How the 2005 Body of Knowledge Compares to the 2002 Certified Quality Auditor—Biomedical Body of Knowledge
The Body of Knowledge for the new Certified Biomedical Auditor exam was developed by combining elements of the Certified Quality Auditor—Biomedical Body of Knowledge with fundamental skills and knowledge areas from the Certified Quality Auditor Body of Knowledge. Under the new Certified Biomedical Auditor exam, candidates will no longer be required to be certified as a Certified Quality Auditor first in order to sit for the exam.
The new Certified Biomedical Auditor Body of Knowledge contains five major Body of Knowledge areas, which include the four areas in the Certified Quality Auditor—Biomedical Body of Knowledge and selected topics from the Certified Quality Auditor Body of Knowledge that have been integrated into the first four Body of Knowledge areas and form topic area five in the new Certified Biomedical Auditor Body of Knowledge.
Here's a map of the new Certified Biomedical Auditor Body of Knowledge, and where the topics came from in Certified Quality Auditor—Biomedical and Certified Quality Auditor Bodies of Knowledge.
There are three parts to this map:
- PART 1: A cross-reference showing where the content of the Certified Quality Auditor—Biomedical Body of Knowledge appears in the new Certified Biomedical Auditor Body of Knowledge.
- PART 2: A cross-reference showing where the content of the Certified Quality Auditor Body of Knowledge went in the new Certified Biomedical Auditor Body of Knowledge.
- PART 3: A cross-reference showing where the content in the new Certified Biomedical Auditor Body of Knowledge came from in terms of the Certified Quality Auditor and Certified Quality Auditor—Biomedical Bodies of Knowledge.
NO content from the Certified Quality Auditor—Biomedical Body of Knowledge was eliminated during the creation of the new Certified Biomedical Auditor Body of Knowledge.
Exam Length Change for Certified Biomedical Auditor Exam
Examinations based on the Certified Biomedical Auditor Body of Knowledge will contain 135 test questions with a 4-hour time limit.
The following table provides a cross-reference from the content of the Certified Quality Auditor-Biomedical Body of Knowledge to the similar or identical material in the new Certified Biomedical Auditor Body of Knowledge:
Body of Knowledge Content Code |
|
|
| Certified Quality Auditor— Biomedical |
Certified Biomedical Auditor | Topic in the 2002 Certified Quality Auditor—Biomedical Body of Knowledge |
1A |
Base U.S. Law |
|
1A1-5 |
3A2 |
Food, Drug, and Cosmetic (FD&C) Act and various sections of the Act; Misbranding and adulteration (Sections 301-304 and 501-502); FDA inspection (Section 704); FDA post-market recall authority (Section 518); and Device classification (Section 513) |
1B |
U.S. Regulation 21 CFR 820 – Quality System Regulation (QSReg) |
|
1B1-3 |
3B1 |
Preample, Scope, and Definitions (820.3) |
1B4 |
3C |
Management responsibility (820.20) |
1B5 |
3D |
Design control (820.30) |
1B6 |
3F1 |
Document and change control (820.40) |
1B7-8 |
3F2 |
Purchasing controls and acceptance activities (820.50 & .80), and Product identification and traceability (820.60 and 820.65) |
1B9-11 |
3F4 |
Production and process controls (820.70), Process validation (820.75), and Calibration (820.72) |
1B12 |
3E2 |
Detection and control of nonconforming product (820.90) |
1B13 |
3E1 |
Corrective and preventive action (820.100) |
1B14 |
2D1 |
Root cause investigation |
1B15 |
3F5 |
Packaging and labeling controls (820.120 & .130) |
1B16 |
3F3 |
Product handling, storage, distribution, and installation (820.140-.170) |
1B17 |
3F1 |
Record types and their requirements (820.180-.186) |
1B18-19 |
3E3 |
Complaint handling (820.198) and Servicing (820.200) |
1B20 |
3F6-7 |
Statistical techniques (820.250) |
1C |
Other 21 CFR Regulations |
|
1C1 |
3A3 |
Labeling (21 CFR 801, Subpart A) |
1C2-3, 1C5 |
3E3 |
Medical device reporting (21 CFR 803), Recalls, corrections, and removals (21 CFR 7 and 806), and Device tracking (21 CFR 821) |
1C4 |
3A4 |
Establishment registration and device listing (21 CFR 807) |
1C6 |
3A5 |
Electronic records and signatures (21 CFR 11) |
1D |
Medical Devices Directive (Council Directive 93/42/EEC of 14 June 1993) |
|
1D1 |
3A1 |
Scope and definitions |
1D2-6 |
3D |
Device classification and conformity assessment pathways (Annex IX); Essential requirements (Annex I); Harmonized standards (Article 5); Risk analysis requirements (Annex I); and Clinical data requirements (Annexes VIII and X) |
1D7-8 |
3E3 |
Product vigilance requirements (Article 10) and Recall provisions (Article 10) |
2 |
Standards and Guidance |
|
2A1 |
3A6 |
FDA guideline for the manufacture of in vitro diagnostic (IVD) products (Jan. 10, 1994) |
2A2 |
3D |
Formal design review (ANSI/ASQC D1160-1995) |
2A3 |
3E3 |
Reporting adverse events (Global Harmonization Task Force SG2-N21 R8) |
2B1 |
4A |
Risk management for medical devices (ISO 14971-2000(E)) |
2B2 |
3B3, 3D, 3F4 |
International quality system guidance for medical device manufacturers |
2B3 |
3B2 |
Quality systems standards |
3A |
Quality system inspection technique (QSIT) |
|
3A1-4 |
2E2 |
Purpose, Applicability, Subsystems, and Sampling tables |
3B |
U.S. compliance programs for medical devices (FDA CPG 7382.845) |
|
3B1-3 |
2E3 |
Inspection types, FDA criteria for action, and Observation categories |
3C |
International auditing guidelines for medical devices (GHTF SG4 (99) 28, SG4 (99) 14, and SG4 (00) 3) |
|
3C1-3 |
2E4 |
General auditing principles, Auditor training, and Documentation in other languages |
4 |
Technical Knowledge |
|
4A1 |
4B1 |
Sterilization: Definitions |
4A2 |
4B2-3 |
Sterilization: Methods |
4A3 |
4B4 |
Sterilization: Packaging of sterile products |
4B |
4C |
Biocompatibility (ISO 10993, FDA Blue Book #G95-1) |
4C1 |
4D1 |
Controlled environments |
4C2 |
4D2 |
Utility systems |
4D1-2 |
4E |
Software development for products, processes, and quality systems; and Change control, revalidation, and configuration management |
4E1-2 |
4F |
Laboratory testing (ISO/IEC 17025: 1999(E): Standards and Test method validation |
The following table provides a cross-reference from the content of the Certified Quality Auditor Body of Knowledge that was included, to the new Certified Biomedical Auditor Body of Knowledge:
Body of Knowledge Content Code |
|
|
Certified Quality Auditor |
Certified Biomedical Auditor |
Topic in the 2004 Certified Quality Auditor Body of Knowledge |
1B |
1A |
Purpose of audits |
1C |
1A |
Types of quality audits |
1D |
2E1 |
Audit criteria (standards only) |
1E |
1B1 |
Roles and responsibilities of audit participants |
1F1-3 |
1B2 |
Ethical, legal, and professional Issues |
2A1-6 |
2A1-6 |
Audit Preparation and Planning |
2B1 |
2B1 |
Opening meeting |
2B2 |
2B2 |
Data collection and analysis |
2B3 |
2B4 |
Working papers |
2B4 |
2B5 |
Objective evidence |
2B5 |
2B6 |
Observations |
2B6 |
2B7 |
Nonconformances |
2B7 |
2B8 |
Audit process management |
2B8 |
2B9 |
Exit meeting |
2C1-3 |
2C1-3 |
Audit Reporting: Basic steps, Effective audit reports, and Records retention |
2D1 |
2D1 |
Elements of the corrective and preventive action processes |
2D2 |
2D2 |
Review of corrective action plan |
2D3 |
2D3 |
Verification of corrective action |
2D4 |
2D3 |
Follow up on ineffective corrective action |
2D5 |
2D4 |
Audit closure |
3C |
2B3 |
Conflict resolution |
3D |
2B3 |
Communication techniques |
3E |
2B3 |
Interviewing techniques |
5A |
5A |
Fundamental quality control tools |
5B |
5B |
Quality improvement tools |
5C |
3F7 |
Descriptive statistics |
5D |
3F6 |
Sampling methods |
5E |
5C |
Process capability |
5F |
5D |
Qualitative and quantitative analysis |
5G |
5E |
Cost of Quality |
The following table provides a topic-by-topic cross-reference from the content of the new Certified Biomedical Auditor Body of Knowledge to the areas of both the Certified Quality Auditor-Biomedical and Certified Quality Auditor Bodies of Knowledge.
Body of Knowledge Content Code |
|
||
Certified Biomedical Auditor |
Biomedical |
Certified Quality Auditor |
Topic in the Certified Biomedical Auditor Body of Knowledge |
1A |
|
1B & 1C |
Purpose & Types of audits |
1B1 |
|
1E |
Participants and their roles and responsibilities |
1B2 |
|
1F1-3 |
Ethical, Legal, and professional Issues |
2A1 |
|
2A1 |
Elements of the audit planning process |
2A2 |
|
2A2 |
Auditor selection |
2A3 |
|
2A3 |
Audit-related documentation |
2A4 |
|
2A5 |
Auditing tools |
2A5 |
|
2A6 |
Auditing strategies |
2A6 |
|
2A4 |
Logistics |
2B1 |
|
2B1 |
Opening meeting |
2B2 |
|
2B2 |
Data collection and analysis |
2B3 |
|
3C, 3D, 3E |
Communication techniques |
2B4 |
|
2B3 |
Working papers |
2B5 |
|
2B4 |
Objective evidence |
2B6 |
|
2B5 |
Observations |
2B7 |
|
2B6 |
Classifying nonconformances |
2B8 |
|
2B7 |
Audit process management |
2B9 |
|
2B8 |
Exit meeting |
2C1 |
|
2C1 |
Audit Reporting: Basic elements |
2C2 |
|
2C2 |
Audit Reporting: Effective audit reports |
2C3 |
|
2C3 |
Audit Reporting: Record retention |
2D1 |
1B14 |
2D1 |
Elements of corrective and preventive action |
2D2 |
|
2D2 |
Review of corrective action plan |
2D3 |
|
2D3-4 |
Conducting Audit Follow up |
2D4 |
|
2D5 |
Audit closure |
2E1 |
|
1D |
Guidelines for Auditing Quality Systems (19011) |
2E2 |
3A1-4 |
|
Quality System Inspection Technique (QSIT) |
2E3 |
3B1-3 |
|
US compliance programs for medical devices (FDA CPG 7382.845) |
2E4 |
3C1-3 |
|
International auditing guidelines for medical devices (GHTF SG4 (99)28, GHTF SG4 (99)14, GHTF SG4 (00)3) |
3A1 |
1D1 |
|
European Directive: Medical Device Directive 93/42/EEC of 14 June 1993 (Article 1) |
3A2 |
1A1-5 |
|
US Requirements (FD&C Act, sections 301-304, 501-502, 704, 518, 513) |
3A3 |
1C1 |
|
Labeling: 21 CFR 801, subpart A |
3A4 |
1C4 |
|
Establishment registration and device listing: 21 CFR 807 |
3A5 |
1C6 |
|
Electronic records; electronic signatures: 21 CFR 11 |
3A6 |
2A1 |
|
FDA guideline for the manufacture of in vitro diagnostic products (Jan 10, 1994) |
3B1 |
1B1-3 |
|
21 CFR 820 |
3B2 |
2B3 |
|
ISO 9001, ISO 9002, ISO 13485, ISO 13488 |
3B3 |
2B2 |
|
GHTF.SG3.N99-8 |
3C |
1B4 |
|
Management Controls |
3D |
1B5, |
|
Design Controls |
3E1 |
1B13 |
|
Existing & potential problem resolution |
3E2 |
1B12 |
|
Identification and control of nonconforming product (820.90) |
3E3 |
1B18-19, 1C2-3, 1C5, |
|
Post market surveillance |
3F1 |
1B6, 1B17 |
|
Document & change controls (820.40, 820.180-820.186) |
3F2 |
1B7-8 |
|
Purchasing controls & acceptance activities (820.50, 820.80, including product identification & traceability: 820.60, 820.65) |
3F3 |
1B16 |
|
Handling, storage, distribution & installation (820.140-820.170) |
3F4 |
1B9-11, 2B2 |
|
Validation & process controls (820.70, 820.75, 820.72, GHTF.SG3.N99-10) |
3F5 |
1B15 |
|
Packaging and labeling controls (820.120, 820.130) |
3F6 |
1B20 |
5D |
Sampling techniques (820.250(b), and others) |
3F7 |
1B20 |
5C |
Statistical techniques (820.250(a)) |
4A |
2B1 |
|
Risk Management |
4B1 |
4A1 |
|
Sterilization: Definitions |
4B2 |
4A2 |
|
Sterilization: Standards |
4B3 |
4A2 |
|
Sterilization: Methods |
4B4 |
4A3 |
|
Packaging of sterile products |
4C |
4B |
|
Biocompatibility |
4D1 |
4C1 |
|
Controlled environments |
4D2 |
4C2 |
|
Utility systems |
4E |
4D1-2 |
|
Software development for products, processes, and quality systems |
4F |
4E1-2 |
|
Laboratory testing |
5A |
|
5A |
Fundamental quality control tools (root cause analysis too) |
5B |
|
5B |
Quality improvement tools |
5C |
|
5E |
Process capability |
5D |
|
5F |
Qualitative and quantitative analysis |
5E |
|
5G |
Cost of Quality |