ISO 13485 is an international standard that outlines the requirements for a quality management system (QMS) for organisations involved in the design, development, production, installation, servicing, sales, and distribution of medical devices (including in vitro diagnostics). Clause 4.2.2 of the standard requires the organisation to document a quality manual. You may be wondering what a quality manual is and what specific information is required to be documented in it. This blog aims to provide useful information to organisations on what information is required to go into aquality manual.
A quality manual is one of the key documents in an ISO 13485 compliant QMS and many organisations choose to create one to document and communicate their quality management system.
Non-Applicable Clauses
In ISO 13485:2016, there are certain clauses that may be deemed non-applicable based on the organisation’s scope of activities or the nature of its QMS. Organisations can declare a clause as non-applicable if the specific requirement of that clause is not relevant to their operations.
However, it’s essential to note that ISO 13485 requires organisations to justify and document their reasons for declaring a clause as non-applicable. This helps to demonstrate that the organisation has considered the requirement and has a valid reason for not applying it. This information should be documented in the quality manual.
ISO 13485 states that “If any requirement in Clauses 6, 7 or 8 of this International Standard is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification”.
Here are some of the common clauses in ISO 13485 where organisations might consider declaring them as non-applicable but the list is not exhaustive, along with reasons for doing so:
Clause 7.3: Design and Development
Clause 7.5.3 Installation Activities
If the organisation does not perform any installation activities that require a qualified engineer, or a trained member of staff to install equipment/software either on site at the end user/customer, or internally.
Clause 7.5.4 Servicing Activities
If the organisation does not carry out any servicing activities, updates, upgrades, calibration on its product either internally or on customer purchased equipment/product.
Clause 7.6: Control of Monitoring and Measuring Equipment:
If the organisation does not use monitoring and measuring equipment that affects product quality, this clause may be declared non-applicable.
Remember, the decision to declare a clause as non-applicable should be made based on a thorough analysis of the organisation’s processes and operations. It should not be used to avoid implementing necessary quality management processes. The organisation should maintain a quality manual that explains the rationale for each declared non-applicable clause. This documentation is subject to audit by approved/notified bodies and/or regulatory authorities.
What Content is Required in a Quality Manual
The content of a quality manual under ISO 13485 can vary from one organisation to another, as it should be tailored to the specific processes and requirements of the company. However, the standard provides a framework and suggests certain elements that may be included.
Table 1 below has been provided as an example quality manual format including applicable procedures. It’s important to note that the content and format of the quality manual can vary, and organisations may choose to combine the quality manual with other documents or distribute the information across multiple documents. The key is to ensure that the information is clear, comprehensive, and aligned with the organisation’s practices and processes.
Table 1: Example Quality Manual Format
| Section no. | Section title | Information that sits under this section |
| 1 | Introduction | · The purpose of the QMS and the quality manual.· Company overview.· Scope of the QMS.· Details of any non-applicable clauses including justifications |
| 2 | Quality Policy | · A statement of the organisation’s commitment to quality.· Objectives related to quality.The quality policy and objectives may also be separate documents which are referenced to within this section of the quality manual. |
| 3 | Organisation Structure and Responsibilities | · Description of the organisational structure including an organisation chart/organogram.· Roles and responsibilities for quality management, including information on who the management representative is and who the Person Responsible for Regulatory Compliance (PRRC) is, if product is being sold into the EU market.The organisation chart may also be separate document which is referenced to within this section of the quality manual. |
| 4 | Documentation Control | · Procedures for controlling documents and records.· Document approval and revision processes.Procedures for document and record control and change control should be referenced here. |
| 5 | Management Responsibility | · Top management commitment.· Customer focus.· Quality planning.Procedure for Management Review should be referenced here. |
| 6 | Resource Management | · Human resources.· Infrastructure and work environment.· Work Environment and Contamination ControlProcedures for Management Review, Infrastructure, Maintenance Activities, Work Environment, Contamination Control and Training, Competency and Awareness should be referenced here. |
| 7 | Product Realisation | · Planning of product realisation.· Design and development (if applicable).· Customer-related processes.· Purchasing and supplier management.· Production and service provision.· Validation activities.· Servicing and Installation.· Particular requirements for sterile products.· Identification, traceability.· Labelling and preservation of product.Procedures for Design and Development (Design control), Risk Management, Sales Order Processing, Purchasing, Supplier Evaluation, Acceptance Activities, Production Control, Post-Market Surveillance, Usability, Clinical Evaluation, Conformity Assessment and Classification, Economic Operators, Servicing Activities, Installation Activities, Sterilisation Validation, Software Validation, Identification and Traceability, Labelling, Preservation of Product and Equipment Control should be referenced here (this is not an exhaustive list and will depend on the product type). |
| 8 | Measurement, Analysis, and Improvement | · Monitoring and measurement of processes· Monitoring and measurement of product· Control of nonconforming product· Analysis of data for continual improvement· Corrective and preventive actionsProcedures for Monitoring and Measurement (Data analysis), Complaint Handling, Nonconforming Product, Rework, Vigilance Reporting, FSCA and FSN, Corrective and Preventive Action, Internal, External and Supplier Audits should be referenced here. |
Before finalising the quality manual, organisations should carefully review the specific requirements of ISO 13485 and ensure that their documentation reflects the reality of their QMS. Additionally, it’s crucial to keep the quality manual up to date through regular reviews and revisions.
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References
- EN ISO 13485:2016+A11:2021 Medical devices – Quality management systems – Requirements for regulatory purposes.
- ISO 13485:2016 Medical devices. Advice from ISO/TC 210. A Practical Guide.
