ISO 9001 Certification

CQ Introduction to ISO 9001 Certification

Introduction to ISO 9001 Certification

ISO 9001 is the international standard for the quality management system (QMS). This certification showcases the organization’s commitment to providing products or services that meet customer and regulatory requirements and shows continuous improvement. In some industries, ISO 9001 certification is mandatory. To become ISO 9001 standard certified, the organization must adhere to the requirements set forth in the standard.

What is ISO 9001:2015 quality management system?

ISO 9001:2015 replaced ISO 9001:2008. The latest iteration acts as guiding principles that are used to create efficiency within an organization by aligning and streamlining processes. The seven quality management principles of ISO 9001:2015 are

Customer focus
Leadership
Engagement of people
Process approach
Improvement
Evidence-based decision making
Relationship management

Objectives of ISO 9001 Certification

The ISO 9001 standard allows businesses to organize processes, improve process efficiency, and continually improve products and services. Having an ISO 9001:2015 certification means that an organization :

Maintains documentation
Follows the guidelines of the regulated ISO 9001 standard
Meets statutory and regulatory requirements
Fulfills its own requirements

What are the benefits of being ISO 9001 certified?

Having ISO 9001 certification is globally recognized and assures the stakeholders that the management systems are consistently assessed and approved. The certificate also offers other benefits such as:

Globally recognized standard
Suitable for both small and large organizations
Better internal management
Minimizes wastage
Improves efficiency, productivity, and profit
Enhanced customer retention and acquisition
Helps achieve consistent outcomes
Compatible with other ISO standards

Best Practices For ISO 9001 Certification

To ensure a successful implementation of ISO 9001, follow these five focus points diligently —

A well-implemented ISO 9001 process will have to be driven from the top, with the senior management completely committed to achieving compliance with ISO 9001 requirements
Co-create and collaborate with the on-ground team to keep up morale and motivation as lack of clear understanding of the processes as well as the need for and impact of change can lead to a failure of ISO implementation
Proper knowledge regarding ISO compliance and implementation is an essential factor for its implementation to bear results
Plan a strategy that has realistic timelines, allocate resources, assess risks and opportunities assessment, conduct periodic audits, and track progress
ISO implementation requires an allocation of budget for consultants, training, quality resources to pay auditors and pay for the certification

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How do I get ISO 9001 certified?

Step 1: Set the Goals for the Business
Identify the results of past quality efforts using a gap analysis with regard to ISO requirements, and delineate the right approach suited to the company’s culture and requirements
Step 2: Document Management
ISO 9001:2015 standard focuses on documentation as it helps maintain business continuity, operations, efficiency, and profitability. The documentation should detail workflows and processes
Step 3: Collaborative Mindset for Implementation
A successful implementation process includes communicating the new requirements to the employees to help them understand the new way of working
Step 4: Automation of Internal Audit, Document Management, CAPA, etc.
On completing the implementation of ISO 9001 processes, evaluate the conformance to ISO 9001 internally. Trained employees or a subcontractor can do the audit, which is not a one-time affair but should be conducted periodically
Step 5: Getting Certified
Upon completion of the documentation process, the organization must have a third-party ISO 9001 audit to achieve the certification within two months of the implementation process.
Step 6: Recertifying
ISO certification is not a one-time process and organizations must get recertified every three years to remain certified.

Requirements For ISO 9001 Certification

Typically, the ISO 9001 standard is adopted by a company either because customers mandate it as part of the contract, governments require the certification to allow trading, or when a business wants to improve its products and customer satisfaction. Simply put, ISO certification assures customers and other vendors that the company can be trusted as the certification is focused on quality.

The ISO 9001 requirements for certification are mandated by ISO in ten clauses. These clauses follow a Plan-Do-Check-Act cycle as mentioned below.

Plan

Clause 1 – Document the scope detailing the various aspects of the business such as product, regulatory requirements, remote locations, activities

Clause 2 – Prepare a list of normative references, including concepts, principles, and definitions that should be understood and applied as defined in ISO 9000

Clause 3 – Identify the various terms and definitions defined in the ISO 9001:2015 standard that will help the organization during the implementation process

Clause 4 – Determine the context of the organization focusing on both internal and external issues that will have an impact on the strategic objective, purpose, and direction of the organization.

Clause 5 – Outline the commitment requirements from the leadership and top management on various issues such as customer focus, quality policy, defined QMS related responsibilities, and authorities

Clause 6 – Align the quality policy with risks, opportunities, and quality objectives

Do

Clause 7 – Create a support system that includes people, infrastructure, knowledge base, communication, and documented information to operate the QMS

Clause 8 – Focus on operational planning and contro, to help uncover customer requirements, review design, delivery, and post-delivery support.

Check

Clause 9 – Prepare a performance evaluation that helps assess data related to customer satisfaction, internal audits, process performance evaluation, analysis, and management review.

Act

Clause 10 – Address nonconformity and process improvement requirements through corrective actions and continual improvement actions.

Steps to get ISO 9001 Certification With ComplianceQuest

Using ISO 9001:2015 helps ensure that customers receive consistent, high-quality products and services, which in turn brings many business benefits. ComplianceQuest – A 100% modern cloud Enterprise Quality & Safety Management System (QHSE) – goes above and beyond the requirements for ISO 9001:2015 while automating your entire ISO 9001 Quality Management System requirements. The QMS solution from ComplianceQuest is mapped to the ISO requirements for enabling businesses to become compliant and thereby make the quality management system efficient and effective. ComplianceQuest’s main goals when embarking on ISO certification are:

Providing a secure, homogeneous, and repeatable internal process execution
Creating a platform for consistency during expansion and growth
Improving client delivery services and customer satisfaction

CQ significantly reduces the effort involved in maintaining your ISO 9001:2015 Quality System by making the required processes automated while maintaining full traceability. In addition, it provides a complete view of your organization’s data concerning the performance and effectiveness of your quality and compliance management system. Some of the features include:

Audit Management
CAPA for Continuing Improvement
Change Management for organization, collaboration and governance for efficient changes
Complaints Management to create loyalty by address customer complaints smartly
Document Management for relevant information to be within reach always
Equipment Management for keeping the tools of the trade in top condition
Inspection Management
Nonconformance Management across departments and locations
Risk Management
Supplier Management
Training

Steps to get ISO 9001 Certification With ComplianceQuest

Using ISO 9001:2015 helps ensure that customers receive consistent, high-quality products and services, which in turn brings many business benefits. ComplianceQuest – A 100% modern cloud Enterprise Quality & Safety Management System (QHSE) – goes above and beyond the requirements for ISO 9001:2015 while automating your entire ISO 9001 Quality Management System requirements. The QMS solution from ComplianceQuest is mapped to the ISO requirements for enabling businesses to become compliant and thereby make the quality management system efficient and effective. ComplianceQuest’s main goals when embarking on ISO certification are:

Providing a secure, homogeneous, and repeatable internal process execution
Creating a platform for consistency during expansion and growth
Improving client delivery services and customer satisfaction

CQ significantly reduces the effort involved in maintaining your ISO 9001:2015 Quality System by making the required processes automated while maintaining full traceability. In addition, it provides a complete view of your organization’s data concerning the performance and effectiveness of your quality and compliance management system. Some of the features include:

Audit Management
CAPA for Continuing Improvement
Change Management for organization, collaboration and governance for efficient changes
Complaints Management to create loyalty by address customer complaints smartly
Document Management for relevant information to be within reach always
Equipment Management for keeping the tools of the trade in top condition
Inspection Management
Nonconformance Management across departments and locations
Risk Management
Supplier Management
Training

Frequently Asked Questions

What is the need for ISO 9001?

ISO 9001 promotes process-based QMS by integrating interrelated processes at the enterprise level, thus ensuring greater effectiveness and better-integrated processes to minimize waste and reduce costs.
A well-implemented ISO 9001 helps businesses make informed decisions as its framework for quality management focuses on facts and data
Being process-oriented with quality as the motivating force, a business can deliver a better quality of products in a timely manner, earning customer loyalty and repeat business.
By implementing ISO 9001 first, businesses can deploy and manage other standards such as ISO 14001 (environmental management), ISO 20000 (IT service management), ISO 13485 (medical devices), or ISO/TS 16949 (automotive industry) easily.
ISO promotes productivity and employee performance as better documentation and predictive analytics enable timely response to challenges and improve employee engagement.

Why should organizations automate the ISO 9001 process with Quality Management Software?

Without a robust QMS to support the operations, businesses can face several challenges such as –

Lack of control on the quality of inputs, manufacturing, or even distribution
Inability to enforce processes and procedures on third-party vendors
Lack of visibility into the processes followed by the vendors except through a few inspections
Inability to meet customer expectations in terms of quality of products and services
Inability Increasingly stringent regulatory bodies that require businesses to conform to the standards and regulations stipulated specific to their industry
Non-compliance with mandatory quality management

Overall, digital transformation and automation are the key to quality management and ISO 9001 compliance. Without automation and digital technologies like AI, data analytics, and the cloud, it’ll be impossible to build an enterprise-wide culture for quality management.

What are the 5 key principles of ComplianceQuest’s Next-Gen QHSE to deliver this Quality Excellence?

ComplianceQuest’s Next-Gen QHSE has been built on our five guiding design principles :

Principle #1: Core Quality Promise that enables critical business decision making
Principle #2: Simple, seamless and consistent user experience
Principle #3: Single source of Data at its Core
Principle #4: Modular, cloud-based, best practices through Standardization and Flexibility
Principle #5: Continued Improvement across quality, business process, systems, design and people