Quality Manual
The top-level document. Defines the scope of the quality system, the processes it covers, who is responsible for each, and how the other documents in this register relate to it.
Document control
| Document reference | LZ-QM-01 |
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| Revision | 3 |
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| Effective from | September 30, 2025 |
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| Next review due | September 28, 2026 |
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| Document owner | Quality Assurance |
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| Covers | Quality management system, ISO 9001 clause 4 |
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Provisions
- Scope: sourcing, manufacture, quality control, batch release, storage and distribution of research reference material
- Process owners named for manufacture, quality control, release and distribution
- Document hierarchy: this manual, then procedures, then work instructions and records
- Management review of the system at defined intervals, with corrective actions tracked to closure
- Explicit exclusion: material is supplied for laboratory research and is not manufactured under a marketing authorisation
Scope. This document forms part of the Lyze Labs quality system and applies to
research reference material supplied for in vitro laboratory use. It is not a
marketing authorisation, a regulatory approval, or a claim that material may be used
in humans.
Document control. LZ-QM-01 is an internal controlled document reference in
the Lyze Labs namespace. It is not an accreditation or certification number issued by
an external body. A superseded revision is archived rather than destroyed, so what was
in force on any given date can be established.
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