Quality Plans are inessential tools for many organisation to manage and handle specific quality projects in an extremely efficient way.

If we take the official definition of a Quality Plan according to ISO 9000:2015 – Quality management systems — Fundamentals and vocabulary, we can find the following wording:

specification of the actions, responsibilities and associated resources to be applied to a specific object.

From more a practical standpoint, the quality plan is a document that specifies everything that is needed for a particular product, service or project, such as quality standards, practices, resources, specifications, and the sequence of activities needed to achieve a specific result.

The ISO 10005:2018 Quality Management – Guidelines for Quality Plans specify the requirements for quality plan either for a project within an established quality system or for the implementation and maintenance of the quality system itself. This standard is of fundamental importance for all the company, including medical device organisations already ISO 13485 certified, which sometimes they have to handle complex project within their quality system.

Here we describe the 10 essential contents of a quality plan, according to ISO 10005:2018. In general, quality plan is not a specific requirements from the ISO 13485:2016 or from FDA Quality System Regulation 21 CFR 820; however it is an essential tool that can help medical device manufacturer to deliver on specific projects.

General Introduction About Quality Plan

In general, a quality plan describes how the organization will achieve a specific output, where the output could be a product, a process, a service or any other specific activities. Although, as mentioned before, there is no specific requirements in place for medical device manufacturer which explicitly require to have these types of plan in place, there are a number of situations where the quality plan is essential, for example:

  • To meet customer or regulatory requirements
  • To develop and validate new products
  • To optimise the use of resources
  • As a tool for measuring compliance against specific requirements
  • Where there is no quality management system established.
  • etc

Here below, we will start to analyse the 10 essential contents of a quality plan and describe how it is possible to prepare and implement an efficient plan to achieve the expected results.

1-Definition and Scope of the Quality Plan

The activity object of the Quality Plan shall be clearly described and it is the starting point for any type of plan. It is essential to start to describe how the required activities needs to be carried, in case by referencing to specific working instructions or SOP. The level of details of the plan shall also be dependent from the objective to be met and the activities to be performed. For example, if the objective it to bring a new device on the market, the multiple level of details shall be used starting from a high level to a more detailed plan.

The scope of the plan could be expressed under different ways and it shall contain:

  • purpose and expected output of the quality plan
  • conditions of its validity
  • aspects of the specific case to which it will be applied

2- Quality Plan Inputs and Objectives

Inputs shall be clearly included or referenced to the plan. Moreover it is essential to periodically review inputs to ensure their validity and reviewing the changes of the inputs to evaluate the consequence on the quality plan.

Moreover the objectives shall also be established and documented. Particular attention shall be provided to, for example:

  • Important issue for customer satisfaction
  • opportunities for improvement

3 – Quality Plan Responsibilities and Resources

Responsibilities shall be clearly identified, in order to:

  • activities and resources are planned, implemented and monitored
  • inputs are continuously reviewed
  • requirements are communicated to all the affected and involved personnel
  • changes are always reviewed and their impact is evaluated.

Resources for the plan implementation shall be clearly identify, and this shall include people, material, products, services and infrastructure.

4- Communications about Quality Plan

Communication is an important part of the plan and clear responsibilities for communication with customers or with other parts shall be clearly mentioned.

Moreover, it is necessary to define the methodology to be used for communication, when communication is necessary and the process to be followed when a feedback or a complaint is received.

5-Design and development

Applicable plans for Design and Development shall be referenced the plan and all the applicable specifications, codes, industry standards and characteristics, regulatory requirements shall be considered.

Moreover, the criteria used to accept design inputs and outputs shall also be clearly considered.

Particular attentions hall be given to the management of changes, including specific requirements related to how changes related to design and development shall be managed, who is authorised to initiate a change, how it will be reviewed and who is authorised to approve a change.

6-Manufacturing

Production and service provision offend are a part of the plan. Obviously, the processes can be quite broad range because it is dependent from the type of manufacturing. Inputs, process and outputs shall be mentioned in the quality plan; the level of details to include in the plan shall be decided using a risk-based approach.

7-Identification and Traceability

If identification and traceability are essential to meet the objective of the plan, the specific requirements for identification and traceability shall be mentioned. Specifically, the quality plan shall include:

  • lan how traceability requirements are identified and incorporated in the quality plan
  • how traceability is documented

8-Cutomer Property

The plan shall clearly states:

  • how customer properties are identified
  • the methods to verify that customer property meets the identified requirements
  • how non-conforming products are controlled

9 – Control of output deviations

Quality plan shall document how deviations are identified and handled to prevent unintended use of the non-conforming products. Specific limits, for example limiting the type of rework which is allowed, might also be mentioned in the quality plan.

10 – Audits

Audits are an important moment and this should be clearly defined in the quality plan. The extent of the audit and definition of how audit results shall be used must be defined in the quality plan.

Audits may be used for different purposes:

  • monitor effective implementation of quality plan
  • verify the conformity to specific requirements
  • for surveillance of external provider to the organisation.

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