Planning of Product Realization ISO 9001 requirement

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Quality plan provides the organization with the means of implementing a quality management system throughout the realization processes; for a product, a project or a service. The quality planning may include or be consist of general generic procedures or specific procedures regarding a specific product or project. When planning the product realization and determining the requirements, the organization must refer to the next issues:

  • The organization is required to plan and develop processes required for the product realization.
  • Planning the realization must compete with other quality management system requirements as required in paragraph 4.1.
  • The quality objectives and quality requirement of the product shall be referred when planning product realization.
  • The organization shall determine the processes, and the documentations specifically required to for these processes.
  • The organization shall determine the resources required for product realization..
  • The organization shall determine the activities required in order to verify, validate and monitor the realization processes and the product. The organization must determine the appropriate criteria (acceptance or rejection) for these activities.
  • The organization shall determine the records required in order to supply the evidences that the realization processes are performed according to the requirements (the quality plan). These records must be kept and included under the records control process as required in paragraph 4.2.4 – control of records.
  • The outputs of these planning activities must be suitable and appropriate to the nature and the characteristics of the organization and its products.    

A quality plan is a list of requirements or activities for the organization to follow or maintain in order to realize a product according to requirements (customer's or regulatory). The objective is to carry out in action the requirements given in paragraph 4.1 - Quality management system – general requirements:

  1. Identifying  all the required processes for product realization
  2. Defining the relations between the various processes
  3. Defining the required resources
  4. Defining the acceptance (or rejection) criteria
  5. Defining the validation and verification of products and processes (control and monitoring processes)
  6. Evaluation of effectiveness  

Furthermore, on clause 5.4.1 – Quality objectives, the Standard refers us to clause 7.1 – requiring that the quality objectives of the product shall be ensured by the top management. I might say that here the circle closes…

Quality plan integrates all the relevant information regarding the product realization, available to any concerned party. You may view it also as a guideline for the product's realization processes; it is consists of all the necessary information that would assist the relevant parties realizing the product according to the requirements. 
The organization shall refer to the relevant quality objectives while planning the product realization. On your quality manual you described your quality objectives; objective and targets that would be achieved when implementing a quality management system. Now it is the time and the place to refer to those objectives regarding the product realization. Allow me to give you an example. Let us assume that the organization declared on its quality manual that it would like to reduce customer's complaints. It is a reasonable quality objective. After reviewing of last year's complaints, it was discovered that most of the complaints regard the packaging of the product. On behalf of this awful discovery, the organization must review the quality plan on the exact defined controls regarding the packaging processes relevant to the packaging processes and redefine the processes and the controls in order to reduce the complaints. In other words, when planning the realization processes, the organization shall refer to the relevant quality objectives – reducing of complaints, and plan the required controls in order to achieve these objectives.

When you are constructing your quality plan you may include the next issues:


The quality plan shall describe the processes with them you are realizing the product. The definitions may include flow charts, diagrams, routing charts, work instructions, procedures etc. you may mention generic procedures or specific procedures. The objective is to provide with the reference for verification. The procedures and processes have outputs. These outputs are the evidences for the realization. Defining the processes is the first step in the defining the quality plan. The definition shall refer to specific documentation that would provide evidences for these processes.

Regulatory requirements

When the organization is producing under regulatory requirements, it is required specifying which regulations, and naturally referring these regulations (where these are available). When planning your product realization, regulatory requirements has an essential role in the designing stage. Therefore you are required keeping track whether there are any changes or updates and when there are, integrating them throughout the plan.

Customer's requirements

The Standard permits the organization not to document the customer's requirements so long it can prove that his nature of activities, its processes and products allow him achieving the quality objectives without documentation. When is it required? Customer's requirements must to be documented when there are particular to the realization process. The intention here is for special quality requirements like reliability or specifications such as requested product or model, delivery date, quantity, and package requirements.
Customer requirements and references to its technical specifications shall be included in the planning of product realization as a component of the quality plan when it is required by the customer.  As well, when it is required by the customer, additional verification and identification requirements are to be included in the quality plan.
One example could be a contract or a project where the organization is delivering to the customer a tailored product; aside from the regular production requirements there are also specification to be fulfilled. These specifications are required to be documented.

Production Requirements/Resources

The organization shall define the required production resources related to the product realization; raw material, required machinery, required production means (molds, tools, safety equipment), production parameters, work instructions, necessary work environment and storage requirements – all the necessary information regarding the production. How shall you input all of the above into a plan? A production order may serve as an appropriate documentation; a document that includes all the relevant details and is available to any relevant party.

Human resources

The organization shall define the human resources related to the product realization; required employees, needed qualifications, special trainings, and working shifts. When it is required employing workers that have specific trainings in order to realize the product, it may be defined and documented; which product or processes and what for a qualification is needed to be fulfilled. Pay attention, this has nothing to do with the job description. On the job description you defined the qualifications required for the function. On the quality plan you must determine the required qualifications for a product or a process.
And as (almost) always you are required to relate to any regulatory requirements regarding human resources. If a regulation demands that employees would acquire a qualification or a certification in order to realize the medical device, you would have to mention it on the quality plan; the relevant regulation and the implication on human resources.

Verification of product

The objective of verification is reviewing whether realization processes advanced according to prior definition and that no short cuts were taken on the way to realization. The organization shall plan, define, and document the stages where the verification shall be conducted. The definition of the verification shall include responsibilities for approval of processes' outputs for the use of future processes.  There is a requirement for maintaining a documented definition of the verification activities for the product. There is no requirement for a procedure though.
For example, a customer's order should not be preceded for production without a set of defined documentations in order to ensure that the relevant inputs are at the right place and at the right time; a copy of the order, updated product's diagram, incoming material's quality tests, product's portfolio, certification of trainings, routing cards.  The organization would have to verify that the requirement was fulfilled. You must define how the organization shall ensure it; a check list, a status management on the information system, required signatures.
Another example is that after each production step, an approval is required before proceeding to the next; before submitting an order for production, in between productions stages, after manufacturing, in storage. Each stage shall be approved by the relevant employee – you must define who is the responsible and how the approval would take place.

Validation of product  

The objective of product's validation is to ensure that it was realized according to prior requirements and objectives.
The organization is required defining which activities would evaluate the compatibility of the product. Say what?!? Relax, all I meant is compatibility. Compatibility is the extent of how much the realized medical device achieved the predefined requirements. In order to ensure, beyond any doubt that the product is performing what it is expected to, you would have to prove it: validate the product. The compatibility is measured with various parameters: Stages of validation, responsibilities, specifications, criteria, resources, and monitoring and measurements.

  • Stages of production – The organization shall determine on which stages of production throughout the realization processes, it is required validating the products or the processes. Stages shall be indicated both on progress of processes and time scales. It could be achieved with flow charts, documented descriptions, and time schedules.
  • Responsibilities – The validation activities shall be planned with reference to responsibilities. In other words, planning of validation activities shall indicate who performs the validations of the products or the processes.
  • Specifications - When required due to the nature of the product, means of validation may include specific procedures and/or work instructions, test specification, test instructions, list of equipment for monitoring and measurement, integration tests, scientific criteria or researches.
  • Criteria - I would start and say that on any case, the acceptance criteria of processes and products must be defined by the organization. A quality plan shall include the means with which the organization would control the realization processes; acceptance/rejection criteria for products or processes, quality tests instructions and inspections, quality protocols, tolerances, production requirements, product's diagram, medical device's samples.
  • Resources – the planning of the validation processes shall refer to the resources required to validate the process. Here you shall refer to monitoring and measuring devices needed to perform the validation activities. Usually the definition would appear on test instructions. This is also the place to mention any special equipment required for validation.
  • The validation of products and processes would be planned according to the standards' specific requirements as shown in clauses 8.2.3 - Monitoring and measurement of processes, and 8.2.4 - Monitoring and measurement of product.  

Product identification

Identification of products throughout the realization process shall be planned. It is required defining the label and its contents that would appear on the medical device. The contents of the label are depended on the medical device and its nature. 
If it is required by a regulation to publish a presence of some material or component (in the medical device) due to considerations (health or danger), you shall refer to it on your quality plan; for example, on the packaging/labeling instruction it would be mentioned that due to a certain regulation (do not forget to mention which regulation and where it is available for studying) an advisory notice should appear and the contents of the notice.

Traceability of the realization process shall be planned and defined on the quality plan. The ISO 9001 requires managing traceability throughout the whole realization process. The purpose is to provide the ability to trace back all of the poroduct components.  The organization may achieve it using a batch number that would follow the realization process from the beginning (raw material or components stage) until delivery of the finished product.

Changes and updates
The next paragraph is not an ISO 9001 standard requirement. But it may help you conducting and managing an effective quality plan. And effectiveness is one game the ISO 9001 likes to be a part of. I highly recommend establishing and maintaining a process to control and react to changes that may influence the product realization; change or updates, initiated by your customer or caused by any of your suppliers. This changes should be assessed, and verification and validation activities should be defined, ensuring compliance with the requirements (customer or regulatory). Changes may occur on product's diagram, packing instructions, or a change on a component or material delivered by a supplier. Such changes should be followed by a review where the objective is to assess whether the changes affected the realization processes and/or the products. After evaluation you may re-plan the quality plan according to the results.  Such follow could be a part of your Records control procedure.

The organization is required to define which evidences are to be regarded as a proof for compatibility. In any case or option that you may choose to define and document the quality plan, you are required to define and maintain the records providing the evidences that products and/or processes meet the requirements. For example, when the definition on the quality plan requires a signed routing card in order to ensure a controlled process – you would be required to produce the routing card and to produce it signed by the relevant function. When the quality plan requires a certain qualification from employees that assemble the medical device, you would be required to provide documented evidence that employees on a certain production session (followed by a batch number for traceability) obtain this qualification.
These records shall be part of your quality management system and would be submitted to the records control process as required in chapter 4.2.4 – control of records.
There is no requirement for a procedure describing the quality plan. It is however highly recommended defining and drawing an independent document baring the title "Quality Plan", or a set of documents specifying the controls over the realization processes as a quality plan; requirements, processes, resources, verifications and validations activities and records. The document may appear on a procedure, on a table, or a form or a set of.

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