ISO 9001 Quality Standard - Quick Guide
This introduction to the ISO 9001 standard is for those that are considering developing a QMS (Quality Management System) based on that standard OR are looking to update or extend an existing management system to also meet its requirements.
ISO 9001:2015 is published by ISO (the International Standards Organization) to specify requirements for a QMS and enable organizations to seek formal certification as an assurance to themselves, their clients, and other interested parties. Read on for a valuable introduction to ISO 9001. In many cases, that certification is a necessary contractual requirement. It can be an essential step to simply be considered.
The following is a brief summary of the requirements of the standard and the most significant changes in the new edition. The standard can be purchased online from ISO or from local standards bodies. For each clause, we also highlight some of the key features in Qudos3 IMS Software that will enable the efficient and effective management of your QMS.
ISO 9001 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.
The context of the organization is the internal and external factors that can affect the ability to achieve your quality-related goals. It is only by understanding this context that you can most effectively develop your management system.
To help you get started, it’s generally a good idea to put some structure in place – such as creating categories like PEST (Political – Economic-Social-Technological) for the external factors. Categories should also be created for the internal factors – such as Culture, Resources and Performance.
You may then consider how significant those factors are, and how well placed you are to address them. For internal factors, are they a Strength or a Weakness? For external factors, are they an Opportunity or a Threat? That process of consideration is typically referred to as a SWOT analysis.
The relevant needs and expectations of interested parties need to be understood. That would include the legal and regulatory environment, any contractual and other obligations.
At that point, the scope and boundaries of the QMS may be determined, and the system can be developed including all the necessary operational and support processes. ISO 9001 is quite definite on its requirements for those processes to be documented.
Qudos3 IMS software resources for this clause include: Full, explanatory guidance material in ISO 9001 Quality Toolkit, Situational analysis and strategy (Context), Interested parties table, and other template documents, Process Plan templates and worked examples, and Project planning tools.
ISO 9001 Clause 5: Leadership
5.1 Leadership and commitment.
5.2 Policy.
5.3 Organizational roles, responsibilities and authorities.
For a QMS to be successful, it needs to be inspired and led from the top. Top management must take accountability for it, express their commitment, give direction, and – critically – ensure that sufficient resources are made available.
Everyone in the organization should be aware of what its policies and objectives are, and their role and responsibilities for achieving them.
In larger organizations, top management may not be able to attend to the day-to-day administration of the system themselves. Other people may perform those roles, but they must be given leadership, support, and adequate resources.
Qudos3 IMS software resources for this clause include: Full, explanatory guidance material in ISO 9001 Quality Toolkit, Template documents including policies, job descriptions etc.
ISO 9001 Clause 6: Planning for the QMS
6.1 Actions to address risks and opportunities.
6.2 Quality objectives and planning to achieve them.
6.3 Planning of changes.
This clause is closely linked to clause 4. Having identified factors that affect its quality performance, the organization needs to develop strategies and actions to:
- Maintain and build on its Strengths
- Correct Weaknesses that might be barriers to meeting requirements and achieving objectives.
- Grasp or maximise Opportunities.
- Mitigate or manage Threats or Risks.
A risk assessment process needs to be developed and Action Plans to address the risks and opportunities identified.
The organization should put a programme in place to set measurable quality objectives, assign them, and monitor progress on them.
Changes to, or that may affect the management system should take place in a planned manner.
Qudos3 IMS software resources for this clause include full, explanatory guidance material in ISO 9001 Quality Toolkit, Risk module (including configurable assessment tool and automatic Risk Register), Objectives module, Change management planning tool, Template procedures.
ISO 9001 Clause 7: Support
7.1 Resources.
7.2 Competence.
7.3 Awareness.
7.4 Communication.
7.5 Documented information.
Determine, plan, and provide the resources and support mechanisms needed for the organization to achieve its objectives.
People with responsibilities in the QMS must be competent to the required level. When the required level in place, action must be taken to acquire it e.g. by training, education, recruitment or outsourcing.
People that work for the organization must be aware of its quality policy, how they should contribute to the system, and any consequences of them not conforming to requirements.
The organization needs to determine how it will communicate – both internally and externally – about matters relating to the QMS.
The QMS should be documented to the extent required for conformance to the various clauses in the standard. The documents should be appropriately managed. For documents, that includes having arrangements in place for approval, review, distribution, managing changes or revisions.
The organization should keep the required records and they should also be properly managed. That includes providing them with the appropriate protection and storage.
Qudos3 IMS software resources for this clause include full, explanatory guidance material in ISO 9001 Quality Toolkit, Training module (for scheduling / recording training, competence assessments, licences etc. including automatic reminders for any necessary renewals / refreshers), Documents module (for all document management requirements), Template awareness presentation, communications plan, procedures., and other documents.
The first step in developing your management system is to conduct a Gap Analysis - a check on how existing arrangements stack up against a selected standard or framework. Qudos can provide qualified and experienced lead auditors to conduct your analysis against ISO 9001as well as many other standards and frameworks on a wide range of topics. Once completed, we can uniquely generate a list of targeted Action plans in Qudos3 IMS Software to help you bridge the gaps identified.
The Gap Analysis can also be provided as part of our system development and management system business partner services.
Contact us now for details.
ISO 9001 Clause 8: Operations
8.1 Operational planning and control.
8.2 Requirements for products and services
8.3 Design and development of products and services
8.4 Control of externally provided processes, products and services
8.5 Production and service provision
8.6 Release of products and services
8.7 Control of nonconforming outputs
Operations are where you plan and manage the critical processes in your production or service delivery. The controls include:
Plan the resources and activities needed to manufacture a product or deliver a service. This may include planning objectives and targets, infrastructure, human and material resources needed, methodologies, measurement and monitoring arrangements, documents needed and records to be retained.
The requirements for products or services must be clearly established and effectively communicated.
You must put in place an appropriate design and development process to facilitate the subsequent provision of your products and services. That is, of course, if you do actually design or develop a product or service.
Ensure that any processes, products or services that are obtained from external providers conform to requirements, and must determine what controls should be applied to them.
Control the conditions for production or service delivery. Those controls may include what equipment or tools are to be used, the qualification or other competence of the people doing the work, the methods used, the working environment, any supervision, monitoring or measurement.
Check the product or service prior to release (and at other stages as appropriate).
Have controls in place to decide what to do when something doesn't meet requirements.
Qudos3 IMS software resources for this clause include: Full, explanatory guidance material in ISO 9001 Quality Toolkit, Template process plans, business continuity plan, procedures., and other documents.
ISO 9001 Clause 9: Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation.
9.2 Internal audit.
9.3 Management review.
All systems need to be checked to verify that they are on track. A QMS is no exception. Having implemented a system of controls, organizations need to measure, monitor, and evaluate performance in meeting requirements and achieving objectives.
Performance evaluation requirements may broadly be divided into these areas:
- Check and evaluate the performance of the system.
- Audit its effective implementation and conformance to requirements.
- Top management to periodically review the system.
The Management Review can be very instrumental in a management system as it also supports planning activities. Although ISO 9001 doesn’t specify as such, it typically takes place in the form of a meeting with a set agenda. See this management review blog article on our web site for further details.
Qudos3 IMS software resources for this clause include full, explanatory guidance material in ISO 9001 Quality Toolkit, Audits module (for scheduling recording internal audits and other measurement / monitoring activities), Meetings module (for management review - including default agenda for inputs, meeting records and action for outputs), Template procedures and other documents, Mobile Audits feature to enable quick and easy recording of checks via smartphone.
ISO 9001 Clause 10: Improvement
10.1 Continual improvement.
10.2 Nonconformity and corrective action.
The organization will need to ensure that it deals with any nonconformities; determining the cause(s) and taking action to eliminate them and or to prevent reccurrence.
Continually improve the system to achieve objectives or increase the likelihood of achieving them.
Qudos3 IMS software resources for this clause include: Full, explanatory guidance material in ISO 9001 Quality Toolkit, Actions module (for recording any issue, assigning responsibility, recording action taken and any follow-ups - including root cause analysis and improvement plans), Mobile Actions feature to enable quick and easy reporting of complaints, nonconformities, suggestions or issues via smartphone.
The above guide is summarised from the much more in-depth version in Qudos ISO 9001 Quality Toolkit - The cost-effective solution to developing or updating your QMS. With its unique combination of comprehensive guidance material, planning tools, and professional, sample documents, it will turn a daunting task into something much more manageable and rewarding.
ISO 9001 Quality Toolkit is exclusively available in Qudos3 IMS Software - The comprehensive solution for an effective and efficient management system for Quality and other compliance and risk management topics such as Information Security, AI, OHS, and Environmental.
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