computer software, glass tubes, guinea pigs (relax, just kidding), supporting tools, rulers, etc. the idea is to define the development environment.
• Requirements on any kind - standard requirements, customer's requirements, technical specifications, marketing requirement, legal requirement etc. 

Anything the organization uses in order to develop, must be defined.
The ISO 9001 requires that the inputs should be documented. The organization must keep records of the design and the development inputs and submit the records to the records control process within the organization. This is not a recommendation but a requirement. These records must be defined as quality records within your records control procedure. For more information about quality records you may review the next article. How to documents the inputs? Well. It's varying from one organization to another.  Another ISO 9001 standard requirement for the inputs – they must be reviewed and approved, by an authorized party before use. The approval must be documented as well. Sorry.

DESIGN AND DEVELOPEMENT OUTPUTS

The ISO 9001 requires defining which outputs are expected at the end of any development step. Remember the mile stones? Now you are required to define, by the end of any step defined, what are the outputs expected. Within outputs, we may encounter documents, samples, prototypes, chemical solutions, diagrams, code lines (within software or computer hardware designers) etc. the same applies to information derived from the development. You are required to define which information should be delivered at the end of any step, in which way this information would be documented, and on which format it would be documented. In order to verify that the outputs are as expected, you must define criteria or requirements for the outputs. In other words, the outputs must be appropriate to the design and development activities. Any output shall be reviewed in order to evaluate its competence.

Another ISO 9001 standard requirement for the outputs – they must be reviewed and approved, by an authorized party before they released. The approval must be documented.

DESIGN AND DEVELOPEMENT REVIEW

The ISO 9001 requires a method to review the design and the development. The goal is to create a reporting about the development progress according to the organization's requirements, goals, and schedules. The design and development review must regard the next issues:

• The issues that must be reviewed during the development review. The intention here is to focus on certain issues that are relevant and has significance importance over the design and the development.
• When the organization must perform the review. What are the time frames.
• The type of the review; samplings, demonstrations, examinations, tours to any kind of facilities. Whatever is appropriate to your organization.
• 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, tasks, etc.
• Where nonconformities are revealed during the design and development review, you must introduce them into a controlled process to eliminate them. This process may a corrective action process. You are not required to define a specific process to 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 kept – that means that the review must be documented. These records must be defined as quality records within your records control procedure. This is not a recommendation but a requirement.

DESIGN AND DEVELOPEMENT VERIFICATION

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 be occurred as samplings, demonstrations, analysis, simulations etc. This paragraph 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 of the design and development review are kept – that means that the verification must be documented. These records must be defined as quality records within your records control procedure. This is not a recommendation but a requirement.

We warned you. It is not easy to develop under the ISO 9001 Standard requirements… As always we are 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. 

DESIGN AND DEVELOPEMENT VALIDATION

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 be to run the software on a computer installed windows. First time on windows 98 OS, second time on windows XP OS and third time windows vista OS. The ISO 9001 Standard require that you define these tests in advance according to the products requirements.
The validation must take place within the identical environment to that where the product must function or perform later, when it would be released. In order to achieve this requirement, the organization must define the 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 documented. These records must be defined as quality records within your records control procedure. This is not a recommendation but a requirement.

CONTROL OVER CHANGES IN THE DESIGN AND DEVELOPEMENT  

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

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

SUMMARY

You are required to prove activity for all activities mentioned above. Actually you are not required to maintain a documented procedure but only to present documentation of all the requirements. Let's review what is required again:

• You are not required for a procedure bur you must present documentation of the developing process.
• You must document which are the development inputs.
• You are not requiring defining a procedure of the development review but you required to present documentation that your organization performed the review.
• You are not required to document the development outputs but you are required to present them after they are approved.
• You are not required to maintain a procedure describing how you verify your development but you required to present documentation of verification activities.
• You are not required to maintain a procedure describing how you validate your development but you required to present documentation of validation activities. 

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.

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