Electronic supplementary material Accreditation and Quality Assurance, Springer Verlag Heidelberg und Berlin, 2015 Application of Indicators and Quality Index as a Tool for Critical Analysis and Continuous improvement of laboratories accredited against ISO/IEC 17025 Raquel Helena Catini, Fernando José Pires de Souza, Maria de Fátima Martins Pinhel, André de Oliveira Mendonça, Vitor Hugo Polisél Pacces, Igor Renato Bertoni Olivares

Systematic for assessment of indicators and index formation

Quality Guidance for Scoring Total Revised Objective Scor Speedomet Order Indicator Points Scoring criteria weight Weight (Goal) e er s criteria 1 No. of 100 % of Check List of 10 10 Comply with quality documents 7 procedures all ISO Manage required related to 17025:2005’s ment ≥75 and <100 requirements document System % of of ISO 17025 requirement. 5 docume documents and master nt required list. (referred ≥50 and <75 % to of documents 3 docume required nts < 50 % of revised documents 0 within required deadline 100 % of 3 ) documents reviewed Quality Guidance for Scoring Total Revised Objective Scor Speedomet Order Indicator Points Scoring criteria weight Weight (Goal) e er s criteria within deadline ≥75 and <100 % of documents 2 reviewed within deadline ≥50 and <75 % of documents 1 reviewed within deadline < 50 % of documents 0 reviewed within deadline 100 % within 12 deadline ≥80 % and <100 % within 9 If no deadline corrective Impleme action ≥50 % and <80 Meet ntati-on occurred in % within 5 requirement of the period, 2 deadline 12 12 4:11 correctiv this indicator (Corrective e <50 % within will be Not 0 Action) actions. deadline Applicable Remove one (NA) for the point for every time. non-effective -1 corrective action Quality Guidance for Scoring Total Revised Objective Scor Speedomet Order Indicator Points Scoring criteria weight Weight (Goal) e er s criteria

8 trainings per 11 employee Total No. of 3 to 7 trainings trainings Meet No. of 7 per employee conducted requirement 3 Internal 11 11 1 to 2 trainings divided per 5.2.2 training 4 per employee total No. of (Personnel) employees. 0 trainings per 0 employee

No. of More than 10 0 non- 5 to 10 NCs 4 conform If the unit has ities 1 to 4 NCs 6 not received Avoid number identifie any audits in of non- d during 4 the period, 10 10 conformities in in then the internal / Audits 0 NC 10 indicator will external audit. (Internal be NA and External ) 5 No. of One point for 1 Encourage 4 4 Meet Internal each non- the requirement non- conformities identification 4.9 (Control of conform with a of non- nonconfor- ities maximum conformities ming testing identifie score of 4 in routine and/or d activities calibration Quality Guidance for Scoring Total Revised Objective Scor Speedomet Order Indicator Points Scoring criteria weight Weight (Goal) e er s criteria

routinely work) by the Stimulate Two points for opening of The No. of each Preventive Preventive Preventi Preventive action given 6 2 actions must 10 10 ve actions with a requirement be actions maximum 4:12 authorized. score of 10 (Preventive Action) Proficiency When Test: Check proficiency the percentage or Intra has of satisfactory not been Encourage the acceptance performed importance of tests in 5 within 5 the tools relation to the deadline having Quality total intended (provided satisfactory Assuran (ex.: 5 x % that justified), results, given 7 ce tools satisfactory = the total of 11 the points). points will be requirement automatically 5.9 (Assuring Satisfying divided the quality of Intra- 2 among the test and laboratorial tools used. calibration For example: 2 results). Unsatisfying If in the term Intra- 0 there wasn't laboratory proficiency, Quality Guidance for Scoring Total Revised Objective Scor Speedomet Order Indicator Points Scoring criteria weight Weight (Goal) e er s criteria Quality Control of routine implemented (Use of Reference Material evaluated by Control Chart, among others): 4 4 1. Check the percentage applied to the scope of the unit; 2. Intra will be Multiply the 5.5 and QC points by the 5.5. If there calculated was not Intra percentage. or Proficiency, QC will be 11.

Applying none 0 0 of these tools

8 No. Form filling 2 Total No. of 7 7 Meet External indicating trainings Requirement Training capacity goal conducted 5.2.2 within deadline divided by (Personnel) (100 % of No. of employees). trainings Quality Guidance for Scoring Total Revised Objective Scor Speedomet Order Indicator Points Scoring criteria weight Weight (Goal) e er s criteria 0.5 points for intended. If each training there was no conducted need for when the 0,5 training, prediction is 0 insert NA (2 points maximum). Scoring calculation: 1. Identify the total number of trainings during the term. 2. Calculate number of trainings applied during the term. 3. Divide number of trainings applied by the number of trainings intended (identified in item 1). 4. Evalute the result:

Score will be ≥ 3 Quality Guidance for Scoring Total Revised Objective Scor Speedomet Order Indicator Points Scoring criteria weight Weight (Goal) e er s criteria 1.0 ≥ 0.5 and < 1.0 2 ≥ 0.1 and < 0.5 1 < 0.1 0 90 -110 % Received / 4 Scheduled 80 -90 % or 110 and 120 % 3 Received / Indicator of Scheduled demand fulfillment. 70 -80 % or 120 If not held or Analyze Check and 130 % scheduled in 9 d 2 4 4 whether what Received / the period samples is being Scheduled will be NA programmed 60 - 70 % or is being 130 and 140 % 1 received. Received / Scheduled <60 % or >140 % Received / 0 Scheduled Received within the period of 12 or 4 Meet No. of 24 months if requirement 10 Internal 4 4 applicable 4.14 (Internal Audits Audits) Not received 0 Quality Guidance for Scoring Total Revised Objective Scor Speedomet Order Indicator Points Scoring criteria weight Weight (Goal) e er s criteria Two points for each Meet No. of improvement requirement 11 Improve 2 8 8 with a 4.10 ments maximum (Improvement) score of 8 No. of Congress / Scientifi 01 point per Articles / Encourage c production will external scientific producti be assigned Lectures and 12 1 3 3 production on and with a seminars / and transfer of knowled maximum guidance of knowledge. ge score of 3. trainees and transfer scholars. 01 point will be awarded per accredited scope test with a maximum No. of score of 3 1 Encourage Accredit points, and o1 13 3 3 scope ed point per accreditation. scopes suspended trials will be removed.

No. accredited 0 scope

No. of Avoid 14 None 3 3 3 Relevant irrelevant Quality Guidance for Scoring Total Revised Objective Scor Speedomet Order Indicator Points Scoring criteria weight Weight (Goal) e er s criteria received and 2 complaints handled RCs complai and handle nts RCs received, relevant registered but 1 complaints not handled MÁX.: 100 100 0 Quality 0 Index