What is ISO 9001?
ISO 9001 is an international standard that provides the framework for an effective quality management system (QMS). It is one of the most widely recognized and commonly used standards throughout the world and applies to all types of businesses regardless of their size, industry, product or service offering. An ISO 9001 Quality Management System is intended to provide customers assurance of the quality of your products or services. A QMS is a set of interrelated activities or processes carried out within an organization to provide a product or service which satisfies customer requirements and expectations.
What is ISO 9001 Certification?
ISO 9001 certification is a seal of quality that indicates an organization’s quality management system meets the ISO 9001 requirements. It is based on an independent evaluation or audit performed by a registrar who provides written assurance that the ISO quality management system standard has been met. ISO certificates are issued for 3 years with the requirement that surveillance audits be performed on an annual basis.
A company that is ISO 9001-conforming means that they meet ISO’s quality management system requirements but have not been formally certified by an independent registrar. Although this may be acceptable for some, an official certificate tends to carry more weight in the market place.
Why Implement ISO 9001?
- Improve financial performance: Reduce operational costs through improved process effectiveness and efficiency.
- Improve customer satisfaction: Improved product and service quality, including on-time delivery. Reduction of defects and product recalls.
- Improve employee satisfaction: Motivate employees by clarifying their roles, responsibilities, and contributions regarding the organization’s objectives.
Benefits of ISO 9001 Certification
- Improved market credibility
- Perceived as having higher quality products and services, and may receive preferential treatment when bidding on contracts
- Display of your ISO certification logo to a worldwide audience over the Internet
- Access to new markets
- Ability to bid on contracts that require ISO 9001 certification as a prerequisite for doing business
What Is the Certification Investment?
Below are the main costs associated with achieving ISO certification.
Internal costs associated with planning, developing, documenting and implementing the QMS including:
- Gap analysis
- Training and awareness
- Internal quality audits
- Purchase of copies of ISO 9000 standards
Costs Associated with Registrar Service
- Application fee, administrative and maintenance fees
- Pre-assessment (optional)
- Certification audit: Cost is dependent on size and complexity of organization
- Surveillance audits: Cost is dependent on size and complexity of organization
- Travel expenses for assessor
- External training
- Consultant services
How long will the initial ISO 9001 certification take?
Most organizations can expect a solid year, but it depends on:
- Management commitment and leadership
- What your organization currently has in place and how quickly you want to become certified
- Internal staff – their knowledge, skills, availability and time commitment
How does a company become ISO 9001 Certified?
- Develop a thorough understanding of the ISO 9001 standard.
- Perform a gap assessment to identify where your current system meets the standard and where it does not.
- Develop an action plan and timeline for achieving certification.
- Select a registrar.
- Develop a Quality Management System that defines your processes and procedures for doing business, and conforms to the standard.
- Define organization’s purpose
- Define quality policy and objectives of your organization
- Identify and document processes that are needed to produce your product/service
- Develop Quality Manual
- Develop documented procedures required by the standard
- Implement your Quality Management System.
- Communicate and provide training
- Perform Internal Audit
- Conduct Management Review
- Have Certification Audit performed by your Registrar.
- Quality System should be in place 2-3 months prior to Certification Audit
How could a quality consultant help me?
- Expertise to guide your organization to timely decisions and activities and reduce the time implementing your Quality Management System.
- Avoid the typical pitfalls companies face when pursuing certification.
- Motivate your employees to perform the tasks needed to achieve certification.
- In-depth knowledge of the standard as it applies to your organization.