ISO/IEC 17025:2017 a tutorial for UKAS Assessment Staff Trevor Thompson
January 2018
Reminder of the principles ISO/IE ISO/ IEC C 170 17025 25 is th the e internation intern ational al standard used t o accr edit the t he comp etence of testing and calibr calibr ation laboratories wor ldwid ldwide e Such comp ete etence nce is taken to b e assur assur ed by the th e presence presence of certain featur fea tures es in the th e laboratory and its or ganisation: 1. Abil ity technically techni cally to get get a valid result. This invo lves people, know ledge ledge,, equipment, suppli es and and proc p roce ess. “getting it right” 2. A system sys tem to ensure impartiality, cons istency, reliabili reliabili ty “once right……always right”
Applying the principles principles These princ iples have appl These applied ied to the t he vario various us earli earlie er version s of the Standard Sta ndard but bu t we w ere descr described ibed in a mor e prescri prescri pti ptive ve way. way.
Now in the t he 20 2017 version the laboratory is left to decide how to achieve any requirement, requirement, expr expre essed more in the form of an requir ed outcom ou tcom e. All l b as A ased ed o n an antt i c i p at ated ed/p /per erc c ei eived ved risk and and opportunit y . Examples: “job descriptions” is now “staff shall be aware of their responsibilities” “quality manual” “procedures” are now “necessary documented information”
Other Changes In rewri rewri ting the Standard Standard we tried also also to modernis m odernise e it t o remove references refe rences to paper and to ensu nsure re it catered catered fo r electr electronic onic data presentation presenta tion , transmis transmission sion , sto storage rage etc and and t o be relatively relatively fu tur tureeproof. There are are very few techni cal changes to the requirements to be met by the laborator ies. Whe Where re ch changes anges have have been been made made we have have inclu ded elements ele ments from doc uments previous ly written wr itten to offer interpretation interpretation.. For exa example, mple, in t race raceability ability and in decisio decision n rules ru les In appea appearance, rance, the bigg est change is that t hat of the stru ctu cture re of the th e document. Completely different!
Why Restructure 17025? Experience wit with h industr indu stry y has shown a need need for c ompatibi ompatibility lity w ith ISO ISO 9001 and related Standards. This needs to apply both ways w ays round…i.e.
A l ab u s i n g 17025 needs need s t o b e co c o n s i d er ered ed as s u i t ab abll e as a 9001 contractor and should not n eed bo th. A n o r g an An anii s at atii o n w i t h 9001 sh s h o u l d b e abl ab l e to ad add d t h e tec h n i c al requirements requireme nts of 17 1702 025 5 to his hi s existing exist ing system and b e consid ere ered da 17025 lab.
Managementt System Managemen Sys tem Options Option A – Using ISO 17025 directly, as before Option B – Using ISO 9001 but ensuring that the MS meets the technical needs of 17025 The difference? Not a lot, as the new 17025 has largely been aligned with 9001 for requirements and terms We assess that the system covers the 17025 requirements
The new structure For a labor labor ato tory ry,, in lin l ine e with th the e other 1700 17000 0 series standards:
Structure: “What it looks like” Resource: “What it needs to have” Process:
“What it needs to do”
Some mandat mandatory ory text text (esp Optio Options ns A and B)
Headlines of Changes Option Opti on to allo allow w ISO 90 9001 01 MS needs nee ds to cov cove er 170 702 25 technical techni cal cla cl aus use es Risks and Opportunit Opportu nities ies to be cons considere idered d measur mea sur es nece n ecessary ssary in a given lab the th erefor e vary Deci cisio sion n Rul Rule es; any sensible sensib le ones to be agr gre eed risks ris ks of o f false accept accept etc reporti re porting ng of de decision cision rule used used
Other Changes
Emph mpha asi sis s on o n Impartialit Impart iality y (measur (measur es) vs Ind ndepe ependence ndence (inate) “Scoping” of Laboratory activities to be included in lab system to de d escri scribe be bou boundaries ndaries of covered covered activity activit y 2nd person for compl c ompla aint handling handlin g (small (small labs) labs) Trace racea abili ty possible possi ble fro from m conformi confo rmity ty certificate certifi cates s
A look at the Standard Foreword Introduction 1 Scope 2 Normative references 3 Terms and definitions 4 General requirements 5 Structural requirements 6 Resource requirements 7 Process requirements 8 Management requirements (with options) Annex A (traceability) (traceability) Annex B (MS Options) Bibliography
A first pass through through the new Standard Remember, there are very few technical changes, these are mainly more philosophical to modernise and introduce Risk and Opportunity. The structure is similar to 17020 and 17065. You will see many of the same clauses as in 2005, but could you suggest if they are Structural, Resource or Process?
A Revised Definition Definition Definition of Laboratory: 3.6 “Laboratory: A body that performs performs one or more of the following activities: Calibration Testing Sampling, associated with subsequent calibration and testing”
Another Definition Definition
Definition of Decision Rule: 3.7 “rule that describes how measurement uncertainty is accounted for when stating conformity with a specified requirement”
4. General Requiremen Requirements ts 4.1 Impartiality There are no references to independence. Impartiality Impartialit y considerations shall be ongoing. 4.1.4 “the laboratory shall identify risks to its impartiality on an on- going basis……..
5. Structural Requirements Scoping “5.3 The laboratory shall define and document the range of laboratory activities for which it conforms with this document. The laboratory laboratory shall only claim conformity with this document for this range of laboratory activities, which excludes externally provided laboratory activities on an ongoing basis
6. Resource Requirements 6.2 Personnel No Job Descriptions specified “6.2.4 The management management of the laboratory shall communicate to personnel their duties, responsibilities and authorities.
but some procedures and records are mandatory
6. Resource Requirements “6.2.5 The laboratory shall have procedure(s) and retain records for: a) determining the competence requirements; b) selection of personnel; c) training of personnel; d) supervision of personnel; e) authorization of personnel; f) monitoring competence of personnel.” and some explicit authorisation authorisations s are mandatory
6. Resource Requirements
“6.2.6 The laboratory shall authorize personnel to perform specific laboratory activities, including but not limited to, the following: a) development, modification, verification and validation of methods; b) analysis of results, including statements of conformity or opinion opinions s and interpretations; c) report, review and authorizati authorization on of results.”
6. Resource Requirements Traceability 6.5 has unchanged intention, but is clearer.. See also Annexe A. clearer Effectively allows “the three ways” but presumes competence for those sources complying with 17025 Calibration and 17034 CRM
Acceptable evidence would be accreditation under the ILAC Arrangement or the CIPM MRA
6. Resource Requirements There are no significant changes about subcontractors and external supplies, but the wording is quite different “6.6 Externally provided products and services”
A requirement to inform and and agree with the client is when laboratory activity is conducted by an external body is elsewhere, in 7.1.1 c)
7. Process Requirements Review of Requests (Contract Review) largely unchanged. The lab may have to divulge the identity of an external supplier “7.1.1c) c) where external providers are used, the requirements of 6.6 are applied and the laboratory advises the customer of the specific s pecific laboratory activities to be performed by the external provider and gains the customer's approval
7. Process Requirements The clause on Decision Rules (Pass/Fail Criteria) is much clearer now and obviates the need for ILAC to specify a method as in ILAC G8. There are clearly choices to make and agree with clients, so suggestions and examples will be useful in new guidance documents documents
7. Process Requirements 7.1.3 When the customer requests a statement of conformity to a specification or standard for the test or calibration (e.g. pass/fail, intolerance/out-of-toleran tolerance/o ut-of-tolerance), ce), the specification or standard and the decision rule shall be clearly defined. Unless inherent in the requested specification or standard, the decision rule selected shall be communicated to, and agreed with, the customer.
7. Process Requirements 7.1.4 Any differences between the request or tender and the contract shall be resolved before laboratory activities commence. Each contract shall be acceptable both to the laboratory and the customer. Deviations requested by the customer shall not impact the integrity of the laboratory or the validity of the results.
7. Process Requirements 7.7.2 The laboratory shall monitor its performance by comparison with results of other laboratories, where available and appropriate. This monitoring shall be planned and reviewed and shall include, but not be limited to, either or both of the following: a) participation in proficiency testing; b) participation in interlabora interlaboratory tory comparisons other than proficiency testing.
7. Process Requirements Three pages of reporting requirements requirements in the new Standard, split into Common, Testing, Calibration and Sampling, but…. 7.8.1.3 When agreed with the customer, the results may be reported in a simplified way. Any information information listed in in 7.8.2 to 7.8.7 that that is not reported to the customer shall be readily available.
7. Process Requirements and when sampling is involved….
7.8.3.2 Where the laboratory is responsible for the sampling activity, test reports shall meet the requirements listed in 7.8.5 with a similar clause for calibration
7. Process Requirements On Sampling (Only?) Reports 7.8.5 f) information required to evaluate measurement uncertainty for subsequent testing or calibration.
7. Process Requirements Complaints Note that there is a detailed section on complaint handling and a complaint is defined as 3.2 Complaint expression of dissatisfaction by any person or organization organizatio n to a laboratory (3.6), relating to the activities or results of that laboratory, where a response is expected
7. Process Requirements Complaints Now we need a 2nd person to handle a complaint 7.9.6 The outcomes to be communicated to the complainant shall be made by, or reviewed and approved by, individual(s) not involved in the original laboratory laboratory activities in question. NOTE This can be performed by external personnel.
8. Management System Requirements 8.1 Options All labs: 8.1.1 General The laboratory shall establish, document, implement and maintain a management system that is capable of supporting and demonstrating demonstrating the consistent achievement of the requirements of this document and assuring the quality of the laboratory results.
8. Management System Requirements 8.1 Options 8.1.1 General “In addition to meeting the requirements of Clauses 4 to 7, the laboratory shall implement a management system in accordance with Option A or Option B” Option A Using Section 8 in the Standard Option B Using ISO 9001
A raison d'être for 17025 vs 9001 Or why bother having 17025?
From An Fro Ann nex exe eB “Conformity of the management system within which the laboratory operates to the requirements of ISO 9001 does not of itself demonstrate the competence of the laboratory to produce technically valid data and results. This is accomplished through compliance with clauses 4 to 7 of ISO/IEC 17025.”
8. Management System Requirements 8.1.2 Option A Section 8 in the Standard A list of minimum features, mainly as before, with useful detail. Note that it now includes.... — actions to address risks and opportunities opportunities
8. Management System Requirements Option B using ISO 9001 “8.1.3 Option B A laboratory that has established and maintains a managementt system, in accordance with the managemen requirements requirement s of ISO 9001, and that is capable of supporting and demonstrating the consistent fulfilment of the requirements of Clauses 4 to 7, also fulfils at least the intent of the management system requirements specified in 8.2 to 8.9.”
SHORT BREAK 10 minutes Now we have a short break to have a cup of tea and mull over the main message so far….. No significant technical changes but a new philosophy. Previously 17025 requirements managed the risks, now the lab manages the risks.
Back in Ten Minutes for Part Two Major Re-structure from 2005 version; clauses and order changed 1999/2005 2017 Very few changes in requirements Standard Managed Ris Risk k Risk and Opp Oppor ortu tunit nit y Ma Managed Allows use of of ISO9001 as basis for management management system system Confirmed that ISO/ILAC/IAF tripartite agreement is renewed Clarification for inclusion of “Stand -alone” Sampling New term “Decision Rule” for deciding pass/fail decisions Consideration Consideration of “Risk and Opportunity” throughout
Part Two The main changes 1. Risk and Opportunity Trevor Thompson
January 2018
A look at Risk and and Opportunity Opportunity From the Foreword: — the risk-based thinking applied in this edition has enabled some reduction in prescriptive requirements and their replacement by performance-based requirements; — there is greater flexibility than in the previous edition in the requirements for processes, procedures, documented information and organizational responsibilities;
Risk and Opportunity From the Introduction: This document requires the laboratory to plan and implement actions to address risks and opportunities. Addressing both risks and opportunities establishes a basis for increasing the effectiveness effectivene ss of the management system, achieving improved results and preventing negative effects. The laboratory is responsible for deciding which risks and opportunities need to be addressed
Risk and Opportunity There is mention of risk throughout the Standard and I take the section on Impartiality as an example: 4.1.4 The laboratory shall identify risks to its impartiality on an on-going basis. This shall include those risks that arise from its activities, or from its relationships, or from the relationships of its personnel…..
Risk and Opportunity and 4.1.5 If a risk to impartiality is identified, the laboratory shall be able to demonstrate how it eliminates or minimizes such risk This type of consideration applies to most lab features and to everything it does.
Risk based approach The General Case
A r i s k b as ased ed ap app p r o ac ach h t o m an anag agem emen entt syste sys tem m impleme im plementation ntation is i s one on e in which whi ch the brea breadth and de depth pth of the imple imp leme mentation ntation of pa parti rticul cula ar cla c lauses uses is va v ari rie ed to t o best suit su it the t he pe perc rce eived risk ris k involv inv olve ed for fo r the pa parti rticul cula ar labo labora rator tory y
Less Prescriptive More Consideration ISO 17025:2005 • Lab shall have policies and procedures to ensure protection of confidential confidential information… including electronic storage and transmission transmission of results
FDIS 17025:2017 • The lab shall ensure the protection of confidentia confidentiall information…. including electronic storage and transmission transmissi on of results
The relaxa relaxatio tion n of pr escripti on makes it essential essential for each lab to con sider the risk fo r each each cl ause To dis d iscus cus s and agree what measu measures res are requi required red To imp leme lement nt that in a known and co ntro lled way for consi c onsi stency To kee k eep p und u nder er review revi ew
Risk for a given clause • How likely that t hat a given area area of compl c ompliance iance might lea lead d to to problems, ie non-complia non-compliance nce with the Sta Standa ndard rd Taking into accoun t, the circ circumst umsta ances of the body, like
• Techn chnical ical nature of the t he work • Cult ultural ural sett setting ing • Ownership • Cust ustomer omer ba b ase • Geogr ogra aphi phics cs and Environm Envir onme ent • Employees
Impartiality and Risk The requirement for impartiality is a good example of where the risk and measures necessary do vary greatly between laboratories. – A p ri vat vatel ely y o w n ed in i n d ep epend end ent l ab ab,, in i n t h e UK, UK , wi w i t h m any c u s t om ers , where the owner has has no ot her activit activit ies or ow nerships is un likely to need extensive measures to protect impartiality. – Consider alternatively: • A l ab w i t h on o n l y o ne c u s t o m er
• A l ab w h ere th t h e ow n er ow o w n s so s o me cu c u s to mer s • A l ab o f a manu m anu f ac actt u r er al als s o t ak akii n g o n t h i r d p art y w or k • A l ab w i t h mi m i n i m u m w age-s t af afff i n a cu c u l t u r e kn k n o w n fo f or corruption • A l ab w h ere it i t s o w n er ers s h i p i s c o m p l ex and k eeps c h ang i n g as d o es that of related bodies
A technical Example Example •
6.4.10 When intermediate checks are necessary to maintain confidence in the performance of the equipment, these checks shall be carried out according to a procedure.
•
The comp complexity lexity of this varies acco ccordin rdin g to risk . A gauge gauge bloc k used as a reference reference may need need litt le by w ay of intermedia i ntermediate te checks but a sensitive electron electronic ic item exhib exhib itin g drif t may need need frequent frequent checks, plotting and calculation from comparisons resulting in a drif tin ting g reference reference value value being d erive erived. d.
• A All l ac c o r d i n g t o r i s k ; s i mi l ar arll y w i t h cal c alii b r at atii o n in i n t er erv v al als s
This philosophy is not new! •
It has always been been a requireme requir ement nt to t o t ake appropri ate steps but b ut a tendency to com pare activiti activities es in dissimilar dissi milar risk l abor bora ator tories ies lead lead to some difficulties. Accredita Accreditation tion Bodies were were critici se sed d for “requiring” activities in some labs but not in others.
•
Now it is qui te clear clear that that the extent extent of activi ty to c ompl omply y with wi th a particular pa rticular clause will vary and it is t he responsibi responsibi lity of the lab lab to achieve this appropri ately.
•
Clause 8.5 of the new 17025 describes the purpose……..
The purpose • 8.5.1 The laboratory shall consider the risks ri sks and opportunities associated with the laboratory activities in order to: • a) give assurance that the management system can achieve its intended results; • b) enhance opportunities to achieve the purpose and objectives of the laboratory; • c) prevent, or reduce, undesired impacts and potential failures in the laboratory activities; and • d) achieve improvement.
The laboratory shall…. • 8.5.2 The laboratory shall plan: • a) actions to address these risks and opportunities; • b) how to: •
integrate and implement the actions into its management system;
•
evaluate the effectiveness of these actions.
• 8.5.3 Actions taken to address address risks and opportunities shall be proportionate to the potential impact on the validity of laboratory results.
Making risk and opportunit opportunity y consideration happen • Ensure a cult culture ure in which risk r isk and opportunity opportu nity can be safe safely ly cons c onsidere idered d ope o penly nly and honestly h onestly • Prov rovide ide a mecha mechanis nism m for f or all staff (whose act ctivi ivities ties can affect affect the t he output of the t he lab) lab) to conside consi derr this, th is, discuss and bring bri ng forwa for ward rd any ideas • Ag A g en end d a it i t em o n d ep epar artt m en entt al m eet eetii n g s an and d reviews . • Ma Majo jorr item i tem on o n MS Re Revi vie ew agenda • Expecte xpected d of o f all staff s taff by their ma m ana nagers gers
Why is this a good thing? • Gives opport opp ortuni unity ty to be b e a be better tter lab! • Can re r educe risk ri sk (or share it it)) • Can provide pr ovide opportunit opport unity y to t o save effor ffortt or money • Can encour enco ura age develo developm pme ent nt,, new new te t ech chni niqu que es, quicker qui cker or easier calibra calibr atio tions, ns, lower prices, pri ces, highe hig herr profi pr ofit, t, ha happi ppie er custo cu stomers, mers, bette betterr reputation • Not all la l abs are the sa same me so the th ey shou s hould ld not all have the same same featu features res in i n their t heir mana manageme gement nt systems
What is not required • There is no n o exp expe ect cta ati tion on of adherenc adherence e to Risk Management Ma nagement fo forr mal stand s tanda ar ds li like ke ISO ISO 310 100 00 alt lthoug hough h the t hese se may may ma m ake useful useful rea readin ding g in in setting setti ng up enhancements in a 17025 labor labora ato tory ry environment • It is i s more m ore expected expected that the t he fea featur ture es wil willl be be inhe inh erent in the normal operati operation on of the t he laboratory usin us ing g 170 17025 wi with th the t he enh enha anc nce ements app ppe eari ring ng in severall pla severa pl aces in the t he manage management ment syst s yste em
Part Two The main changes 2. Management System Options Trevor Thompson
January 2018
Management System Option A Annex B.2 “Option A (see 8.1.2) lists the minimum requirements for implementation of a management system in a laboratory. Care has been taken to incorporate all those requirements of ISO 9001 that are relevant r elevant to the scope of laboratory activities that are covered by the management system. La Laboratories boratories that compl y with wit h Clauses Clauses 4 to 7 and and imp impleme lement nt Opti ption on A of Clause 8 wi will ll th the erefor refore e als lso o ope op erate gene generall rally y in in accordance with the principles of ISO 9001.”
Management System Option B Annex B.3 “Option B (see 8.1.3) allows laboratories to establish and maintain a management system in accordance with the requirements of ISO 9001, in a manner that supports and demonstrat demon strates es the the consist consistent ent fulfilm fulfilment ent of Labor bora ator tories ies that imple impl ement Clauses 4 to 7. La Opti ption on B of o f Clause Clause 8 will there therefor fore e also also operate in accordance with ISO 9001. “
The important clauses Clauses 4 to 6 4 4.1 4.2 5 6 6.1 6.2 6.3 6.3 6.4 6.5 6.6
General requirements Impartiality Confidentiality Structural requirements Resource requirements General Personnel Lab Laborato ratory ry fa facil cilitie ties and and env enviiron ronment ental co condi ndition tions s Equipment Metrological traceability Externally pr provided pr products an and se services
The Important Clauses Clause 7 7 7.1 7.2 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.9 7.1 7.10 7.11
Process requirements Review of of re requests, te tenders and co contracts Sel Selectio tion, veri erific ficatio tion and and valid lidati ation of of me method thods s Sampling Handling of of te test or ca calibration it items Technical records Evaluation of measurement uncertainty Assuring the quality of results Reporting of results Complaints Mana Manage geme ment nt of of no nonco nconfo nformi rming wo work Control of data – Information management
Clause 8 offers the choice This contains the management system requirements to be met by laboratories: Using 17025 directly – Option A Using 9001 – Option B On visits this might often appear as: LA for for Cl 8 TA for Cl 6-7 but it is not quite as simple simple as that, with Cl 4-5 covered by either or both. It may be that the the visit split is not by clause. clause.
Part Two The main changes 3. Decision Rules Trevor Thompson
January 2018
Decision Rules This is not new. new. Previously Previously,, in Reporting: compliance/non5.10.3.1 b) where relevant, a statement of compliance/noncompliance with requirements and/or specifications; 5.10.4.2 When statements of compliance are made, the uncertainty of measurement shall be taken into account.
There are many ways of doing this and potential for lack of comparability between labs. ILAC developed guidance….. But….
Decision Rules (Pass/Fail Criteria) Previously, 17025 simply stated that a statement of compliance Previously, (pass/fail) takes uncertainties uncertainties into account. account. This was was augmented by ILAC G8 suggesting that the so called ILAC model was used Result
Uncertainty – Limits of possible results
PASS Mark
Clear Pass
Pass Likely
Fail Likely
Clear Fail
Decision Rules Now we have a need to agree and specify the “decision rule” used 7.8.6.1 When a statement of conformity to a specification or standard is provided, the laboratory shall document the decision rule employed, taking into account the level of risk (such as false accept and false reject and statistical assumptions) associated with the decision rule employed and apply the decision rule. NOTE Where the decision rule is prescribed by the customer, regulations or normative documents, a further consideration of the level of risk is not necessary.
Decision Rule Choices To be agreed with client, taking risk level into account:
• ILAC model (default ?) • Simple pass/fail ? • In specification • In legislation • Industry expectation • Client required • Ot Othe hers rs,, inc inc sp spec ecif ifie ied d ris risk k ie ie % PFA PFA
Example Decision Rule Customer makes widgets and wants an average of 95% of his widgets to meet the specification of ≥100 mm height. The laborato laboratory ry can measure measure to an uncertai uncertainty nty of +/- 5 mm at 95% confidence. For this “single tailed” at 95% confidence the coverage factor is 1.64. The acceptance tghreshold for 100 mm is therefore 104.1 mm (at u = 2.5 mm) He tells tells the laboratory laboratory to pass pass all samples samples that appear to be be at least 104.1 mm height. They have agreed a decision rule. If he wanted less wastage he could have the measurement made more accurately and reduce his PFR.
Decision Deci sion Rule 2.5% PF PFA A
For single tailed test at 95% confidence level the coverage factor is threshold for 100 mm limit is therefore therefore 104.1 104.1 mm (for k = 2 Accept threshold u = 2.5 mm).
Limit Observed Size
Big
Small 100
105
mm
Example Decision Rule A Police Force considers considers prosecuting prosecuting a driver who who was measured to have driven at 35 miles per hour in a 30 mph limit The uncertain uncertainty ty of the measureme measurement nt is +/- 3 mph at 95% (ie 2σ) confidence. confidence. They could confidently suggest that 99.96 out of every 100 drivers caught like this were guilty. They must never loose a case on technical grounds or else the whole system will be discredited so they agree a decision rule to deduct 6 mph (i.e. 4 σ) before deciding if a prosecution is made. This gives a confidence of at least 99.997 %
Decision Rule 0.01% PFR
For single tailed test at 99.99% confidence level the coverage factor is k = 3.719 Prosecution threshold for 30 mph limit is therefore 35.58 mph (for u = 1.5 mph).
Limit Observed Speed
Fail
Pass 25 30 35 40
Mil Miles per Hour our
The UKAS Transition Plan (More details later for Ops Staff affected) Trevor Thompson United Kingdom Accr editation Service Service
UKAS Transition Arrangements This is i s our la l argest ever ever transi transitio tion n Arr o u n d 1500 ext A ex t r a As A s s es ess s m en entt Day Days s ex exp p ec ectt ed ed.. Ab A b o u t £1.5M ext ex t r a in i n c o m e ov o v er t h r ee year y ears s Several ext extra ra new AMs to be recruit recru ite ed Spe peci cia al te t emp LO resou resourc rce e to be provid pro vide ed
UKAS Transition Arrangements Each lab to have a tr tra ans nsit itio ion n WRAP WRAP made by suppor sup portt staff after after new new Da Darwi rwin n in Jun June e. Earl rlier ier one on es to t o be b e made by releva relevant nt AM AM Most labs will wi ll ha have ve severa severall cha c hances nces to transition at routine visi visits ts Fir irst, st, all all labs will w ill com complete plete a rea readin dine ess pape paperr assessm ssessme ent; a sor sortt of ga gap p analys analysis is..
UKAS Transition Plan Summary Sep 20 2017 Tast ste ers by b y webinar for staff s taff and and la l abs Oct 2017 Develop velopment ment of Gap An Ana alys lysis is metho methods ds Jan 201 018 8 Publ Publis ished hed Sta Stand ndard ard Jan 201 018 8 Traini Training ng of Staff Staff and and TAs TAs Marr 201 Ma 018 8 New Sta Stand nda ar d app ppli licati cation ons s acc acce ept pte ed Jan 2019 Unt ntil il then bo both th or eit either her ass sse ess ssment ment Jan 2019 Fro rom m then new st sta and nda ard only on ly ass asse ess sse ed Jun Ju n 2020 Transi ransiti tion on co comp mpleted leted Dec 20 2020 Old sta st andard no longer lo nger vali valid d
Key points for Transition
• All labs will be transitioned, they need not apply apply • Normally no extra site time by LA or TAs • Labs will complete readiness gap analysis doc • Extra office time needed for LA and AM/CM • Small charge for this to labs (most ½ or 1 day equiv) • La Larg rge e labs labs pay pay mor more e (esp (espec ecia ialllly y Wend Wendy’ y’s s ones ones))
transitioned by June 2020. • All labs to be transitioned • 17025:2005 accreditations invalid from Dec 2020
Questions?
• No Now, w, lilive ve,, cli click ck on “q “que uest stio ion” n” in in Sh Shor oret etel el Co Cont ntro roll Box • by email to
[email protected] • On Staff Room via forum
