1、The FDA and Worldwide Quality System Requirements Guidebook for Medical DevicesSecond EditionAlso available from ASQ Quality Press:ISO 13485:2003: Medical devicesQuality management systemsRequirements for regulatory purposesISOSafe and Sound Software: Creating an Efficient and Effective Quality Syst
2、em for Software Medical Device OrganizationsThomas H. FarisDevelopment of FDA-Regulated Medical Products: Prescription Drugs, Biologics and Medical DevicesElaine WhitmoreMeasurement Matters: How Effective Assessment Drives Business and Safety PerformanceBrooks Carder and Patrick RaganThe Internal Au
3、diting Pocket Guide: Preparing, Performing, Reporting and Follow-up, Second EditionJ.P. Russell5S for Service Organizations and Offices: A Lean Look at ImprovementsDebashis SarkarManaging Service Delivery Processes: Linking Strategy to OperationsJean HarveyThe Executive Guide to Understanding and Im
4、plementing Lean Six Sigma: The Financial ImpactRobert M. Meisel, Steven J. Babb, Steven F. Marsh, and James P. SchlichtingLean Kaizen: A Simplified Approach to Process ImprovementsGeorge Alukal and Anthony ManosRoot Cause Analysis: Simplified Tools and Techniques, Second EditionBjrn Andersen and Tom
5、 FagerhaugThe Certified Manager of Quality/Organizational Excellence Handbook: Third EditionRussell T. Westcott, editorEnabling Excellence: The Seven Elements Essential to Achieving Competitive AdvantageTimothy A. PineTo request a complimentary catalog of ASQ Quality Press publications, call 800-248
6、-1946, or visit our Web site at http:/www.asq.org/quality-press.The FDA and Worldwide Quality System Requirements Guidebook for Medical DevicesSecond EditionC o m p i l e d a n d W r i t t e n b yAmiram Danielthe QSReg spells some of them out in subsequent sections of the regulation.5.3Quality polic
7、yNo significant differences.5.4Planning5.4.1Quality objectivesNo significant differences.5.2Customer focusThe Standard distinctly focuses on meeting customer requirements in addition to meeting regulatory requirements. The QSReg is entirely focused on meeting those requirements that have as their ob
8、jective the design, manufacture, distribution, and support of safe and effective medical devices.The Standard includes requirements for determining customer requirements during the entire product realization process, while the QSReg includes requirements that identify product and process requirement
9、s focused on ensuring safe and effective medical devices. 820.20(b) Organization(1)Responsibility and authority5.5Responsibility, authority, and communication 5.5.1Responsibility and authorityNo significant differences. 820.20(b) Organization(1)Responsibility and authority5.5.3Internal communication
10、sNo significant differences; the QSReg implicitly requires the necessary communication processes that make for successful interrelationships.xviiiQSReg, 21 CFR 820ISO 13485:2003Authorsnotes 820.20(b)(2) Resources6.2Human resources6.2.1General6.2.2Competence, awareness, and trainingNo significant dif
11、ferences. 820.20(b)(3) Management representative5.5.2Management representativeNo significant differences, except the requirements in the Standard reflect the focus on meeting customer requirements. 820.20(c) Management review5.6Management review5.6.1GeneralNo significant differences.5.6.2Review inpu
12、tThe requirements for review input spelled out in the Standard are logical and would be expected by an FDAinvestigator during an inspection that focused on management responsibilities.5.6.3Review outputThe requirements for review output spelled out in the Standard are logical and would be expected b
13、y an FDAinvestigator during an inspection that focused on management responsibilities.8.5Improvement8.5.1GeneralThere is no one section of the QSReg that corresponds directly with subclause 8.5.1 of the Standard. The intents of the two documents as they relate to improvement of the QMS through the u
14、se of corrective and preventive action are consistent.xixQSReg, 21 CFR 820ISO 13485:2003Authorsnotes 820.20(d) Quality planning5.4.2Quality management system planningThe QSReg contains the prescriptive requirement for a quality plan and quality system procedures. It is not clear what the FDAis looki
15、ng for in a quality plan. It seems to be a combination of a high-level quality planning document containing policy and key objectives (with a mandate to drive those objectives down into the organization) and a set of high-level procedures that illustrate how that plan will be met. It may also be a q
16、uality plan established on a product-by-product basis. Both the QSReg and the Standard require the establishment of these kinds of procedures; only the QSReg gives them special standing as quality system procedures. 820.20(e) Quality system procedures4Quality management system4.2Documentation requir
17、ements4.2.1GeneralThere is no separate section in the Standard specifically targeted at quality system procedures. The documentation requirements are covered in the general QMS requirements. There is no substantive difference in the documentation requirements. 820.22 Quality audit8.2.2Internal audit
18、No significant differences. 820.25 Personnel(a)General6.2Human resources6.2.1General6.2.2Competence, awareness, and trainingNo significant differences. 820.25(b) Training6.2Human resources6.2.1General6.2.2Competence, awareness, and trainingNo significant differences.xxQSReg, 21 CFR 820ISO 13485:2003
19、Authorsnotes 820.30 Design controls(a)General1.2ApplicationThere is no comparable section in the Standard. The QSReg limits the applicability of design controls to more high-risk medical devices, while the Standard applies them to all medical devices. The regulation excludes all ClassI devices other
20、 than those specifically listed in the 820.30(a) from the requirement to establish procedures for design control. The Standard recognizes such regulatory exclusions. 820.30(b) Design and development planning7.3.1Design and development planningThe overall objectives related to design control planning
21、 are consistent in the two documents. 820.30(c) Design input7.3.2Design and development inputsNo significant differences. 820.30(d) Design output7.3.3Design and development outputsThe intents of the two documents are consistent with each other, with the QSReg containing specific requirements associa
22、ted with the approval and release of design outputs. 820.30(e) Design review7.3.4Design and development reviewThe intents of the two documents are consistent with each other, with the Standard illustrating in more detail the objectives of the design review, and the QSReg including prescriptive desig
23、n review process requirements not contained in the Standard. 820.30(f) Design verification7.3.5Design and development verificationThe intents of the two documents are consistent with each other, with the QSReg including prescriptive design verification process requirements not contained in the Stand
24、ard.xxiQSReg, 21 CFR 820ISO 13485:2003Authorsnotes 820.30(g) Design validation7.3.6Design and development validationThe intents of the two documents are consistent with each other.The QSReg seems to indicate that risk analysis is a design validation process. This is not consistent with the teachings
25、 of the Standard, which calls for risk management activities throughout the product realization process. See the chapter in this book related specifically to risk management. The Standard addresses a scenario not addressed by the QSReg (e.g., where final assembly of the medical device is accomplishe
26、d upon delivery to the customer). The QSReg contains a number of design validation process requirements not included in the Standard. 820.30(h) Design transfer7.3.1Design and development planningThere is no comparable section in the Standard addressing design transfer directly. Design transfer is ad
27、dressed in a note in section 7.3.1 of the Standard.7.5.1Control of production and service provisionNo significant differences. 820.30(i) Design changes7.3.7Control of design and development changesThe Standard contains requirements related to the effect of design changes on a product already deliver
28、ed to customers and records of design changes that do not appear in the QSReg. 820.30(j) Design History File7.3.1Design and development planningWhile the Standard requires the creation of design control documentation and records, the QSReg requires the establishment of a Design History File (DHF), w
29、hich either contains or refers to all the documents and records associated with the application of the design control processes to a particular product. 820.40 Document controls4.2.3Control of documentsThe requirements are essentially the same, except that the QSReg has the specific requirement to c
30、ommunicate changes to documents to the affected personnel.The Standard requires the organization to define a retention period for “obsoleted” documents.xxiiQSReg, 21 CFR 820ISO 13485:2003Authorsnotes 820.50 Purchasing controls7.4Purchasing7.4.1Purchasing processNo significant differences. 820.50(a)
31、Evaluation of suppliers, contractors, and consultants7.4Purchasing7.4.1Purchasing processNo significant differences. 820.50(b) Purchasing data7.4.2Purchasing informationThe intents of both documents are consistent with each other.The Standard contains a requirement associated with the organization e
32、nsuring the adequacy of purchasing requirements prior to communicating them to the supplier.The QSReg contains a requirement that the organization obtain, where possible, the agreement of the supplier to notify the organization of changes to the product or service so that the organization can assess
33、 the potential effect on the quality of the medical device. 820.60 Identification7.5.3Identification and traceability 7.5.3.1IdentificationThe Standard addresses the identification and traceability of product returned to the organization in order to ensure it is distinguished from normal product. 82
34、0.65 Traceability7.5.3.2TraceabilityThe Standard includes some general requirements associated with traceability not found in the QSReg. The requirements for implantable and active implantable devices found in both documents are supplementary and shall be incorporated into the QMS of an organization
35、 supplying such medical devices. 820.70 Production and process control7.5Production and service provisionThe intents of both documents are consistent with each other, with each of the documents providing details of control or the types of processes that must be controlled in a way that supplements t
36、he other. It is suggested that the sections be read together in order to get a complete list of processes and process controls that are to be included in the QMS.xxiiiQSReg, 21 CFR 820ISO 13485:2003Authorsnotes 820.70(a) General7.5Production and service provision 7.5.1Control of production and servi
37、ce provision 7.5.1.1General requirementsThe intents of both documents are consistent with each other, with each of the documents providing details of control or the types of processes that must be controlled in a way that supplements the other. It is suggested that the sections be read together in o
38、rder to get a complete list of processes and process controls that are to be included in the QMS.7.5.1.3Particular requirements for sterile medical devices This section requires the establishment of process parameters for sterilization processes and records traceable to each batch of medical devices
39、 that were subjected to sterilization.7.5.4Customer propertyAside from the general controls exerted by the organization over purchased product, the QSReg does not specifically address the issue of care exercised over customer property when it is being held or processed by the organization.8.2.3Monit
40、oring and measurement of processesThe intents of the two documents are consistent with each other, even though the QSReg is far more detailed and has a product focus. 820.70(b) Production and process changesThere is no specific section of the Standard that addresses production and process changes. 8
41、20.70(c) Environmental control6.4Work environmentThe intents of both documents are consistent with each other; the Standard specifically calls for control of used product to prevent contamination of other products, the manufacturing environment, or personnel. 820.70(d) Personnel6.2Human resources6.2
42、.1General6.2.2Competence, awareness, and trainingNo significant differences.6.3Infrastructure6.4Work environmentThe intents of the two documents are consistent with each other.xxivQSReg, 21 CFR 820ISO 13485:2003Authorsnotes 820.70(e) Contamination control6.4Work environmentThe intents of both docume
43、nts are consistent with each other; the Standard specifically calls for control of used product to prevent contamination of other products, the manufacturing environment, or personnel.7.5.1.2.1Cleanliness of product and contamination controlThis section of the Standard introduces cleanliness control
44、s related to product that is to be sterilized. 820.70(f) Buildings6.3InfrastructureThe intents of the two documents are consistent with each other. 820.70(g) Equipment6.3InfrastructureThe intents of the two documents are consistent with each other; the QSReg contains a number of specific requirement
45、s related to the creation of maintenance schedules, inspections, and adjustment of equipment. 820.70(h) Manufacturing material6.3InfrastructureThe intents of the two documents are consistent with each other; the QSReg contains a number of specific requirements related to manufacturing materials. 820
46、.70(i) Automated processes7.5.2Validation of processes for production and service provisionNo significant differences. 820.72 Inspection, measuring, and test equipment7.6Control of monitoring and measuring equipmentThe intents of the two documents are consistent with each other, with the Standard pr
47、oviding generalized guidance as to the control of monitoring and measuring devices and the QSReg focusing more specifically on the process of calibration of such equipment.8Measurement, analysis, and improvement 8.1GeneralThere is no one section of the QSReg that corresponds to clause 8.1 of the Sta
48、ndard. It is clear from a reading of the overall QSReg that the objectives of this clause of the Standard and the QSReg are consistent with each other. 820.75 Process validation7.5.2Validation of processes for production and service provision 7.5.2.1General requirementsNo significant differences.The
49、 QSReg contains a number of prescriptive requirements associated with documentation of validation activities. There are no specific requirements related to process validation of sterilization processes in the QSReg.xxvQSReg, 21 CFR 820ISO 13485:2003Authorsnotes 820.80 Receiving, in- process, and finished device acceptance (a)General8.2.4Monitoring and measurement of productThe intents of the two documents are consistent with each other, even though the QSReg is far more detailed and prescriptive. The acceptance records requir
