ISO 9001 is a global standard for quality management systems (QMS) based on seven principles. To be certified, a company must comply with the ten essential clauses of ISO 9001 quality management. The company must also comply with the four action groups (Plan, Do, Check, and Act). Best Practice Certification is an ISO 9001 accredited certification body that can provide the support you need to get certified.
The Principle of a Quality Management System
There are seven fundamental principles of a QMS:
- Customer focus
- Continuous improvement
- Engaging people
- Leadership
- Process approach
- Managing relationships
- Making decisions based on evidence
ISO 9001: The Ten Clauses
Listed below are the ten ISO 9001 clauses and their action headings:
PLAN
ISO 9001’s first six clauses deal with initial planning and are under the planning phase. They include:
Clause 1: Scope
Clause 2: Normative approaches
Clause 3 Terms and definitions
Clause 4: Context of the organisation
Clause 5: Leadership
Clause 6: Planning
DO
In clauses seven and eight, companies are required to take action to ensure that they operate efficiently and produce high-quality products. In clause seven, you are required to monitor and measure your company infrastructure and resources. The eighth clause deals with the operational aspects of your business, such as designing and developing products and services and planning and controlling operations.
Clause 7: Support
Clause 8: Operation
CHECK
As part of clause nine, performance evaluation is addressed and includes measurement and evaluation of customer satisfaction. Clause 9.3 emphasises the need for an internal audit, and clause 9.4 calls for a frequent review of top management.
Clause 9: performance evaluation
ACT
In clause ten, the corrective actions necessary for continuous improvement are addressed.
Clause 10: Improvement
ISO 9001 Certification Documentation
The ISO 9001 certification process requires both mandatory and non-mandatory documents. Records are compulsory to demonstrate your company’s compliance with ISO 9000 standards and obtain certification. It is beneficial to submit procedure documents during the gap analysis stage, but it isn’t compulsory.
ISO 9001 2015 does not require the quality manual that ISO 9001 2008 requires. However, it is still valuable for your company as it serves as the foundation document for your QMS.
Records (Compulsory)
- Calibration records for monitoring and measuring equipment
- Training, qualifications, skills, and experience records
- Records of product/service requirements reviews
- Records of review of design and development outputs
- Development and design inputs records
- Output records for design and development
- Records of design and development changes
- Product and service characteristics
- Customer property records
- Change control records for production/service provision
- A record of conformity between the product/service and the acceptance criteria
- Nonconforming outputs records
- Program for internal audits
- Internal audit results
- Management review results
- Corrective action results
Procedures (Voluntary)
Procedures for:
- Establishing the context of the organisation and interested parties
- Addressing risks and opportunities
- Competence, training, and awareness
- Maintenance and measurement of equipment
- Documents and records control
- Sales
- Design and development
- Service provision and production
- Internal audit
- Management review
Process Mapping
Since ISO 9001 is process-based, an essential part of implementing ISO 9001 is understanding the processes. It’s not always straightforward to comprehend a text-based system, mainly if you use an integrated management system. Visual representations such as process maps can make it easier for you to follow processes and result in better QMS efficiency.
A process map displays the whole process from start to finish and entails the following:
- Inputs and outputs of the process
- Responsibility and activities
- Process loops, parallel processes, and pathways
- Decision points
- Metrics, objectives, targets, and critical measures
- Interactivity with other processes
Bottomline
It may seem daunting to attain ISO 9001 certification, but most companies already have the relevant procedures and records in place. By analysing gaps, a certification body can determine what you need to change or implement. Once that is done, creating an ISO 9001 quality management system becomes seamless.
