How to structure ISO 13485 Documentation According to Quality Management System

The international standard for medical device Quality Management Systems industry, ISO 13485 does require certain list of documentation. But, that documentation serves a number of purposes – and not one of them involves making the organization simply appear to be compliant.

Following are the list of mandatory documents required by ISO 13485:2016:

ISO 13485 Manual

ISO 13485 Procedures

ISO 13485 Exhibits

Sample Formats / Templates

Quality SOP

ISO 13485 Filled forms

ISO 13485 Audit Checklist

The purpose of ISO 13485 documentation is threefold:

To provide a clear framework for the company’s operations

To provide facility for process consistency and better understanding of the Quality Management System(QMS)

Showing the evidence of the company’s achievement of its goals and objectives

So, whenever set to create the ISO 13485 documents, the focus should be on efficiency, and on creating only those processes and documents that will beneficial to organization.

How to structure the ISO 13485 documentation

The ISO 13485 standard requires different types of information to be documented; but, not every piece of information has to have its own separate document. The 13485:2016 standard allows an organization the flexibility to decide on the amount of documentation it requires, and the level of detail to include. Such as, small organizations may choose to document a simple overview of their procedures in the Quality Manual.

1. ISO 13485 Manual:

The contents of the ISO 13485 manual, and the overall structure, are going to be dependent on the characteristics of the organization itself, such as size, operational complexity, and staff competencies. While a small organization can probably document their entire Quality Management System in a single ISO 13485 manual, a large multi-national company may need several Quality Manuals, and all other required documents.

A typical ISO 13485 Manual will include:

Title and table of contents

Information about document version and approvals

A description of the QMS

The scope of the QMS

ISO 13485 exclusions, and the reasoning behind them

The company’s business process model

Roles and responsibilities of personnel

References to additional relevant documents and appendices

The Quality Policy and objectives

2. ISO 13485 Policy:

The statement of the company’s commitment to quality is ISO 13485 Policy, to continual improvement, and to fulfilling its legal and regulatory obligations. Basically, policy outlines the organization’s quality goals, which are defined by quantifying its quality objectives.

3. ISO 13485 Procedures:

The ISO 13485 procedures are the spine of an organization’s Quality Management System. Mainly the procedure’s purpose is to establish processes that will ensure the company’s activities conform to ISO 13485 requirements. These procedures can be descriptive, such as in narrative form; it also in a more structured format, such as tables; it can be more illustrative, such as a flow chart; or it can be all of the above.

Following are the elements of ISO 13485 procedures and should include:

The title is used to identify the procedure

Purpose has the reasons for the procedure

Scope is to define what is included in the procedure, and what is not

Roles, responsibilities, and authorities involved in the procedure

A list and definition of records that result from the activities described in the procedure

Identification of changes, date of review and approval, and version of the document, in accordance with the established practice for document control

A description of the activities in the procedure – describing what should be done, how, when, where, and by whom. In some cases, the "why" should be clarified as well, plus the inputs and the outputs of the activities, including the necessary resources.

Appendices, if needed

4. Work instructions:

Work instructions are typically structured in the same way as the procedures, and cover the same elements; but, the work instructions provide greater detail about the activities that need to be performed, with an emphasis on the sequence of steps to be taken, the tools and methods to be used, and the accuracy requirements. Work instructions are included as a part of a procedure, or simply reference them in the procedure. The use of competent personnel, and adequate staff training, will eliminate the need for highly detailed work instructions.

5. Records:

Records are the low-level documents that provide evidence that a process is in place and performed according to the procedure or work instruction. Such that consider an example inspection records show that an inspection was performed, along with some specific findings.

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