ISO 9001:2015 QMS - Creating and updating Documented information - Part 2

ISO 9001:2015 QMS - Creating and updating Documented information - Part 2

Developing documented information

Responsibility for development of documented information should be defined. These documented information may include scope of the quality management system, quality policy, quality objectives, information to support the operation of organization's processes, operational planning and control, characteristics of products/services, activities to be performed and results to be achieved and the determined documented information being necessary for the effectiveness of the organization's quality management system (including documented procedures, work instructions, forms etc.) and necessary records Performa. Defining the responsibility will lead to better understanding of necessary requirements. It will also provide a sense of responsibility, including the sense of involvement and ownership by personnel.

It is suggested that a task force with someone as its coordinator should be set up for developing the documented information. Initial training may also be necessary on developing documented information. Developing documented information is the most important activity in the implementation process. A list of documented information to be developed should be drawn up and the responsibility for writing the documented information should be assigned to persons concerned in various functional departments. Responsibility to develop documented information (for example: procedures, work instructions) should be given to those persons, who are involved with the processes and activities. This will lead to ownership of documented information and better understanding of the processes and related activities.

Documented information may be any type of media, such as hard copy or electronic media. Presently there is an increasing trend of using electronic media. The reasons are many including the following:
- Appropriate persons may have access to the documented information with up-to-date information all times.
- Access to documented information may be easily made and controlled.
- Necessary changes to the documented information and entry of relevant data in the documented information may be easily made and controlled.
- Distribution of electronic documented information is fast.
- Option of printing documented information as hard copies is possible.
- Electronic version of documented information can be accessed from remote locations.
- It is easy, simple and effective to withdraw obsolete documented information.

Quality manual (or QMS manual, description book or instructions manual)

The primary purpose of Quality manual (QMS manual, description book or instructions manual) is to provide an adequate description of the quality management system and to serve as a permanent guide to the implementation and maintenance of that system. A Quality manual (or QMS manual, description book or instruction manual) may be unique to each organization. Clause 3.8.8 of ISO 9000:2015, Quality management systems - Fundamentals and vocabulary, defines 'quality manual' as 'specification (document stating requirements) for the quality management system of an organization'. Quality manual of one organization can vary from other organizations in detail and format to suit the size and complexity of an individual organization.

A small organization may have the description of its entire quality management system within a single manual. Large organizations may need several manuals and more complex hierarchy of documented information.

Looking to the requirements of ISO 9001:2015 QMS standard, a Quality manual (QMS manual, description book or instructions manual) may contain the following:
- Scope of the organization's quality management system (4.3)
- Information to support the operation of organization's processes (4.4.2)
- Quality policy (5.2)
- Quality objectives (6.2.1)
- Operational planning and control (8.1)
- Documented information that defines the characteristics of the products and services to be produced/provided, activities to be performed, and the results to be achieved (8.5.1)
- Determined documented information (to maintain) as being necessary for the effectiveness of the organization's quality management system. (7.5.1)

The Quality manual (QMS manual, description book or instructions manual) normally contains the following:
- Title and scope - such as name of the organization and reference of the standard
- Table of contents
- Scope of the quality management system (boundaries and applicability including justification if any requirements of the standard is not applicable to the scope of the organization's quality management system)
- Issue number
- Date of issue
- Amendment record
- Evidence of review, approval and revision status
- Quality policy
- Quality objectives
- Organization's structure
- Organizational roles, responsibilities and authorities
- Flow chart of activities
- Description of applicable elements of the QMS including operational planning and control, characteristics of products and services to be produced/provided, activities to be performed, results to be achieved and other details as being necessary.
- References - List of documented information
- Definition section including vocabulary and terms
- An appendices showing supporting documented information, if appropriate.

The coordinator of the task force is normally the person who coordinates the activity of developing the Quality manual (QMS manual, description book or instructions manual) and other related documented information. Following steps may be useful for the preparation of the Quality manual (QMS manual, description book or instructions manual):
- The coordinator should make a list of all existing quality-related documented information and he/she should obtain copy of each documented information for reference.
- The coordinator should study each process and prepare a flow chart of activities.
- The coordinator should examine interfaces and lack of interfaces between the processes.
- The coordinator should review the process flow charts and identify duplication or omissions in the information or process flow.
- The coordinator should map out what is to be written in the Quality manual (QMS manual, description book or instructions manual).
- The coordinator should verify the presence of all the required elements of ISO 9001:2015 QMS in the current system.
- The coordinator should allocate responsibilities for preparing drafts of relevant parts of the Quality manual (QMS manual, description book or instructions manual) to the persons actually concerned with specific operations.
- It is always better to first deal with documented information covering critical areas and thereafter deal with documents that can be prepared easily.
- The coordinator should circulate the completed drafts to persons concerned for comments.
- The coordinator should consider comments received and incorporate necessary corrections.
- The coordinator should take actions to prepare final manuscript of the Quality manual (QMS manual, description book or instructions manual).

There are two approaches to write the Quality manual (QMS manual, description book or instructions manual):
- The first approach is to write the Quality manual (QMS manual, description book or instructions manual) according to the sequence and layout of the standard.
- The second approach is to write the Quality manual (QMS manual, description book or instructions manual) according to the organization work flow. Under this approach, cross-references are given in a schedule of conformity to the relevant clauses of the standard.

The first approach is generally used for writing the Quality manual (QMS manual, description book or instructions manual) by most organizations, particularly small and medium sized organizations, as it has advantage of making it easy to establish concordance with the requirements of the standard. The second approach is practical for large organizations.

Procedures

Clause 3.4.5 of ISO 9000:2015, Quality management systems - Fundamentals and vocabulary, defines 'procedure' as 'specified way to carry out an activity or a process (set of interrelated or interacting activities)'. A procedure can be a documented or not. When a procedure is documented, it is usually referred to as a 'written procedure' or 'documented procedure', which is a documented information.

A documented procedure usually covers the following:
- Title
- Document number
- Reference
- Cross-reference
- Purpose
- Scope
- Responsibility and authority
- Description of activities - Procedures (what, when, where, how, etc.), process controls, defining necessary resources, defining input and output of the process, defining measurements etc.
- Documented information to be retained related to the activities
- Appendices - Information supportive to the activities
- Review, approval and revision status
- Identification of changes

ISO 9001:2015 QMS standard does not specify specific mandatory documented procedures, however it is suggested that organization should determine procedures that the organization consider necessary for the effectiveness of the organization's quality management system. A list of suggested procedures can be as under:
- Determining context of the organization (4.1)
- Determining Interested parties (4.2)
- Addressing risks and opportunities (6.1)
- Determining resources (7.1) and monitoring and measuring resources (7.1.5)
- Determining competence (7.2)
- Creating and updating documented information (7.5.2)
- Control of documented information (7.5.3)
- Operational planning and control (8.1)
- Determining and reviewing requirements for products / services (8.2)
- Design and development of products / services (8.3)
- Control of externally provided processes / products / services (8.4)
- Production and service provision (8.5)
- Control of nonconforming output (8.7)
- Measuring customer satisfaction (9.1)
- Internal audit (9.2)
- Management review (9.3)
- Nonconformity and corrective action (10.2)

The following steps for developing procedures may be useful:
- The coordinator of the task force should determine the need.
- The coordinator should identify the person concerned to write the procedure.
- The coordinator should authorize the person concern to develop specific procedure(s).
- The person concerned should collect relevant information about the procedure.
- The person concerned should prepare a draft procedure and should handover to the coordinator.
- The coordinator should circulate the draft procedure to relevant persons in the organization who deal with the activity/process. He/she should obtain comments on the draft procedure and incorporate necessary changes.

Work Instructions

Work Instructions (WI) should be developed and maintained to describe the job correctly. Work instructions ensure processes to be consistent, timely and repeatable. A work instruction is a tool that provides the worker to do a job correctly. Performance of job would be adversely affected by lack of such work instructions. The structure, format and level of detail used in the 'Work Instructions' should be according to the needs of the organization and its people, and should depend on the complexity of the work, methods used and the competence of the people of the organization. Work instructions should describe critical activities.

The structure of work instructions may vary from that of documented procedures. However, work instructions should include the following:
- Title
- Unique identification
- Contents - Description of critical activities
- Purpose, scope and objectives approval
- Reference to the pertinent documented procedures
- Review, approval and revision status
- Documented information to be retained (records), where applicable
- Identification of changes, where practicable - the nature of changes identified either in the document or the appropriate attachment

Following steps for developing work instructions may be useful:
- The coordinator of the task force or the department head should identify the need of work instructions.
- The coordinator of the task force or the department head should identify the person concerned to write the work instructions.
- The coordinator of the task force or the department head should authorize the person concerned to develop specific work instructions.
- The person concerned should collect relevant information about the work instructions.
- The person concerned should prepare a draft work instructions and should handover the same to the coordinator of the task force or the department head.
- The coordinator of the task force or the department head should circulate the draft work instructions to persons handling/supervising the work, then should obtain comments on the draft work instructions and incorporate necessary changes.

Forms

Forms are created to fill a business need and to collect relevant data. It should be ensured that forms should not be boring and painful. It should be easy to use, collects what is necessary, and can sometimes enhance the process or activity it belongs to. Efforts should be made to develop forms that are clear and concise. The form should contain the following:
- Title
- Identification number
- Revision level and date of revision
- Contents - To collect relevant

Quality Plan

Clause 3.8.9 of ISO 9000:2015, Quality management system - Fundamentals and vocabulary, defines 'quality plan' as 'specification (document stating requirements) of the procedures (specified way to carried out an activity or a process) and associated resources to be applied when and by whom to a specific object (entity, item or anything perceivable or conceivable, such as a product, service, process, person, organization, system, resource).' Quality plan procedures generally include procedures referring to quality management system processes and operation related processes. A quality plan often makes reference to parts of the Quality manual (QMS manual, description book or instructions manual) or to documented procedures. A quality plan is generally one of the results of quality planning. Thus, a quality plan should contain scope, unique procedures, work instructions and/or documented information to be retained (records).

Approval of Documented Information

After developing a particular documented information, appropriate steps regarding approval of the documented information should be taken to ensure appropriate approval for suitability and adequacy.

- Keshav Ram Singhal


For details on the Training Handbook on 'ISO 9001:2015 QMS Awareness', please CLICK HERE.

For details on 'Checklist for ISO 9001:2015 QMS', please CLICK HERE.

ISO 9001:2015 QMS - Creating and updating Documented information - Part 1

ISO 9001:2015 QMS - Creating and updating Documented information - Part 1

Documented information in ISO 9001:2015 QMS

ISO 9001:2015 QMS standard does not specify any particular format or design for documented information to maintain and to retain. Earlier version ISO 9001:2008 QMS standard used the terms 'documents', 'documented procedure', 'quality manual' and 'quality plan', however these terms are not used in the requirements of ISO 9001:2015 QMS standard, instead a new term 'documented information' has been used in ISO 9001:2015 QMS standard requirements. Clause 3.8.6 of ISO 9000:2015, QMS - Fundamentals and vocabulary, defines the term 'documented information' as an information (meaningful data) required to be controlled and maintained by the organization and the medium on which it is contained. Documented information can be in any format. It can be in any media. It can be from any source. However, Annex A of ISO 9001:2015 QMS standard provides freedom to organizations to use terms which suit their operations, such as 'records', 'documentation' or 'protocols' rather than 'documented information'. Accordingly, organizations can use the terms 'documentation', 'quality manual', 'QMS manual', 'documented procedures', 'records', 'quality plan' that suit them.

ISO 9001:2015 QMS standard has used two types of terms: 'maintain documented information' and 'retain documented information'. The term 'maintain documented information' is equivalent to keeping a 'document', or 'documented procedure', 'quality manual' or 'quality plan'. The term 'retain documented information' is equivalent to keeping records. In this connection Para A.6 of Annex a of ISO 9001:2015 QMS standard should be referred to.

As per the provisions of ISO 9001:2015 QMS standard (reference Clause 7.5.1), the organization's quality management system documentation need to include the following:
- Documented information required by ISO 9001:2015 QMS standard, and
- Documented information determined by the organization.

ISO 9001:2015 QMS standard requires: (i) to develop a quality policy, (ii) to establish quality objectives at relevant functions, levels and processes, (iii) to create, update, control and retain documented information (as mentioned in the standard and as determined by the organization as being necessary for the effectiveness of the organization's quality management system, and (iv) to maintain documented information to support the operation of its processes and retain them to have confidence that the processes are carried out as planned.

ISO 9001:2015 QMS standard requires to maintain following documented information:
- Scope of the organization's quality management system (4.3)
- Information to support the operation of organization's processes (4.4.2)
- Quality policy (5.2)
- Quality objectives (6.2.1)
- Operational planning and control (8.1)
- Documented information that defines the characteristics of the products and services to be produced/provided, activities to be performed, and the results to be achieved (8.5.1)
- In addition to the above, the organization should determine documented information (to maintain) as being necessary for the effectiveness of the organization's quality management system. (7.5.1)

ISO 9001:2015 QMS standard also requires to retain following documented information:
- Processes carried out as planned (4.4.2)
- Monitoring and measuring resources - evidence of fitness, and basis used for calibration and verification, where no international or national measurement standard exists (7.1.5)
- Evidence of competence (7.2)
- Operation planning and control (8.1)
- Results of the review of requirements, including any new or changed requirements, for the products and services, and where requirements for products and services are changed, amendment of relevant documented information (8.2.3)
- Confirmation that design and development requirements are met (8.3.2)
- Design and development inputs (8.3.3)
- Design and development controls activities (8.3.4)
- Design and development outputs(8.3.5)
- Design and development changes, results of reviews, authorization of changes, and actions taken to prevent adverse impacts (8.3.6)
- Evaluation, selection, monitoring of performance, and re-evaluation activities of external providers and any necessary actions (8.4.1)
- Necessary information to maintain traceability (8.5.2)
- Information regarding property belonging to customers or external provider is lost, damaged or otherwise found to be unsuitable for use and reporting to the customer or external provider (8.5.3)
- Results of the review of changes, personnel authorizing the changes, and any necessary action (8.5.6)
- Evidence of product/service conformity with the accepted criteria (8.6)
- Traceability to the person(s) authorizing release of products and services for delivering to the customer (8.6)
- Release of product/service including evidence of conformity with acceptance criteria, Information that describes nonconformity, the actions taken, any concession obtained, and that identifies the authority deciding the action (8.7.2)
- Evidence of results in monitoring, measurement, analysis and evaluation (9.1.1)
- Evidence of the implementation of the internal audit programme, and internal audit results (9.2)
- Evidence of the results of management review (9.3)
- Evidence of nature of nonconformities and subsequent actions, and results of any corrective action (10.2)
- In addition to the above, the organization should determine documented information (to retain) as being necessary for the effectiveness of the organization's quality management system. (7.5.1)

Structure of documented information

QMS documented information is the basis for establishing, implementing and maintaining a quality management system in an organization. ISO 9001:2015 QMS standard does not specify any particular format or design for documented information to maintain and to retain, however most organizations prefer to opt for three-levels documented information, which are as under:

- Level 'A' Documented Information: Consisting of Quality Policy, Quality Objectives and Quality Manual (or QMS Manual).
- Level 'B' Documented Information: Consisting of documented information that are required to maintained, such as documented procedures, work instructions.
- Level 'C' Documented Information: Consisting of documented information that are required to retained by the organization, such as records, and others that are needed by the organization, such as various forms, standards, drawings, specifications, etc.

It is not necessary for an organization to have three levels of documented information separately. An organization can combine Level 'A' and Level 'B' documented information in one manual or can have separate manual for different documented information. QMS documented information of one organization can differ from the other due to the following reasons:
- The size of an organization may differ from the size of other organization.
- The type of activities of an organization may be different from the activities of other organization.
- The products/services of an organization may be different from the products/services of other organization.
- The complexity of processes and their interactions of an organization may be different from the complexity of processes and their interactions of other organization.
- The competence of personnel of an organization may differ from the competence of personnel of other organization.

Purposes and Benefits of Documented Information

There are several purposes and benefits of having documented information in the quality management system. Documented information generally serves the following purposes:
- Documented information in the quality management system establishes that the organization is dependent on the system, and not on person.
- Documented information in the quality management system describes the quality management system of the organization.
- Documented information in the quality management system provides evidence of management commitment to the system.
- Documented information in the quality management system provides an invaluable training aid to its employees. It defines and guides how the quality management system is managed in the organization. It provides a basis for training new employees and periodic re-training of current employees.
- Documented information in the quality management system assists employees to carry out their jobs effectively by removing ambiguities, defining the system, allocating responsibilities and authorities and identifying those responsible for the activities. It helps employees to understand their roles within the organization.
- Documented information in the quality management system provides mutual understanding between employees and management.
- Documented information in the quality management system provides results of periodic audit and management review.
- Documented information in the quality management system provides operational planning and control guidelines.
- Documented information in the quality management system demonstrates to the organization's customers, certification body and interested parties that the quality management system has been systematically planned.
- Documented information in the quality management system defines the characteristics of the products/services to be produced/provided, activities to be performed, and the results to be achieved that form basis for expectation of work performance.

Is quality manual required in ISO 9001:2015 QMS?

ISO 9001:2015 QMS standard no longer includes the requirement of a documented quality manual, where ISO 9001:2008 QMS standard requires a documented quality manual. Although there is no explicit requirement for the quality manual in ISO 9001:2015 QMS standard, however its clause 7.5.1 (b) states to include documented information determined by the organization as being necessary for the effectiveness of the quality management system. Accordingly, most organizations would determine a Quality manual (or QMS manual, description book or instructions manual) that may define and provide clear direction to the organization's people regarding implementing ISO 9001:2015 QMS in the organization.

- Keshav Ram Singhal

... To be continued


For details on the Training Handbook on 'ISO 9001:2015 QMS Awareness', please CLICK HERE.

For details on 'Checklist for ISO 9001:2015 QMS', please CLICK HERE.

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