Customised ISO 9001 Package

The Challenges Business Owners Face When Implementing ISO 9001

Management of quality is of paramount importance in all organisations. Essentially, management of quality of a product or service demands two approaches. While the product quality deals with the quality of the final product, the process quality is about the quality of the processes necessary for producing goods and services. The ISO 9000 standard combines the two into one comprehensive QMS or Quality Management System.

While defining a framework for management systems, the ISO 9000 standard also includes the necessary elements for the systematic management of quality. Therefore, ISO 9000 is a family of standards relating to Quality Management Systems while also assisting organisations in meeting the needs of their customers and their stakeholders. These include both the stated needs as well as those implied.

While implementing ISO 9001, businesses all over the world face several challenges. Some of these challenges are because of the misconceptions some organisations have about ISO 9001, while others are due to several barriers they need to overcome.

Misconceptions about ISO 9001

Misconceptions about ISO 9001 vary widely based on geographical location and the nature of the organisation, but some of the most common misconceptions can be listed as follows, ISO 9001

  • Exposes intellectual property
  • Guarantees defeating competition
  • Requires huge financial resources
  • Requires all departments to be certified
  • Certification is awarded by ISO, Geneva
  • Certification has no expiry date
  • Assures quality of goods and services
  • Certificate is awarded only to private sector organisations
  • Implementation decreases productivity
  • Implementation and certification require a long time

Before and after certification, internal auditing is the only way by which data and procedures of an organisation may be exposed to external auditors. ISO certifies external auditors as bodies functioning worldwide. ISO Geneva trains and accredits internal auditors very well. Auditors use methods such as observation, asking questions, verification of record-keeping and selecting records for identifying and reporting evidence about the areas that require corrective action. There is no scope for leaking out data or secrets pertaining to an organisation by the auditors.

That ISO 9001 assures defeating the competition is a widely held misconception. ISO 9001 is a QMS required by customers or countries and does not guarantee successful competition. To succeed in the competition arena, instead of focusing on the value of the standard, the organisation must focus more on the entire governance of this quality certification.

Certification does require financial resources, but these are not inhibitive. Organisations can cut down on expenses significantly with training employees on internal auditing. With adequate education on the ISO 9001, it is possible to qualify the entire organisation, one of its departments, or only one of its processes to get the ISO 9001 certification. The qualifying and registration agencies handle certification of organisations and the ISO, Geneva does not. Moreover, the ISO certification is not awarded for life, but only for three years, during which, several scheduled and unscheduled reviews are held. The registration agency may renew the certification upon request from the organisation based on these reviews.

A product marked with ISO 9001 may not imply top quality, as ISO 9001 is not concerned with the final quality of goods and services produced. Rather, it is concerned with the quality management system within the organisation. On compliance with requirements, any organisation may be ISO certified, and this is not restricted to any specific type of organisation, whether private, public, service or manufacturing. In most cases, implementation of ISO 9001 quality management systems in organisations has resulted in cost savings based on improvement in processes, efficiency and effectiveness. The implementation time depends entirely on the size of the organisation, the nature of its operations and the maturity of its quality systems. In general, certification may take between 6 months to two years.

Barriers in Implementing ISO 9001

Similar to misconceptions, barriers in implementing the ISO 9001 QMS also vary with geographical locations. Extensive research has been done in this area, revealing recurring patterns in which the barriers manifest themselves. The most important barriers are discussed here.

Commitment from Top Management

Lack of commitment from the top management is one of the topmost barriers to successful implementation of the QMS and its sustainability thereafter. Of the several factors responsible, the most attributable are low education quality, high top management turnover and low leadership dedication to quality.

Top management may react to external pressures for the company being certified. If they consider ISO 9001 certification to be their prime goal in itself, they may prefer to adopt a minimalistic approach towards certification, thereby achieving only a limited internal performance achievement.

Resistance from Employees

This barrier originates more from a fear caused by the lack of information about ISO 9001 requirements. It may also originate from believing in the difficulty of changing the mindset of employees regarding quality programs. That makes the understanding and support of employees crucial to implementing ISO 9001 QMS.

Difficulties in Conducting Internal Audits

This is an important barrier as it results from lack of understanding of the QMS, level of education of the employees, lack of training and low worker morale. For successful implementation, internal audition is a means of improvement and for confirming compliance with the requirements of the standards.

Lack of Suitable Consulting Boards

Lack of suitable consulting boards in a region can be a huge barrier towards proper understanding and interpretation of the requirements of the standards, sometimes because of language barriers. Absence of certifying boards in their specific region is another barrier that plagues many business owners.

Unrealistic Requirements of ISO 9001

This barrier stems from people believing that quality is realizable only through inspections, with the standards causing sub-optimization of performance. People also believe that the standards depend on how quality is interpreted and that the standards bring in more bureaucracy than what is good for the organisation.

Lack of Financial Resources

Lack of financial resources can be a serious impediment to mobilizing the implementation of ISO 9001. Funds are necessary for instituting training programs, providing quality resources, paying external consultants, auditors and for initiating certification.

Lack of Human Resources

Lack of human resources can be one essential factor acting against the implementation of ISO 9001. This barrier may also be the result of insufficient employee training or insufficient overall knowledge about quality programs among employees.

Recommendations to Business Owners Considering Implementation of ISO 9001

Organisations considering implementing the ISO 9001 QMS would do well to make a pre-assessment to determine their present capabilities, strengths and weaknesses through internal scrutiny. A vital initial step is considering why the QMS needs to be implemented, because the success of implementation and its continuity depends on the right reasons and the intended and desired benefits.

At the initial stages, it is important to activate and engage the complete management team. It is necessary to obtain their valuable views and opinions to decide on the purpose, vision and the desired results. A simple cost versus benefit analysis will then determine whether a QMS is worth pursuing.

When the organisation has established the worth of pursuing a QMS, an internal scrutiny can determine the preconditions necessary and the organisation’s capabilities for adopting a QMS. Appointing an external interviewer to conduct the interviews will avoid any bias. Keeping interviewers anonymous will give them the opportunity to speak freely and answer questions honestly and truthfully. This step is essential in revealing the misconceptions and barriers prevalent, which may ultimately jeopardize the implementation.

This is also the right phase to start educating the managers throughout the organisation. This should enable them to match the preconditions or the organisation to the specific requirements of the QMS for identifying barriers. This is an important step and the organisation may require time and effort for eliminating these barriers.

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