What Is an ISO 9001 Certification?

When you begin your hunt for a contract manufacturer, you may notice that some advertise ISO 9001 certification. While not exclusive to manufacturing, this certification is often coveted within the industry for a host of reasons. As the most basic level, ISO 9001 is a set of standards for an organization’s Quality Management System.

Checking for an active ISO 9001 certification is a quick way to check if a manufacturer or supplier can deliver consistent results. Many companies searching for manufacturing partners even require an ISO 9001 certification. Before choosing your manufacturing partner, it’s helpful to understand the ISO 9001 standards, why they are essential and what it takes for a manufacturer to become certified to them.

What Is ISO 9001, and What Does It Stand For?

ISO is an abbreviation for the International Organization of Standards. Its founders decided to call it ISO, derived from the Greek word “isos,” meaning equal. As an organization, ISO’s goal is to create consensus-based worldwide standards. Any ISO standard must have approval from several national standards organizations.

The ISO 9001 standard, in particular, regards an organization’s Quality Management System (QMS). It applies to companies providing products or services, helping them meet customer expectations. While the ISO 9000 family encompasses the whole range of quality management standards, ISO 9001 describes the system itself. It is the only standard an organization can be certified to.

The ISO 9001 has a total of 10 clauses, with seven mandatory provisions for a Quality Management System. The first three lay out the scope of the framework and define terms. The seven primary standards include:

• Context of the organization: Clause 4 asserts an organization must develop a deep understanding of itself. The company must identify internal and external issues and the expectations of interested parties. Leaders must understand the current processes and how they interact. Then, the company can outline the scope for their QMS.
• Leadership: Clause 5 requires an organization’s leadership support. The QMS needs the motivation of the top management to ensure success. The organization’s leaders should encourage a strong customer focus, outline and communicate the quality policy and assign responsibilities.
• Planning: Adequate planning, as laid out in Clause 6, ensures the ongoing role of the QMS. As part of the planning stage, management should assess risks and opportunities. They must also identify objectives and corresponding plans for quality improvement.
• Support: A company needs many well-managed resources to support a QMS. Clause 7 describes how to control human resources, the work environment, buildings and infrastructure, monitoring tools and institutional knowledge. Supporting the new system also requires competence, awareness, communication, documentation and record-keeping.
• Operation: Clause 8 details the planning and creation of the product or service itself. The business must set and adhere to requirements on planning, design and product specifications. It must control external suppliers, the creation of the offering and any nonconforming outputs.
• Performance evaluation: To determine how successful its QMS is, the organization must monitor it. Clause 9 indicates that assessing customer satisfaction and measuring your processes are essential. It’s also vital to conduct internal audits and management reviews of the QMS.
• Improvement: Managing quality necessitates making adjustments and improvements. Clause 10 describes the requirements to strengthen the QMS. It involves assessing process nonconformity and taking corrective actions.

As the market becomes increasingly global, becoming ISO 9001 certified is more crucial than ever. Most large enterprises work with hundreds or even thousands of suppliers. If suppliers follow ISO 9001, then the purchasing organization can receive consistent quality. It ensures Supplier B provides the same results as Supplier A. It’s also useful for brands to achieve the same high quality worldwide. It’s one reason why your fast food meals taste the same wherever you travel.

ISO 9001 has an extensive range of applications. Since its focus is on consistency, any business with customers, large or small, and in any industry can benefit from adopting the ISO 9001 standard. Today, over 1 million companies in over 170 countries have achieved ISO 9001 certification. It is so popular that many sectors and industries have adopted the ISO standards for their own uses. For example, the medical devices industry uses ISO 13485:2016, which applies more rigor to the ISO 9001 framework.

What Is the Importance of ISO 9001 in Manufacturing Standards?

While the ISO 9001 standards apply to any industry, they hold particular relevance in manufacturing. Some of the most quality-critical sectors like aerospace, automotive and pharmaceuticals use ISO 9001 as a basis for their quality standards. It is a testament to the standard’s value to manufacturers.

Quality assurance is central to manufacturing because defects are costly, even when caught. When they make their way to customers, they can damage a company’s reputation. Both the manufacturer and purchaser lose time and resources to inconsistent quality.

If a batch of 10,000 units gets ruined, the manufacturer must scrap or rework the items. It that batch ships out, the manufacturer risks losing the customer, who receives unsellable goods. If those items reach consumers, the brand risks their reputation and may even issue a recall.

All these issues, no matter when stage they get caught, stem from the manufacturer. A sophisticated ISO 9001 quality management system can prevent defects from occurring. It can also stop faulty products from ever leaving the factory. As such, many organizations require that all external providers follow ISO 9001. Becoming ISO 9001 certified lets manufacturers prove that a client’s needs come first. The high standards for certification give manufacturers a reputation for uniformity.

For manufacturers, implementation of the ISO 9001 standard can achieve many benefits, including:

• Well-defined processes: Consistency starts with a documented, repeatable process. The ISO standards ask organizations to define their operations and how they interact before determining where a QMS fits. As a result, ISO 9001 aligns company processes, making them efficient and customer-focused.
• Standardized products: By setting detailed requirements for products, as described in Clause 8, manufacturers can meet their customers’ demands. For example, the company may create a list of approved, quality-conscious suppliers for raw materials.
• Valuable resources and staff: A QMS needs dedicated resources to make it sustainable. Pursuing ISO 9001 certification means an organization must hire and train knowledgeable staff. Certification shows that a manufacturer invests and manages resources effectively.
• Continual improvement: Constant review and measurement form natural quality checkpoints throughout production. By monitoring equipment, output and customer satisfaction, a plant can identify when quality begins to dip and take action to bring it back into an acceptable range. When an incident occurs, the manufacturer already has a plan in place to correct it swiftly. Close attention to rooting out issues builds increased trust with customers.

Why Working With an ISO 9001:2015-Certified Manufacturer Is Advantageous

It can be helpful to work with ISO 9001-certified manufacturers. Many customers see the certification as a guarantee of quality and consistency. Partnering with a manufacturer certified to ISO 9001, like EMSG, can provide:

• On-time delivery: A focus on quality means producers make fewer mistakes and reworks. Besides physical quality, meeting or exceeding deadlines is a key customer satisfaction metric.
• Higher satisfaction: Any ISO 9001-certified manufacturer places your satisfaction as the top priority. These partners will not accept good enough and strive to meet your needs, no matter how demanding.
• Fewer defects: By catching mistakes early and prioritizing quality control, fewer errors leave the factory. Attention to detail places less of the inspection burden on you because you know your components will work when incorporated into the final product.
• Accountability: Manufacturers who certify to ISO 9001 fix problems when they arise. While the first line of defense is preventing errors, the second is fixing issues quickly. They acknowledge their responsibility and recover as much lost time and resources as possible by acting fast.
• Commitment: The ISO 9001 standard places management involvement at a premium. When working with a certified organization, you know it is living up to the standard because its leaders are a driving force behind it. Further, inspections every year and recertifications every three years ensure that companies continue to follow the ISO 9001 principles. So, you know the company is actively involved in quality management.
• Plans for the future: Through continual improvement, ISO 9001-certified manufacturers invest in the future. These organizations know investments now will help them stay ahead later, and they pass those results onto you.

What Is the Difference Between ISO 9001:2015 and Previous Versions?

When asked why the ISO 9001 changed in 2015, ISO gave several reasons:

• Globalization
• The move toward service-based economies
• Greater complexity in the supply chain

As a result, ISO 9001 places more focus on the customer and consistency than ever before.

To understand how the 2015 version differs, consider how ISO 9001 has evolved since its first edition.

The Introduction of ISO 9001

ISO 9001’s first edition came out in 1987, with a minor revision in 1994. These early versions prescribed a list of 20 procedures an organization should follow. They could be broken down into three main ideas:

1. Write down what you do.
2. Do what you write down.
3. Make sure you are doing it.

While these procedures helped bring organizations in line with worldwide standards, they didn’t focus on the organization as a cohesive unit. The three mantras also created a good deal of paperwork, which was inefficient. One benefit introduced in the 2015 version is no prescribed documentation processes. As a result, organizations have greater flexibility in how they document procedures.

The First Major Revision to ISO 9001

ISO 9001:2000 introduced the first round of significant changes and established quality management principles. The standards encompassed everything a company does to create its products. This version placed the focus on process management. Senior management inherited the responsibility of ensuring quality management.

ISO 9001:2008 made minor revisions to the 2000 framework and was the most current version until 2015. It clarified some concepts and included measures for the standard to be integrated with ISO 14001:2004, a set of rules for environmental management systems.

The Second Major Revision to ISO 9001

The current version of the ISO 9001 standards arrived in 2015. Any ISO 9001-certified organization should be following the 2015 version, as of September 2018. It’s a complete rewrite of the 2000 and 2008 versions and introduces many new concepts.

The 2015 version highlights integration with other business activities. It places responsibility for the QMS throughout the organization to achieve such harmonization. While quality became a shared priority for the entire company, there’s even more involvement from organizational leaders. It also places a greater focus on processes over procedures and enhances the “Plan-Do-Check-Act” process cycle. Within the check phase of the cycle, there’s more emphasis on performance monitoring.

The two most significant changes are the introduction of Clause 4 regarding organizational context and the replacement of preventive actions with the concept of risk-based thinking.

Here are all the areas where ISO 9001:2015 has changed from the previous 2008 version:

• General structure: ISO 9001:2008 featured eight clauses, corresponding with eight principles. In 2015, there are a total of 10 clauses and seven principles. Three introductory clauses provide context. The 2008 version includes six mandatory procedures, which evolved into six mandatory documents.
• Context of the organization: The 2015 ISO 9001 standards now require an organization to study and monitor itself. It must track all internal and eternal issues and relevant interested parties, like regulators. The organizational context must be considered, continually monitored and periodically reviewed. By understanding the organization’s unique needs, the ISO 9001 standards become more tailored to each organization that uses them.
• Risk-based thinking: The ISO 9001:2015 standards did away with the model of preventive actions. Instead, an organization must monitor and evaluate risks and opportunities. It places upper-level management in charge of identifying, documenting, eliminating and mitigating risk.
• Terminology: In recognition of the ever-evolving global economy, the ISO 9001:2015 standard assigns new terms to its concepts. Significantly, “product” became “products and services” and “supplier” became “external provider.”
• Excluding requirements: In the interest of flexibility, ISO 9001:2015 allows organizations to exclude any inapplicable requirement as long as it’s justified. Of course, organizations must answer for these exclusions during their evaluation.

Background and History of Quality Management Systems and Total Quality Management (TQM)

The ISO 9001 standards represent an internationally recognized approach to Quality Management Systems. The 2015 version, in particular, ushered in a new era for quality management. To see just how much these standards have transformed manufacturing and continue to improve quality assurance, consider its predecessor, Total Quality Management (TQM).

Both QMS and TQM have a long-standing history in business management techniques. Both arose out of the principles of scientific management, which became popular in the 1920s. Many ideas were introduced through these concepts. Some we can identify in quality management techniques today include:

• Use the scientific method to study work and determine the most efficient way to perform tasks, rather than relying on rules of thumb or habits.
• Divide business responsibilities, so managers focus on planning and training, while workers carry out plans and perform tasks most efficiently.
• Provide instructions and supervision while monitoring worker performance to ensure they’re using the most efficient ways of working.

The Origins of Total Quality Control

Engineer Walter Shewhart developed the ideas of statistical analysis and control of quality for manufacturing during the 1920s. During that period, the focus for quality control emphasized the final product rather than the processes involved. Quality was achieved through inspections, where final outputs were measured against set specifications.

As companies expanded and manufactured more and more goods, one final inspection wasn’t enough. They needed to catch mistakes earlier to keep costs and defects down. So, in the 1940s, production personnel began performing inspections at specific intervals.

In the 1950s, Japanese executives and engineers learned these ideas from mathematician and statistician W. Edwards Deming. As they applied these concepts to their business management, TQM was born. In 1968, the Japanese coined the term “company-wide quality control” to describe their methodology for ensuring quality. The Japanese philosophy used statistics to improve quality while embracing the entire organization’s role in ensuring quality.

To keep up with the vast improvements in quality and success in exported goods, U.S. manufacturers adopted the TQM approach in the late 1970s and early 1980s. It became standard practice for American business by the late 1980s.

The Origins of the Quality Management System

The term “Quality Management System” was coined around the same time as the Japanese “company-wide quality control.” As TQM picked up steam around the world, companies needed to know exactly what was involved in implementing the philosophy. Independent organizations began creating standards for building and implementing quality management systems. As standards evolved, ISO eventually consolidated them into the ISO 9000 series.

The ISO 9001 standards, which specifically concern Quality Management Systems, were established in 1987. In many respects, the standards for the QMS evolved directly out of the principles of TQM. As the ISO 9000 standards continue to develop and are recognized as the worldwide best practice, the term TQM has fallen out of practice. However, the ideas are alive and well in the ISO 9000 standards, where they have become more refined.

What Are the Decision Factors for ISO 9001 Certification?

When manufacturers apply for ISO 9001 certification, a third-party auditor visits the facility to evaluate compliance with the ISO standards. A third-party auditor will only review the organization after it has passed an internal audit.

Manufacturers first choose internal auditors from among their employees, who will compare the existing QMS against the ISO 9001 standards. Each auditor will have a checklist of the clauses and subsections of the ISO 9001 standard and check off whether the company meets the requirement.

So, the primary decision factor for ISO 9001 certification is the presence of a QMS that adheres to the seven mandatory principles:

• Context of the organization
• Leadership
• Planning
• Support
• Operation
• Performance evaluation
• Improvement

Each principle corresponds with a section of the standards document, which lists the specific requirements involved in meeting each principle in great detail. Once an organization passes its internal audit, a third-party auditor will start a two-part evaluation. First, the auditor will look at all documentation to make sure they demonstrate compliance with the standards. If the documentation is in order, the auditor will conduct an on-site evaluation of the organization’s processes. They will also evaluate:

• Staff and management’s commitment and adherence to the established system.
• The effectiveness of the system and its relationship to every area of the organization.
• Staff’s training on the system and requirements.

Steps for ISO 9001 Certification

For a manufacturer or another organization wondering how to get an ISO 9001 certification, the process can take months or even years. It can depend on how closely aligned the current QMS is with the ISO 9001 principles.

The first step is the full implementation of an ISO 9001-compliant QMS. Creating a qualifying system involves careful consideration of the ISO 9001 guidelines. Upper-level management will need to develop an implementation plan, set objectives and create quality policies. Next, they will assign roles and responsibilities for creating the QMS. After all processes, policies and other necessary information have been carefully documented, the organization can roll out the QMS.

Once the QMS is firmly in place, getting an ISO 9001 certification requires these steps:

• Internal audit: An internal audit helps a company discover weak points in the system. The company’s own staff members, who have studied the ISO 9001 rules, examine all the records to confirm processes are being followed. They can also identify shortcomings in operations, notably where they deviate from the ISO 9001 rules.
• Management review of audit: As with every aspect of ISO 9001, management must take the lead. The certification process requires management to perform a formal analysis of the results of the audit. They must assign resources where they are needed and make decisions based on the results.
• Corrective actions: The organization needs to correct any problems in the QMS by addressing their root cause. Any corrective actions taken need documentation showing how issues were resolved. Certification bodies look for at least three months of documentation that proves the QMS is being refined and continually improved.
• Certification registration: Once the QMS has been in place for at least three to six months, and has proven itself stable, the organization can register for certification. ISO does not certify organizations and relies on third-party certifying bodies to assess organizations for ISO 9001 compliance. Organizations can choose a certifying agency of their choice when registering.
• Stage One certification review: The first stage focuses on the documentation. The independent auditor will look at all documented processes and records of your improvements to see that the organization’s QMS meets standards and is documented. If those documents are in order, the audit can continue to the next phase. After the review, the auditor might give the company some advice for changes to make before Stage Two.
• Stage Two certification review: Around six weeks after the first review, an auditor will visit the business to confirm that processes are in line with ISO 9001 and happening according to the documentation of the organization’s own operations.
• Continual improvement: Once the certification is granted, an organization needs to continue to follow the ISO 9001 standards and improve its QMS. While a certification lasts for three years, the certifying body will visit the facility once or twice a year for surveillance to ensure the standards and internal documentation are being followed.

How Much Does It Cost to Become ISO 9001 Certified?

The ISO 9001 certification cost depends on many factors. The first is how you define the total cost. Becoming certified starts with developing a QMS system that meets the requirements of ISO 9001. Those costs vary widely from company to company. Of course, allocating appropriate resources is part of the ISO 9001 requirements. Some may also factor in the time and effort of creating a QMS system into this cost. Many organizations hire consultants or take classes to help them bring their QMS up to speed.

If you look only at the cost of getting audited and certified, the price point can also vary significantly. The complexity of the QMS system and the number of employees involved will affect the amount of time and effort needed for a third-party auditor to assess the company. Each certification body charges their own rates for their services.

EMSG Is ISO 9001 Certified — Contact Us to Learn More

At EMSG, we pride ourselves on our commitment to our customers and high-quality electronics. As a contract electronics manufacturer, we work to understand your quality expectations and perform robust quality testing using visual and automated optical inspection (AOI). As a testament to our customer-first approach and dedication to consistency and quality, we are ISO 9001:2015 certified. To learn more about our Quality Management System and everything we do to ensure you’re happy with our work, get in touch with us today.