business-owners-checklist

Basic requirements needed for ISO 9001

It does not matter what systems you have in place when thinking about ISO 9001 certification. ISO 9001 has a standard set of guidelines for implementing, maintaining and improving a Quality Management System (QMS) for your organisation. These are applicable to any type of organisation of any size.

The requirements are broken down into sections called clauses. The first three clauses are not mandatory but the rest are except for clause 8 which may not be relevant to your organisation.

Clause 4 – Context of the organisation

Context of the organisation deals with the internal and external factors. These affect the objectives you set and how you meet them. External factors can include legal and financial and internal factors include the structure and governance of your organisation. Clause 4 also includes identifying the needs and expectations of stakeholders such as employees and suppliers.

 

Clause 5 – Leadership

Clause 5 focuses on the commitment of top management to implementing a QMS. The requirements include:

  • Developing and implementing a Quality Policy that gives clear direction.
  • Instilling a culture of customer focus throughout the organisation.
  • Determining the roles and responsibilities and authorities for the QMS.
  • How you will communicate objectives and policies across the organisation.

 

Clause 6 – Planning

For an effective QMS, risk-based thinking is essential. It includes the requirements for determining risks and opportunities, and quality objectives that align with the Quality Policy and how you plan you meet them.

 

Clause 7 – Support

Clause 7 is all about top management providing adequate resources to implement and maintain the QMS. These include:

  • Human resources.
  • Work environment such as lighting, dust and temperature control.
  • Infrastructure such as equipment, building facilities, software and hardware.

It also details the importance of communication, competence, awareness, and creating, maintaining and controlling documentation for the QMS.

 

Clause 8 – Operations

You can choose to exclude sections clause 8. For example, your company may not do design work, so you can exclude the design requirements. Clause 8 deals with planning products and services for customers. These include:

  • Determining and reviewing service and product requirements.
  • Testing and monitoring the quality of goods and services.
  • Creating procedures for controlling nonconformities.
  • Processes for generating and storing company records.

 

Clause 9 – Performance evaluation

In Clause 9 contains the requirements for evaluating the performance of the QMS. These include:

  • Assessing customer satisfaction.
  • Monitoring, analysing, and evaluating the performance of your processes.
  • Internal audits.
  • Inputs and outputs of management review meetings.
  • Retaining documentation as evidence.

 

Clause 10 – Continuous improvement

Clause 10 is all about corrective actions to continually improve your QMS to increase customer satisfaction. So you need to implement procedures and policies to investigate incidents, nonconformities and for corrective action. Continually improving quality in your business will benefit you over the long term.

Download your free information pack for full implementation requirements.

Quality is an important part of all businesses. It can make or break a business. Contact us for more information. We can show you how to grow your business so it reaches its potential.

Lots of old standards

The complete history of ISO 9001

ISO 9001 is an international standard that defines the requirements for implementing a quality management system in organisations. It is dynamic and adaptable which makes it suitable for all industries and businesses of any size. And it is the only standard in the ISO 9000 series your organisation can achieve certification for. 

 

ISO 9001 timeline

The ISO 9001 standard has a long history dating back to the 1950s when the US and UK government departments established standards for procuring military supplies. Organisations supplying the military had to comply with quality assurance requirements in their contracts. This led to publishing British Standard 5750 in 1979 which was the first specific quality management system for organisations. 

 

Since its first publication, ISO 9001 has gone through a series of updates to ensure it meets the changing requirements of businesses across the world.

 

The following is the timeline of ISO 9001 since its inception:

  1. 1980. In 1980, the Technical Committee 176 was formed.
  2. 1987. In 1987, ISO 9001 was first published in 1987. 
  3. 1994. In 1994, ISO 9001 went through its first minor update. This included clarifications and changes to improve the design and development clause.
  4. 2000. In 2000, ISO 9001 had its first major revision.
  5. 2008. In 2008, was the second minor revision to clarify the issues raised by the major revision in 2000.
  6. 2015. In 2015, ISO 9001 went through its second major revision. And it remains the current version organisations have to meet for certification.

 

ISO 9001 certification benefits

By achieving ISO 9001:2015 certification, your organisation demonstrates it:

  • Understands, accepts and follows the ISO 9001 guidelines.
  • Works to fulfil the organisation’s own requirements.
  • Maintains the documentation required for a quality management system.
  • Meets customer, regulatory and statutory requirements.

Receiving ISO 9001 certification can improve your organisation’s reputation. It demonstrates to your customers that the services and products you provide meet their expectations. 

 

While ISO 9001 is suitable for all industries, it has particular benefit for the following industries:

  • Construction. By adhering to ISO 9001, construction companies can achieve a reduction in waste, better efficiencies and a safer workplace.
  • Manufacturing. With manufacturing becoming more automated, implementing quality management systems assists in communicating value to local and international markets. 
  • Engineering. Quality assurance is vital for engineering companies. Adhering to ISO 9001 demonstrates the ability to identify nonconformities and potential hazards, and plan to mitigate the risks.
  • Community service organisations. By putting quality management systems in place, community service organisations can better handle feedback and demonstrate an increase in successful projects.
  • Technology service organisations. ISO 9001 helps technology service organisations streamline their complex internal processes for more effective outputs. 
  • Healthcare industry. Implementing quality management systems in health care facilities provides a powerful assessment tool. This will create more efficient and effective operations that benefit the community.

 

So if quality is important to your business, contact us for more information about ISO 9001 certification. We can show you how to implement a quality management system to earn consumer trust and grow your business so it reaches its potential. 

ISO 9001 To Beat Competition

How ISO 9001 can help you slash your competition

ISO 9001 is an international standard that specifies the requirements for a quality management system. It provides guidelines to help you decide and what documents and records your company needs to keep and control. The standard does not dictate how you do this. It is open for interpretation to suit individual businesses. Achieving ISO 9001 certification can help slash your competition when they do not have a focus on quality management.

 

Certification boosts competitiveness and credibility

ISO 9001 certification allows companies to improve processes and procedures to deliver products or services more consistently. It also allows you to see where you can improve efficiencies across the company and how to use resources more effectively

Implementing a quality management system promotes better communication, planning and administrative processes. And boosts the competitiveness and credibility of your business throughout your industry.

 

Benefits of a quality management system

Benefits of implementing a quality management system include:

  • Building trust with consumers as you demonstrate a willingness to prove you are trustworthy.
  • Remaining competitive as consumers are more likely to choose an ISO 9002 certified business than a competitor without it.
  • Decreasing the cost of reworking products and delivering poor services.
  • Increasing profit by attracting more customers because you strive to continuously improve your products and services.
  • Tracking where defects may have occurred as the process is fully documented.
  • Building customer loyalty by ensuring they have an excellent customer experience so they will recommend your business.
  • Increasing market share and annual profits as you are more responsive and adapt quickly to meet customers’ needs. This helps build trust in potential customers when your business is competing against non-certified businesses.
  • Improving productivity with staff involvement in defining operational processes and procedures.
  • Identifying poor suppliers and fixing the situation.
  • Completing regular internal audits to improve quality and to check that staff are using the quality system.
  • Reducing mistakes as it provides employees with clear processes and procedures.

If you are agreeing with any of these benefits and have not yet achieved ISO 9001 certification, your business will benefit.

 

Internationally recognised

ISO certification is internationally recognised. It is the most commonly used type of quality management system used throughout the world. The system is popular because it provides a common base for organisations no matter where they are geographically.

Certification is also a symbol of trust. It is instantly recognised and respected worldwide. And this is essential if you are doing business outside of your own country. In fact, many organisations will only deal with ISO certified organisations as they know the quality standards these organisations strive to meet.

Contact us for more information about obtaining ISO 9001 certification. We can show you how to grow your business so it reaches its potential.

iso-9001-coworkers

How ISO 9001 can increase your ROI

Many service, distribution and manufacturing organisations find meeting quality requirements consistently costly. So it makes sense to implement ISO 9001 NZ right across your organisation. It increases your quality performance and saves money on your bottom line.

A Quality Management System (QMS) helps lower expenses which increases profits. Investing in a quality system makes your company attracts more customers. Focusing on quality encourages customer loyalty which gives you a competitive edge. A QMS lowers your expenses by:

  • Reducing the need to carry inventory so you do not need so much working capital.
  • Streamlining processes and procedures which lowers your production costs.

Your return on investment (ROI) in quality will outweigh the costs of implementing and maintaining a QMS.

 

What is quality costing you?

It is natural to want to know if a QMS is cost-effective. First you need to assess what quality costs you:

  • Cost of prevention. How much do you spend on preventing recurring quality problems? This can include the cost of creating procedures and processes, quality plans and training.
  • Cost of appraisal. How much do you spend on measuring and monitoring activities to achieve consistent quality across the company?
  • Cost of internal failures. What are internal failures costing you? This includes scrapping and reworking a product, and the time and labour spent replacing products.
  • Cost of external failures. Cost of external failures includes warranties and loss of business.

The cost of preventing quality issues is a lot less than dealing with customer complaints. But you probably already know this. Poor quality products and services cost your organisation 10 times more to deal with once it reaches your customer than it does to prevent the issue in the first place.

 

ISO 9001 benefits

The following are just a few of the financial benefits of a QMS:

  1. Reduces manual processes which reduces human error and increases employee productivity.
  2. Access to real-time reporting. This allows you to make more informed decisions which means less overall downtime.
  3. Improved processes and efficiency means higher productivity.
  4. Consistent quality control across the whole organisation. This reduces defects, mistakes and customer complaints.
  5. Increased customer satisfaction which boosts sales and business opportunities.

Understanding and measuring what quality costs you allows you to see how spending more on prevention and appraisal helps reduce costs. Spending more in advance implementing a QMS lowers the cost of poor quality. Understanding all this helps you can calculate your ROI.

Our specialists understand quality and how you can use a QMS to get the best out of your business. Contact us today to find out how ISO 9001 can increase your ROI. We are passionate about helping businesses grow too their full potential using ISO certification.

Business meeting

Benefits of ISO 9001 for business

Implementing ISO 9001 provides your business with a practical Quality Management System (QMS) that allows you to monitor all areas of your business. A QMS establishes a set of workable procedures for your organisation. It allows you to define how you will meet stakeholder and customer requirements.

The basis of ISO 9001 is continual improvement. It is flexible so is suitable for use by any organisation. The standard does not specify quality objectives or how to meet customer needs. But expects an organisation to define these objectives and strive to continually improve their processes to meet them. Once your business reaches its targets, reassess them in pursuit of continual improvement.

 

ISO 9001 advantages for business

By putting a QMS in place, it helps your business to focus on what is most important. QMS processes provide a solid framework which increases productivity and profitability and boosts efficiency. It also increases customer acquisition and retention through greater confidence in your organisation.

ISO 9001 advantages for businesses includes it:

  • Is suitable for organisations of all sizes.
  • Allows for better internal management.
  • Produces less waste.
  • Is a globally recognised standard.
  • Can integrate with other ISO standards.
  • Increases efficiency, productivity and profitability.
  • Improves customer numbers and loyalty. ISO 9001 gives customers confidence your business has procedures and processes, so they have confidence in receiving a high standard of customer service.
  • Gives you the ability to expand into new markets where clients require certification before doing business with an organisation.
  • Can help identify and address organisational risks.

 

ISO 9001 advantages for customers

Customers understand the advantages of working with a business with ISO 9001 certification. And some customers will only work with certified organisations as it gives them confidence your business continually assesses its management systems.

ISO 9001 advantages for customers includes:

  • Access to improved services and products.
  • Predictable schedules for production runs and deliveries.
  • Promoting good communication and reporting.
  • Minimising mistakes.
  • Maintaining standards through annual assessments.
  • Putting customers first so you can meet their needs consistently and enhance customer satisfaction.
  • Fewer complaints and returned products.

 

ISO 9001 advantages for staff

One of the most important things people want from employment is security. But staff also want work satisfaction. By engaging them through a QMS it can improve job satisfaction by recognising the importance of your people.

ISO 9001 advantages for employees includes:

  • Boosting productivity and performance.
  • Promoting higher employee engagement.
  • Providing employees with insight into the organisation’s processes and procedures.
  • Reducing inefficiencies to improve employee’s workflow by focusing on preventive measures which decreases internal costs.
  • Improving customer service and their experience with the organisation.
  • Establishing continuous training programs to equip them with the skills to deal with changing needs.
  • A commitment to get it right the first time.

ISO certification is important for all organisations as it allows business growth, cost savings and profitability. It establishes ongoing quality standards for continuous improvement and a sustainable positive customer experience.

Contact us today for more information. We are passionate about assisting businesses achieve greatness through ISO certification.

ISO_9001_2015_QICE_NZ

Successfully transition your organisation to ISO 9001:2015

The holiday season is over, we’re almost through the second month of the new year and it’s time to begin planning ahead for the rest of 2018. Now is the time to begin digging into one of the most critical obligations your organisation faces: it’s time to prepare for the transition to ISO 9001:2015, required before the September 2018 deadline.

I know what you’re thinking: “September is still more than half a year away, we have plenty of time. There’s no rush.” Well, you’re half right: September is still 6+ months away, but time is definitely an issue. It’s been almost three years since ISO 9001:2015 was announced, certificates based on the 2008 edition will no longer be valid, no further auditing will be performed per the 2008 edition and you’re still waiting… for what?!? If yours is like most organisations I talk with, the wait is due to any of a number of factors: the transition is complex and requires time and other resources to be set aside, it’s going to be costly and requires budget preparation, or even “Maybe if we ignore it, it will just go away!”

I’m here to tell you transitioning to ISO 9001:2015 is easier, faster and less complex than you think. And it’s also NOT going away. Key to realising a smooth and satisfactory transition is knowing the facts, including the primary differences between the 2008 and 2015 standards. Here’s what you need to know to make your organisation’s transition a successful one, with as little hassle as possible.

What Is ISO 9001:2015?

Some organisations are delaying transition because they don’t understand ISO 9001:2015 or what it means to their business. If this describes you, you’re in luck. I’ve prepared a handy ISO 9001:2015 summary that tells you everything you need to know, with answers to the most frequently asked questions. Now that the basics are covered, let’s move on…

5 Primary Differences Moving from ISO 9001:2008 to ISO 9001:2015

The 2015 edition has a more intent focus on business management and how an organisation’s entire business activity is viewed, analysed and managed. The certificate itself should be more than simply a check marked item or a piece of paper on the wall, but a tool deployed for ongoing use in organising operations and defining management rules. This updated philosophy is best tracked in the five primary changes from ISO 9001:2008 to ISO 9001:2015:

  1. Structure

Probably the biggest difference between the ISO 9001 standard 2008 and 2015 versions is the structure: 2008 has eight principles and 2015 has ten. In version 2015, the last seven clauses are arranged according to the PDCA cycle (Plan – clauses 4,5,6,7; Do – 8; Check – 9; Act – 10).

ISO_9001_2015_QICE

  1. Risk-Based Thinking

The ISO 9001:2015 standard frequently highlights using strategies and tools for risk analysis in addressing quality management challenges. Contrast this to the 2008 standard, where the concept of risk is only mentioned a handful of times. Within the new standard, organisations are encouraged to use strategies and tools that fully enable them to successfully perform risk analysis as a significant component of quality management challenges and potential solutions.

  1. Leadership and Commitment

ISO 9001:2015 emphasises the involvement of top managers and organisational leadership in quality management system control. This top-down focus encourages more effective integration and alignment with business processes and strategies. Unlike the 2008 version, quality is recognised as important to everyone, and at all levels within the organisation.

  1. More Focus on Process Input and Output Components

Every organisation needs to understand and respond to the expectations of all stakeholders within a process, to best realise success. Organisations also need to establish the number and types of processes necessary to achieve their business goals. ISO 9001:2015 focuses on measuring and accurately evaluating all relevant process inputs and outputs. This requires monitoring all specifications and information involved in the production process. All processes should be aligned with the scope of the organisation’s quality and complexity management system.

  1. Documented Information

ISO 9001:2015 provides fewer enforcement requirements for records and documentation. Organisations can now independently decide what documentation is required for operations and processes, as well as the appropriate format. At the same time, there are changes to some conditions, including the addition of 69 new definitions.

What If You’re Still Using ISO 9001:2008?

The answer is simple: upgrade and transition to ISO 9001:2015 as soon as possible. It’s not just a matter of doing the bare minimum required to satisfy regulatory obligations. The 2015 standard can help your business more successfully meet the challenges and expectations of the current marketplace. ISO 9001:2015 is not just an obligation. It’s a tool you can you use to better organise and manage your business, with improved outcomes for all stakeholders, including your staff, leadership, partners and customers. ISO 9001:2015 is an investment in your success and growth.

Making Your Implementation a Success

By familiarising yourself with what’s changed from 2008 to 2015 and what’s remained the same, you’re already on the right track. Those changes demonstrate that the scope of the transition may not be as daunting as you presume… but that’s just the beginning. Perform an audit to identify your organisation’s needs within the context of the new requirements, then develop a plan to make the necessary changes. Provide adequate training, update your quality management system and, if necessary, contact Certification Body for the transition.

Under no circumstances should you give up existing procedures and documentation! Satisfactory systems should always be maintained; just because certain requirements are no longer obligatory per ISO 9001:2015, that doesn’t necessitate they be eliminated. Stick with what works, especially those procedures that have helped your organisation progress and grow. It’s better to hang on to what you are happy with and what is working, rather than initiate an unnecessary overhaul from the ground up.

The new version of the ISO 9001 standard provides you a new opportunity to improve your quality management system. Now it’s up to you to seize that opportunity and implement positive changes.

Why ISO 9001?

  • ISO 9001 is accepted as the standard for managing quality in a large number of very diverse industries.
  • ISO 9001 empowers you to identify strategies and tools to meet the evolving needs of customers and stakeholders.
  • ISO 9001 helps ensure a high and sustainable level of quality in your services and products.
  • ISO 9001 makes your processes more efficient, so you can continue to optimise them and create a procedural structure in which everyone benefits.

ISO 9001 will evolve and be further refined as industries, technologies and society itself continue to grow; future updates are a certainty. Your organisation can always rely on ISO 9001 as a source for focus, guidance and improvement… and isn’t that something every organisation needs? To learn more about how you can make ISO 9001:2015 work for your business, contact QICE – our expert quality management consulting team can explore your options and guide you to the most effective solution.

ISO 9001

ISO 9001

FAQ: What Is ISO 9001?

ISO 9001 was published in 1987 by the International Organization for Standardization (ISO) and since then has evolved into the world’s most trusted and used management tool. ISO, headquartered in Amsterdam, is composed of the national standards bodies of more than 160 participating countries.

ISO 9001 is the international standard that specifies requirements for a quality management system (QMS). One testament to its popularity and enduring effectiveness: more than 1 million organizations around the world are currently certified to ISO 9001 standards.

But what is ISO 9001? Let’s take a closer look:

• ISO 9001 standard is a basic set of principles that define best practices for efficient processes and competent people to consistently deliver a good product or service.

• ISO 9001 provides guidance and systemic tools for companies and organizations to ensure their goods and services consistently meet customer needs and expectations for quality.

• ISO 9001 boosts efficiency, optimises quality, improves customer satisfaction, elevates staff motivation and allows for sustainable performance improvement.

• ISO 9001 framework can be applied to virtually any service or manufacturing process.

Professional business management consultants who implement the ISO 9001 standard are continually providing feedback to ISO’s technical committees and advisory groups – this allows the standard to be regularly reviewed and improved, including the current iteration launched September 2015.

Current Standard – ISO 9001:2015

ISO/TC 176 is the committee officially responsible for ISO 9001 review, development and improvement. In 2012, the committee celebrated 25 years of implementing ISO 9001 and embarked on an ambitious effort to thoroughly review and improve their QSM model. This effort included integrating the newest, most effective QSM principles developed since ISO 9001’s debut.

After intensive work, the updated standard was published on 23 September 2015 as “ISO 9001:2015.” While much of the original framework remains the same, the new core terms allow easier, more effective integration with other international management systems standards. ISO 9001:2015 is applicable to any company or organization, large or small, regardless of its field of activity.

ISO 9001:2015 is less prescriptive and puts a greater focus on performance. This is possible because the update combines the process approach with risk-based analysis, to create a more relevant standardization protocol. ISO 9001:2015 also incorporates the “Plan-Do-Check-Act Cycle” (PDCA) in all organizational contexts and levels. PDCA is integral to evaluating, controlling and improving businesses processes.

The core mission of ISO 9001:2015 remains unchanged: help organizations organize processes, improve efficiency and sustain excellence and further improvement. ISO 9001:2015 certification leads to high-quality products and services, which in turn supports revenue boost.

The International Accreditation Forum (IAF) and the ISO Committee on Conformity Assessment (CASCO) are initiating there a three-year transition period to completely move on from ISO 9001 to ISO 9001:2015. But why wait? All organizations currently certified to the original ISO 9001 standard are encouraged to transition as soon as possible to ISO 9001:2015, in order to enjoy the full benefits of standardization.

Benefits of ISO 9001:2015

QMS integration using ISO 9001:2015 delivers six major benefits to your organization:

1. Better process integration allows you to identify areas for efficiency improvements for resource use, creating cost savings.

2. Enable support for additional fiscal benefits through optimisation, including positive effects on investment, market share, sales growth, and competitiveness.

3. Optimal employee and management engagement is created by defining roles and responsibilities, which creates an additional excellence feedback loop.

4. Customer satisfaction is greatly improved by your ability to sustain high quality in products and services.

5. You create a continuous improvement culture that becomes an integral part of your organization.

6. Access to more relevant and qualitatively superior information allows you to make better decisions, efficiently negotiate challenges and engage opportunities sooner.

Because ISO 9001:2015 is an international standard and expected of competent organizations, potential partners may resist engaging your organization if you are not certified. ISO 9001 certification boosts your credibility and image within the marketplace.

Getting Started with ISO 9001:2015
Achieving ISO 9001:2015 certification is the first step in a process of continuous improvement and excellence. With certification, you demonstrate professionalism, responsibility, and leadership to your stakeholders.

QICE specializes in QMS consulting for New Zealand manufacturers and product developers. Trust QICE for:

• Complete and up-to-date ISO 9001:2015 certification
• Knowledge leadership for QMS support
• Leading experience in the field
• 24/7 availability
• Defined, affordable costs

Contact us to discuss how QICE can add value and help your organization engineer its most efficient path to greatness.