Quality Management Standard
The most significant change to ISO 9001:2015 from ISO 9001:2008 is the move to an annex SL structure. This structure is based on ten sections. The current version, ISO 9001:2015, focuses more on harmonization with other ISO standards than introduction of significant changes to the requirements. The annex SL structure is the basis of the harmonization, as all ISO management system standards will move towards the same 10 sections and will share approximately 30% of the same requirements. Organizations using multiple management systems (e.g. Quality, Environmental, and Information Security) will benefit, as integration of these systems is far less complicated.
These changes have also made the standard more applicable to service industries. Much of the language that was specific to manufacturing organizations has been removed and replaced with more generalized statements of requirements. For example, Control of Nonconforming Products is replaced by Control of Nonconforming Outputs.
ISO 9001:2015 Requirements
ISO 9001:2015 has ten sections. Three sections are general information for your company about the standard and are not auditable. Certification focuses on the seven key auditable sections:
- Context of the Organization
- Performance Evaluation
The evolution of the standard brought increased requirements for companies to demonstrate continual improvement, reduced risk, and provided overall focus on customer satisfaction using a process approach.
ISO 9001 Quality Management System Standard – Background and General Information
ISO 9000 is a family of management system standards, ISO 9000, ISO 9001, and ISO 9004, that can be applied to any manufacturing or service organization. They provide a proven, successful approach for building a management system that achieves customer and operational quality goals. ISO certification is the foundation for the development of your quality system; it enables process improvement and boosts the effectiveness and efficiency of your system.
ISO 9000:2015 and ISO 9004:2009 are guidance documents. ISO 9001:2015 outlines requirements for companies to be compliant with the standard. The ISO organization also releases regular updates to the standards to meet the evolving needs and environment of business worldwide today. The current version of ISO 9001 is ISO 9001:2015, an updated version following ISO 9001:2008.
Registration is typically a service provided by an independent third-party registrar (certification body), which is capable and qualified to assess whether an organization has successfully and effectively adopted and implemented a set of requirements. The steps to certification generally involve a quality manual review, an on-site pre-assessment or readiness review, and an on-site registration assessment, which will confirm that the documented system meets the specifications of the standard.
Hundreds of Thousands Have Chosen ISO 9001
There are over a half million organizations worldwide that have adopted and implemented ISO 9001. Organizations implementing ISO 9001 report improved profit, lower employee turnover, better than national performance average on benchmark indicators, and improved effectiveness and efficiency.
Continual Improvement: A Quality Paradigm
The desire for continued improvement in the quality systems of organizations has been well documented. Organizations must determine what is the most beneficial, proven, and cost-effective approach. Just as important is the practice of aligning quality management systems with business goals. Such goals and objectives likely include:
- Reduced variation in work practices
- Clear standardized work instructions
- Enhanced intra- and interdepartmental communications
- Practical metrics that reflect progress
- Reduced operating costs
- Error prevention
- Reduced liability exposure and cost
- Top management commitment and support
What is the Process Approach?
ISO 9001 is based on the “process approach” i.e., a chain of added value activities delivering a product or service to a customer (internal or external) of the process. A process focused approach includes:
- Understanding and meeting customer requirements
- Attention to customer satisfaction
- Continual improvement
- Application of the “Plan-Do-Check-Act ” (PDCA) or equivalent cycle
- Managing interrelated processes
- Links between quality and business plans and objectives
- Defining and using process metrics
Every business operates via processes. ISO 9001 can be applied to any organization’s quality management system.
Third Party Certification – Letting Everyone Know You are Committed
Achieving registration provides a tangible goal and a publicly recognized and listed attribute of your organization. In many cases, it validates your conformance to a mandated requirement. An ISO 9001 certificate has become a requirement to many large purchasers, including the military, government, auto industry, electronics industry, and aerospace organizations.
Benefits of ISO 9001 Registration
Implementing a quality management system registered to ISO 9001 can lead to benefits such as:
- A demonstrated commitment to customers and stakeholders of strengthening “organizational capability”
- Improved processes that result in reduction of errors and risk of rework
- Increased customer satisfaction
- An enhanced image of the organization through proactive quality focused leadership
- A recognized responsibility for, and involvement with, quality by the entire organization
- Better defined processes and sub-processes, including their critical links
- Recognition of deterrents to an operation’s or service’s efficiency and effectiveness
- Identified opportunities for improvement
- A strengthened commitment toward the organization’s satisfaction of regulatory requirements
- Improved communications among employees
It may not be readily apparent, but quality management systems registered to ISO 9001 can also be applied to address items such as: customer concerns, administration issues, equipment up/downtime, and process efficiencies.
Choosing a Registrar: Why SRI?
The auditing staff at SRI is uniquely qualified to be a value-added part of your journey to develop your quality system. The process of third party assessment helps you implement effective systems to improve overall performance.
To each audit, SRI brings industry experience, value-added contributions, and people that have a practical understanding of your organization. The result: effectiveness, efficiency, satisfaction, and a valuable relationship you can rely on to achieve your success.
SRI Brings Its Own Unique Combination of Successful Assessment Practices
- Fully accredited – SRI has conducted ISO 9001 assessments in North America, Europe, and Asia since 1990, and is one of the top five USA-based, owned, and operated registrars
- Involved – a member of TC176 team that creates and adopts new ISO standards
- Committed – SRI qualifies assessors, sponsors, speakers, and local seminars
- Electronic methodology – uses SRI’s exclusive e-VENTS online site for clients and assessors to access their schedules, audit results, reports, and status of any event
- “No surprises” – is our approach to auditing: day-ending caucuses, an open-book relationship to the registration process, optimizing communication and success
- OFI – SRI auditors provide value-added OFIs, “Opportunities For Improvement” comments based on their expertise and your business processes (never compromising other company’s intellectual property or competitive advantage)
- Training – SRI has conducted public training since 1990 on documentation, interpretation, implementation, and internal auditing for all the management, quality, safety, and environmental standards to which SRI certifies
ISO 9001 Training
Understand how the ISO 9001 Standard relates to your organization, to all employees beginning at the very top, and to your QMS. SRI Quality System Registrar offers public training through iQ Training to help you and your organization understand the language of ISO 9001.
Trainers are experienced, practicing Lead Assessors, who have conducted hundreds of audits and who understand the standard inside and out. We have been providing this very same benefit to other organizations for nearly 25 years. We translate the standard into terms and examples with which you are familiar. Training provides the tie that binds all levels of your staff into the cohesive, effective, and efficient quality-focused organization you desire.
Please visit the iQ Training website for additional information regarding course descriptions and training registration.