Views:27 Author:Natalia Publish Time: 2015-12-31 Origin:Biotech Articles
1. Management Responsibility:
The quality policy shall be defined, documented, understood, implemented and maintained.
Responsibilities and authorities for all personnel specifying, achieving and monitoring quality shall be defined.
In-house verification resources shall be defined, trained and funded.
A designated management person sees that the Q91 program is implemented and maintained.
2. Quality System:
Procedures shall be prepared.
Procedures shall be implemented.
3. Contract Review:
Incoming contracts (and purchase orders) shall be reviewed to see whether the requirements are adequately defined, agree with the bid and can be supplied.
4. Design Control:
The design project shall be planned.
Design input parameters shall be defined.
Design output, including crucial product characteristics shall be documented.
Design output shall be verified to meet input requirements.
Design changes shall be controlled.
5. Document Control:
Generation of documents shall be controlled.
Distribution of documents shall be controlled.
Changes to documents shall be controlled.
Potential subcontractors and sub-suppliers shall be evaluated for their ability to provide stated requirements.
Requirements shall be clearly defined in contracting data.
Effectiveness of the subcontractor's quality assurance system shall be assessed.
7. Customer-Supplied Material:
Any customer-supplied material shall be protected against loss or damage.
8. Product Identification & Tracability:
The products shall be identified and traceable by item, batch or lot during all stages of production, delivery and installation.
9. Process Control:
Production (and installation) processes shall be defined and planned.
Production shall be carried out under controlled conditions: documented instructions, in-process controls, approval of processes and equipment, and criteria for workmanship.
Special processes that cannot be verified after the fact shall be monitored and controlled throughout the processes.
10. Inspection and Testing:
Incoming materials shall be inspected or verified before use.
In-process inspection and testing shall be performed.
Final inspection and testing shall be performed prior to release of finished product.
Records of inspection and test shall be kept.
11. Inspection/Measuring/Test Equipment:
Equipment used to demonstrate conformance shall be controlled, calibrated and maintained.
Identify measurements to be made.
Identify affected instruments.
Calibrate instruments (procedures and status indicators).
Periodically check calibration.
Assess measurement validity if found out of calibration.
Control environmental conditions in metrology lab.
Measurement uncertainty and equipment capability shall be known.
Where test hardware or software is used, it shall be checked before use and rechecked during use.
12. Inspection and Test Status:
Status of inspections and tests shall be maintained for items as they progress through various processing steps.
Records shall show who released conforming product.
13. Control of Nonconforming Product:
Nonconforming product shall be controlled to prevent inadvertent use or installation.
Review and disposition of nonconforming product shall be formalized.
14. Corrective Action:
Problem causes shall be identified.
Specific problems and their causes shall be corrected.
Effectiveness of corrective actions shall be assessed.
15. Handling, Storage, Packaging & Delivery:
Procedures for handling, storage, packaging and delivery shall be developed & maintained.
Handling controls shall prevent damage and deterioration.
Secure storage shall be provided. Product in stock shall be checked for deterioration.
Packing, preservation and marking processes shall be controlled.
Quality of the product after final inspection shall be maintained. This might include delivery controls.
16. Quality Records:
Quality records shall be identified, collected, indexed, filed, stored, maintained and dispositioned.
17. Internal Quality Audits:
Audits shall be planned and performed.
Results of audits shall be communicated to management.
Any deficiencies found shall be corrected.
Training needs shall be identified.
Training shall be provided.
Some tasks may require qualified individuals.
Records of training shall be maintained.
Servicing activities shall be performed to written procedures.
Servicing activities shall meet requirements.
20. Statistical Techniques:
Statistical techniques shall be identified.
Statistical techniques shall be used to verify acceptability of process capability and product characteristics.
The debate on the effectiveness of ISO 9000 commonly centers on the following questions:
1. Are the quality principles in ISO 9001:2000 of value? (Note that the version date is important: in the 2000 version ISO attempted to address many concerns and criticisms of ISO 9000:1994).
2. Does it help to implement an ISO 9001:2000 compliant quality management system?
3. Does it help to obtain ISO 9001:2000 certification?
Effectiveness of the ISO system being implemented depends on a number of factors, the most significant of which are:
1. Commitment of Senior Management to monitor, control, and improve quality. Organizations that implement an ISO system without this desire and commitment, often take the cheapest road to get a certificate on the wall and ignore problem areas uncovered in the audits.
2. How well the ISO system integrates into their business practices. Many organizations that implement ISO try to make their system fit into a cookie-cutter quality manual rather than create a manual that documents existing practices and only adds new processes to meet the ISO standard when necessary.
3. How well the ISO system focuses on improving the customer experience. The broadest definition of quality is "Whatever the customer perceives good quality to be". This means that you don't necessarily have to make a product that never fails, some customers will have a higher tolerance for product failures if they always receive shipments on-time, or some other dimension of customer service. Your ISO system should take into account all areas of the customer experience, the industry expectations, and seek to improve them on a continual basis. This means taking into account all processes that deal with the three stakeholders (your customers, your suppliers, and your organization), only then will you be able to sustain improvements in your customer experience.
4. How well the auditor finds and communicates areas of improvement. Now, ISO auditors may not provide consulting to the clients they audit, however, there is the potential for auditors to point out areas of improvement. Many auditors simply rely on submitting reports that indicate compliance or non-compliance with the appropriate section of the standard, however, to most executives, this is like speaking a foreign language. Auditors that can clearly identify and communicate areas of improvement in language and terms executive management understands allows the companies they audit to act on improvement initiatives. When management doesn't understand why they were non-compliant and the business implications, they simply ignore the reports and focus on what they do understand.
It is widely acknowledged that proper quality management improves business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation. The quality principles in ISO 9000:2000 are also sound, according to Wade and Barnes, who say that "ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive implementing ISO often gives the following advantages:
1. Create a more efficient, effective operation
2. Increase customer satisfaction and retention
3. Reduce audits
4. Enhance marketing
5. Improve employee motivation, awareness, and morale
6. Promote international trade
7. Increases profit
8. Reduce waste and increases productivity.