This informal CPD article ISO 9001:2015 Documentation Structure and Its Requirement was provided by Devang Jhaveri at Punyam Academy, an industry leader in training of international compliance standards.
ISO 9001 Requirements
Every organization wants to improve the way it operates, whether that means increasing market share, driving down costs, managing risk more effectively or improving customer satisfaction. ISO 9001 quality management system (QMS) gives a framework you need to monitor and improve performance in any area you choose.
ISO 9001 is now the world’s most established quality framework, being used by an estimated over three-fourth of a million organizations across the globe. The current version of the QMS standard, ISO 9001:2015, sets the standard not only for quality management systems, but management systems in general. It helps all kinds of organizations to succeed through improved customer satisfaction, staff motivation and continual improvement.
ISO 9001:2015 Documentation
ISO 9001:2015 standard requires the organization’s quality management system to include documented information required by this standard as well as documented information determined by the organization as being necessary for the effectiveness of the quality management system. The term ‘Documented information’ refers to information and its supporting medium. It is a guideline that should be followed to comply with the requirements of the standard to prevent any mistake, and therefore, its effective implementation should be ensured. In ISO 9001:2015, “Documented information” is a common term used for both “documents” and “records”.
Documented information of ISO 9001:2015 quality management system is categorized as Maintain Documented Information and Retain Documented Information. The former is basically all the documents of the management system. Examples of such documents are: Quality Manual, Policies, Procedures, SOPs, Plans, drawings/maps/charts, software specifications, Instructions and manuals, standards, normative documents, etc. Retain Documented Information refers to forms, registers and other records of the management system. Records are evidence of the results achieved and that the system is followed.
ISO 9001: 2015 Documentation Structure
The ISO 9001: 2015 standard does not require any specific form of documentation or many procedures. It suggests some documented information only. However, for establishing and implementing a good quality management system and ISO 9001 certification, organizations should have four- tier documentation structure:
1. Quality Manual (Not mandatory but advisable to prepare as a good practice)
2. QMS Procedures, Process Approach, etc.
3. Work Instructions, Operating Procedures, Exhibits, etc.
4. Forms, Registers, Records
Quality Manual: It states the Quality Policy and describes the QMS of an organization. It may relate to an organization’s all activities or to a selected part of it, e.g. specified requirements depending upon the nature of products or services, processes, contractual requirements, governing regulations, etc. Quality Manual is a typical form of main document used in drawing up and implementing a QMS. It is expected to provide an adequate description of the management’s intention to fulfill system requirement while serving as a permanent reference for implementation and maintenance of the system.
Some people might confuse a Quality Manual with a Quality Plan. A Quality Manual describes the totality of the system of quality management system operated by a company with regard to all the products/services of the company. A Quality manual gives macro level details of how the system is implemented for all ISO 9001: 2015 requirements.
Procedures: Quality procedures are core of documentation system. They support the operation of QMS processes to establish confidence in the system. Quality procedures describe the methods of meeting requirements of relevant clauses of ISO 9001:2015. These documents are meant for internal use or external use and should be protected from inadvertent exposure.
Work Instructions and Standard Operating Procedures
As good work practice, it is advised to prepare work instructions to be available, whereas the absence of such instruction would adversely affect quality. In the practical sense, work instruction may be written, drawings, photographs, computer menu options, machine care / operation, work production documentation, etc. These are practical documents. Work instructions deals with shop-floor level of activities. Their purpose is to clearly direct the operator as to what has to be done and what standard of workmanship is required. The instructions must therefore clearly identify:
- What has to be done?
- The correct sequence of activities
- Any special, environmental conditions, e.g. temperature, humidity cleanliness etc.
- Reference to standards / codes of practice which must be complied with
Quality Records, Forms and Other Documents: These are required to be retained in a QMS. All these are supporting documents used by the company to record information for different procedures followed. They belong to the last and fourth tier of documentation. They link the activities written in the procedure to the records kept in the department. This type of documentation serves to demonstrate that the QMS is operating efficiently to produce the products or services in accordance with specified requirements of the QMS.
ISO 9001:2015 Audit Checklist
In addition to the above-mentioned documentation structure, organizations should prepare an audit checklist based on the requirements of ISO 9001:2015 standard. Depending on the organization structure, department wise audit checklist can also be prepared. Basically audit checklists are a set of questionnaire based on ISO 9001:2015 requirements. Checklists are considered very useful tool for QMS implementation and internal audit of the implemented system for its effectiveness. It is also very useful for organizations and auditors in preparing for internal audit or any third party audit.
Flexibility in documentation
ISO 9001:2015 allows flexibility to the organization in developing quality management system documentation, which may differ from one organization to other, due to different size of the organization and type of its activities, processes, goods and services, complexity of processes and their interactions and training and competence of personnel. The bottom-line is that the amount of ISO 9001:2015 documentation should support an efficient quality management system without creating a paper bureaucracy.
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