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We wrote the templates with the many years of laboratory experience that we employ and proven quality management systems.

We also wrote the templates the way the ISO 15189:2007 dictates a Medical Laboratory Quality Manual is to be written. There is no other product on the market like this.

ISO 15189 Clause 4.2.4 (paragraph 3) specifically states:

The table of contents of a quality manual for a medical laboratory might be as follows:

a) Introduction.

b) Description of the medical laboratory, its legal identity, resources, and main duties.

c) Quality policy.

d) Staff education and training.

e) Quality assurance.

f) Document control

g) Records, maintenance and archiving.

h) Accommodation and environment.

i) Instruments, reagents and/or relevant consumables management.

j) Validation of examination procedures.

k) Safety.

l) Environmental aspects.

m) Research and development.

n) List of examination procedures.

o) Request protocols, primary sample, collection and handling of laboratory samples.

p) Validation of results.

q) Quality control (including interlaboratory comparisons).

r) Laboratory information system.

s) Reporting of results.

t) Remedial actions and handling of complaints.

u) Communications and other interactions with patients, health professionals, referral laboratories and suppliers.

v) Internal audits.

w) Ethics.

To summarize: the ISO 15189 Quality Manual Template follows the suggested layout by the ISO 15189 standard.