ISO 9001:2008 Procedures; 6 Mandatory Procedures

ISO 9001 Standard and Quality Procedures

ISO 9001:2008 is an international standard that defines the requirements for a quality management system, the system by which your com any can ensure that all of your rocesses are controlled and re eatable to ensure the quality of your roducts and ser!ices" #our rocesses are normally controlled through the resence of and the audit of written quality ISO9001 rocedures which define what has to be done"ISO 9001 defines best ractice for each rocess within your organi$ation to ensure control, howe!er it only defines % mandatory rocedures that you must ha!e"

ISO 9001 Procedure Flowchart

&rocedures ISO 9001

'lowchart &rocedure ISO 9001

hat is a Quality Procedure

( rocedure is a statement of what will be done, when it will be done, and by whom" It is a set of instructions and intent that anyone in the com any can follow )*ot a to secret com any document for management eyes only as one quality manager once told me+, It is a s ecific way to carry out a rocess, a set of clear instructions that the staff can refer to hel them understand and conduct their daily wor- in an efficient and re eatable manner" ISO 9001 says that only certain requirements within your quality management system ha!e to ha!e a documented rocedure, other rocedure requirements de end on the si$e and com le.ity of the rocesses and the o!erall system as well as the com etence of the staff"

Si!"le ISO 9001 Procedure

ISO 9001 &rocedure

'low /hart ISO 9001 &rocedures !s 0ord 1ocuments

ritin# an ISO 9001 Procedure

(n ISO 9001 rocedure does not ha!e to be a hundred age document telling the indi!idual how and when to ic- u a en, chec- that there is in- of the correct hue before forming letters in the s ecifically highlighted bo. on form no"2#3" 4oo many eo le and organi$ations o!er5 com licate their ISO 9001 rocedures" If you s lit your rocedures and wor- instructions then the rocedures themsel!es can be !ery sim le, remember that they only ha!e to contain the right amount of information for the eo le

doing the 6ob to do it efficiently and in the best roscribed way" If your eo le are of high quality, well trained, e. erienced, or the rocess is !ery sim le and ob!ious then there may be no need for a rocedure at all" I refer to use sim le flow charts to create rocedures, use software such as 7isio in the office suite of rograms" 4hey need to be 6ust sim le ste by ste instructions saying what is to be done, then the ne.t ste in the sequence" 4hey do not ha!e to be o!erly com le." 'or wor- instruction le!el there is also the o ortunity to clarify the rocess using things li-e hotogra hs to highlight and clarify s ecific things" 'ar too many organi$ations go o!er the to with regard to their ISO 9001 rocedures, thin-ing that the weight of their rocedure manual is a reflection of the effecti!eness of their system" 4oo many, too com licated rocedures 6ust leads to confusion and the li-ely hood that the system will ne!er be read and followed"

ISO 9001 Procedures $ideo Mandatory ISO 9001 Procedures

0ithin ISO 9001 there are only si. rocedures that are mandatory, you must document these si." 4his does not mean that you can get away with 6ust these si., the rocedures you need will !ery much de end on the si$e and com le.ity of your organi$ation, these si. howe!er are the ones that you must ha!e"

%he 6 !andatory ISO 9001 Procedures;

&'2'( ) *ontrol O+ ,ocu!ents

( written rocedure to control the a ro!al and re5a ro!al of rocedures rior to issue as well as ensuring that the current re!ision status is dis layed" 4o ensure that documents are legible and that the current !ersions are a!ailable at oint of use" 4o also ensure that obsolete documents are controlled and documents from e.ternal arties such as your customers"

&'2'& ) *ontrol o+ -ecords

( rocedure to control the identification, storage, rotection, retrie!al, retention and dis osal of records"

8'2'2 ) Internal .udits

( rocedure to define a lanned rogram of audits to ensure that your rocesses meet both ISO 9001 requirements and your own requirements" (lso for the re orting, follow u and records of these audits"

8'( ) *ontrol o+ /on0con+or!in# Product

( rocedure to ensure that non5conforming roduct is not used and action is ta-en"

8'1'2 0 *orrecti2e .ction

( written rocedure to ensure that root causes of roblems are identified and actions ta-en to correct them, actions must be !erified to ensure effecti!eness

8'1'( ) Pre2enti2e .ction

( written rocedure similar to that for correcti!e action but the organi$ation should ta-e ste s to identify &O48*4I(9 roblems and eliminate them before a roblem occurs"

I!"le!entin# ISO 9001 Procedures Quality "rocedure structure

( rocedure can come in many different forms, it can be an o!er!iew of a rocess stating urely what is to be done, by whom and when or it can be s ecific detailed instructions" :ost com anies try to se arate the two le!els of documentation for the sa-e of clarity, ha!ing rocedures and then standard o erating instructions, wor- instructions, or other detailed documents at a lower ;local< le!el in the system with the detailed ;how to< instructions" ( rocedure should detail out a few sim le sections before the actual detail of what the rocedure actually is so that you can maintain control of the s ecific rocedure= Sco e= 0hat is the area co!ered by the rocedure, i"e" Incoming deli!ery of consumable items, not including intercom any items"< >es onsibility= 0ho is the owner and res onsible erson for this rocedure, after all these are rocess s ecific documents so the quality manager is not res onsible for a ro!ing and creating the urchasing rocedures for e.am le, that would be the lace of the head of urchasing+ /ontrol or Issue= 0hat is the issue date, a ro!al etc" #ou ha!e to maintain control of your rocedures, they need to be a ro!ed, eo le must be able to be sure that this is the current re!ision etc" >eferences or >elated 1ocuments= 9ist out the other documents and forms that may be related and rele!ant to this rocedure"

(fter these sections would come the actual body of the rocedure=

Procedures on 34ay
ISO9001:2008 1ocumentation )?uality :anual,&rocedures, @ 4raining Ait ):fg" /o", *urrent 5id: B21"C0 ISO9001:2008 1ocumentation )?uality :anual, &rocedures, @ 4raining Ait )Ser!ice, *urrent 5id: B21"C0 ISO9001:2008 1ocumentation )?uality :anual, &rocedures, @ 4raining Ait )I4 /os", *urrent 5id: B21"C0

6eneric o++ the shel+ "rocedures

If you are going to de!elo your ISO 9001 quality management system rocedures you might want to consider an alternati!e to roducing e!ery thing from scratch" 4here are many systems that you can buy that ha!e generic rocedures and forms already designed and formatted" Dy entering your com any name and other information they can create basic documents that meet the requirements of ISO 9001" 4hese systems are OA as a starting oint to sa!e you the effort of designing from nothing, they will also ensure that you co!er all ISO 9001 rocedural requirements including the mandatory rocedures" :ost consultants e. erienced in installing ISO 9001 systems will use something li-e this, either a urchased ac-age or something home made" Deware of com anies that ad!ertise to create all of your rocedures and ro!ide you with a certificate to say that you meet the requirements of ISO 9001, many of these com anies are scams and the certificates are worthless" Enless they are registered with EA(S )lin- below, then they are not an accredited body that can issue an ISO 9001 certificate"