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Working with an ISO 9001 Consultant (Part 2 - Competence Requirements)

 

Competence Requirements for ISO 9001 Quality Management System Consultants

In my series of blogs on working with a consultant when designing and implementing a quality management system in accordance with the requirements of ISO 9001, I would like to focus a bit on the competence requirements for prospective consultants, as described in ISO 10019, which provides guidance to organizations on the selection of suitable consultants. I would also like to add a bit of my own experience.

In the last blog I focused a bit on the desirable attributes of a consultant. Today I want to look at the relevant education, knowledge and skills and work experience that is important for consultants to have, if your organization is going to make use of their services. This is covered in sections 4.2.3, 4.2.4, 4.2.5 and 4.2.6 of the standard.

Education, knowledge and skills requirements

When assessing the education, knowledge and skills of a prospective consultant, the organization needs to look at education (including all relevant training courses attended) and work experience (involvement in quality management and implementation of quality management systems).

The consultant needs to have substantial knowledge of the requirements of the standard, as well as the design and implementation of a quality management system. Regarding to 2015 version of ISO 9001, the consultant needs to possess certain basic business management knowledge, as well as being experienced in risk management.

Also look at things like language ability (which must be suitable for the organization’s needs), communication skills, etc.

Knowledge and skills specific to quality management

Standards

The prospective consultant must be able to understand and apply all the relevant ISO standards which can affect the organization. Examples given in ISO 10019 include:

·         ISO 9000: QMS – Fundamentals and vocabulary

·         ISO 9001: QMS – Requirement

·         ISO 9004: Guidance to achieve sustained success (latest title)

·         ISO 19011: Guidelines for auditing management systems

In the Bibliography section in the back of ISO 9001:2015 we find a list of additional guideline standards related to ISO 9001. The consultant should know which of these standards are relevant to the organization, and be able to advise on their application within the quality management system.

Other standards to be considered include:

·         Sector specific standards

·         Measurement control system standards

·         Accreditation standards

·         Conformity assessment standards

·         Product standards

·         Dependability management standards

·         Standards related safety aspects

ISO TC-176, the technical committee responsible for the publication of ISO 9001, has also published a series of guidance documents to assist organizations when implementing a quality management system. The consultant should have sufficient knowledge of the contents of the documents. Included are:

·         ISO 9001:2015 and risk

·         ISO 9001:2015 – Guidance on documented information

·         ISO 9001:2015 – Guidance on process approach

·         ISO 9001:2015 – Managing change

·         ISO 9001:2015 – Risk Based Thinking

·         Etc.

National and international certification/registration and accreditation systems

Quality management consultants must have at least a general knowledge of the standardization, certification and accreditation systems at national and international level. They need to know the requirements for certification of such system. They also need to have knowledge of the processes and procedures for national certification of products, system, and personnel. Examples of standards and guidance documents in this regard include:

  • ISO Guide 62: General requirements for bodies operating assessment and certification/registration of quality systems
  • ISO 17021 - 1: Conformity assessment — Requirements for bodies providing audit and certification of management systems — Part 1: Requirements 
  • ISO 17025: Testing and calibration laboratories
  • Etc.

General quality management principles, methodologies and techniques

Quality management consultants must have sufficient knowledge of appropriate quality principles, methodologies and techniques. They must also be able to apply this knowledge in practice. Examples include:

·         Quality management principles

·         Continual improvement tools and techniques

·         Appropriate statistical techniques

·         Auditing methodologies and techniques

·         Principles for economics of quality

·         Team work techniques

·         Pan-Do-Check-Act methodology

·         Policy deployment methodology

·         Process mapping techniques

·         Problem solving techniques

·         Techniques for monitoring customer and employee satisfaction

·         Brainstorming techniques

·         Etc.

Knowledge and skills specific to the organization

Statutory and regulatory requirements

It is essential that the prospective consultant is knowledgeable on the statutory and regulatory requirements that are relevant to the organization’s activities. They cannot reasonably be expected to have experience in the application of this knowledge prior to initiating their services, but they must know about these potential requirements.

This knowledge includes knowledge about the statutory and regulatory requirements pertaining to the product or service, as well as those pertaining to the organization’s activities.

An example is an organization which, in their operational processes, emits hazardous fugitive emissions. There are specific legal requirements regarding to allowable emissions, as well as the licences of permits required for these activities, and the consultant should be able to advise on this aspect of the operational requirements.

Product, process and organizational requirements

A consultant is required to have reasonable knowledge of the organization’s products, processes and customer expectations prior to initiating their consultation services. They need to understand the key factors that are relevant to the product sector in which the organization operates.

The standard requires that the consultant must be able to apply this knowledge as follows:

·         To identify the key characteristics of the organization’s processes and related product

·         To understand the sequence and interaction of the organization’s processes and their effect on meeting product requirements

·         To understand the terminology of the sector in which the organization operates

·         To understand the nature of the structure, functions and relationships within the organization

·         To understand the strategic linkage between business objectives and competence resource needs

·         Etc.

Obviously a lot of this understanding will be established during the initial phase of the consultation process. Good consultants may require some of this information to be made known during the quotation or tendering phase. But is is essential that, when the actual consultation process starts, the consultant is knowledgeable on these issues.

Management practices

A good quality management consultant must have sufficient knowledge of relevant management practices to be able to understand how a quality management system integrates with the overall business management system of the organization. This includes, for example, human resources and their deployment to achieve the goals and objectives of the organization.

With the latest version of the standard, things like strategic and tactical planning, business risk assessment, corporate governance and business improvement tools and techniques have also become important.

Work experience

Having been a quality management system auditor is not sufficient experience to become a quality management system consultant. A consultant must have relevant work experience in managerial, professional and technical aspects of the consultation services to be provided.

Work experience includes the exercising of judgment, problem solving and communication with all interested parties.

It is important that the consultant must be able to provide verifiable references to past work experience and achievements.

The consultant’s relevant experience should include at least some of the following aspects:

·         Practical work experience

·         Experience in management

·         Experience in quality management

·         Experience in quality management system auditing

·         Experience in implementing a quality management system, in one or more of the following capacities:

o   Providing consultant services

o   As a quality management system management representative

o   Performing a function related to the management of quality

How much experience is necessary? The standard guidelines require, as a rule of thumb, 4 years for people who have a tertiary qualification, and 6 years for a person with only a secondary school qualification.

Work experience in quality management must be at least 2 years.

A prospective quality management system consultant must have completed at least 3 quality management system implementations with adequate participation.

The experience of the consultant must be relevant to the quality management system implementation that he or she wants to consult on.

It is important that the consultant must maintain and improve his or her competence thorough means that can include:

·         Additional work experience

·         Auditing

·         Training

·         Continuing education

·         Self study

·         Coaching

·         Attending professional meetings, seminars and conferences

·         Other relevant activities

I hope that you find this blog helpful, especially if your organization is considering the services of a consultant. Remember that consultants are not only useful for the initial implementation of systems, but also for maintaining and improving existing systems, and, if they have sufficient knowledge and experience, the integration of management systems.

Also be aware of the fact that knowledge and experience in ISO 9001 quality management systems is not sufficient for the implementation of sector specific management systems, such as ISO 13485 (medical devices), ISO 22000 (food safety), etc. Additional knowledge and experience is required.

I can be contacted at koosgouws10@gmail.com for further assistance or information, and our website is available at www.sheqmamagementsystem.co.za, or, alternatively, www.sheq-management-system.webnode.com.

Koos

 

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