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Dear Rose:
The accurate answer to your question goes as follows.
ISO 9001:2000 Requires 3 Documents and 6 documented procedures
The 3 Documents are:
1- Quality policy, as per Clause 4.2.1a
2- Quality objectives, as per Clause 4.2.1a
3- Quality Manual, as per Clause 4.2.1b
The 6 Documented Procedures are:
1- Control of documents, as per Clause 4.2.3 (to keep your life simple, this need an off-the-shelf application in order to control revision level, approval, archiving, etc)
2- Control of records, as per Clause 4.2.4
3- Internal Audit, as per Clause 8.2.2
4- Control of nonconforming product, as per Clause 8.3
6- Corrective action, Clause 8.5.2
7- Preventive Action, Clause 8.5.3
Note: Some companies combine Corrective and Preventive into the same document.
The problem is that in practice, the organization needs to create other documentation in order to enhance the ability of the Quality Management System to both achieve and demonstrate conformance to several ISO 9001:2000 requirements. That is why you may need to create additional documents such as (i.e. this is why the consultant incorrectly stated that you need to create a document for every clause) :
1- Process Maps or Process Flow chart are great tools to define your processes
2- Organization Charts
3- Work instructions (Assembly, Test, Maintenance, Calibration, etc).
4- Approval of suppliers
5- Management Reviews
6- etc, etc, etc
Note: The rational of the ISO 9001:2000 implementation is simple,
1- Identify the ISO 9001:2000 record requirements
2- Identify the activities/processes that generate the required record
3- Document the activity/process that are required
4- Document additional activities/processes that will help you to maintain compliance
5- Don't overlook that ISO 9001:2000 shall be value added. Documented processes shall help you to: train new hires easier, implement cross training, achive the same result; on-time, and with the required quality level.
The above Documented Procedures need be controlled as per clause 4.2.3 and your records need to be controlled as per clause 4.2.4.
Some example of ISO 9001:2000 records requirements include:
1- Management reviews (5.6.1)
2- Education, training, skills and experience (6.2.2e)
3- Evidence that the realization processes and resulting product fulfill requirements (7.1d)
4- Design and development inputs (7.3.2)
5- Results of design and development reviews (7.3.4)
6- Results of design and development verification
7- Results of design and development validation
8- Results of review of design and development changes (7.3.7)
9- Results of supplier evaluations (7.4.1)
10- To demonstrate process validity where output cannot be measured (7.5.2d)
11- The unique identification of a product (7.5.3)
12- Customer property (7.5.4)
13- Basis for calibration of measuring equipment (7.6a)
14- Results of calibration (7.6)
15- Internal audits (8.2.2)
16- Release of product (8.2.2)
17- Nonconforming product (8.3)
18- Results of corrective action (8.5.2)
19- Results of preventive action (8.5.3)
Note: You need to read every clause carefully in order to make sure you meet the intent of each clause. You can always have more if needed, but you can not effort to miss a requirement. Since ISO 9001:2000 focus on what is required, the client has great freedom with regards the how to do it.
It is sad that your consultant is weak. A season ISO 9001:2000 practitioner shall be a mentor (i.e. ISO 9001:2000 is conceptually easy). Unfortunately your consultant is not able to communicate effectively.
Cuadra
The accurate answer to your question goes as follows.
ISO 9001:2000 Requires 3 Documents and 6 documented procedures
The 3 Documents are:
1- Quality policy, as per Clause 4.2.1a
2- Quality objectives, as per Clause 4.2.1a
3- Quality Manual, as per Clause 4.2.1b
The 6 Documented Procedures are:
1- Control of documents, as per Clause 4.2.3 (to keep your life simple, this need an off-the-shelf application in order to control revision level, approval, archiving, etc)
2- Control of records, as per Clause 4.2.4
3- Internal Audit, as per Clause 8.2.2
4- Control of nonconforming product, as per Clause 8.3
6- Corrective action, Clause 8.5.2
7- Preventive Action, Clause 8.5.3
Note: Some companies combine Corrective and Preventive into the same document.
The problem is that in practice, the organization needs to create other documentation in order to enhance the ability of the Quality Management System to both achieve and demonstrate conformance to several ISO 9001:2000 requirements. That is why you may need to create additional documents such as (i.e. this is why the consultant incorrectly stated that you need to create a document for every clause) :
1- Process Maps or Process Flow chart are great tools to define your processes
2- Organization Charts
3- Work instructions (Assembly, Test, Maintenance, Calibration, etc).
4- Approval of suppliers
5- Management Reviews
6- etc, etc, etc
Note: The rational of the ISO 9001:2000 implementation is simple,
1- Identify the ISO 9001:2000 record requirements
2- Identify the activities/processes that generate the required record
3- Document the activity/process that are required
4- Document additional activities/processes that will help you to maintain compliance
5- Don't overlook that ISO 9001:2000 shall be value added. Documented processes shall help you to: train new hires easier, implement cross training, achive the same result; on-time, and with the required quality level.
The above Documented Procedures need be controlled as per clause 4.2.3 and your records need to be controlled as per clause 4.2.4.
Some example of ISO 9001:2000 records requirements include:
1- Management reviews (5.6.1)
2- Education, training, skills and experience (6.2.2e)
3- Evidence that the realization processes and resulting product fulfill requirements (7.1d)
4- Design and development inputs (7.3.2)
5- Results of design and development reviews (7.3.4)
6- Results of design and development verification
7- Results of design and development validation
8- Results of review of design and development changes (7.3.7)
9- Results of supplier evaluations (7.4.1)
10- To demonstrate process validity where output cannot be measured (7.5.2d)
11- The unique identification of a product (7.5.3)
12- Customer property (7.5.4)
13- Basis for calibration of measuring equipment (7.6a)
14- Results of calibration (7.6)
15- Internal audits (8.2.2)
16- Release of product (8.2.2)
17- Nonconforming product (8.3)
18- Results of corrective action (8.5.2)
19- Results of preventive action (8.5.3)
Note: You need to read every clause carefully in order to make sure you meet the intent of each clause. You can always have more if needed, but you can not effort to miss a requirement. Since ISO 9001:2000 focus on what is required, the client has great freedom with regards the how to do it.
It is sad that your consultant is weak. A season ISO 9001:2000 practitioner shall be a mentor (i.e. ISO 9001:2000 is conceptually easy). Unfortunately your consultant is not able to communicate effectively.
Cuadra
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