5 Golden Rules for Implementing ISO 9001

There are several reasons why management may decide to develop a QMS, and these reasons can contribute to the level of support they provide.  For example, if it is a decision made begrudgingly or reluctantly as a result of external pressures, management backing is likely to be low.  However, if the decision is based on a desire or need to improve productivity, efficiency and customer satisfaction (and to foster growth), then strong management support is more likely.

The level of management commitment has a strong correlation with the success of a QMS, and this can be easily determined by considering how well management:

• Provides direction and leadership
• Ensures the adequacy of resources, including personnel and budgets
• Maintains focus on strategic, long-term benefits to the organisation and not just the achievement of short-term goals
• Ensures processes operate effectively to produce quality products and/or services
• Empowers employees to be involved in the change and improvement processes.

Employees naturally follow the example set by their manager – after all, managers are responsible for performance appraisals, development, salary increases, etc.  As such, if employees perceive a manager has little time or regard for quality or the QMS, they will likely follow suit.

A QMS is a mechanism to support the successful implementation of business processes.  It is not a one-off event, but a long-term undertaking where success is dependent upon how well this management tool is utilised.
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Clause 4.2 of ISO 9001:2015 requires organisations to identify interested parties, and their needs and expectations. This typically includes:

• Company personnel
• Customers
• Suppliers.

It is not unknown for organisations, particularly small businesses, to leave the responsibility for a QMS to one person – however, this approach is only appropriate to a one-person business.

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A frequently asked question is ‘What is the most important element of a QMS?’

The answer – the people who implement it.

A QMS, the same as any other tool, needs to be fully used and implemented by people if it is going to be effective.  Whilst automation (such as artificial intelligence or ‘AI’) has become a core part of our business landscape, people are still at the core of any successful ISO 9001 implementation project.

Employees can ignore or resist the implementation of a QMS for many reasons, not least because:

• It is a change to the company culture
• They have heard bad things about ‘quality’
• They perceive a threat to their authority or job security
• They believe it’s going to take more time/ effort
• They feel they will be ‘blamed’ for things going wrong
• They have been doing something the same way for a long period of time.

Employees implement applicable processes daily and will often be able to make significant and valuable contributions on how things could be improved.  As such, it is important to encourage their involvement and foster a culture of ongoing improvement as early as possible.  

It is also important to identify how the QMS will benefit everyone concerned and to communicate this clearly and often.  Your staff members are more likely to become invested and involved if they understand how the QMS is relevant to their function and operations, and how it can benefit them.

There are various methods of encouraging this involvement, such as:

• Establishing relevant two-way communication, such as informal chats for small groups in different business areas, competitions for the best improvement suggestions, etc.
• Providing training sessions
• Development of competencies (e.g., internal auditors)
• Clear and constant communications (e.g., bulletins, newsletters etc.)
• Allocation of responsibilities and authorities
• Coordination of activities between teams and groups
• Recognition/rewarding of contributions
• Including representatives in the development of the QMS
• Creating a website on the company intranet for FAQs and easy access to the system
• Improving organisational knowledge.

It is also vital to understand who your customers are and what they want.  This may sound simple and obvious, but not every organisation has a clear picture of their customers’ needs and expectations.  It is not uncommon, in our experiences, for organisations to make assumptions based on what they think their customers need, without taking the time to develop this understanding properly and fully.  

We have seen, for example, organisations implement ISO 9001, only to receive complaints and comments about the changes made to services as a result of their certification, and a drop in customer satisfaction.  This fundamentally reflects a lack of understanding of customer needs and expectations and why the customer wants to deal with your organisation rather than another.  

Knowing who your existing (and potential) customers are and what they need and expect can help to define the objectives for the system and focus efforts, so it is worth spending some time and effort to collect and analyse this information.

Supplier relationships are also important to the success of an organisation – when things go wrong, customers do not blame the supplier, they blame you.  Considering what you need from your suppliers, and what your suppliers need from you, as well as addressing any current issues, helps to embed solid working relationships that are mutually beneficial.

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ISO 9001 does not apply to products or services, but instead applies to the processes that produce and deliver products and services in accordance with requirements, specifications, etc.

The Standard promotes the integration of its requirements into business operations, for example:

• One of the principles of the Standard is the ‘Process approach’, i.e., understanding how processes within the organisation interrelate and managing them accordingly (a system is made up of its processes)
• Clause 5.1.1 states management shall ensure the integration of the quality management system requirements into the organisation’s business processes
• Clause 8.1 requires the organisation to plan, implement and control the processes needed to meet the requirements for the provision of products and services, where the output of planning is suitable for the organisation’s operations.

The intent is not to align the organisation with the requirements of the Standard, but to apply the requirements of the Standard to the organisation and its operations (within the scope of the QMS).

It is worth noting that the Standard defines requirements to be met, but it does not dictate how they are to be met.  As such, each management system should be bespoke.

Unfortunately, it is not unknown for organisations to

• Think of the QMS and their business as separate entities
• Ignore the business operational structure and design the QMS around the ISO 9001 Standard, e.g., develop processes along the lines of the clauses of the Standard
• Use the same structure as applied by another organisation under the assumption that what works for another organisation will work for their own
• Focus purely on ISO 9001 certification and marketing, rather than improving business processes.

We would strongly recommend that you conduct a gap analysis before designing the QMS.  It is likely that the analysis will reveal your organisation is already conforming to to a significant proportion of requirements and can provide valuable input into determining the best system structure for your business.

This is not to say that there will be no need to make any changes to existing business operations. In quality management, changes mean improvement and the gap analysis can also identify areas where improvements can be made, e.g., considering efficiencies.

When designing and developing a QMS, it is important to ensure the requirements of ISO 9001 are applied and met in the appropriate areas.  However, be careful to avoid:

• Unnecessary over-complication of the system – it does not matter if your activities are complex, the structure of the system itself does not have to be.  The simpler the structure, the easier it is to understand, maintain and change.
• Excessive bureaucracy – consider the skills and competence of your employees and determine an appropriate level of documentation, e.g., procedures, work instructions, etc.  For example, a qualified electrician does not need step-by-step instructions on how to fit a light switch!
• Overreliance on manual systems such as spreadsheets – if you have electronic systems that can fulfil requirements, use them.
• An immediate goal of achieving 100% perfection – continual improvement is an important part of any QMS, and some improvements or changes can be added to the list for future action.  Do not try to do everything at once, as this creates a strain on resources and can detract from the key focus of establishing and implementing a QMS and addressing priorities.
• Too much focus on short-term results – there may be some immediate pay-offs, but generally a QMS is established to achieve and maintain required results in the long term.
• Ignoring real business objectives, such as profit growth – shareholders/owners are, after all, interested parties with needs and expectations.  A QMS should not ignore related business realities.
• Panic and concern if, especially in the early stages, there appears to be an increase in nonconformities.  There is no increase, it is just the system establishing itself and bringing to light previously undiscovered nonconformities.  This will settle down.
• Over-emphasis on quality and ISO 9001 requirements, instead of emphasis on the business – remember, users generally do not need to know which ISO clauses apply where, they just need to follow the processes.

The activities needed for the initial development and establishment of a QMS should be:

• Planned with definite objectives – the Plan-Do-Check-Act cycle can be applied to all processes, including the development and establishment of the QMS.
• Well timed and with due dates – unrealistic timeframes increase pressure on those involved and generally mean deadlines cannot be met.
• Provided with a budget – depending on what needs to be done, the development and implementation of a QMS can be expensive.
• Allocated to appropriate and competent resources.

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Knowledge of ISO 9001 and its requirements is obviously important, as this will help ensure the correct understanding and application of requirements, as well as dispelling any misconceptions.

This knowledge can be gained internally, and/or from external consultants.  When using consultants, it is important to select advisors who will help you develop and understand your QMS system and, where preferred, facilitate the in-house management of the system going forward.

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Not all organisations that implement a QMS based on the Standard apply for certification. This is usually because the organisation believes there is no benefit to spending the extra time, effort and money required for ISO 9001 certification.

However, where a decision is made to receive external certification, it’s important to:

• Look for certification bodies that are ‘accredited’. This means they in turn are audited and must meet specific standards.  In the UK, UKAS is the main accreditation body, while in America it is ANAB.
• Provide a clear description of the scope of your QMS, to ensure the scope of their accreditation covers the activities of your organisation.
• Obtain several quotes for comparison purposes.

Be aware of any other potential costs involved, e.g., if you ever need to postpone an audit date.

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Once a QMS has been implemented and (where required) certified, it can lead to a bit of a ‘morning after’ feeling!  At this point, you may be tempted to feel as though your primary objective (i.e., to establish and potentially certify the QMS) has been achieved.  However, this is a very dangerous period for QMS' as, perhaps unsurprisingly, there is a tendency to ease off and let standards slip.

In reality, the post-establishment/certification period is when the ‘Plan-Do-Check-Act’ cycle kicks in.  So, you should ensure your organisation follows the processes and maintains, sustains and improves the system.  With the QMS, you are looking to achieve consistent conformance to the Standard, and it is important that you:

• Do not ignore the importance of analysing the data received from the QMS processes (Checking). This helps to focus efforts in the right areas, rather than dissipating energies in unnecessary changes.
• Support and encourage the implementation of the continual improvement processes, including management of nonconformities and corrective actions.
• Provide and maintain competencies required to monitor and improve, e.g. trained internal auditors.
• Ensure adequate documentation and recordkeeping – we need evidence to prove our performance and compliance.
• Continue with communication and involvement of people.
• Ensure management maintains accountability.

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