ISO 15189 quality manual and procedures
An ISO 15189 quality manual describes how your laboratory meets the standard. It is the overview; the procedures, work instructions and records are the details underneath. An assessor from the RvA wants to see that the manual matches what happens on the shop floor. The ideal manual is short, refers to the right documents and leaves no requirement unanswered.
The manual belongs to the management system in chapter 8 of the requirements. If you are starting with the scope, first read what ISO 15189 is. Whether you put everything into one manual is up to you. Whether the standard requires a manual with that name, check in the current text of the standard.
Short answer: a manual describes what you do and refers to the procedures. It does not have to copy the standard. For each requirement, make clear where the detail is set out, so the assessor can find it in one go.
What belongs in the manual?
A workable manual has a fixed structure. That structure largely follows the chapters of the standard, so you can find the requirements easily. The table below shows what you include for each part.
| Part | What it covers | Source or reference |
|---|---|---|
| Scope | Which tests, locations and equipment fall under the accreditation | List of tests |
| Organisation | Legal form, organisation chart, authorities | Organisation chart, job descriptions |
| Impartiality | Risks of influence and how you control them | Impartiality register |
| Staff | Requirements per role, training and authorisation | Competence matrix |
| Equipment and reagents | How you calibrate, maintain and check | Equipment register |
| Pre-analysis | Request, collection, transport and identification | Work instructions per sample type |
| Analysis | Methods, validation and quality control | Validation reports, control charts |
| Post-analysis | Review, reporting and critical results | Critical results procedure |
| Management system | Document control, non-conformities, audits, review | Document register, non-conformity log |
The table is a tool, not a mandatory layout. Use the structure that suits your laboratory, as long as every requirement can be found.
Example: a quality manual in practice
The following is a fictional example of a small independent lab that carries out blood tests for GPs. It shows how to work out one part.
Part: pre-analysis, patient identification.
At collection, we check two identifiers of the patient, namely name and date of birth, against the request. The sample receives a label with the patient details and the request number. If there is any doubt, the sample is not processed and we contact the requester. See procedure PA-01 for the full steps and work instruction WI-03 for labelling.
Notice what this paragraph does. It describes the action, refers to the right documents and says what you do when in doubt. An assessor can check that in one go.
What does a procedure look like?
A procedure describes one process. A work instruction describes one action within that process. A register keeps track of the outcome. Keep those three layers separate.
Procedure
Describe the process: who does what, when and with what result. One process per procedure.
Work instruction
Describe the concrete action, for example how you label a sample tube or start up an analyser.
Record
Record that it happened: who, when, which sample, which result. A missing record counts in the assessment as not done.
Document register
Keep track of which version of which document applies. That way you are sure staff use the current version.
What the assessor looks for in the manual
An assessor may read the manual first. They pay attention to three things: whether the scope is correct, whether the references work and whether the text matches practice.
Check the references. A document that does not exist, or a version that is out of date, stands out quickly. Also check the scope. The list of tests in the manual must match exactly what your accreditation covers. A difference between the two is a common finding.
The assessor also looks at coherence. A manual that names the risks but nowhere shows which measure belongs to which risk does not work. See also the management review and the internal audit as parts of that system.
Common mistakes
The manual is a copy of the standard. That helps nobody. Write what you do, not what the standard asks. The standard is already there.
Taking procedures from another lab. A procedure that works elsewhere often does not fit your equipment and your patients. Adapt it to what truly applies.
The manual is not kept up to date. A manual that has not been changed after a change in equipment, staff or method is already out of date at the time of the assessment. Record who manages it and when it is updated.
References to old versions. Before the assessment, check that all document numbers and versions are correct.
How do you keep the manual current?
A manual goes out of date quickly if nobody manages it. Appoint one owner, usually the quality officer, and record who may approve changes. This does not have to be a heavy procedure, but it must be fixed.
Use a change log. For each change, note the date, what changed, who approved it and which document was amended. That way you can see at a glance whether the manual still matches what happens on the ward.
Link the review to fixed moments. A management review is a logical moment to check the manual, as is any change in equipment, staff or method. See the management review for what that discussion covers.
A short checklist for the manual
- Is the scope included, and does it match the list of tests?
- Does each chapter of the standard refer to a document that exists?
- Are all document numbers and versions current?
- Is the organisation described, with responsibilities per role?
- Is the manual signed by the laboratory management?
- Are the risks named, and does the manual link them to measures?
- Is the date of the last review visible?
Go through that list before every assessment. It takes an hour and prevents a lot of discussion afterwards.
How do you start?
Start with the scope. Write out the list of tests and check it against what you actually do. Then work through the chapters of the standard, and for each requirement choose the document that sets it out. That is how the manual takes shape.
Plan this as part of your preparation for accreditation. The manual can take up a large part of the preparation time.