ISO 9001:2000 - Templates for procedures and forms

C

claud

#1
Hello,

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.
My email is:
(please contact through my profile, added Howard)
Thank you in advance for your help!
claud
 
Last edited by a moderator:
Elsmar Forum Sponsor
T

Ted Schmitt

#2
Re: Iso 9001:2000

Claud,

Welcome to the Cove !

You can find examples of OP right here.... up on the top of the screen next to the light house, there is a green button "POST ATTACHMENTS LIST" AND "MORE FREE FILES".... try looking there, or use our SEARCH button on the top menu... You should be able to find examples of formatting there....

BUT....

use them only as formatting... OP, work instructions and other docs should be unique to your company and your system !
 

Howard Atkins

Forum Administrator
Staff member
Admin
#3
Re: Iso 9001:2000

Hello,

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.
My email is:

Thank you in advance for your help!
claud
claud,
there is a forum for this issue Documentation Systems, Procedures, Forms and Templates Have a look there.
The best way is to see some examples and then decide what style is the best for you. If you have specific question ask again.
 
C

claud

#4
I know that part of ISO 9001:2000 are the following OP:

OP 4.2.3 Control of Documents
OP 4.2.4 Control of Records
OP 5.6 Management Review
OP 6.2.2 Competence, Awareness and Training
OP 6.3 Facilities and Equipment Maintenance
OP 7.1 Product Quality Planning
OP 7.2.2 Product Requirements Identification and Review
OP 7.3 Design and Development
OP 7.4.1 Supplier Evaluation
OP 7.4.2 Purchasing
OP 7.5.1 Job Planning and Control
OP 7.5.2 Validation of Product Realization Processes
OP 7.5.3 Production Identification and Traceability
OP 7.5.4 Control of Customer Supplied Property
OP 7.5.5 Preservation of Product
OP 7.6 Control of Monitoring and Measuring Devices
OP 8.1 Statistical Techniques
OP 8.2.1 Customer Satisfaction
OP 8.2.2 Internal Audit
OP 8.2.3 Monitoring and Measurement of Processes
OP 8.2.4 Monitoring and Measurement of Product
OP 8.3 Control of Nonconforming Product
OP 8.5 Continual Improvement


I found something in this forum but I would like to have a full set of examples if it is possible and to adopt them to my company because i don't have any idea how to start with the OPs.
At the moment I have a sample of the Qaulity manual!
 

Stijloor

Staff member
Super Moderator
#5
Hello Claud,

Please be aware that ISO 9001:2000 requires only 6 (documented) procedures:
  • 4.2.3 Control of documents
  • 4.2.4 Control of records
  • 8.2.2 Internal audits
  • 8.3 Control of nonconforming product
  • 8.5.2 Corrective action
  • 8.5.3 Preventive action
The rest is really up to you. Don't fall into the "documentation trap."
As my Fellow Covers already pointed out, there are examples available for download. You got to do some searching though.

Stijloor.
 
Last edited:
B

Britman - 2012

#6
As Stijloor stated - this may help?

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.?
 
Last edited by a moderator:

Stijloor

Staff member
Super Moderator
#7
Hello,

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.
My email is:
(please contact through my profile, added Howard)
Thank you in advance for your help!
claud
Hello Claud,

Attached are:
  • An example of how to write a procedure
  • An example of an Internal Audit procedure
Please keep in mind that there are different ways to document a process:
  • Traditional procedure
  • Process map
  • Flow chart
Pick the format that best suits your operation.

Stijloor.
 

Attachments

R

richgibson

#8
There is some help on site called biztomax about QMS and iqualityengineer site had some free downloads will help for CQE.
Regards

Thanks
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#9
Just some information: The Poster has not been back since this post in 2007. But, if you have suggestions, continue to provide them or start a new thread.

Here is a more current thread that touches base, upon this question: Read Here
 
Last edited:
S

shawnann

#10
Hello Claud,

Please be aware that ISO 9001:2000 requires only 6 (documented) procedures:
  • 4.2.3 Control of documents
  • 4.2.4 Control of records
  • 8.2.2 Internal audits
  • 8.3 Control of nonconforming product
  • 8.5.2 Corrective action
  • 8.5.3 Preventive action
The rest is really up to you. Don't fall into the "documentation trap."
As my Fellow Covers already pointed out, there are examples available for download. You got to do some searching though.

Stijloor.
OK, I know this thread is old, but I had a question about the above.

I'm probably being blind, but where does it state that you only have to have procedures for those 6?

We have been updating our manuals, procedures, and forms and since we have procedures written for more than just those 6 listed above, I'd like to propose that we eliminate the others if we can (still have to see which ones we would really need to keep) but I don't want to propose the change or make the change without having a reference somewhere that I can show the auditor during our next audit if questioned.

TIA
 
Thread starter Similar threads Forum Replies Date
R Key Process Indicators (KPIs) for ISO 9001:2000-certified Service Organization ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
P Internal Audit for ISO 9001:2000 vs. Internal Audit for OHSAS 18001:2007 Internal Auditing 4
H ISO 9001:2000 Certificate - Original approval date 18 July 1995 and valid until 2012 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 27
E ISO 9001:2000 transition to ISO 9001:2008 - Do I have to rewrite the QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
M Advantage between ISO 9001:2000 vs ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
A Quitting ISO 9001:2000 - Necessary Changes to product literature, logos, etc. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
M Updating a Quality Manual from ISO 9001:2000 to ISO 9001:2008 Quality Management System (QMS) Manuals 57
B Updating from ISO 9001:2000 to ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
B Advice needed for ISO 9001:2000 update to 2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
K How to update from Procedure to Process - ISO 9001:2000 to ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
F How much longer can a company declare registration to ISO 9001:2000? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
N ISO 9001: 2000 to ISO 9001: 2008 - How to change the documents & procedures? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Transition from ISO 9001:2000 to ISO 9001:2008 and TS 16949:2002 to TS 16949:2009 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
V ISO 9001:2000 to ISO 9001:2008 - Identification in meeting notes. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
E Validity of ISO 9001:2000 Certificates - How to handle supplier ISO 9001 certificates ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
K Interpretation of the differences between ISO 9001: 2000 & 2008? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Q How long is ISO 9001:2000 good for (valid) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
N ISO 9001:2000 version to ISO 9001:2008 - Necessary Document Revisions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q ISO 9001:1994 Upgrading to ISO 9001:2000 or ISO 9001:2008? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
D Time frame for validity of ISO 9001:2000 Certifications IATF 16949 - Automotive Quality Systems Standard 3
H Effectiveness of ISO 9001:2000 Implementation in small industrial organizations? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 29
J Is Version Change needed for ammending ISO 9001:2000 to 2008 Document Control Systems, Procedures, Forms and Templates 1
L ISO 9001:2000 vs. ISO 9001:2008 differences and concerns ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
R ISO 9001:2000 to ISO 9001:2008 Transition - Changing documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
C Recertification for ISO 9001:2000 - framework ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
D Relationship between ISO 9001:2000 and EFQM ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
D Acquisition (Merger) of an ISO certified to ISO 9001:2000 company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A Is ISO 9001 Transition (from 2000 to 2008 version) Training Required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
P Calibration - Clause 7.6 of ISO 9001:2000 - Is all this necessary? General Measurement Device and Calibration Topics 42
D To change or not to change? Our documents reference ISO 9001:2000 Document Control Systems, Procedures, Forms and Templates 31
A Registration to ISO 9001:2000 in 2009? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S What are the consequences of having an expired ISO 9001:2000 Certificate ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A A macro-process structure approach to auditing for ISO 9001:2000(8) General Auditing Discussions 19
B CNC Controls under ISO 9001:2000 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Marc Summary of ISO 9001:2000 and ISO 9001:2008 Changes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 166
A Brief discussion about ISO 9001:2000 clauses ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
K Advice on exclusion of 7.5.2 of the ISO 9001:2000 Standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
L ISO 9001:2000 and CMMI v1.2 Integration and Org Deployment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
GStough REACH and ISO 9001:2000/13485:2003 - Never the Twain Shall Meet? RoHS, REACH, ELV, IMDS and Restricted Substances 4
S GAP Analysis for ISO 9001:2000 vs. ISO 13485:2003 ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 9001:2000 - Implementation in an Environmental Consulting Firm ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
K Getting started with ISO 9001:2000 Templates Document Control Systems, Procedures, Forms and Templates 18
Z Synchronizing two quality management systems: ISO 9001:2000 Quality Manager and Management Related Issues 5
J ISO 9001:2000 4.2.3- Quality Records, Production Travelers Records and Data - Quality, Legal and Other Evidence 9
C ISO 9001:2000 Certificate - How to have a 3 year validity instead of 1? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
N When will ISO 9001:2000 Certificates turn into ISO 9001:2008? General Auditing Discussions 11
J Should product brochures be controlled per ISO 9001:2000? Document Control Systems, Procedures, Forms and Templates 2
I ISO 9001:2000 Recertification controls ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J ISO 9001:2000 7.3.5 "Verification" and 7.3.6 "Validation"- Clarification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 29
J Must you use an ISO 17025 lab in order to receive ISO 9001:2000 Certification ISO 17025 related Discussions 16

Similar threads

Top Bottom