Our experience of implementing ISO 15189 (NABL Certification)

Sharing some insights and learning from our experience of implementing the ISO 15180 standard for medical laboratories in our organization. Implementing quality system is a very intricate process for any organization. It can be quite challenging and intimidating for many, especially when the goal is to get a certification. The uncertainties regarding the expectation and attitude of the assessor combined with the past experience of the participants across organizations leads to a lot of apprehension and assumptions. The quest for certification is often the main driver / motivation for implementing a quality system. However, it also often shifts the focus of the people from ‘improving quality’ to ‘achieving compliance’. Standard The certification process is anchored around a specific standard e.g. ISO 9000 – Quality Management, ISO 14000 – Environment Management, ISO 15180 – for medical laboratories etc. (visit //www.iso.org/iso/home/standards.htm for more understanding on types of standards). The standards are often generic and applicable to a wide variety of organizations. Even when the standard is specific to a particular industry (e.g. Medicine, Labs or Education), they still cover a wide gamut of organizations in terms of specializations, variety of work and size. Hence most standards are defined very broadly. They cover various requirements and pose a question, like ‘How do you manage the human resources?’ Or ‘What are the processes for measuring vendor performance’ or ‘what is the policy and procedure for equipment maintenance’ and likewise. The auditee needs to answer the various questions by detailing its organizational policy, processes and related evidence/documents. Training Many standards have a mandatory requirement of training the quality manager or employee/s of the organization on the particular standards. Such trainings are either organized by the standards body or consulting/training organizations. Check for the validity, coverage and endorsement of the training program with respect to the meeting the training requirements set by the assessing body. Also check about the reputation and experience of the trainer. We had sent our quality manager to attend one such mandatory training for ISO 15189 standards. The trainer was very experienced and famous and the training was quite extensive. However, it was a lot of content to absorb in a short time and was overbearing for a scientific/technical person. The major challenge was in relating the various guidelines to the actual area of work and how to implement it. Consultants It is quite common to hire consultants who help the organization in implementing the standards and preparing for the assessment. There are a wide variety of consultants ranging from freelance individuals to large organizations. Consultants bring in a lot of experience and standard documentation which can help in faster implementation. They also understand the assessment process and can guide the team better in preparing for the assessment. However, many a times hiring consultants leads to a force fitting of processes and copying of a policy/process/guideline without validating its relevance and fit with the auditee organization. We chose not to hire any consultants. Instead, we started documenting our various processes that we were following. We referred to the quality manuals of other organizations to identify the gaps. The documentation was followed up by pre-audits. We had two pre-audits – one was based on the documents and another through site visit. The pre-audits highlighted the various gap areas and the auditor comments and report provided the guidance on fixing the lacuna. Our Approach We had set up few principles for ourselves while developing and implementing the quality system.

• Relevance: Ensure that the documents fulfil a purpose and improve the process. The focus was again on need, relevance and efficiency.
• Utility:All documents should be working documents – i.e. part of the process of work and not just for compliance. This would ensure that the documents are always complete and there is no need to complete their backlog just before the audit.
• Elegance: the documents should look neat, easy to use/refer/understand. A design format evolved over several iterations which included proper index, sections and cross-referencing amongst the documents.
• Access: all documents needed to be easily accessible by all those who needed them. The most commonly used forms were printed in bulk. Shared folders on the intranet were set up with different access levels. The document control policy and register were the key elements in ensuring proper access, updation and intimation to all the employees.

  We may not have complied with all the principles that we had set for ourselves for each and every document or process. However the goal gave a direction and we could balance the need, utility, elegance and effectiveness for most of the processes. This was off course achieved through several iterations, reviews, audits and suggestions from all the team members and few external advisors. The ongoing implementation of the quality policy rests on three elements:

Documentation This is the most visible aspect of any quality system. It is imperative that the organization defines a proper policy, guideline and process for various organizational activities. The performance of each task needs to be documented through tracking sheets. Proper documentation of every aspect of works ensures that a) consistency in performance b) tracking of when & how the activity was done and c) traceability in case of any errors. Training Training is important cornerstone of a quality system. Unless the employees are told about what they need to do and how, there will be performance and expectation gaps. The technical and job related trainings are often addressed proactively and on priority if they affect the performance of the job. The quality system cannot be implemented without requite trainings, especially with respect to the documentation and process defined for various activities. Since quality system invariably involves the creation and implementation of a variety of processes and associated documents, it becomes essential to train the staff on how to do the activities to ensure compliance and quality. Audit This is an essential element to verify whether the activities are being performed as planned and if there are any gaps in terms of understanding or performance. The first important contribution of audit function is to create a slight fear and accountability in the employee with respect to compliance to the defined process and quality. The audit helps in highlighting any discipline, lethargy or attitude issues. Audit further provides important inputs on the training needs for the employees. These may related with technical process, quality process, documentation or simply demonstration of best practice. Finally audit is an input for improvement. It can highlight the gaps or deficiencies in the process or documentation and provide direction for their improvements. Audit needs to be taken up with an open mind. It is possible that the actual performer of the task has a better idea or method for doing the activity. He or she can provide essential inputs for spreading the best practice amongst other colleagues by improving the documentation or training. <p.Finally, as they say, Quality is a journey not a destination. So it is with Quality Management and ISO/NABL implementation. It is not that once the quality system is implemented and the organization is accredited that the quality and system is maintained forever. In fact, the accreditation is the starting point. A good quality system would invariably have a provision for improvement. In fact the latest version of ISO 15189 – 2015 has included a requirement for ‘continual improvement’. This is often done through various procedures and practices which incorporate the popular PDCA concept of ‘Plan – Do –Check –Act’ in some form or the other. The quality and accreditation journey is worth taking as it highlights several opportunities for improvement in the organization and also helps build on sustainability and a spirit of evaluation and improvement.