I want to implement ISO 9001:2000 and i’m at the document preparation step.
Could s.o help me with Operating procedures templates and forms (example doc) for the standard OP or ISO 9001 manager software.
Within ISO 9001:2001, there is only a mandatory requirement for the following documented procedures
· 4.2.3 Control of Documents
· 4.2.4 Control of Records
· 8.2.2 Internal Audits
· 8.3 Control Of Non-Conforming Product
· 8.5.2 Corrective Action
· 8.5.3 Preventative Action
The term used within ISO9001: 2001 is “documented procedure”; this means that the procedure is established, documented, implemented and maintained.
A good structure for a new “Quality Management System” could follow the 4-tier approach:
Level 1 - Quality Manual - Company Scope and Interactions of Process within the QMS.
Level 2 - Quality Procedures – Defines responsibilities, controls and activities within the QMS that effect customer service.
Level 3 – Records - Records / states objective evidence to demonstrate our goal in achieving “customer satisfaction”.
Level 4 – Forms, Reports – Information that supports the QMS processes
Control of Documents
· How “Your Company” approves documents prior to use e.g. sign off for paper versions, password protected for computer network forms.
· How “Your Company” updates and re-approve amended documents
· How “Your Company” identifies changes e.g. by date or issue number, identify different fonts / colours
· How “Your Company” ensure documents are available where they are needed
· How “Your Company” control external origin
· How “Your Company” prevents the inadvertent use of obsolete documentation.
Definition – “document” is an instruction to achieve a process, were unauthorised changes could cause a problem.
Examples – Quality Manual, procedures, flow charts, project plan, National Standards, Industry Requirements, Codes of Practice, Drawings, Software, Customer Specifications, visual samples.
Control Of Records
· “Your Company” must define which records are kept
· “Your Company” must define by whom is the record kept
· “Your Company” must define a how long a period each record is retained
· “Your Company” must define how they are disposed
With ISO9001 instruction “see 4.2.4” means records must be retained these include the following:
· 5.6.1 Management Review Minutes
· 6.2.2 Records of education, training, skills and experience
· 7.1 Evidence that product realization processes and product fulfils requirement
· 7.3.2 Design and development inputs
· 7.3.4 Design and development reviews and any related actions
· 7.3.5 Design and development verification (paper exercise) and any related actions
· 7.3.6 Design and development validation (produce confirmation) and any related actions
· 7.3.7 Design and development changes and any related actions
· 7.4.1 Results of Supplier evaluation and any actions arising
· 7.5.2 Records to demonstrate the validation of special processes
· 7.5.3 Where traceability is required, the unique identification of the product is recorded
· 7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable
· 7.6 Basis used for calibration of measuring equipment where no international standards exist
· 7.6 Validity of the previous measuring results when measuring equipment is found to be out of calibration
· 7.6 Results of calibration and verification of measuring equipment
· 8.2.2 Internal audit results and follow-up actions
· 8.2.4 Indication of the person(s) authorizing release of product
· 8.3 Records of the product nonconformities and any subsequent actions
· 8.5.2 Results of corrective action
· 8.5.3 Results of preventive action
Internal Audit
· “Your Company” must define the audit criteria e.g. what do we audit against, procedures, regulations, contractual requirements
· “Your Company”must define the Scope of the audit e.g. how far must we go, that would be sufficient to prove processes and interactions
· “Your Company” must define the Program Frequency (the whole QMS at least once a year)
· “Your Company” must define method e.g. interviewing staff, observation, viewing relevant records
· “Your Company” must report results
· “Your Company” must keep audit records
Control of Non-Conforming Product
· “Your Company” must define actions to stop the use of reject or suspect items
· “Your Company” must define how the concession system works
· “Your Company” must define actions to correct the problem
· “Your Company” must define how an item is checked following rework
· “Your Company” must define how a product recall or retro-fit is controlled
Corrective Action Procedure
Note: - Corrective action is re-active, dealing with the problem AFTER the event.
· “Your Company” must locate the cause of the problem
· “Your Company” must decide an appropriate course of action to stop the problem recurring
· “Your Company” must put the plan into action
· “Your Company” must ensure that the actions has solved the problem
· “Your Company” must review non-conformance report and customer complaints.
Preventive Action Procedure
Note: - Preventive action is a pro-active procedure i.e. dealing with the problem BEFORE it happens.
· “Your Company” must review potential problems
· “Your Company” must decide the potential cause of the problem
· “Your Company” must decide an appropriate course of action to stop the problem occurring
· “Your Company” must put the plan into action
· “Your Company” must ensure that the preventive action has solved the potential problem
·
Possible review to action: -
· Analysing data (8.4) and setting objectives (5.4.1)
· Clarifying customer requirements (7.2 and 7.3)
· Applying a proven corrective action (8.5.2) to other areas of the business analysing data (8.4) and setting objectives (5.4.1)
· Disaster recovery plan - what will you do if your building burns down, you lose a major customer, a raw material is no longer available, etc.?
You need to buy or download for manual.
The Quality Manual includes:
* Scope
* Normative Reference
* Definitions
* Quality Management System
* Management Responsibility
* Resource Management
* Product Realization
* Measurement, Analysis and Improvement
Keep in mind the ISO 9001:2001 is quickly being phased out.
Here is a site I found with lots of ISO 9001 2008 info.
It was helpful for me when I was recently trying to learn ISO 9001 2008.
ISO 9001:2008 and Quality Management
http://www.iso9001compliance.com/ISO-9001-2008/ISO-9001-2008-Articles/iso-90012008-and-quality-assurance.html
More ISO 9001 2008 Resources
http://www.iso9001compliance.com/ISO-9001-2008/
QMBeauty
[quote=QMbeauty]Keep in mind the ISO 9001:2001 is quickly being phased out.
Here is a site I found with lots of ISO 9001 2008 info.
It was helpful for me when I was recently trying to learn ISO 9001 2008.
More
QMBeauty[/quote]
Hi,
Thanks very much for this comment. It help me to think about my ideals.
Apart from that, you also can ref more resources at: ISO 9001-2008
http://Iso-90012008.net
Tks again and pls keep posting.
[quote=ChrisOB]I want to implement ISO 9001:2000 and i’m at the document preparation step.
Could s.o help me with Operating procedures templates and forms (example doc) for the standard OP or ISO 9001 manager software.[/quote]
ISO 9000 Operating Procedure
The ISO 9000 Operating Procedure Template includes and integrates the top level ISO 9000 quality manual and the six required quality procedures, thus containing the most difficult part of the ISO 9000 documentation. The ISO 9000 Operating Procedure Template include the detailed samples of the Operating Procedures to fulfill the ISO 9001 : 2008 requirements for the procedures, making the customization process even easier. The entire manual follows the structure of ISO 9001 : 2008.
ISO 9000 Operating Procedures Consist Of:
Control of documents
Control of records
Internal Audit
Control of non-conformance product
Corrective Action
Preventive Action
Training
Purchasing
ISO 9000 Forms
ISO 9001 : 2008 does not require forms but ISO 9001 : 2008 requires to keep records. Our well-designed forms make it easy to record the necessary information. In addition, our well-designed forms guide the user through a business process (for example, our Corrective & Preventive Action Plan Form guides you through the entire corrective action process), ensuring not only that all data is recorded but that all steps have properly been executed.
All our ISO 9000 Forms:
can immediately be used without any or with only little modifications(if you really need to, you can easily edit and customize in Microsoft Wordor Excel).
are designed by experienced quality managers and ISO 9000 auditors so that all forms are fully compliant with ISO 9001 : 2008 requirements.
are professionally laid out so that they are really easy to use without separate instructions.
Please visit ISO 9001
http://iso-90012008.net/
. I really hope that it’s useful for you.
Best rgs
[quote=gokeeffe]Within ISO 9001:2001, there is only a mandatory requirement for the following documented procedures
· 4.2.3 Control of Documents
· 4.2.4 Control of Records
· 8.2.2 Internal Audits
· 8.3 Control Of Non-Conforming Product
· 8.5.2 Corrective Action
· 8.5.3 Preventative Action
The term used within ISO9001: 2001 is “documented procedure”; this means that the procedure is established, documented, implemented and maintained.
A good structure for a new “Quality Management System” could follow the 4-tier approach:
Level 1 - Quality Manual - Company Scope and Interactions of Process within the QMS.
Level 2 - Quality Procedures – Defines responsibilities, controls and activities within the QMS that effect customer service.
Level 3 – Records - Records / states objective evidence to demonstrate our goal in achieving “customer satisfaction”.
Level 4 – Forms, Reports – Information that supports the QMS processes
Control of Documents
· How “Your Company” approves documents prior to use e.g. sign off for paper versions, password protected for computer network forms.
· How “Your Company” updates and re-approve amended documents
· How “Your Company” identifies changes e.g. by date or issue number, identify different fonts / colours
· How “Your Company” ensure documents are available where they are needed
· How “Your Company” control external origin
· How “Your Company” prevents the inadvertent use of obsolete documentation.
Definition – “document” is an instruction to achieve a process, were unauthorised changes could cause a problem.
Examples – Quality Manual, procedures, flow charts, project plan, National Standards, Industry Requirements, Codes of Practice, Drawings, Software, Customer Specifications, visual samples.
Control Of Records
· “Your Company” must define which records are kept
· “Your Company” must define by whom is the record kept
· “Your Company” must define a how long a period each record is retained
· “Your Company” must define how they are disposed
With ISO9001 instruction “see 4.2.4” means records must be retained these include the following:
· 5.6.1 Management Review Minutes
· 6.2.2 Records of education, training, skills and experience
· 7.1 Evidence that product realization processes and product fulfils requirement
· 7.3.2 Design and development inputs
· 7.3.4 Design and development reviews and any related actions
· 7.3.5 Design and development verification (paper exercise) and any related actions
· 7.3.6 Design and development validation (produce confirmation) and any related actions
· 7.3.7 Design and development changes and any related actions
· 7.4.1 Results of Supplier evaluation and any actions arising
· 7.5.2 Records to demonstrate the validation of special processes
· 7.5.3 Where traceability is required, the unique identification of the product is recorded
· 7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable
· 7.6 Basis used for calibration of measuring equipment where no international standards exist
· 7.6 Validity of the previous measuring results when measuring equipment is found to be out of calibration
· 7.6 Results of calibration and verification of measuring equipment
· 8.2.2 Internal audit results and follow-up actions
· 8.2.4 Indication of the person(s) authorizing release of product
· 8.3 Records of the product nonconformities and any subsequent actions
· 8.5.2 Results of corrective action
· 8.5.3 Results of preventive action
Internal Audit
· “Your Company” must define the audit criteria e.g. what do we audit against, procedures, regulations, contractual requirements
· “Your Company”must define the Scope of the audit e.g. how far must we go, that would be sufficient to prove processes and interactions
· “Your Company” must define the Program Frequency (the whole QMS at least once a year)
· “Your Company” must define method e.g. interviewing staff, observation, viewing relevant records
· “Your Company” must report results
· “Your Company” must keep audit records
Control of Non-Conforming Product
· “Your Company” must define actions to stop the use of reject or suspect items
· “Your Company” must define how the concession system works
· “Your Company” must define actions to correct the problem
· “Your Company” must define how an item is checked following rework
· “Your Company” must define how a product recall or retro-fit is controlled
Corrective Action Procedure
Note: - Corrective action is re-active, dealing with the problem AFTER the event.
· “Your Company” must locate the cause of the problem
· “Your Company” must decide an appropriate course of action to stop the problem recurring
· “Your Company” must put the plan into action
· “Your Company” must ensure that the actions has solved the problem
· “Your Company” must review non-conformance report and customer complaints.
Preventive Action Procedure
Note: - Preventive action is a pro-active procedure i.e. dealing with the problem BEFORE it happens.
· “Your Company” must review potential problems
· “Your Company” must decide the potential cause of the problem
· “Your Company” must decide an appropriate course of action to stop the problem occurring
· “Your Company” must put the plan into action
· “Your Company” must ensure that the preventive action has solved the potential problem
·
Possible review to action: -
· Analysing data (8.4) and setting objectives (5.4.1)
· Clarifying customer requirements (7.2 and 7.3)
· Applying a proven corrective action (8.5.2) to other areas of the business analysing data (8.4) and setting objectives (5.4.1)
· Disaster recovery plan - what will you do if your building burns down, you lose a major customer, a raw material is no longer available, etc.?[/quote]
Hi,
Good ideal, pls try to keep posting. I like this topic very much and I will digged this one. Tks again.
If you want to get more materials that related to this topic, you can visit: ISO 9001 2008 requirements
http://iso-90012008.net/iso-9001-2008-requirements/
Best regards.
Hi,
There are the basics of manual that can guide you throughout the whole process.You need to have a look on that-
There are 8 sections in ISO 9001:
- Scope
- References
- Terms and conditions
- Quality management system
- Management responsibility
- Resource management
- Product realisation
- Measurement, analysis and improvement
In order to achieve certification an organization should have proper documented quality system and not a system of documents. It has various sections 4,5,6,7 and 8 which contain the requirement themselves.
Thanks!!!
ISO Certification
http://www.almir.biz/index.php/iso-9001-iso27001-iso13485-iso-certification-consultants
ISO 9001:2008 doesn’t introduce major changes to the requirements, when compared to ISO 9001:2000. However, to benefit from the changes, we suggest you get acquainted with the new version of the standard and the clarifications introduced. If, during your analysis of the clarifications you find there are differences from your current interpretation of ISO 9001:2000