Tom Mancuso VP of Manufacturing

1. Tom Mancuso VP of Manufacturing

2. Introduction Quality in general ISO ISO 17025 ISO Guide 34 Discussion Conclusion

3. Quality Systems Supplier A makes a product and delivers it to Customer A Supplies Manufacture Customer (example another RM manufacturer) Customer A becomes Supplier B who makes a product and delivers it to Customer B Supplies Manufacture Customer (example Testing lab) Customer B becomes Supplier C who makes a product and delivers it to Customer C and so on Supplies Manufacture Customer (example engineer)

4. What you end up with Product that has influences from various suppliers quality systems You x x x x x xxxxx xxxxx xxxxx xxxxx xxxxx xxxxx xxxxx xxxxx xxxxx xxxxx xxxxx xxxxx xxxxx xxxxx xxxxx xxxxx xxxxx xxxxx xxxxx xxxxx xxxxx xxxxx xxxxx xxxxx xxxxx xxxxx xxxxx xxxxx xxxxx xxxxx

5. What is ISO not into? ISO 24638:2008 establishes the baseline requirements for the design, fabrication and testing of space flight pressure components. ISO 23551-4:2005 specifies safety, constructional and performance requirements of valve-proving systems, hereafter referred to as VPS ISO 22222:2005 defines the personal financial planning process and specifies ethical behaviour, competences and experience requirements for personal financial planners. ISO 3356|IDF 63:2009 specifies a method for the determination of alkaline phosphatase activity in milk.

6. What is the history of ISO 9001:2000? Mil-Q-9858 was adopted by NATO (AQAP-1) British Standard (BS) 5750 evolved from the NATO standard and was adopted by the British Standards Institute in 1979. ISO 9001:2000 was created by the International Organization of Standards in 1987 primarily based on BS 5750. ISO 9001:2000 standards are reviewed and revisions are adopted every five years. The second edition of the standard was issued in 1994. ISO 9001:2000 activity in the United States is governed by ANSI and the American Society of Quality (ASQ). Standards issued are titled ANSI/ISO/ASQ.

7. More History Originally known as ISO/IEC Guide 25 General Requirements for the competence of testing and calibration laboratories., ISO/IEC 17025 was initially issued by the ISO in 2000. ISO 17025 was re-issued in 2005 ISO/REMCO began to draft Guide 34 General requirements for the competence of reference material producers in 1991 Guide 34 was published in 1996 Guides are more that GuidesGuides are more that Guides

8. Current Status ISO reports Quality Systems are active in 175 countries ISO 9001 very general, very good ISO 17025 is widely accepted ISO Guide 34 is continuing to gain momentum new issue is in review The Europeans prefer ISO accreditation for a RM producer over ISO 9001 or ISO Guide 34 certification.� REMCO and ILAC prefer ISO 9001 or ISO Guide 34 certification for the production, characterization, certification and sales of RM together with ISO 17025 accreditation for the analytical facilities involved in RM characterization.�

9. ISO 9001 Introduction 1: Scope 2: Normative Reference 3: Terms and definitions 4: Quality Management System 5: Management Responsibility 6: Resource Management 7: Product Realization 8: Measurement, analysis and improvement

10. New in ISO 9001 ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000 and to improve compatibility with ISO 14001:2004 (requirements for environmental management systems). ISO 9001:2008 does not introduce additional requirements nor does it change the intent of the ISO 9001:2000 standard.

11. ISO - Reverence Material Related ISO 17025:2005 General Requirements for the competence of testing and calibration laboratories. ISO Guide 30:1992/Amd1-2008 Revision of definitions for reference material and certified reference material ISO Guide 31:2000 Reference materials -- Contents of certificates and labels ISO Guide 32:1997 Calibration in analytical chemistry and use of certified reference materials ISO Guide 33:2000 Uses of certified reference materials ISO Guide 34:2000/Cor 1-2003 General requirements for the competence of reference material producers ISO Guide 35:2006 Reference materials -- General and statistical principles for certification

12. Interested Parties ISO/CASCO and ISO/REMCO Accreditation Bodies Reference Material Producers Customers of Reference Material Producers

13. ISO 17025 ISO 17025:2005 General Requirements for the competence of testing and calibration laboratories. Considered a stand alone document. Management Technical Not sufficient detail for Reference Material Manufacturers Our lab is a combination of: Reference Material Manufacturer Testing Lab Not a Calibration Lab

14. ISO 17025 Contains all of the requirements that testing and calibration laboratories have to meet if they wish to demonstrate that they operate a management system, are technically competent, and are able to generate technically valid results. The acceptance of testing and calibration results between countries should be facilitated if laboratories comply with this International Standard and if they obtain accreditation from bodies, which have entered into mutual recognition agreements with equivalent bodies in other countries using this International Standard. The use of this International Standard will facilitate cooperation between laboratories and other bodies, and assist in the exchange of information and experience, and in the harmonization of standards and procedures. �

15. ISO 17025 1. Scope 2. Normative References 3. Terms and Definitions 4. Management Requirements 4.1 Organization 4.2Management System/Quality system 4.3Document control 4.4Review of requests, tenders and contracts 4.5Subcontracting of tests and calibrations 4.6Purchasing services and supplies 4.7Service to client 4.8Complaints 4.9Control of nonconforming testing and/or calibration work 4.10 Improvements  4.11Corrective action 4.12Preventive action 4.13Control of records 4.14 Internal audits 4.15Management reviews

16. ISO 17025 5. Technical Requirements 5.1 General 5.2 Personnel 5.3 Accommodation and environmental conditions 5.4 Test and calibration methods and method validation 5.5 Equipment 5.6 Measurement traceability 5.7 Sampling 5.8 Handling of test and calibration items 5.9 Assuring the quality of test and calibration results 5.10 Reporting the results

17. ISO Guide 34 ISO Guide 34:2000/Cor 1-2003 General requirements for the competence of reference material producers Also considered a stand alone document. Management Technical Full of valuable information/requirements It has been suggested that RM producers would be meeting all requirements if they followed only Guide 34. Specifically the requirements is section 5.9 of Guide 34 call out for information in ISO 17025

18. ISO Guide 34 The use of reference materials makes possible the transfer of the values of measured or assigned quantities between testing, analytical and measurement laboratories. Such materials are widely used for the calibration of measuring equipment and for the evaluation or validation of measurement procedures. There are an increasing number of reference material producers, and a demonstration of their scientific and technical competence is now a basic requirement for ensuring the quality of reference materials. The demand for new reference materials of higher quality is increasing as a consequence of both the increased precision of measuring equipment and the requirement for more accurate and reliable data in the scientific and technological disciplines. Same previously acceptable reference materials may not meet these more stringent requirements. It is, therefore, not only necessary for reference material producers to supply information about their materials in the form of reports, certificates and statements, but also to demonstrate their competence in producing reference materials of appropriate quality.

19. ISO Guide 34 Introduction 1 Scope 2 Normative references 3 Terms and definitions 4 Organization and management requirements 4.1 Quality system requirements 4.2 Organization and management 4.3 Document and Information control 4.4 Request, tender and contract reviews 4.5 Use of collaborators 4.6 Procurement of services and supplies 4.7 Client feedback 4.8 Control of non-conforming (poor quality) reference materials 4.9 Corrective action 4.10 Preventative action 4.11Records 4.12Internal audits 4.13Management reviews �

20. This is where it gets interesting 5 Technical and production requirements 5.1 Management, staffing and training 5.2 Collaborators 5.3 Production planning 5.4 Production control 5.5 Environment 5.6 Material handling and storage 5.7 Post-distribution service 5.8 Material preparation 5.9 Assessment of homogeneity and stability 5.10 Measurement methods 5.11 Measuring equipment 5.12 Traceability and validation 5.13 Data evaluation 5.14 Characterization 5.15 Assignment of property values and their uncertainties 5 16 Certificates and information for users Annex A (informative) Examples of traceability of the property values of reference materials

21. Relating 17025 to Guide 34 Our customers that are 17025 accredited were/are looking for suppliers that are also 17025 to meet their QA requirements. Reference Material Manufacturers are generally not independent testing labs as in they do not take in samples, perform the test and give their customer the results. ISO 17025 lends itself to the link between Guide 34 and our customers.

22. What 17025 has and does not have 17025 has the technical aspects required by testing labs to demonstrate competency. Lacks the specific requirements that would be associated with a reference material producer namely: Sourcing acquisition of raw material Transformation of raw material into product Sampling and packaging procedures Assessment of homogeneity and stability Estimation of shelf life Development and validation of measurement methods Fixing the traceability and estimation of uncertainty Certification of reference material Post-certification activities, stability monitoring

23. ISO 17025 5.2.2 The management of the laboratory shall formulate the goals with respect to the education, training and skills of the laboratory personnel. The laboratory shall have a policy and procedures for identifying training needs and providing training of personnel. The training programme shall be relevant to the present and anticipated tasks of the laboratory. The effectiveness of the training actions taken shall be evaluated. �5.2.3 The laboratory shall use personnel who are employed by, or under contract to, the laboratory. Where contracted and additional technical and key support personnel are used, the laboratory shall ensure that such personnel are supervised and competent and that they work in accordance with the laboratory's management system. 5.9 Assuring the quality of test and calibration results 5.9.1 The laboratory shall have quality control procedures for monitoring the validity of tests and calibrations undertaken. The resulting data shall be recorded in such a way that trends are detectable and, where practicable, statistical techniques shall be applied to the reviewing of the results. This monitoring shall be planned and reviewed and may include, but not be limited to, the following: a) regular use of certified reference materials and/or internal quality control using secondary reference materials; b) participation in interlaboratory comparison or proficiency-testing programmes; c) replicate tests or calibrations using the same or different methods; d) retesting or recalibration of retained items; e) correlation of results for different characteristics of an item.

24. Guide 34 Section 5.9 5.9 Assessment of homogeneity and stability �5.9.1 Where appropriate, the reference material producer shall carry out an assessment of the homogeneity of any candidate reference material by analyzing a representative number of randomly, systematically or stratified randomly chosen units. This should be done by means of a measurement method, the repeatability of which is fit for the purpose required (i.e. good enough to not contribute significantly to the combined uncertainty). The assessment procedure shall be documented and conducted in accordance with acceptable statistical procedures.

25. Guide 35 Stability Months Result 0 97.76 12 101.23 24 102.14 36 97.72 x y average 18 99.7125 slope 0.006583 intercept 99.594 standard deviation of the points on a line s2 s u 7.97 2.823709 0.10523344 Student's t-factor for n-2 degrees of freedom and p=0.95 (95% level of confidence) from standard table is equal to 4.30 Since the absolue value of the slope 0.006583 is less than 0.452503782 (t-factor times uncertainty) the slope is insignificant. As a consequence, no instability was observed

26. Nature of problems� Guide 34 4.9.2 Often the root cause is not obvious and thus a careful analysis of all potential causes of the problem is required. Potential causes could include, the nature of the reference material and its specification, methods and procedures used for characterization, staff skills and training, and the materials and equipment (and/or its calibration) used in the production processes.

27. Who are your customers? Environmental Material Science Semi-Conductor Process Chemistry ISO Guide 34 4.1.1 It should be recognized that a reference material needs to be characterized mainly to the level of accuracy required for its intended purpose (i.e. appropriate measurement uncertainty). The reference material producer shall describe the procedure for establishing the quality of materials as a component of the quality system.

28. Accreditation and Scope for ISO 17025 SPEX CertiPrep 17025 Accreditation

29. Accreditation and Scope for ISO Guide 34 SPEX CertiPrep ISO Guide 34

30. Conclusion ISO Guide 34 is almost perfect for Referenced Materials Producers ISO Guide 34 in conjunction with ISO 17025 is the best option because of all of the testing required to properly characterize a reference material.

31. References ISO Website Accreditation of reference material producers: Let�s get it right! Henery F. Steger Accreditation and Quality Assurance (2003) Accreditation of reference material producers: an update Henery F. Steger Accreditation and Quality Assurance (2005) Wikipedia

32. Demming cycle