Creating A Quality Manual for The ISO 13485 Certification!

Producing high-quality medical devices offers understandable benefits to manufacturers and users. Obtaining the ISO 13485 certification is one of the keys to developing and maintaining safe and effective medical devices.

However, to gain the ISO 13485:2016 accreditation, you must follow its guidelines religiously, including creating a quality manual.

You must consider the quality manual as a user guide for the medical device quality management system. The purpose of this document is to help stakeholders and auditors navigate their quality management system.

Today’s article will take you through the ISO 13485 requirements regarding the quality manual, focusing on what needs to be included in the manual.

So, keep reading!

Creating Quality Manual for ISO 13485 Certification and What to Include

An ideal quality manual should communicate a company’s QMS objectives, purpose, roles, and responsibilities.

Besides that, here is what your ISO 13485 quality manual should include.

The ISO 13485 Certification Requirements for A Quality Manual

According to the ISO 13485:2016 requirements, your company’s quality manual must include the following things:

• A detailed description of the scope of the QMS, including the ISO 13485 clauses you have excluded from your QMS and justification for excluding them
• List of standard operating procedures (SOP) of the QMS
• An outline of the QMS documentation structure.
• Description of each interaction between QMS processes.

Here are additional details and key points for how to draft your quality manual for the ISO 13485 certification.

What To Include in The Quality Manual to Meet the ISO 13485 Certification Requirements

1. Write Down the Scope

Consider all the ISO 13485 requirements your quality management system must meet when drafting the scope. Remember that clauses 6, 7, and 8 are the only clauses you may exclude. If you do exclude them, the QMS scope should give satisfactory and apparent reasons for the exclusion.

Also, the scope should include information on internal audits, lists of activities, addresses of the companies you are selling to, responsibilities of third-party contractors, and their contact information.

2. List the Standard Operating Procedures

The ISO 13485 certification has several documentation requirements. It requires companies to refer to their standard operating procedures in the quality manual. Therefore, including the following documents in the manual is necessary.

• Control of documents
• Control of records
• Internal audit
• Control of non-conforming products
• Corrective and preventive actions
• Validation of computer software
• Customer specifications for inspection, manufacturing, delivery, and packaging
• Monitoring and measurement
• Servicing and installation
• Management review
• Contamination control and work environment
• Design and development
• Validation of sterilization and sterile barrier systems
• Identification and traceability
• Preservation of product
• Calibration and or verification for measuring equipment
• Feedback and complaint handling
• Reporting to regulatory authorities
• Advisory notices, data analysis, and reworks

It is noteworthy that the ISO 13485 does not require companies to write every procedure step-by-step in the manual. Therefore, you may need only include lists or indexes, tables, or appendices of the SOPs as needed.

3. Describe Process Interactions

The ISO 13485 certification requires companies to describe how their different processes interact.

An uncomplicated way to do this is by including a process flowchart. You can use the chart to demonstrate the interactions and dependencies of various processes.

Remember that it is essential to highlight the outputs and inputs of the corresponding processes. Also, consider management responsibility, risk-based approaches, and supplier evaluation when creating the chart.

4. Determine Document Structure

The quality manual shall include an outline of your document structure. The structure should be rational and clearly defined and meet the form of a pyramid. For instance, you may put the quality manual at the top, followed by the device master record and quality procedures, then place the work instructions, forms, specifications, and drawings, and lastly, put the quality records, design history files, and device history records.

There are many ways to structure your documents. Regardless of the way you choose, ensure that it clearly explains the documents in your quality manual.

Besides the above documents, you may consider adding quality policies, company descriptions, definitions of abbreviations, job titles, and followed regulations to the quality manual.

Wrapping Up

The requirements of the ISO 13485 certification regarding the quality manual are flexible. You can determine the structure of your manual if it meets the above criteria.

Yet, you should keep in mind that the manual should not be book-length. Also, your key stakeholders should have access to the manual, as necessary.

Author Bio- Damon Anderson is the project manager of a renowned ISO consultation firm. With his team, he delivers consultation and internal audit services to companies around the US.