NEWS TECHNICAL REGULATIONS
& STANDARDISATION

Capacity Building Initiative for Trade
Development in India (CITD)

Act. 2.1.7 & 2.2.1 – Act. 222c - Accreditation of Certification Bodies on Personal Certification

In order to implement this activity, CITD has organised a three days relevant training in Delhi which took place during 22-24 November 2016 and was attended by 26 trainees. It has further received the appreciation of the participants which qualified it as very good providing a weight voting evaluation of 4.2 for the training and 4.4 for the organization on the maximum of 5.0.

From that time, the interestregarding the sector of medical devices in India has been increased consistently during the recent years.This increased in interest is basically due to the following key points which accompanied radical changes in the sector:

The specific objective of this assignment was to improve knowledge regarding a globally accepted benchmark for certification bodies managing the certification of persons on the basis of EN ISO/IEC17024.

Discussions has focused on building an understanding of the standard’s requirements in particular regarding the standard new edition of 2012, to consider its benefits, and to explain why it has become the benchmark for personnel certification. Additionally, to analyse in what Certification Organisations had to comply in order to demonstrate their capacity of compliance.
Furthermore, participants has been part of case studies of accredited certification bodies, they learned on how to navigate successfully in the internet for a relevant successful application for certification, they further were trained in new paradigms in personnel certification, had better understanding on the evolving credentialing landscape etc.
At the end of the training the following findings were considered

FINDINGS

Finding 1: Present status of personnel certification in India

NABCB is starting to work on accreditation schemes for personnel certification.

  • Not already under the provision of EN ISO/IEC 17024 but NABCB will go this way.
  • They started to elaborate a scheme for Yoga trainers together with interested parties
  • The very next scheme to be started shall deal with natural medicine (people healer).
  • They want to spread the system over other interested countries as well after it is finished.

Finding 2: Knowledge of the participants of the training after the training

Participants has got advantages from the training explaining the requirements of EN ISO/IEC 17024 and their relevant knowledge has increased consistently.

  • They knew to follow the requirements of the standard
  • They knew about the differences between accreditation scheme, regulation and standard
  • They were aware how to create a new accreditation scheme

Finding 3: Skills of the participants in view of the preparation of training material

  • They were overcoming bad practices, such as text-heavy PowerPoint slides; promotion of visual materials
  • They demonstrated improvement of formatting skills ( PowerPoint 2007)
  • They get used in the possibilities of the text animation for a better structure of a presentation when more text shall be shown within one slide.
  • Production of non-linear PowerPoint presentations (with embedded hyperlinks on the Slide Master).

RECOMMENDATIONS

Recommendation 1 : Future work on personnel certification

After consultation with beneficiaries...

  • it is agreed that they will follow the way to establish a lot of schemes for personnel certification in India under the head of the international standard ISO/IEC 17024
  • to get rid of the judge amount of self-defined “experts” in several fields
  • and so, to improve the trust of the people in real experts in India.

Act. 2.4.1c – To develop expertise in the Accreditation of Reference Materials Producers.

Reference materials are commonly used for calibration of equipment, assessing measurement methods, for assigning values to other materials and for education and training. India is importing reference materials from abroad and the high cost of these materials has severe implications to the budget of testing laboratories.

Developing national capacities to accredit reference materials producers has reduce these costs, as well as the risk of undue import delays, and has contributed to enhance quality of Indian products through the smooth calibration of testing equipment.

CITD has provided already in the past two trainings in Bombay and Delhi regarding Reference Materials Producers (RMPs). Following to these trainings they were accredited 3 RMPs which two of them are operating in the oil sector. In agreement with the above, India had make already around 10 million dollars of savings..

Considering the importance for India to have available more accredited RMPs, NABL, asked CITD to organise a further training with the same experienced and titled experts. This additional training took place finally in Delhi on 11-15 October 2016.

Two Senior Short Term Experts, Dr Thierry Le Goff from LGC (formally the Laboratory of the Government Chemist), London, UK and Dr Ulf Örnemark (independent training consultant), from Emendo Dokumentgranskning, Ulricehamn, Sweden were both approved to undertake the present training programme.

The result of this exercise was to develop a fully trained and competent workforce in NABL, including a knowledgeable group of assessors, which would be able to meet the future needs of the Government of India in establishing a Reference Material Producers’ Accreditation System that is internationally recognised (EN ISO Guide 34), and ensure the acceptance of national accreditation, testing and certification systems overseas.

The revised programme in Delhi has addressed ISO Guides 30, 31, 33, 34 and 35 and was agreed with NABL, the CITD final beneficiary concerned by this training. This program has specifically covered the internationally recognised documents for setting up Reference Materials Producers’ Accreditation in accordance with ISO Guide 34. The 22 participants were representing RMs producers and testing laboratories in sectors like Food, Oil and Gas, Mining, Pharmaceutical industry, Materials (metals, plastics and precious metals) and Laboratory Medicine, the Indian Pharmacopoeia Commission and the Export Inspection Council.

Delegates demonstrated good knowledge of key documents, e.g. ISO Guide 34 and ISO/IEC 17025. Hence, the training focused on the interpretation and practical implementation of ISO guides 34 and 35. It has to be underlined that the pace and content of the training programme was discussed regularly during the course of its implementation to make sure that it was understood at the right level. Relevant Q&A sessions were organised several times during the training as well as recap sessions has taken place at the beginning of days 2 to 5. Presentations as well as workshop sessions (case studies) were rated very useful (adequacy of examples: 4.4/5) by the participants and kept participation high, while the knowledge of the trainers was rated as 4.8/5 by the participants. Relevant Feedback shows that the workshop sessions were particularly useful when it came to applying the knowledge acquired during the presentations. The selected case studies on two types of RMs were the opportunity for the delegates to cover all the steps involved in the production and certification of RMs. Following feedback arising from the participants, the following conclusions can be drawn.

  • The delegates are able to implement the principles of ISO Guides 34 and 35 in the production of their own RM and obtain accreditation.
  • More training in method validation, uncertainty calculations and practical use of spreadsheet programme would be beneficial.

It is important to underline that Participants’ selected by NABL had some knowledge of RM production in accordance with ISO Guides 34 and 35 prior to the course. On the other hand their level of interest was very high and was manifested in excellent challenges and discussions during the entire duration of the course. .

At the end of the training, experts assessed participants knowledge acquired during the all duration of the training. The graphic bellow shows a median score of 93 % which implies an excellent understanding of RM production and understanding of ISO Guide 34 and 35.

The score of 93 % further to show an excellent understanding of the main principles of producing and certifying RMs, is higher than the 90 % which came out following the training delivered in Mumbai in July 2015).

From the participants’ feedback again in agreement with their evaluation of the training, the following conclusions can be drawn.

  • The course met their objectives (adequacy between training and expectations; 4.1/5);
  • The case studies were relevant and kept the interest of the participants high;
  • The delegates should be able to implement the principles of ISO Guides 34 and 35 in the production of their own RM and obtain accreditation;
  • More training in uncertainty calculations would benefit the participants.

RECOMMENDATIONS

At the end of the training, even if the result of understanding and of the participants was considered quit high, implementing experts recommended that additional training in the following particular areas:

  • Practical implementation of the Guide to the Expression of Uncertainty in Measurement (GUM), using both top-down and bottom-up approach;
  • Validation of measurement procedures;
  • Basic/advanced statistics.

Will be beneficial to the participants selected.

CONCLUSIONS

All the participants have now access to the LGC on-line training library containing all the presentations (with speaker notes), workshops, spreadsheets and additional information requested by the participants. This includes topics such as the use of 2-way ANOVA, the determination of uncertainty of prediction from linear regression, guidance on setting target measurement uncertainty, and a position paper from ISO REMCO on commutability of RMs.

Food Quality and SPS, Technical Regulations and
Standardisation, and Support to Onsite Post
Clearance Audit (OSPCA) Function in Indian Customs