Are you ready for the FUTURE of your Quality Management system?

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Jonathan Pierce
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Are yu ready fr the FUTURE f yur Quality Management system? BACKGROUND Quality Management System standard, ISO 9001 has made sme majr changes released in September 2015.

2 Are yu ready fr the FUTURE f yur Quality Management system? BACKGROUND Quality Management System standard, ISO 9001 has made sme majr changes released in September Organizatins are studying and reviewing changes t the standard, planning a series f tactical changes with actinable time-lines t ensure implementatin f the standard is efficient and timely. Hwever, with the significance f 9001:2015 revisins, it becmes critical fr yu t knw where t start. ISO Cnsulting Services has designed sme training curse and material t unravel the mystery surrunding terminlgy used in the internatinally recgnised ISO 9001:2015 standard fr Quality Management Systems. It explains all the elements in these standards in a way that is easy t understand. It prvides the knwledge and skills required t develp a QMS capable f achieving custmer satisfactin, supprting business imprvement and helping manage business risk. ISO Cnsulting Services can assist yu in: Cnducting Gap Assessment r Gap Analysis; Reviewing the existing dcumentatin and systems and identifying any ptential gaps between existing and desired situatin Training yur team thrugh ur public r in-huse training curses Develping r upgrading dcumentatin accrding t new standards Reviewing and Simplifying Prcesses, dcuments and systems during upgrade Prviding training, Cnsultatin and guidance fr implementatin f system Cnducting Internal Audits Please cntact ur ffice fr mre infrmatin: Did yu knw? Mre than ne millin cmpanies are already certified t the ISO 9001 standard.

3 ISO 9001:2015 Self-assessment Checklist Use this shrt checklist fr assessing Quality Management system t determine whether ISO 9001:2015 requirements are being met and, if nt, what steps shuld be taken t ensure they are met successfully. Cntext f the rganisatin This clause requires the rganizatin t cnsider a wide range f ptential factrs which can impact n the management system, in terms f its structure, scpe, implementatin and peratin. Des the rganisatin determine external and internal issues that are relevant t its purpse and its strategic directin and that affect its ability t achieve the intended result(s) f its quality management system? Des the rganisatin mnitr and review infrmatin abut these external and internal issues? Understanding the external cntext can be facilitated by cnsidering issues arising frm legal, technlgical, cmpetitive, market, cultural, scial and ecnmic envirnments, whether internatinal, natinal, reginal r lcal. Understanding the internal cntext can be facilitated by cnsidering issues related t values, culture, knwledge and perfrmance f the rganizatin. Des the rganisatin determine: a) the interested parties that are relevant t the quality management system? b) the requirements f these interested parties that are relevant t the quality management system? Des the rganisatin mnitr and review infrmatin abut these interested parties and their relevant requirements? Has the scpe f the QMS been determined taking int accunt the external and internal issues, interested parties and yur prducts and services? Has QMS been established including the prcesses needed and their sequence and interactin? Have the criteria fr managing these been established tgether with respnsibilities, methds, measurements and related perfrmance indicatrs needed t ensure the effective peratin and cntrl? Nte: Interested parties culd include; Emplyees Cntractrs Clients/Custmers Suppliers Regulatrs Sharehlders Neighbrs Nn-Gvernmental Organizatins (NGOs) Parent rganizatins Leadership This clause includes a gd prprtin f cntent which will be familiar frm ISO 9001:2008 but als intrduces sme significant changes n verall leadership and cmmitment and the expectatins fr tp management t engage mre fully with the critical aspects f the quality management system. Des tp management demnstrate leadership and cmmitment with respect t the quality management system by:

4 a) taking accuntability fr the effectiveness f the quality management system? b) ensuring that the quality plicy and quality bjectives are established fr the quality management system and are cmpatible with the cntext and strategic directin f the rganisatin? c) ensuring the integratin f the quality management system requirements int the rganisatin s business prcesses? d) prmting the use f the prcess apprach and risk-based thinking? e) ensuring that the resurces needed fr the quality management system are available? f) cmmunicating the imprtance f effective quality management and f cnfrming t the quality management system requirements? g) ensuring that the quality management system achieves its intended results? h) engaging, directing and supprting persns t cntribute t the effectiveness f the quality management system? i) prmting imprvement? j) supprting ther relevant management rles t demnstrate their leadership as it applies t their areas f respnsibility? NOTE: Reference t business in this Internatinal Standard can be interpreted bradly t mean thse activities that are cre t the purpses f the rganisatin s existence, whether the rganisatin is public, private, fr prfit r nt fr prfit. Des tp management demnstrate leadership and cmmitment with respect t custmer fcus? Has rgaqnisatin determined custmer requirements and applicable statutry and regulatry requirements? Are they met and cmmunicated thrughut the rganisatin? Have the risks and pprtunities that are relevant t the QMS been established? Has the rganisatin established and cmmunicated the respnsibilities and authrities fr the effective peratin f the QMS? Planning This clause is an additin t ISO 9001:2015, intrducing the cncept f risk and pprtunity. In basic terms, this clause requires the rganizatin t understand the range f risks and pprtunities relevant t the scpe f the rganizatin and determine actins, bjectives and plans t address them. des the rganisatin cnsider the issues referred t in 4.1 and the requirements referred t in 4.2 and determine the risks and pprtunities? Has the rganisatin planned actins t address these risks and pprtunities and integrated them int the system prcesses? Is there a defined prcess fr the determining the need fr changes t the QMS and managing their implementatin? Supprt An effective quality management system cannt be maintained r imprved withut adequate resurces. As a functin f planning, such resurces shuld be determined and prvided. This clause gathers tgether in ne place all the areas relating t the peple, place and prcedural aspects f the management systems. Has the rganisatin determined and prvided the resurces needed fr the establishment, implementatin, maintenance and cntinual imprvement f the QMS (including peple, envirnmental and infrastructure requirements)?

5 If mnitring r measuring is used fr evidence f cnfrmity f prducts and services t specified requirements, has the rganisatin determined the resurces needed t ensure valid and reliable mnitring and measuring f results? Has the rganisatin determined the knwledge necessary fr the peratin f its prcesses and achievement f cnfrmity f prducts and services and implemented a lessns learnt prcess? Has the rganisatin ensured that thse persns wh can affect the perfrmance f the QMS are cmpetent n the basis f apprpriate educatin, training, r experience r taken actin t ensure that thse persns can acquire the necessary cmpetence? Has the dcumented infrmatin required by the standard and necessary fr the effective implementatin and peratin f the QMS been established? Operatin This clause basically represents the prductin and peratinal cntrl parts f the standard and includes main service r prductin f rganisatin. Des the rganisatin determine and prvide the resurces needed fr the establishment, implementatin, maintenance and cntinual imprvement f the quality management system? Des the rganisatin cnsider the capabilities f, and cnstraints n, existing internal resurces? Are any utsurced prcesses managed and cntrlled? Is there a defined prcess fr reviewing and cmmunicating with custmers in relatin t infrmatin relating t prducts and services, enquiries, cntracts r rder handling? Is this review cnducted prir t the rganisatin s cmmitment t supply prducts and services? If yu design and develp prducts r services, are these prcesses established and implemented in line with the requirements f the standard? D yu ensure that externally prvided prcesses, prducts, and services cnfrm t specified requirements? D yu have criteria fr the evaluatin, selectin, mnitring f perfrmance and reevaluatin f external prviders? Is the prvisin f prducts and services carried ut in cntrlled cnditins which include: The availability f dcumented infrmatin that defines the characteristics f the prducts and services; The availability f dcumented infrmatin that defines the activities t be perfrmed and the results t be achieved? Mnitring and measurement activities at apprpriate stages t verify that criteria fr cntrl f prcesses and prcess utputs, and acceptance criteria fr prducts and services, have been met? The peple carrying ut the tasks are cmpetent? D yu have effective methds f ensuring traceability during the peratin prcess? Where prperty belnging t custmers r external prviders is used in the prvisin f the prduct r service, is this cntrlled effectively? If there is a requirement fr pst-delivery activities assciated with the prducts and services such as warranty, maintenance services, recycling r final dispsal, are these defined and managed? Are any nncnfrming prcess utputs managed s as t prevent their unintended use?

6 Perfrmance evaluatin Cllectin and analysis f relevant data is necessary t measure the suitability and effectiveness f the management system and t identify pprtunities fr imprvement. Business gals and bjectives shuld be cnsidered when deciding what t analyse and cmment. Has the rganisatin determined what needs t be mnitred and measured and the methds fr mnitring, measurement, analysis and evaluatin, t ensure valid results? Has it established when the results frm mnitring and measurement shall be analysed and evaluated? Have methds f mnitring custmer perceptins f the prvisin f prducts and services been established? Has it determined the need r pprtunities fr imprvements within the QMS and hw these will be fed int management reviews? Has the rganisatin established a prcess fr an internal audit f the QMS? Has an apprach t perfrm management reviews been established and implemented? Imprvement This clause prvides an verview f what imprvement means in the cntext f ISO 9001:2015 an verall apprach requiring review f prcesses, prducts and services and quality management system results, with sme useful reminders that the mechanisms fr such imprvements can be achieved by a variety f means; crrectin, crrective actin, cntinual imprvement, breakthrugh change, innvatin and re-rganizatin. Des the rganisatin determine: a) what needs t be mnitred and measured? b) the methds fr mnitring, measurement, analysis and evaluatin needed t ensure valid results? c) when the mnitring and measuring shall be perfrmed? d) when the results frm mnitring and measurement shall be analysed and evaluated? Des the rganisatin evaluate the perfrmance and the effectiveness f the quality management system? Des the rganisatin retain apprpriate dcumented infrmatin as evidence f the results? Has the rganisatin determined and selected pprtunities fr imprvement and implemented the necessary actins t meet custmer requirements and enhance custmer satisfactin? Has the rganisatin apprpriate prcesses fr managing nncnfrmities and the related crrective actins? Has the rganisatin decided n hw it will address the requirement t cntinually imprve the suitability, adequacy, and effectiveness f the QMS?

7 ISO 9001:2015 vs. ISO 9001:2008 ISO 9001:2015 Clause Number Equivalent ISO 9001:2008 Clause Number 1 Scpe 1 Scpe 2 Nrmative Reference 2 Nrmative Reference 3 Terms and Definitins 3 Terms and Definitins 4 Cntext f the Organizatin (Sectin title) N/A 4.1 Understanding the rganizatin and its cntext 4.2 Understanding the needs and expectatins f interested parties 4.3 Determining the scpe f the quality management system Nne (althugh in spirit this requirement was fund under 1.1) Nne (althugh in spirit this requirement was fund under 1.1) Nne (althugh this cntent was previusly specified under 4.2.2) 4.4 Quality management system and its prcesses Leadership (Sectin title) N/A 5.1 Leadership and cmmitment 5.1, Plicy Organizatinal rles, respnsibilities and authrities Planning (Sectin title) N/A 6.1 Actins t address risks and pprtunities 6.2 Quality bjectives and planning t achieve them Nne (althugh this new requirement brrws ideas previusly fund in 8.5.3, and 7.1) Planning f changes Supprt (Sectin title) N/A 7.1 Resurces General Peple Infrastructure Envirnment fr the peratin f prcesses Mnitring and measuring resurces Organizatinal knwledge Nne

8 7.2 Cmpetence Awareness Cmmunicatin Dcumented Infrmatin 4.2.3, General 4.2.3, Creating and Updating 4.2.3, Cntrl f Dcumented Infrmatin 4.2.3, Operatin (Sectin title) N/A 8.1 Operatinal planning and cntrl Requirements fr prducts and services Custmer cmmunicatin Determinatin f requirements related t prducts and services Review f requirements related t prducts and services Changes t requirements fr prducts and services 8.3 Design and develpment f prducts and services General Design and develpment planning Design and develpment inputs Design and develpment cntrls 7.3.4, 7.3.5, Design and develpment utputs Design and develpment changes Nne (althugh the ideas behind this requirement are rted in clause 7.3 at large) 8.4 Cntrl f externally prvided prcesses, prducts and services General Type and extent f cntrl 7.4.1, Infrmatin fr external prviders Prductin and service prvisin 7.5.1, Cntrl f prductin and service prvisin Identificatin and traceability ,

8.5.3 Prperty belnging t custmers r external prviders 7.5.4 8.5.4 Preservatin 7.5.5 8.5.5 Pst-delivery activities 7.5.1, 7.2.1 8.5.6 Cntrl f changes 4.2.3, 5.4.2, 7.3.7 8.

1, 8.2 9.1.2 Custmer satisfactin 8.2.1 9.1.3 Analysis and evaluatin 8.4 9.2 Internal audit 8.2.2 9.3 Management review 5.6 10 Imprvement (Sectin title) N/A 10.1 General 8.3, 8.5 10.

9 8.5.3 Prperty belnging t custmers r external prviders Preservatin Pst-delivery activities 7.5.1, Cntrl f changes 4.2.3, 5.4.2, Release f prducts and services Cntrl f nncnfrming utputs Perfrmance evaluatin (Sectin title) N/A 9.1 Mnitring, measurement, analysis and evaluatin 8.1, General 8.1, Custmer satisfactin Analysis and evaluatin Internal audit Management review Imprvement (Sectin title) N/A 10.1 General 8.3, Nncnfrmity and Crrective Actin 8.3, Cntinual Imprvement A: Level 5, 7 Eden Park Drive, Macquarie Park 2113 W:

STANDARDISATION IN E-ARCHIVING. I N T E R N AT I O N A L S TA N D A R D S Alain Wahl

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