As media. Diverse forms of evidence or documentation are

As Osprey CSL’squality contractor, responsibility is vested in me to assist the ManagingDirector in meeting his quality responsibilities and advising him asappropriate in ensuring the company has a quality system that’s not only fitfor purpose but provides added value in terms of producing a better product,more efficiently and effectively.

I hope this haspaper answers some of those questions which you didn’t know the answer to andwill reinforce some of the thinking behind some of the newer initiatives OspreyCSL has undertaken of late.Finally, thethird key change for employees is the role interested parties must play withinan organisations quality system.  This isclosely linked to RBT as they work hand in glove together.Second,leadership focus is key, and leaders are expected to take a much more focussedinterest in how the QMS is managed and exploiting the benefits that come fromit.  Top management can no longer sit inan ivory tower and take no interest or delegate all responsibility.  They are expected to understand andlead!  ISO 9001:2015requires a different mind set and thought process to be applied to anorganisation’s quality activities when compared to how it operated under theaccreditation of ISO 9001:2008.  The mainchanges have been listed in this paper, however from an employee’s perspectivethere are only really 3 significant changes that affect the day to day businessthat’s carried out.  First, RBT shouldform a part of everybody’s routine activities.

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 Everybody should be thinking about the inherent and external riskspresented and how these risks may be best managed and, where appropriate, whatopportunities that result can be exploited. ConclusionThere is nolonger any mention of ‘records’ neither, but of ‘retaining documentedinformation’. In order to prevent wholesale change when transitioning to thenew standard, Osprey CSL opted to retain its Quality Manual for simplicity,which is updated along with the remainder of the company’s BMS.  The definitionstates that it concerns ‘information that the organisation has to control andmaintain’. The information can be in any format and come from various sourcesand media.

Diverse forms of evidence or documentation are therefore possible.ISO 9001:2015no longer requires obligatory documented procedures or a quality manual. Thisis noteworthy. This is now referred to as ‘documented information’ inpractically all clauses of ISO 9001:2015.Documented InformationAs anorganisation, you must be aware of the importance of these interested parties'(changing) requirements and standards, and anticipate them in the features ofyour products and services.

  You cannotmake or deliver a good product without knowing the requirements andexpectations of customers and interested parties in any case. This is the basisof a quality management system.  Linksare provided within Osprey CSL’s BMS to its Interested Parties (both internallyand externally), this is a work in progress and as the new system matures, thelists will be updated to offer employees the sighting of perceived importanceand influence of its interested parties.In ISO9001:2008, customers were often named as being the only interested party.

Thisconcept has been extended in ISO 9001:2015. Suppliers, personnel, shareholders,legislative bodies, society, internal customers, etc. are now included asinterested parties, in addition to customers.Interested PartiesISO 9001:2015requires an organisation to construct its quality management system from thespecific context within which it is active. This means, among other things,that, as an organisation, you have to take into account the needs andexpectations of interested parties and that you evaluate and deal with internaland external strategic questions. You must show that, as an organisation, youunderstand and respond to the expectations of all the parties concerned.

  Organisational ContextThe ‘managementrepresentative’ of ISO 9001:2008 was a member of the management committee whohad the responsibility and authority for steering the quality management systemalong the right lines (for Osprey CSL this was the Operations Director).  ISO 9001:2015 does not mention this aspect anymore. The idea behind the change is that quality is a matter for everyone andfor all levels within the organisation, however as previously stated, theManaging Director and Operations Director are the quality drivers andimplementers.

Because ISO9001:2015 pays more attention to risk management, interested parties and thecontext of the organisation, the quality management system also fits in betterwith the needs of the top management.  Thequality management system is now more than ever a means for being strategicallysuccessful by addressing the needs of interested parties and by managingopportunities and threats.This way, ISO9001:2015 is intended to encourage integration and harmonisation with businessprocesses and business strategies. The Top Management now must take moreresponsibility for the effectiveness of the quality management system.  In Osprey CSL terms, the Managing Directorand Operations Director are seen as the QMS ‘Top Management’ implementers andleaders, with the remaining directors taking a less active role, however thisdoesn’t devolve them of any QMS responsibilities!ISO 9001:2015also places more emphasis on leadership and management commitment; it isprobably the second biggest change from ISO 9001:2008.  It requires much greater involvement by topmanagers and business leaders in controlling the quality management system.Leadership and CommitmentThe addition ofrisk-based thinking has made the ‘preventive measures’ of ISO 9001:2008redundant. These preventive measures no longer appear in ISO 9001:2015.

Formal riskanalysis is required at all levels but particularly from Principal Consultantupwards within Osprey CSL, and this has and continues to take place via Riskand Opportunity registers, Bid checklists and alike.  To emphasise their dominance, the concept of’risk’ occurs forty-eight times in ISO 9001:2015, compared with only threetimes in ISO 9001:2008.RBT has a veryimportant place in ISO 9001:2015, in fact it is probably the most importantchange from ISO 9001:2008 and one in which the(CBs) take the most note of andfocus during audit activities.  OspreyCSL has embraced RBT as you may expect from an organisation that specializes inRisk based activities for its own clients.Risk Based Thinking (RBT)Figure 3:  Inputs v Outputs According toISO 9001:2015, you must closely monitor which articles, information andspecifications are involved in the production process (read Projects/Proposalsfor Osprey CSL) and the quality of output is of greater interest.  Generically as shown in Figure 3:Whilst therewas a focus on input/output in ISO 9001:2008, there is more emphasis in ISO9001:2015 on measuring and properly assessing the input and output ofprocesses. Focus on Input/Output Figure 2:  ISO HLSThe coreelements of ISO 9001, ISO 14001, ISO 22000, OHSAS 18001, etc. are therefore allnow the same.

This has made the integration of various management systems muchsimpler. If, for example, an organisation wishes to implement ISO 14001 inaddition to ISO 9001, the parts that cover the same topic can easily be seen inthe standards as illustrated in Figure 2.As a result ofthe new arrangement in ten clauses, ISO 9001:2015 now has the same unambiguousstructure as all standardised management systems, known as a ‘High LevelStructure’ (HLS).ISO High Level StructureWith thisarrangement, the new ISO 9001:2015 strives to give additional momentum to thecontinuous and systematic improvement of processes within organisations.Clauses 4, 5, 6and 7 of ISO 9001:2015 come under PLAN, clause 8 comes under DO, clause 9 comesunder CHECK and clause 10 is covered by ACT. You could argue that clause 5 sits over the whole cycle with a lesserinterest in DO than in CHECK, ACT and PLAN Figure 1: PDCA CycleThe first threeclauses in ISO 9001:2015 are largely the same as those in ISO 9001:2008, butthere are considerable differences between ISO 9001:2008 and ISO 9001:2015 fromthe fourth clause onwards. The last seven clauses are now arranged according tothe PDCA cycle (Plan, Do, Check, Act). You may recall the PDCA cycle fromSafety work you have undertaken previously (or are currently).

  The following figure demonstrates how theylink together:  ISO 9001:2008 ISO 9001:2015 0. Introduction 0. Introduction 1. Scope 1. Scope 2. Normative reference 2.

Normative reference 3. Terms and definitions 3. Terms and definitions 4. Quality management system 4.

Context of the organisation 5. Management responsibility 5. Leadership 6.

Resource management 6. Planning 7. Product realisation 7. Support 8. Measurement, analysis and improvement 8. Operation   9.

Performance evaluation   10. Improvement The Standardsare structured around many clauses (which are further sub-divided).  ISO 9001:2015 has ten clauses, whereas ISO9001:2008 had eight. The following table shows the relationship of the ISO9001:2008 clauses to those in the new ISO 9001:2015.Structure of the StandardsISO 9001 wasfirst issued in 1987: at that time, you had to describe in detail what yourbusiness did. The 1994 version, required organisations to ‘say what you do anddo what you say’.

In the 2000 version, the focus was placed on proper processesto continually improve and thereby increase your customer satisfaction – thiswas the most important output. There was nothing added in 2008, but it was moreprecise about the interpretation of the standard. ISO 9001:2015 was publishedon 23 September 2015 and organisations given three years to comply.  Osprey CSL were accredited with the 2015standard in November 2017, which lasts for three years providing the standardis maintained.

  This is important toOsprey CSL as circa 50% of itsrevenue is generated by carrying out work for companies that mandate Osprey CSLare accredited.HistoryISO does notprovide certification or conformity assessment. This is performed by accreditedCertification Bodies (CBs), which for Osprey CSL is currently LRQA. These areestablishments that evaluate an organisation’s management system and certifythem with respect to the published standards.ISO 9001 ismanaged by the International Organisation for Standardisation (ISO) in Geneva, Switzerland.

ISO is an independent membership organisation and the world’s largest developerof voluntary international standards. ISO 9001:2015 was developed by the ISO /TC 176 / SC 2 – Quality Systems Technical Committee.BackgroundTHE MAIN DIFFERENCES BETWEEN ISO9001:2015 AND ISO 9001:200814 December2017