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2006-12-16 00:49 |
Quality Manual
我以前搵過資料
ISO 9001 可以代替 ISO 17025 / GMP
唔知有冇人知? 有冇真實example?
千樺做廣告o既枇杷膏個間野
好似拎左 GMP 同 ISO 9001
咁會唔會重疊?
有冇d係應該申請 GMP 而只去申請 ISO 9001o既公司?
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ISO 9001 : 2000 (一般)
1. Scope
2. Normative references
3. Terms and definition
4. Quality management system
5. Management responsibility
6. Resource management
7. Product realization
8. Measurement, analysis and improvement
Summary of the ISO 9001 Standard:
Section 1: Quality Management System
This section of the ISO 9001:2000 standard outlines the necessary steps to implement the ISO 9001 quality management system:
> Identify the process (or activities) needed for the quality management system,
> Determine the sequence and interaction of these processes,
> Determine how these processes are effectively operated and controlled,
> Ensure that all information is available to support the operation and monitoring of these processes,
>Measure, monitor and analyze these processes, and implement action necessary to correct the processes and achieve continual improvement.
The ISO 9000 quality management system requires documentation that includes a quality manual, certain procedures, as well as work instructions. All documentation (including quality records) must be controlled according to a document control procedure. Also in this section, ISO 9001 emphasizes the need for continuous improvement.
Section 2: Management Responsibility
ISO 9001:2000 places great emphasis on top management’s commitment to quality. This section requires a quality policy and quality objectives, and it reinforces the involvement of top management with customer requirements.
This ISO 9001 section also requires top management to establish responsibilities and authorities within the company, including the establishment of an ISO 9000 management representative.
Section 3: Resource Management
This section of ISO 9001:2000 clarifies the requirement for a company to determine and provide, in a timely manner, resources (for example, equipment, facilities, etc) needed to implement and improve the processes of the ISO 9001 quality management system and to address customer satisfaction. This section also includes requirements for employee training, as well as for the physical facilities and the work environment.
Section 4: Product Realization
The ISO 9001:2000 standard defines Product Realization as “that sequence of processes and sub processes required to achieve the product.” This is how your product is designed, produced, tested, handled, shipped, etc. This section also applies to service providers. Emphasis is placed on how the company understands, communicates and actually meets customer requirements. This section also contains various requirements for the design of products and for the planning of processes, projects and services.
Section 5: Measurement, Analysis and Improvement
The last section of the ISO 9001:2000 standard closes the loop by providing requirements for measurement and monitoring activities, so that the company can immediately identify when not on track. Measurement and monitoring activities also include internal audits and the monitoring of customer perception as to whether the company has fulfilled customer requirements. All of these activities must be defined, planned and implemented. Measuring and monitoring allows the company to manage by fact, not by guess.
Source: http://www.iso9000council.org/
GMP: (食物/藥物)
1. The Quality System Regulation -- An Introduction
2. Quality Systems
3. Design Controls
4. Process Validation
5. Personnel
6. Buildings and Environment
7. Equipment and Calibration
8. Device Master Record
9. Document and Change Control
10. Purchasing and Acceptance Activities
11. Labeling
12. Product Evaluation
13. Packaging
14. Storage, Distribution, and Installation
15. Complaints
16. Servicing
17. Quality Systems Audits
18. Factory Inspections
19. Appendix (Index of appendices)
http://www.fda.gov/cdrh/qsr/contnt.html
Good Manufacturing Practice' is a set of regulations, codes, and guidelines for the manufacture drug products. It is for the control and management of manufacturing and quality control testing of pharmaceutical products.
Since sampling products will statistically only ensure that the samples themselves (and perhaps the areas adjacent to where the samples were taken) are suitable for use, and end-point testing relies on sampling, GMP takes the holistic approach of regulating the manufacturing and laboratory testing environment itself.
An extremely important part of GMPs is documenting every aspect of the process, activities, and of operations. If the documentation is not correct and in order, showing how the product was made and tested, that allows for traceability, and recall from the market in the event of future problems, then the product does not meet the required specification and is considered contaminated.
Additionally it is a GMP requirement that all manufacturing and testing equipment and utilities have been qualified as suitable for use; and that all operational methodologies and procedures (such as manufacturing, cleaning, and analaytical testing) utilized in the drug process have been validated to demonstrate that they can perform the activities they purport to, according to predetermined specifications.
[Source: http://en.wikipedia.org/wiki/Good_Manufacturing_Practice ]
ISO 17025:2005 (實驗室)
Introduction
Quality Policy Statement
1.0 Scope
2.0 References
3.0 Terms and Definitions
4.0 Management Requirements
4.1 Organization
4.2 Management System
4.3 Document Control
4.4 Review of Requests, Tenders, and Contracts
4.5 Subcontracting of Tests and Calibrations
4.6 Purchasing Services and Supplies
4.7 Service to the Client
4.8 Complaints
4.9 Control of Nonconforming Testing and/or Calibration Work
4.10 Improvement
4.11 Corrective Action
4.12 Preventive Action
4.13 Control of Records
4.14 Internal Audits
4.15 Management Reviews
5.0 Technical Requirements
5.1 Technical Requirements - General
5.2 Personnel
5.3 Accommodations and Environmental Conditions
5.4 Test and Calibration Methods and Method Validation
5.5 Equipment
5.6 Measurement Traceability
5.7 Sampling
5.8 Handling and Transportation of Test and/or Calibration Items
5.9 Assuring the Quality of Test and Calibration Results
5.10 Reporting the Results
http://www.iso.org/iso/en/commcentr...005/Ref956.html
ISO 17025:2005 - Abstract
ISO/IEC 17025:2005 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.
It is applicable to all organizations performing tests and/or calibrations. These include, for example, first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification.
ISO/IEC 17025:2005 is applicable to all laboratories regardless of the number of personnel or the extent of the scope of testing and/or calibration activities. When a laboratory does not undertake one or more of the activities covered by ISO/IEC 17025:2005, such as sampling and the design/development of new methods, the requirements of those clauses do not apply.
ISO/IEC 17025:2005 is for use by laboratories in developing their management system for quality, administrative and technical operations. Laboratory customers, regulatory authorities and accreditation bodies may also use it in confirming or recognizing the competence of laboratories. ISO/IEC 17025:2005 is not intended to be used as the basis for certification of laboratories.
Source: http://www.iso.org/iso/en/CatalogueDetailPage.CatalogueDetail?CSNUMBER=39883&ICS1=3&ICS2=120&ICS3=20
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