ISO 9001:2015 Quality management systems — Requirements
ISO 9001 is a quality management system standard published by International Organization for Standardization (ISO). It is designed by ISO/TC/176 which was formed in 1979.
The ISO 9000 International Standards are revised at least every 5 years:
- ISO 9001 1st Series was published in the year 1987;
- ISO 9001 2nd Series was published in the year 1994;
- ISO 9001 3rd Series was published in the year 2000;
- ISO 9001 4th Series was published in the year 2008;
- ISO 9001 5th Series was published in the year 2015; and
- the next edition of ISO 9001 will likely be published in 2030.
ISO 9001 Quality Management Principles
ISO 9001 is developed with seven quality management principles to which a company is required to subscribe to improve its organisation's performance:
- customer focus;
- leadership;
- engagement of people;
- process approach;
- improvement;
- evidence-based decision; and
- relationship management.
Who Should Use ISO 9001?
ISO 9001 is the world's most recognised Quality Management System (QMS) standard.
Organizations of all types and sizes and natures can implement ISO 9001 QMS.
It does not matter what size your organization is.
- Any organisation with as few as 2 persons to as large as million persons can benefit from ISO 9001 QMS.
It does not matter what industry you are in.
- Any organisation in service or manufacturing, profit or non-profit organisation, private or public or government can implement ISO 9001 QMS.
More than one million organizations from more than 160 countries have applied the ISO 9001 standard requirements to their quality management systems. Organizations of all types and sizes find that using the ISO 9001 standard helps them: Organize processes. Improve the efficiency of processes.
Why Should You Use ISO 19001?
Any organisation that wants to establish, implement, maintain and improve a Quality Management System and give assurance that your organization has implemented effective management controls to:
- streamline business processes;
- increase business opportunities and in turn increase revenue;
- gain worldwide quality recognition;
- manage business risks;
- build credibility;
- enhance customer satisfaction; and
- improve supplier relationships.
You may face the risks and lost opportunities involved with not having an ISO 9001 QMS:
- where ISO 9001 QMS may be a legal or contractual requirement; and
- you will potentially be eligible for more lucrative, large scale both government and private sector contracts that are only offered to organisations that have ISO 9001 QMS.
You want to demonstrate your ability to consistently provide services that meet customers' needs.
Requirements of ISO 9001:2015 QMS
Clause 4 Context Of The Organization
4.1 Understanding the organization and its context
4.2 Understanding the needs and expectations of interested parties
4.3 Determining the scope of the quality management system
4.4 Quality management system and its processes
Clause 5 Leadership
5.1 Leadership and commitment
5.1.1 General
5.1.2 Customer focus
5.2 Policy
5.2.1 Developing the quality policy
5.2.2 Communicating the quality policy
5.3 Organizational roles, responsibilities, authorities
Clause 6 Planning
6.1 Actions to address risks and opportunities
6.2 Quality objectives and planning to achieve them
6.3 Planning of changes
Clause 7 Support
7.1 Resources
7.1.1 General
7.1.2 People
7.1.3 Infrastructure
7.1.4 Environment for the operation of processes
7.1.5 Monitoring and measuring resources
7.1.6 Organizational knowledge
7.2 Competence
7.3 Awareness
7.4 Communication
7.5 Documented information
7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented information
Clause 8 Operation
8.1 Operational planning and control
8.2 Requirements for products and services
8.2.1 Customer communication
8.2.2 Determining the requirements related to products and services
8.2.3 Review of requirements related to products and services
8.2.4 Changes to requirements for products and services
8.3 Design and development of products and services
8.4 Control of externally provided processes, products and services
8.4.1 General
8.4.2 Type and extent of control
8.4.3 Information for external providers
8.5 Production and service provision
8.5.1 Control of production and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or external providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes
8.6 Release of products and services
8.7 Control of nonconforming outputs
Clause 9 Performance Evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation
9.2 Internal audit
9.3 Management review
9.3.1 General
9.3.2 Management review inputs
9.3.3 Management review outputs
Clause 10 Improvement
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
MLOK’s methodology and approach to making your company comply with ISO 9001 QMS
We adopt four stages of the most practical and methodological process to help you certified for ISO 9001.
Stage 1: Planning
Our 1st consultation session with you begins with planning:
- to introduce you to ISO 9001 QMS;
- to set up Project Time Line;
- to establish Committee Members which consists of Steering Committees, Working Committees, Quality Management Representative, Document Controller and Internal Auditor with Terms of Reference clearly defined;
- to confirm the Scope of Certification;
- to establish QMS Documentation Framework or Structure; and
- to explain ISO 9001 QMS certification process.
Stage 2: Documentation
Our consultation session with you on Stage 2 is the drafting and writing of quality management documents to comply with ISO 9001 which consists of:
Core Procedures
Core procedures are determined based on your company’s nature of business (i.e. type of products and services). A typical example of the core procedures with the corresponding ISO 9001 clauses would consist of:
- Tender/RFP/Sales & Marketing Process and Contract Review Process (ISO 9001 clause 8.2);
- Design & Development Control Process (if applicable) (ISO 9001 clause 8.3);
- Operation or Project Planning Control Process (ISO 9001 clause 8.1);
- Operation or Project Execution and Management Control Process (ISO 9001 clause 8.5); and
- Quality Control Plan or Inspection and Testing Procedure (ISO 9001 clause 8.6).
Supporting Process Procedures
These are the processes that support the core processes. For example, a supporting process might be to recruit staff. There may also be sub-processes, decisions and activities. Depending on the size and complexity of the organizational structure, the supporting process procedures with the corresponding ISO 901 clauses are commonly made up of:
- Human Resource Competence, Training and Awareness Process (ISO 9001 clause 7.1, 7.2 & 7.3);
- Purchasing Control Process for Supplier, Sub-contractor and other services providers (ISO 9001 Clause 8.4);
- Infrastructure Maintenance of Equipment (ISO 9001 clause 7.1.3); and
- Calibration of Equipment (ISO 9001 clause 7.1.5).
Management/System Procedures
These are the mandatory system procedures which consist of:
- Control of Documented Information (ISO clause 7.5)
- Internal Audit & Management Review (ISO 9001 clause 9.2 & 9.3)
- Control of Non-Conformity (ISO 9001 clause 8.7 & 10.2)
- Corrective Action (ISO 9001 clause 10.2)
- Risk Assessment Analysis (ISO 9001 clause 6.1)
Forms
Forms automate data compilation and analysis. They are necessary to gather, capture, and process the quality data that need to be reported and analyzed as part of compliance with ISO 9001 requirements. The forms that support the core procedures, supporting process procedures and system procedures will also be developed.
Quality Manual
Quality Manual states your company's intentions for operating and executing your organisational processes within the framework of the quality management system. It includes all the following documented information which we often put as appendices:
- ISO 9001 Quality Policy (ISO 9001 clause 5.2.1);
- ISO 9001 Quality Objectives (ISO 9001 clause 6.2);
- ISO 9001 External & Internal Issues & Interested Parties (ISO 9001 clause 4.1 & 4.2);
- Organisation Chart (ISO 9001 clause 5.3); and
- Job Description (ISO 9001 clause 5.3).
Our written procedures are not complicated, not too tight or restrictive. They are written in a way that is easily understood, using simple and clear words so that your people would know what to do, when to do it, how to do it, and how not to get it wrong. You will have less frustration and can save a tremendous amount of time and effort.
Stage 3: Implementation
Our consultation session with you on Stage 3 Implementation is to put into practice the documented quality management system. The significant implementation sequences to be followed are:
- To approve the documented QMS by the respectively authorized personnel determined in accordance with the Control of Documented Information;
- To create a Master Copy and Controlled Copy of QMS;
- To distribute the Controlled Copy of QMS for implementation purposes;
- To check evidence of implementation;
- To conduct an ISO 9001 Internal Audit training;
- To develop an ISO 9001 Internal Audit Checklists;
- To conduct an ISO 9001 Internal Audit. This will be performed approximately 3 months after you have used your QMS and generated sufficient records to prove that you have implemented the documented QMS;
- To guide in closing Internal Audit findings;
- To prepare Internal Audit Reports;
- To conduct an ISO 9001 Management Review Meeting; and
- To prepare Management Review Minutes.
Stage 4: External Audit
Our consultation session with you on Stage 4 External Audit is the final step in your preparation for ISO 9001 certification.
The external certification audit is completed in two stages:
- Stage 1 Documentation Audit; and
- Stage 2 Compliance Audit.
The purpose of a Stage 1 Audit is to determine your preparedness for your Stage 2 Certification Audit. The Stage 2 Audit assesses the implementation and success of your ISO 9001 management system.
We will address the non-conformances for you if any, found during the audit by the Certification Body.
You will then receive your ISO 9001 certificate.
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