D 010v22 - ISO 15189 Procedures, processes and records medical biology laboratory version 2022 - Set of documents
This package—comprising 34 procedures, 26 processes, and 71 records—is a comprehensive, ready-to-use resource for the quality management system of a medical biology laboratory accredited to ISO 15189 (2022 version). The documents are editable (Word format) and exhaustive. The collection totals 131 documents spanning 391 pages and covers all requirements of the standard. Key benefits include: compliance (documents aligned with the standard's requirements); time savings (no need to draft procedures and instructions from scratch); flexibility (editable files to suit your organization); comprehensiveness (covers all aspects of the quality management system); and practical examples (PDF templates available for content visualization).
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See the D 22v16 document set: ISO 13485 readiness See the T 65v22 online training: ISO 15189 Medical Laboratory soon See the T 50v22 online training: ISO 15189 Internal Audit soon |
You have an unlimited access for one year to the whole set of documents. This includes access to all the modifications (improvements) which could be made during that period.
Description
Main content
131 ready-to-use documents (processes, procedures, and records) to structure a management system for a medical biology laboratory (MBL) compliant with the ISO 15189:2022 standard.
The documents are editable (Word format) and cover all key requirement areas:
- structural and governance
- resource-related
- process-related
- management system-related
Benefits:
- compliance with ISO 15189 requirements
- time savings (no need to draft from scratch)
- flexibility (adaptable to each organization)
- comprehensiveness (includes all necessary processes, procedures, and records)
For organizations looking to link documentation, skills development, and operational deployment, this package can effectively support a broader initiative regarding ISO 15189 compliance for medical laboratories. Document details:
391 pages in total, organized into:
- procedures (34)
- processes (26)
- records (71)
each document is linked to the relevant clauses and Annex A of ISO 15189 to ensure precise compliance
Target audience
- anyone within an organization wishing to implement or improve a medical laboratory management system in accordance with ISO 15189 (2022 version)
Requirements of the ISO 15189 standard (2022 version).
See also the following training courses:
- T 65v22 ISO 15189 Medical Laboratory: Preparation (2022 version)
- T 50v22 ISO 15189 Internal Audit (2022 version)
- and the training pack T 90v22 ISO 15189 (2022 version)
To better prepare for ISO 15189 accreditation, it may be useful to supplement this document set with a training resource dedicated to the standard's requirements.
Other documents regarding ISO 15189 accreditation and ISO 15189 internal auditing are available in sets D 65v22 and D 50v22.
Documents included in the package:
- D 90v22 ISO 15189 Medical Laboratory pack (2022 version)
See also the free "Oxebridge Totally Free ISO 9001:2015 QMS Documentation Template Kit"
| D 010v22 Processes, procedures and records ISO 15189 version 2022 | |||
| Codification | Title | Sub-clause and annex A of ISO 15189 | Pages |
| Processes | |||
| PQBD010v22M01 | Manage complaints (pdf) | 7.7 | 2 |
| PQBD010v22M02 | Address risks | 5.6 ; 8.5 | 2 |
| PQBD010v22M03 | Improve | 8.6.1 | 1 |
| PQBD010v22M04 | Audit | 8.8.3 | 2 |
| PQBD010v22M05 | Conduct management review | 8.9 | 2 |
| PQBD010v22R01 | Manage patient rights | 4.3 | 1 |
| PQBD010v22R02 | Manage reagents and consumables | 6.6 | 2 |
| PQBD010v22R03 | Manage suppliers | 6.7 ; 6.8 | 2 |
| PQBD010v22R04 | Collect samples | 7.2.4 | 2 |
| PQBD010v22R05 | Transport samples | 7.2.5 | 2 |
| PQBD010v22R06 | Receive samples | 7.2.6 | 1 |
| PQBD010v22R07 | Secure samples | 7.2.7 | 1 |
| PQBD010v22R08 | Validate examination methods | 7.3.3 | 1 |
| PQBD010v22R09 | Control internal quality | 7.3.7.2 | 2 |
| PQBD010v22R10 | Compare performance | 7.3.7.3 | 1 |
| PQBD010v22R11 | Validate result reports | 7.4.1 | 2 |
| PQBD010v22R12 | Store samples | 7.4.2 | 2 |
| PQBD010v22R13 | Manage business continuity | 6.4 ; 7.8 | 2 |
| PQBD010v22R14 | Control nonconformities |
8.7.1 |
1 |
| PQBD010v22R15 | Implement corrective actions | 8.7.2 | 2 |
| PQBD010v22R16 |
Govern POCT (Ponit-of-Care Testing) |
Annex A.2 | 2 |
| PQBD010v22S01 | Manage personnel | 6.2 | 1 |
| PQBD010v22S02 | Manage facilities | 6.3 | 2 |
| PQBD010v22S03 | Manage equipment | 6.4 | 2 |
| PQBD010v22S04 | Control data | 7.6 | 2 |
| PQBD010v22S05 | Manage documentation | 8.2 ; 8.3 ; 8.4 | 1 |
| PQBD010v22List | List of ISO 15189 processes version 2022 | 1 | |
| Total | 44 | ||
| Procedures | |||
| PQBD010v22pr01 | Personnel management (pdf) | 6.2 | 4 |
| PQBD010v22pr02 | Facilities management | 6.3 | 3 |
| PQBD010v22pr03 | Equipment management | 6.4 | 3 |
| PQBD010v22pr04 | Camibration and metrological traceability | 6.5 | 4 |
| PQBD010v22pr05 | Reagent and consumables management | 6.6 | 4 |
| PQBD010v22pr06 | Contract management | 6.7 | 3 |
| PQBD010v22pr07 | External providers | 6.8 | 3 |
| PQBD010v22pr08 | Patient and user information management | 7.2.2 | 3 |
| PQBD010v22pr09 | Examination request management | 7.2.3 | 4 |
| PQBD010v22pr10 | Sample collection | 7.2.4.1 | 4 |
| PQBD010v22pr11 | Sample identification and labeling | 7.2.4.2 | 3 |
| PQBD010v22pr12 | Sample transportation | 7.2.5 | 3 |
| PQBD010v22pr13 | Sample reception | 7.2.6.1 | 4 |
| PQBD010v22pr14 | Pre-examination handling | 7.2.7 | 4 |
| PQBD010v22pr15 | Verification of examination methods | 7.3.2 | 4 |
| PQBD010v22pr16 | Validation of examination methods | 7.3.3 | 4 |
| PQBD010v22pr17 | Biological reference intervals | 7.3.5 | 4 |
| PQBD010v22pr18 | Examination procedures | 7.3.6 | 4 |
| PQBD010v22pr19 | Validity of examination results | 7.3.7.1 | 4 |
| PQBD010v22pr20 | Internal quality control | 7.3.7.2 | 4 |
| PQBD010v22pr21 | External quality assessment | 7.3.7.3 | 4 |
| PQBD010v22pr22 | Internal and external communication | 7.4 | 4 |
| PQBD010v22pr23 | Nonconforming work | 7.5 | 4 |
| PQBD010v22pr24 | Data control | 7.6 | 4 |
| PQBD010v22pr25 | Complaints management | 7.7 | 3 |
| PQBD010v22pr26 | Documentation control | 8.2 ; 8.3 | 4 |
| PQBD010v22pr27 | Record control | 8.4 | 3 |
| PQBD010v22pr28 | Risk and opportunity management | 8.5 | 4 |
| PQBD010v22pr29 | Continual improvement | 8.6.1 | 3 |
| PQBD010v22pr30 | Nonconformity management | 8.7.1 | 3 |
| PQBD010v22pr31 | Corrective actions | 8.7.2 | 3 |
| PQBD010v22pr32 | Internal audits | 8.8.3 | 4 |
| PQBD010v22pr33 | Management review | 8.9.1 | 4 |
| PQBD010v22pr34 | Point-of-Care Testing (POCT) | Annex A | 4 |
| PQBD010v22prList | List of procedures | 2 | |
| Total | 126 | ||
| Records | |||
| PQBD010v22en01 | Declaration of no conflict of interest (pdf) | 4.1 | 1 |
| PQBD010v22r02 | Confidentiality agreement | 4.2.3 | 1 |
| PQBD010v22r03 | Patient needs and expectations | 4.3 | 2 |
| PQBD010v22r04 | Legal status | 5.1 | 1 |
| PQBD010v22r05 | Laboratory director position | 5.2.2 ; 8.2.3 | 2 |
| PQBD010v22r06 | Scope of application | 5.3.1 | 2 |
| PQBD010v22r07 | Compliance register | 5.3.2 | 1 |
| PQBD010v22r08 | Advisory activities | 5.3.3 | 2 |
| PQBD010v22r09 | Organizational chart | 5.4.1 | 2 |
| PQBD010v22r10 | Service hours register | 5.4.1 | 2 |
| PQBD010v22r11 | Quality policy | 5.5 | 2 |
| PQBD010v22r12 | Welcome booklet | 6.2.1 | 2 |
| PQBD010v22r13 | Job description | 6.2.1 | 3 |
| PQBD010v22r14 | Skills matrix | 6.2.2 | 2 |
| PQBD010v22r15 | Staff authorization register | 6.2.3 | 2 |
| PQBD010v22r16 | Training register | 6.2.4 | 4 |
| PQBD010v22r17 | Personnel file | 6.2.5 | 2 |
| PQBD010v22r18 | Authorization record | 6.2.5 | 1 |
| PQBD010v22r19 | Facilities register | 6.3.2 | r |
| PQBD010v22r20 | Cleaning and disinfection | 6.3.3 | 2 |
| PQBD010v22r21 | Waste register | 6.3.3 | 2 |
| PQBD010v22r22 | Pest prevention and control | 6.3.3 | 2 |
| PQBD010v22r23 | Temperature register | 6.3.5 | 2 |
| PQBD010v22r24 | Equipment register | 6.4.1 | 1 |
| PQBD010v22r25 | Equipment maintenance | 6.4.5 | 1 |
| PQBD010v22r26 | Calibration certificate register | 6.5.2 | 1 |
|
PQBD010v22r27 |
Reagent and consumables register | 6.6.7 | 1 |
| PQBD010v22r28 | Supplier contracts | 6.7.1 ; 6.8.1 ; 7.6.5 | 1 |
| PQBD010v22r29 | Supplier evaluation | 6.8.2 | 2 |
| PQBD010v22r30 | Register of products and services provided by external providers | 6.8.3 | 2 |
| PQBD010v22r31 | Patient communication | 7.2.2 | 3 |
| PQBD010v22r32 | Examination request register | 7.2.3 | 2 |
| PQBD010v22r33 | Sample collection register | 7.2.4 | 2 |
| PQBD010v22r34 | Sample labeling sheerts | 7.2.4.2 | 1 |
| PQBD010v22r35 | Sample transpot register |
7.2.5 |
2 |
| PQBD010v22r36 | Sample reception register | 7.2.6 | 2 |
| PQBD010v22r37 | Pre-examination handling register | 7.2.7 | 2 |
| PQBD010v22r38 | Method verification reports | 7.3.2 | 4 |
| PQBD010v22r39 | Method validation reports | 7.3.3 | 5 |
| PQBD010v22r40 | Evaluation measurement uncertainty | 7.3.4 | 4 |
| PQBD010v22r41 | Reference interval register | 7.3.5 | 3 |
| PQBD010v22r42 | List of examination procedures | 7.3.6 | 3 |
| PQBD010v22r43 | Examination result validity register | 7.3.7 | 3 |
| PQBD010v22r44 | Internal quality control register | 7.3.7.2 | 4 |
| PQBD010v22r45 | External quality assessment register | 7.3.7.3 | 4 |
| PQBD010v22r46 | Comparability results | 7.3.7.4 | 3 |
| PQBD010v22r47 | Result reports | 7.4.1 | 2 |
| PQBD010v22r48 | Orally communicated results | 7.4.1.4 | 3 |
| PQBD010v22r49 | Sample results archive register | 7.4.2 | 4 |
| PQBD010v22r50 | Nonconforming results | 7.5 | 4 |
| PQBD010v22r51 | Root causes of nonconformity | 7.5 | 6 |
| PQBD010v22r52 | Data access log | 7.6.2 | 4 |
| PQBD010v22r53 | Data backup log | 7.6.3 | 4 |
| PQBD010v22r54 | Business continuity plan (BCP) | 7.6.4 ; 7.8 | 9 |
| PQBD010v22r55 | BCP testing log | 7.6.4 ; 7.8 | 3 |
| PQBD010v22r56 | Complaints log | 7.7.2 | 4 |
| PQBD010v22r57 | List of documents |
8.2 ; 8.3 ; 8.4 |
5 |
| PQBD010v22r58 | Risk register | 8.5 | 12 |
| PQBD010v22r59 | Opportunities for improvement | 8.6.1 | 8 |
| PQBD010v22r60 | Nonconformities and corrective actions | 8.7.3 | 3 |
| PQBD010v22r61 | Quality meeting minutes | 8.8.1 | 3 |
| PQBD010v22r62 | Quality indicators | 8.8.2 | 8 |
| PQBD010v22r63 | Audit program and reports | 8.8.3 | 5 |
| PQBD010v22r64 | List of auditors | 8.8.3 | 1 |
| PQBD010v22r65 | Management review minutes | 8.9.3 | 3 |
| PQBD010v22r66 | Contracts with POCT sites | Annex A.2 | 4 |
| PQBD010v22r67 | POCT site register | Annex A.2 | 5 |
| PQBD010v22r68 | POCT equipment register | Annex A.2 | 4 |
| PQBD010v22r69 | POCT sample register | Annex A.2 | 4 |
| PQBD010v22r70 | POCT site audit report | Annex A.3 | 5 |
| PQBD010v22r71 | POCT training register | Annex A.4 | 5 |
| PQBD010v22rList | List of records | 2 | |
| Total | 221 | ||
| Grand total | 391 | ||
