What is a quality manual, and is one required for pharma and medical devices?

1What a quality manual is.

In ICH Q10, the quality manual is where the pharmaceutical quality system is described. Section 1.8 says “A Quality Manual or equivalent documentation approach should be established”, and that the description should include:¹

• the quality policy;
• the scope of the pharmaceutical quality system;
• the quality system’s processes, “as well as their sequences, linkages and interdependencies”, for which process maps and flow charts can be useful;
• management responsibilities within the quality system.

The quality policy it contains is senior management’s statement of the company’s overall intentions and direction related to quality. Q10 says it should include an expectation to comply with regulatory requirements, facilitate continual improvement, be understood at all levels and be reviewed periodically.¹

For device makers, the regulators’ MDSAP audit approach says the quality manual “is to outline the structure of the documentation and to describe the interaction of processes”, for example how nonconformities are identified and corrected and how they are investigated for root cause and corrective action. It adds that high-level, non-product-specific quality system procedures, sometimes called Level 1 documents, “can usually be found in the Quality Manual”.²

2Whether one is required.

It depends on the product and the jurisdiction.

In the EU, Chapter 1 of the GMP Guide says the pharmaceutical quality system “should be defined and documented. A Quality Manual or equivalent documentation should be established and should contain a description of the quality management system including management responsibilities.”³ WHO’s GMP main principles use the same words.⁴ The phrase “or equivalent documentation” matters: what is expected is the description, and a set of documents that together give it can meet the expectation.

In the US, Part 211 does not use the term quality manual.⁵ FDA’s 2006 quality systems guidance does not use it either, but recommends that, when documenting a quality system, a manufacturer addresses the scope of the system including outsourcing, the quality standard it follows, its policies and objectives, and the procedures needed to establish and maintain it. It also says senior managers should ensure the organisation’s structure is documented.⁶ Those cover much of what ICH Q10 puts in a quality manual, under another name.

For medical devices, the Quality Management System Regulation, in force since 2 February 2026, requires manufacturers to document a quality management system that complies with ISO 13485:2016, which it incorporates by reference.⁷ FDA’s Compliance Program 7382.850 for device inspections lists the quality manual, under ISO 13485 clause 4.2.2, as an element of its Management Oversight area,⁸ and the MDSAP audit approach directs auditors to “Verify that a quality manual has been documented.”² The former Quality System regulation asked for quality system procedures and “an outline of the structure of the documentation used in the quality system” where appropriate, rather than a manual by name.⁹

3Quality manual, site master file and SOPs.

Two other documents sit close to the quality manual.

A site master file is a document “describing the GMP related activities of the manufacturer”, one of the documents EU GMP Chapter 4 lists.¹⁰ The European Commission’s explanatory notes say it is prepared so that a regulatory authority can plan and conduct GMP inspections, should if possible not exceed 25 to 30 pages plus appendices, and should carry an edition number, an effective date and a review date. Its quality section gives only a brief description of the quality management system, the standards used and the responsibilities for maintaining it.¹¹ A site master file describes one site for an inspector; a quality manual describes the system for the people who run it.

Procedures, also known as standard operating procedures or SOPs, “give directions for performing certain operations”, in the words of EU GMP Chapter 4.¹⁰ The MDSAP approach says an organisation may call its high-level quality system procedures, those not specific to a product or process, Level 1 documents, and that these can usually be found in the quality manual itself.² The manual describes the system and how its processes link; the procedures say how each operation is done.

4Keeping it current.

A quality manual is a controlled document like any other. EU GMP Chapter 4 says documents within the quality management system “should be regularly reviewed and kept up-to-date”.¹⁰ Q10 expects the quality policy in it to be reviewed periodically for continuing effectiveness,¹ and the MDSAP approach asks auditors to verify that changes to the quality management system are managed so that it and the devices produced continue to conform.² When the processes or responsibilities a manual describes change, the manual changes with them.

5How it runs in Seal.

Seal’s QMS covers deviations, CAPA, change control, documents, training, audits, suppliers, complaints and risk: the processes a quality manual describes and links together. The manual itself is a controlled document: in document control, each version moves from draft through review and approval to effective, signature records show who approved it, when and with what meaning, and where policy requires periodic review, the interval, reminders and escalation are held on the document record.

A revision can identify the roles it affects and assign the training it requires, and the periodic review draws on deviations, audit findings, CAPAs and changes before ending in a recorded decision to continue, revise, consolidate, replace or retire the document.