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by Dexter A. Hansen

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ISO 9000 Procedure Writing Information

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ISO Procedure Definition:

Responsibilities for Procedures:

Requirements of Procedures:

Procedures should specify:

Other considerations to incorporate in procedures:

The Bottom Line:

Tips on Procedures:

Work Instructions vs. Procedures:

Work Instruction Definition:

Responsibilities for Work Instructions:

Requirements of Work Instructions:

Work Instructions should specify:

Other considerations to incorporate in work instructions:

Return to ISO Help Page:


ISO 9000 Procedure Writing Information

Procedure: A procedure (for purposes of the ISO 9001 implementation) is defined as a documented process for quality activities that are interdepartmental. The intent of the procedures are to be used as a reference where they will provide guidance and consistency when employees perform quality related tasks.

Responsibilities for Procedures:

  • Each department must be responsible for writing their procedures.

  • Managers for the departments have approval of all procedures under their areas of responsibility.

Requirements of Procedures:

  • Procedures must be under some form of document control. (numbered, revision, signed & dated)

  • Procedures should reference inner-related procedures and quality system documentation created from following the procedure.

  • Quality Records as required by the ISO 9001 standard that are generated by a procedure or work instruction must be listed in a Quality Records Procedure (This is not always required by all registrar's, however, is a required by many and is appreciated.

Procedures should specify:

  • What should be done?
  • Who will do it?
  • When will it be done and in what sequence?

  • How will it be done?

  • What equipment, tools or materials will be used?

  • What forms or other documents will be used.?

  • An appendix for all forms used in the procedure

  • A flow chart for the procedure (where applicable ­ the flow chart can be the procedure if it is understandable)

  • Signed, dated authorizations under revision control with controlled distributions.

Other considerations to incorporate in procedures:

  • Definitions

  • Referencing standards

  • Safety or danger warnings related to the procedure

  • Documentation

  • Quality Records

The Bottom Line:

For ISO 9001 compliance, the bottom line is to write what you do, then do what you have written.

Tips on Procedures:

Tip 1: The more general the procedure, the more flexible, however, the more specific the guidance, for those responsible for carrying out job duties, the easier the system is to maintain.

Tip 2: There must be at least one procedure for each element for the standard, dependant upon complexity of the element. Writing separate procedures for manageable activities will be less confusing than one grand activity.

  • Note: At this time all the elements are to be covered, however, as a company changes, it changes how it does, hence, the number of procedures may change.

Tip 3: A reference can be put into the procedures referencing other procedures if you are documenting the elements other than by the ISO Standard numbering scheme.

  • Note: The systems currently set up by the author are done so that the Quality Manual references Quality System Procedures and the Quality System Procedures reference Departmental Work Instructions.

Tip 4: Try to keep the procedures from being to specific. Assign who (by job title) does a task and when does it happen.

  • Note: Specific instruction on how to do tasks are work instruction.

Tip 5: When assigning responsibility, the use of assignee, designee or successor following the title of the person responsible in the process will keep the process flexible and provide an option should the responsible person be unavailable at any specific time.

Tip 6: Keep the use of symbols minimized.

Tip 7: There must be consistency in action.

Tip 8: Use of a flow chart is not required, however, is highly recommended.   I recommend visiting the Flowcharting Help Page (Tutorial) at http://home.net.att/~dexter.a.hansen/flowchart/flowchart.htm

  • Note: The reason flow chart is recommended is that the auditor may chose to flow chart the procedure to check it out. He/she may make an error to the flow because of the complexity of the procedure which may not readily be found. This could be a problem if he/she determines there is a noncompliance and the error can't be found..

Work Instructions vs. Procedures:

Work instructions are not as general as procedures and are very task specific. They should tell how to do or use something (i.e. How to solder. How to use loctite. How to assemble a Widget.).

Work Instruction: A work instruction (for purposes of the ISO 9001 implementation) is defined as a documented process for quality activities that are intradepartmental. The intent of the work instructions are to be used as a reference where they will provide guidance and consistency when employees perform specific quality related tasks within a department.

Responsibilities for Work Instructions:

  • Each department must be responsible for writing their procedures.

  • Managers/Supervisors for the departments have approval of all work instructions under their areas of responsibility.

Requirements of Work Instructions:

Procedures and Work Instructions must be under some form of document control by the generating department. (numbered, revision, signed & dated, distribution maintained) Work Instructions should reference related procedures and quality system documentation created from following the procedure. Quality Records required by the ISO 9001 standard that are generated by a procedure or work instruction must be listed in a Quality Records Procedure.

  • Note 1: Quality Records are typically referenced in Quality System Procedures, but may be generated as a part of a work instruction. A separate Quality Records section is not required for work instructions provided general instruction exist within the Quality System Procedures that reference the record.

  • Note 2: The Quality Records Element requires that records be listed.  It is recommended to list them under under the appropriate ISO element within  the Quality Records Procedure, list the proper name of the record, location where stored, person responsible for maintaining the record, by title and the retention period for the document.

Work Instructions should specify:

  • What should be done?

  • Who will do it?

  • When will it be done and in what sequence?

  • How will it be done?

  • What equipment or materials will be used?

  • What forms or other documents will be used.?

  • An appendix for all forms used in the procedure

  • A flow chart for the procedure (where applicable ­ the flow chart can be the procedure if it is understandable)

  • Signed, dated authorizations under revision control with controlled distributions.

Other considerations to incorporate in work instructions:

  • Definitions
  • Referencing standards

  • Safety or danger warnings related to the procedure

  • Documentation

  • Quality Records

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ISO Help Page List of Recommended Quality System Implementation Books


ISO 9000 Documentation, Quality Manual and 32 Operational Procedures (AQA ISO 9000 Series) by Jack Kanholm. Paperback
ISO 9000 In Our Company, Self-Study Course for Personnel (AQA ISO 9000 Series) by Jack Kanholm. Mass Market Paperback

ISO 9000 Requirements, 72 Requirements Checklist and Compliance Guide (AQA ISO 9000 Series) by Jack Kanholm. Hardcover


Iso 9000 Quality System : Department by Department Implementation for the Certification Audit -- Jack Kanholm; Hardcover. 

ISO 9000: 2000 (DIS) New Requirements, 28 Requirements Checklist and Compliance Guide -- Jack Kanholm; Paperback. 
Tool Kit : Forms, Checklists, Project Planning Tools, Transparency Masters; Vincent Zottola; Card Edition  This is a little more costly than the Jack Kanholm book, however, you don't have to create training materials.
ISO Help Page List of Recommended Other Quality Books


QS-9000 In Our Company, Self-Study Course for Personnel (AQA QS-9000 Series) by Jack Kanholm. Mass Market
QS-9000 Requirements, 119 Requirements Checklist and Compliance Guide (AQA QS-9000 Series)
-- Jack Kanholm; Hardcover
QS-9000 Documentation, Quality Manual and 43 Operational Procedures (AQA QS-9000 Series)
by Jack Kanholm. Paperback

ISO 13485 (EN 46000) Documentation, Quality Manual and 36 Operational Procedures (AQA ISO 13485 (EN 46000) Series)
by Jack Kanholm, Lynette Howard. Paperback
ISO 13485 (EN 46000) In Our Company, Self-Study Course for Personnel (AQA ISO 13485 (EN 46000) Series)
by Jack Kanholm. Mass Market Paperback
ISO 13485 (EN 46000) Requirements, 99 Requirements Checklist and Compliance Guide (AQA ISO 13485 (EN 46000) Series) by Jack Kanholm, Lynette Howard. Hardcover
ISO 14000 In Our Company, Self-Study Course for Personnel (AQA ISO 14000 Series) by Jack Kanholm. Mass Market Paperback
ISO 14000 Requirements, 61 Requirements Checklist and Compliance Guide (AQA ISO 14000 Series) by Jack Kanholm. Hardcover
ISO 14000 Documentation, Environmental System Manual and 20 Operational Procedures (AQA ISO 14000 Series) by Jack Kanholm. Paperback
Quality Is Free : The Art of Making Quality Certain; This has it's fine points, however, can be dry. Best not taken in one or two sittings. Philip B. Crosby; Mass Market Paperback.


Quality Is Still Free : Making Quality Certain in Uncertain Times; Philip B. Crosby; Hardcover

Quality Is Free : The Art of Making Quality Certain; Philip B Crosby; Hardcover; (Special Order)

A History of Managing for Quality : The Evolution, Trends, and Future Directions of Managing for Quality; J.M. Juran (Editor); Hardcover
Juran on Leadership for Quality : An Executive Handbook; Joseph M. Juran; Hardcover

Juran on Quality by Design : The New Steps for Planning Quality into Goods and Services;  Joseph M. Juran; Hardcover
Juran's Quality Control Handbook; Frank M. Gryna (Editor), J. M. Juran; Hardcover

Quality Planning and Analysis : From Product Development Through Use (Industrial Engineering and Management Science); J.M. Juran, Frank M. Gryna; Hardcover

ISO Help Page List of Recommended Management Books


The 7 Habits of Highly Effective People : Powerful Lessons in Personal Change; A great book on how to get organized if your into self improvemnt and feel organizationally handicapped; Stephen R. Covey; Paperback

Critical Chain; A book dealing with supplier chains. Not too bad, but hard to find in a book store. Eliyahu M. Goldratt; Paperback

The Goal : A Process of Ongoing Improvement; One of the "Classics", used by practitioners and graduate schools alike. Eliyahu M. Goldratt, Jeff Cox; Paperback; $17.96

The Goal : A Process of Ongoing Improvement/Cassettes; For those who would rather listen while driving thier car, rather than read. Eliyashu M. Goldratt, et al; Audio

ISO Help Page List of Recommended Humorous Management Books (Humor for the those who have been there.)


Dogbert's Top Secret Management Handbook;   If you need a little humor in your life, you can also visit Scott Adam's at his Web Site http://www.dilbert.com/ for a daily dose.  Scott Adams; Hardcover; Published 1996

Access Denied : Dilbert's Quest for Love in the Nineties; Scott Adams; Hardcover;

Always Postpone Meetings With Time Wasting Morons; Scott Adams; Paperback; Published 1994

Access Denied : Dilbert's Quest for Love in the Nineties; Scott Adams; Hardcover

Always Postpone Meetings With Time Wasting Morons; Scott Adams; Paperback; Published 1994

The Boss : Nameless, Blameless and Shameless ;Scott Adams; Hardcover; Published 1997

Bring Me the Head of Willy the Mailboy!;  Scott Adams;Paperback; Published 1995

Casual Day Has Gone Too Far : A Dilbert Book; Scott Adams;  Paperback; Published 1997

Conversations With Dogbert (Dilbert Book);    Scott Adams; Hardcover; Published 1996

The Dilbert Principle : A Cubicle'S-Eye View of Bosses, Meetings, Management Fads & Other Workplace Afflictions; Scott Adams; Paperback; Published 1997

The Dilbert Principle : A Cubicle's Eye View of Bosses, Meetings, Management Fads, & Other Workplace Afflictions / Audio Cassette / Abridged; Scott Adams; Audio Cassette; Published 1996

Dilbert : A Book of Postcards; Scott Adams; Paperback; Published 1996

The Dilbert Future : Thriving on Stupidity in the 21st Century; Scott Adams (Narrator); Audio Cassette; Published 1997

The Dilbert Future : Thriving on Stupidity in the 21st Century; Scott Adams; Hardcover; Published 1997

The Dilbert Principle : A Cubicle's-Eye View of Bosses, Meetings, Management Fads & Other Workplace Afflictions; Scott Adams; Hardcover; Published 1996

Dogbert's Clues for the Clueless; Scott Adams; Paperback; Published 1993

Dogbert's Top Secret Management Handbook; Scott Adams;Audio Cassette; Published 1996

Fugitive from the Cubicle Police : A Dilbert Book (Adams, Scott, Dilbert Book.); Scott Adams; Paperback ; Published 1996

It's Obvious You Won't Survive by Your Wits Alone : A Dilbert Book (Adams, Scott, Dilbert Book.); Scott Adams; Paperback; Published 1995

Shave the Whales (A Dilbert Book); Scott Adams; Paperback; Published 1994


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Dexter Hansen
Publications

SmartDraw logo
English   German

JobGenie
12,700 job Descriptions
on CD ROM



Amazon.com now has tools, tooling and gas powered generators in their Amazon.com's Home Improvement Store.  Click on Amazon.com's Home Improvement Store or the logo below to go there or use the Search feature.

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