QMS Audit - Closing meeting

QMS Audit - Closing meeting

Guidelines for conducting closing meeting are mentioned in clause 6.4.10 of ISO 19011:2011 standard. A closing meeting is conducted at the end of an onsite audit with an objective to present the audit findings and audit conclusions in such a manner that they are understood and acknowledged by the auditee's management.

Participants of the closing meeting: The closing meeting should be chaired by the audit team leader and attended by the following:
- audit team members,
- auditee's management,
- as applicable, personnel responsible for the functions/processes that have been audited,
- as applicable, audit client,
- as applicable, other relevant interested parties as determined by the auditee/audit client.

Introduction: The audit team leader should thank the auditee for their cooperation during the audit

Recording attendance: An attendance sheet should be retained that mentions all members present in the closing meeting.

Restate audit objectives, scope and criteria: The audit team leader should restate and confirm audit objectives, scope (auditing against ISO 9001:2015 QMS standard) and criteria of the audit during the closing meeting.

Explain situations encountered and the audit findings etc: The audit team leader should advise the situations encountered during audit, the audit findings and the method of reporting. The audit team leader should also explain that the audit only looked at a sample of the auditee's activities, therefore, the absence of recorded nonconformities does not indicate its non-existence. It may be expected that the auditee's internal performance evaluation activities will discover additional nonconformities similar to those that are found by the audit team. With regard to an action plan to address audit findings, the participants should agree on the time frame and how the audit findings should be addressed based on agreed norms. The audit team leader should also advise the degree of the effectiveness of the quality management system as per ISO 9001:2015 QMS standard in achieving the auditee's objectives, including implementation of risk-based thinking. The audit team leader should also state the familiarity of the auditee with the audit process and this will ensure communication of correct details during the closing meeting. The audit team leader should also explain (i) the possible consequences of not adequately addressing the audit findings, and (ii) related post-audit activities, such as corrective action by the auditee, review of corrective action by the audit team, addressing audit complaints, appeal process.

Audit findings and conclusions should be presented in such a manner that are understood and acknowledged by the auditee's management. if there is any difference of opinion with regard to the audit findings or conclusions between the audit team and the auditee, the same should be discussed and resolved. If difference of opinion is not resolved then the same should be recorded.

The audit team leader should conclude the closing meeting with one more thanks to all participants present in the closing meeting. Thank them for coming to the closing meeting, and also for their cooperation and assistance during the audit.

The closing meeting in an internal audit may be short and less formal, where the audit team leader may solely communicate the audit findings and audit conclusions. The closing meeting for an internal audit can be accomplished in little more than fifteen minutes. The closing meeting in an external audit should be formal as per the guidelines mentioned above, however it is suggested that such meeting should be completed within 30 -45 minutes time. It is believed that a well-organized closing meeting adds value to the audit.

Best wishes,

Keshav Ram Singhal

QMS Audit - Opening meeting

QMS Audit - Opening meeting

Guidelines for conducting an opening meeting for an audit are mentioned in clause 6.4.3 of ISO 19011:2018 standard. An opening meeting is conducted at the start of an onsite audit with the following objectives:
- confirming that all participants (audit team and auditee) agree to the audit plan,
- introducing audit team members and their roles during the audit to the auditee, and
- ensuring that all planned activities of the audit can be performed during the audit.

Who should participate in the opening meeting?: The opening meeting should be chaired by the audit team leader. Audit team members, auditee's management and, where appropriate, personnel, responsible for the functions/processes to be audited, should participate in the opening meeting.

Introduction: There should be an introduction of the audit team members and auditee present at the meeting. The roles of each team members should be communicated, as necessary, during the meeting.

Recording attendance: An attendance sheet should be retained that mentions all members present in the opening meeting.

Confirmation of audit objectives, scope and criteria: The audit team leader should state and confirm audit objectives, scope (auditing against ISO 9001:2015 QMS standard) and criteria of the audit during the opening meeting.

Confirmation of audit plan: The audit team leader should state and confirm the audit plan and other relevant arrangements including (i) date/time/place for closing meeting, (Ii) any interim meetings needed, and (iii) any changes needed.

Familiarity with the audit process: The audit team leader should state the audit process so that the auditee familiarize with the audit procedures and methods. The audit team leader should also state that the audit will be a representative sampling of evidence, not a 100 percent inspection. This should be obvious to all participants, but it is important to declare this limitation before the audit begins.

Confirmation of formal communication channels and the language: The audit team leader should state and confirm (i) the formal communication channels between the audit team and the auditee, and (ii) the language to be used during the audit.

Progress reporting: The audit team leader should state and confirm progress reporting arrangements with the auditee's management.

Confirmation of audit resources and facilities: The audit team leader should mention and confirm the adequate resources and facilities available for the audit team.

Confirmation of confidentiality and information security: The audit team leader should mention and confirm matters relating to confidentiality and information security. The audit team leader should make a general commitment to maintain confidentiality related to the evidence gathered and conclusions generated during the audit.

Confirmation of access, health and safety, security, emergency and other arrangements for the auditors: The audit team leader should mention and confirm matters relating to access, health and safety, security, emergency and other arrangements, such as, security equipment, availability of other participants including observers, guides, interpreters etc and an outline of their roles.

Confirmation of activities on site: The audit team leader should mention and confirm, as appropriate, the activities on site, which can impact the auditing.

Presentation of information: The audit team leader should consider and mention, as appropriate, presentation of information relating to the audit findings reporting methods, including ant criteria for grading, for example - minor, major, observation etc.

Opportunity to ask questions: The audit team leader should provide an opportunity to ask questions with regard to the audit during the opening meeting to the participants and provide necessary clarification on the question asked during the opening meeting. The audit team leader should conclude the opening meeting with one more thanks to all participants present in the opening meeting. Thank them for coming to the opening meeting, and also for their cooperation and assistance related to the audit.

The opening meeting in an internal audit may be short and the audit team leader may (i) communicate conducting an internal audit, and (ii) explain the nature of the audit. The opening meeting for an internal audit can be accomplished in little more than five minutes. The opening meeting in an external audit should be formal as per the guidelines mentioned above, however it is suggested that such meeting should be completed within 20 - 30 minutes time. It is believed that a well-organized opening meeting leads to a successful audit.

Best wishes,

Keshav Ram Singhal

Short Note - ISO 19011:2018 - Guidelines for auditing management systems - Changes in the principles of auditing - Specific reference to risk-based approach

Short Note - ISO 19011:2018 - Guidelines for auditing management systems -
Changes in the principles of auditing - Specific reference to risk-based approach

The previous edition of ISO 19011:2011 had suggested taking into consideration the adoption of a risk-based approach, but it (please refer to clause 5.3.4 - ISO 19011:2011) provided limited guidelines on the matter. ISO 19011:2018 standard document has placed an improved and enhanced focus. Now adoption of risk-based approach will essentially be a critical determinant while planning, conducting and reporting of the audit. It has added a new principle 'the risk-based approach' that provide guidelines to auditors to consider risks and opportunities during auditing at every phase while planning, conducting and reporting. Clause 5.3 of ISO 19011:2018 standard document specifies guidelines for determining and evaluating audit programme risks and opportunities. It is better for an auditor to understand risks and opportunities related to the context of the auditee that may affect achievement of audit objectives. The people, involved in managing an audit, should identify and consider (i) the associated risks and opportunities, and (ii) resource requirements, when developing an audit programme. These identified risks and opportunities, and resource requirements should be communicated to the audit client so that these are addressed suitably.

Risks may be associated with: (i) planning, (ii) resources, (iii) selection of auditor(s) for the audit, (iv) communication, (v) implementation, (vi) control of documented information, (vii) monitoring the audit programme, (viii) reviewing the audit programme, (ix) improving the audit programme, (x) availability of auditee, (xi) cooperation (and coordination) of auditee, and (xii) availability of evidence to be sampled.

Opportunities may be available that can improve the audit programme. Such opportunities may relate to: (i) multiple audits in a single visit, (ii) minimizing time and distances involved in travelling of audit team members, (iii) availability of competent audit team members, and (iv) aligning audit dates with the availability of relevant key auditee.

The application of risk-based approach in auditing management systems will serve as a tool for risk prevention. It will optimize efficiency and effectiveness of the audit process and audit outcome.

Thus, the new standard (ISO 19011:2018) places improved emphasis on risks, opportunities and auditor competence.

Best wishes,

Keshav Ram Singhal

Short Note - PDCA Cycle Activities as per ISO 19011:2018 - Guidelines for auditing management systems

Short Note - PDCA Cycle Activities as per ISO 19011:2018 - Guidelines for auditing management systems

PLAN activities
- Clause 5.2 - Establishing audit programme activities
- Clause 5.3 - Determining and evaluating audit programme risks and opportunities**
- Clause 5.4 - Establishing an audit programme
- Clause 6.2 - Initiating audit
- Clause 6.3 - Preparing audit activities

** Please note that 'risk-based approach' to the principles of auditing is a new addition in ISO 19011:2018

DO activities
- Clause 5.5 - Implementing audit programme
- Clause 6.4 - Conducting audit activities
- Clause 6.5 - Preparing and distributing audit reports

CHECK activities
- Clause 5.6 - Monitoring audit programme
- Clause 6.6 - Completing audit

ACT activities
- Clause 5.7 - Reviewing and implementing audit programme
- Clause 6.7 - Conducting audit follow-up

Best wishes,

Keshav Ram Singhal

Short Note - Developing and implementing ISO 9001:2015 QMS in an organization

Short Note - Developing and implementing ISO 9001:2015 QMS in an organization

It is a strategic decision for an organization to adopt ISO 9001:2015 QMS standard. Once the top management of an organization takes a decision to develop and implement ISO 9001:2015, following step-by-step process may be useful:
Step 1 - Leadership and Commitment from Top Management
Step 2 - Assigning responsibilities and authorities
Step 3 - Establishing a steering committee
Step 4 - Establishing a task force
Step 5 - Appointing a QMS consultant
Step 6 - Obtaining Information about QMS and ISO 9000 Family
Step 7 - Start 'ISO 9001:2015 QMS Awareness' Programme
Step 8 - Formulate an Action Plan
Step 9 - Training and Guidance
Step 10 - Conducting Initial Status Survey
Step 11 - Establishing and Developing Quality Policy and Quality Objectives, and Creating and Updating Documented Information
Step 12 - Implementation
Step 13 - Conducting Internal Audit
Step 14 - Conducting Management Review
Step 15 - Arranging Pre-assessment Audit
Step 16 - Going for Certification

For more information on these steps, please visit my blog - Please CLICK FIRST LINK and also CLICK SECOND LINK.

Best wishes,

Keshav Ram Singhal

Short Note - Understanding the organization and its context

Short Note - Understanding the organization and its context

Clause 4.1 of ISO 9001:2015 QMS standard provides the requirements related to captioned matter.

The organization needs to (i) determine internal and external issues (positive and negative factors or conditions) relevant to the organization's purpose, strategic direction and that can affect organizational ability to achieve intended results or desired outcomes, and (ii) monitor and review information (data) about the determined external and internal issues (positives and negative factors or conditions).

We should have a clarity that there are many issues that can help or make easier the understanding the external context of the organization and such issues may arise from legal, technological, competitive, cultural, social and economic environments and that can be global, national, regional or local. There are many other issues that can help or make easier the understanding the internal context of the organization and such issues may relate to the organization's values, culture, knowledge and performance.

To know more on the understanding the organization and its context, please refer to the following relevant articles:
- ISO 9001:2015 QMS - Understanding organization and its context - Source of information about internal and external issues - CLICK HERE.
- Understanding the organization and its context - CLICK HERE.
- ISO 9001:2015 QMS - Understanding the organization and its context - CLICK HERE.

Best wishes,

Keshav Ram Singhal

Short Note - Documented information

Short Note - Documented information

Please refer to clause 4.4.2 of ISO 9001:2015 QMS standard.

The organization needs to (i) maintain documented information to support the operation of the organization's processes, and (ii) retain documented information that provides confidence and evidence about the processes carried out as planned.

Requirements with regard to the documented information are mentioned in clause 7.5 of ISO 9001:2015 QMS standard.

To know more on documented information, please refer to relevant articles:
- ISO 9001:2015 QMS - Creating and updating Documented information - Part 1 - CLICK HERE
- ISO 9001:2015 QMS - Creating and updating Documented information - Part 2 - CLICK HERE

Best wishes,

Keshav Ram Singhal

Short Note - Improving the quality management system including the processes

Short Note - Improving the quality management system including the processes

Please refer to clause 4.4.1(h) of ISO 9001:2015 QMS standard.

The organization needs to improve its (organization's) processes and its (organization's) quality management system.

In this connection, requirements as mentioned in clause 10 are relevant. Determining the necessary actions by using the analysis results and evaluation results are important to improve the quality management system including the processes of the organization. Improvements can be carried out in an individual process by reducing variations in its activities and by reducing unnecessary paperwork associated with the system, so as to enable persons associated with the system to concentrate more on process implementation and management.

Best wishes,

Keshav Ram Singhal

Short Note - Evaluating processes and implementing any changes

Short Note - Evaluating processes and implementing any changes

Please refer to clause 4.4.1(g) of ISO 9001:2015 QMS standard.

With a purpose to ensure that organization's processes achieve intended (desired) results (outcomes), the organization needs to (i) evaluate its (organization's) processes, and (ii) implement any changes needed. For evaluating processes, the organization should (i) consider the performance facts obtained through monitoring, measurement and internal audit, and (ii) analyze and evaluate these performance facts. In this connection, implementing requirements of clause 9 of ISO 9001:2015 QMS standard is relevant.

Best wishes,

Keshav Ram Singhal

Accreditation

Accreditation

When an organization decides to implement and obtain certification to ISO 9001:2015 QMS or any other standard, the first work is to choose a certification body from which the organization will obtain the certification. A number of certification bodies are operating in our country, so you have a wide choice to select a certification body. It is always suggested to obtain accredited certification. A question may arise in our mind - What is accreditation? Accreditation is a link in the chain of trust. If an organization meets the requirements of ISO 9001:2015 QMS standard, the organization will receive a certificate of conformity to the standard from a certification body (also known as assessing body or conformity assessment body) after formal assessment. This certificate has most value if the certification body is professional, impartial, competent and independent. The accreditation body with the aim of checking the expertise, impartiality and independence of certification bodies carries out accreditation task. If the results are positive, an accreditation mark is issued to certification body. Accreditation is a term widely used in certification industry. It provides us confidence in the certification body that grants us management systems certification, such as ISO 9001 certification, ISO 14001 certification etc. In simple terms, accreditation is the action or process of officially recognizing someone as having a particular status or qualified to perform a particular activity. It is an acknowledgement of someone's responsibility for achievement of something.

Accreditation really means 'creating trust'. Accreditation by an authoritative body is the formal recognition of the competence of the certification body to perform a specific task such as analysis, calibration, inspection or certification. Accreditation is the mechanism for indicating that the assessing organization for a demarcated area, the 'scope', justified confidence. Accreditation is the formal recognition that is based upon a series of international standards that focus particularly on the elements of expertise, independence, impartiality and continuity.

Nationally and internationally buyers want to be able to trust blindly the quality and safety of products/services provided by the certified organizations. If these are guaranteed, it not only benefit the buyer but also to the organization that supply the product/service. This strengthens the supplier organization's position in the market. In order to be able to provide an objective guarantee, the organization can have its quality management system assessed by an accredited certification body.

When an organization opts for ISO 9001:2015 QMS or any other standard certification, it finds in the initial stage that the certification body is accredited from an accreditation body. There are a number of accreditation bodies operating in the world that carry out the accreditation work. In India, NABCB (National Accreditation Board of Certification Bodies) grants accreditation to certification bodies. There are many accreditation bodies in the world, such as UKAS (United Kingdom Accreditation Service) in UK, RvA (The Dutch Accreditation Council - Raad Voor Accreditatie) in Netherlands, ANAB (ANSI-ASQ National Accreditation Board) in USA, JAS-ANZ (Joint Accreditation System) in Australia and New Zealand etc.

RvA Public Report 2016 says, "Accrediting really means: creating trust. Nationally and internationally buyers want to be able to trust blindly the quality and safety of products and services provided. If these are guaranteed, it not only benefits the buyer but also the supplier. This strengthens his position in the market. In order to be able to give an objective guarantee, the supplier can have his products and services assessed by an accredited organization. This also applies to every area imaginable: health, environment, construction, energy, food, transport, finance etc."

The certificate issued by a certification body which has been accredited by an accreditation body which is an IAF MLA signatory for the scope covering the certificate should be acceptable in the world under the principle of international equivalence. This is a very significant reason for making an appropriate choice of a certification body.

International Accreditation Forum (IAF)

The International Accreditation Forum (IAF) is the world association of Conformity Assessment Accreditation Bodies and other bodies interested in conformity assessment in the fields of management systems, products, services, personnel and other similar programmes of conformity assessment. Its primary function is to develop a single worldwide program of conformity assessment which reduces risk for business and its customers by assuring them that accredited certificates may be relied upon. Accreditation assures users of the competence and impartiality of the body accredited.

Accreditation in India

Since 1992 a need had been felt for the establishment of an accreditation body in India to establish internationally acceptable mechanism for recognition of conformity assessment results. As regards laboratories, an accreditation body under the Ministry of Science and Technology was already functioning. A committee which included various interested ministries and stakeholders including industries was established to make suitable recommendations. The work was coordinated by the then Department of Industries (Department of Industrial Policy and Promotion) and the recommendations were submitted to the Cabinet in 1996. Key recommendations included the Need for establishing an organization jointly by the Government and the industry and the need for the organization to be self-sustaining and be away from the government. Accepting the recommendations, the Cabinet Committee decided to set up Quality Council of India (QCI) as a non-profit autonomous society registered under Societies Registration Act XXI of 1860 to establish an accreditation structure in the country and to spread quality movement in India by undertaking a National Quality Campaign. Accordingly, QCI was established as the National body for Accreditation on recommendations of Expert Mission of EU after consultations in Inter-ministerial task force, Committee of Secretaries and Group of Ministers in 1996.

There is a governing council (known as Council) as the apex level body responsible for formulating the strategy, general policy, constitution and monitoring of various components of Quality Council of India (QCI) including the accreditation boards with objective to ensure transparent and credible accreditation system. Following accreditation boards are working under the structure of QCI:
- National Accreditation Board for Certification Bodies - NABCB
- National Accreditation Board for Education and Training - NABET
- National Accreditation Board for Hospitals and Healthcare Providers - NABH
- National Accreditation Board for Testing and Calibration Laboratories - NABL - However, it should be noted that NABL continues to be a separate legal entity.
The National Accreditation Board for Certification Bodies (NABCB) provides accreditation to Certification and Inspection Bodies based on assessment of their competence as per the Board's criteria and in accordance with International Standards and Guidelines. The National Accreditation Board for Certification Bodies (NABCB) is internationally recognized and represents the interests of the Indian industry at international forums through membership and active participation with the objective of becoming a signatory to international Multilateral / Mutual Recognition Arrangements (MLA / MRA).
NABCB is a member of International Accreditation Forum (IAF) & Pacific Accreditation Cooperation (PAC) as well as signatory to its MLAs for Quality Management Systems, Environmental Management Systems and Product Certification. Global G.A.P., Food Safety Management Systems and Information Security Management Systems NABCB is also a full member of International Laboratory Accreditation Cooperation (ILAC) and Asia Pacific Laboratory Accreditation Cooperation (APLAC) as well as signatory to its MRAs for Inspection. National Accreditation Board for Certification Bodies (NABCB), linked to Quality Council of India (QCI), grants accreditation to certification bodies. In addition to this, many foreign accreditation bodies have also granted accreditation to certification bodies operating in India. Some of the foreign accreditation bodies are:
- UKAS - United Kingdom Accreditation Service
- RvA - Raad voor Accredatie (The Dutch Council of Accreditation)
- ANAB - ANSI-ASQ National Accreditation Board
- JAS-ANZ - Joint Accreditation System of Australia and New Zealand
- SCC - Standards Council of Canada
- JAB - Japan Accreditation Board
- IAR - IAR Accreditation Service

There are accreditation bodies in neighbouring countries too, some of which are:
- CNAS - China National Accreditation Service for Conformity Assessment
- PNAC - Pakistan National Accreditation Council
- SLAB - Sri Lanka Accreditation Board for Conformity Assessment

Many of the accreditation bodies are the members of International Accreditation Forum (IAF) and these accreditation bodies agree to the IAF Multilateral Recognition Agreement (MLA) recognizing the equivalence of other embers' accreditation to their own.

There are more than fifty certification bodies operating in India, which have been granted accreditation either from NABCB or from any other foreign accreditation body. In such a situation, first you should collect information about the certification bodies operating in your country and then you should contact the certification bodies with brief description about your organization, nature of your business and your assessment requirements. You should also find out whether the certification body is accredited to provide certification in your area of business. In this connection, it is important to check that its accreditation scope includes the technical sector of your organization. The certification bodies are accredited scope wise. There are 39 scope sectors as mentioned by IAF, a few of them are as under:
- Agriculture, forestry and fishing,
- Mining and quarrying,
- Food products, beverages and tobacco,
- Nuclear fuel,
- Chemicals, chemical products and fibres,
- Pharmaceuticals,
- Transportation, storage and communication,
- Information technology,
- Engineering services,
- Education, etc.

Selection of a certification body

Since there are too many certification bodies operating in our country, you need to select a accredited certification body, for which you should know the details of accreditation, certification services and cost of certification. Therefore it is better to write letters or send emails to several certification bodies asking their accreditation, certification services and cost of certification. Upon receipt of your letter/email, the certification body will advise you the certification process and a quotation for the costs including the certification fee. Accordingly, you will have quotations from several certification bodies and you will be in a position to decide a certification body by which you will obtain ISO 9001:2015 QMS certification. Quotation will normally include a one-time certification fee (covering a period of three years), costs per day of auditing work (before, during and after certification), travel and other expenses. The number of workdays required for each audit will depend on the size of operation and the location of the organization to be audited. Please note that while deciding a certification body, don't just go for a cheap or non-accredited certification. You need to make a wise choice to get maximum benefits out of certification.

Best wishes,

Keshav Ram Singhal

Short Note - Addressing risks and opportunities

Short Note - Addressing risks and opportunities

Please refer to clause 4.4.1(f) and clause 6.1 of ISO 9001:2015 QMS standard.

The organization needs to
(i) address determined risks and opportunities, and
(ii) ensure take and implement any actions needed to address determined risks and opportunities.

Relevant articles in this connection, please refer to:
- Determining and addressing risks and opportunities - CLICK HERE.
- Risk Matrix - CLICK HERE.
- Risks and opportunities in ISO 9001:2015 QMS - Process-diagram - CLICK HERE.
- Why we need a risk-based thinking? - CLICK HERE.
- A simple method to determine risks and opportunities - CLICK HERE.

Best wishes,

Keshav Ram Singhal

Short Note - Assigning responsibilities and authorities for processes

Short Note - Assigning responsibilities and authorities for processes

Please refer to clause 4.4.1(e) of ISO 9001:2015 QMS standard.

The organization needs to assign the responsibilities and authorities of its (organization's) processes, for which following should be considered and determined:
- What are the activities of each process?
- Who will perform the activity/activities?
- What will be the responsibilities and authorities of the person performing the activity/activities?

Considering the above, steps should be taken to assign the responsibilities authorities in a documented information. Documented information may be organization chart, documented procedure, operational policies, job descriptions, or instructions.

Best wishes,

Keshav Ram Singhal

Short Note - Determining resources and their availability

Short Note - Determining resources and their availability

Please refer to clause 4.4.1(d) of ISO 9001:2015 QMS standard.

The organization needs to determine the resources needed for its (organization's) processes and ensure availability of determined resources. Resources include people, infrastructure, environment for the operation of processes, monitoring and measurement resources, and organizational knowledge. In this connection requirements of clause 7.1 is relevant that require consideration of (i) the capabilities of existing internal resources, (ii) constraints on existing internal resources, and (iii) what the organization will obtain from external providers.

Infrastructure includes buildings and associated utilities, equipment (hardware and software), transportation resources, information and communication technology.

People needs to be competent for the operation of relevant process (related to their work) and aware of quality policy, relevant quality objectives (related to their work), their contribution to the effectiveness of the quality management system, benefits of improved performance, and the implications of nonconforming requirements.

In addition to the above resources, the organization needs to determine documented information as being necessary for the effectiveness of the quality management system. In this connection, please refer to clause 7.5 of the standard.

Best wishes,

Keshav Ram Singhal

Short Note - Effective operation and control of processes

Short Note - Effective operation and control of processes

Please refer to clause 4.4.1(c) of ISO 9001:2015 QMS standard.

The organization needs to first determine and then apply the criteria and methods needed to ensure the effective operation and control of its (organization's) processes. Effective operation and control of processes is possible by applying process control criteria and methods including monitoring and measurement, using process parameters, specifications for products/services, performance indicators, reports, charts, audit results etc. Therefore, first determine process control criteria and methods and then apply such determined control criteria and methods.

Best wishes,

Keshav Ram Singhal

Short Note - Determining sequence and interaction of processes

Short Note - Determining sequence and interaction of processes

Please refer to clause 4.4.1(b) of ISO 9001:2015 QMS standard.

The organization needs to determine the sequence and interaction of its (organization's) processes. When we look to the definition of a process, we find that a process is a set of interrelated or interactive activities that use inputs in order to deliver intended results (outputs). Sequence and interaction mean the links with the inputs and outputs of the previous and subsequent processes. Output of one process may be input to subsequent process. There are various methods (such as, process map, flow diagram, written description, etc.) for providing the details of the sequence and interaction of the processes and it depends on the organization the method it uses.

Best wishes,

Keshav Ram Singhal

Short Note - Determining inputs required and outputs expected from processes

Short Note - Determining inputs required and outputs expected from processes

Please refer to clause 4.4.1(a) of ISO 9001:2015 QMS standard.

The organization needs to determine the inputs required and the outputs expected from its (the organization's) processes. Inputs required for a process may be determined by considering what are the inputs that will implement the processes effectively as planned. inputs may be tangible (such as - materials, components, equipment, machinery, human resource etc) and/or intangible (such as - data, information, knowledge, experience etc.). Expected outputs from a process may be determined by considering the expectation of intended result by the subsequent process or customer. Outputs may be tangible and/or intangible.

Example - Process of Cooking Rice
Inputs - Person, Kitchen, Rice, Water, Cooking pan, Gas stove and lighter
Outputs - Cooked rice, Cooking pan for cleaning

Example - Process of reading a book
Inputs - Person and book
Outputs - Person with added information

Best wishes,

Keshav Ram Singhal

ISO 9001:2015 QMS - Understanding organization and its context - Source of information about internal and external issues

ISO 9001:2015 QMS - Understanding organization and its context - Source of information about internal and external issues

What can be the source of information about internal and external issues?

There are many sources that can provide information about internal and external issues of an organization, such as:
- Internal records / documented information of the organization,
- Internal and external meetings,
- National and international news and reports,
- Various websites, for example - website of government, regulatory body, tax authority, competitors etc.
- Various publications, for example - government, professional, technical, sector publications,
- Conferences,
- Professional and business associations, such as - Confederation of Indian Industry (CII), Association of Computing Machinery (ACM), SME Chamber of India, Ajmer Zila Laghu Udhyog Sangh etc.

Best wishes,

Keshav Ram Singhal

Adding Value to Internal QMS Audit - Outside auditor be asked to internal audit the QMS

Adding Value to Internal QMS Audit - Outside auditor be asked to internal audit the QMS

The purpose of internal audit is to ensure that the quality management system of the organization conforms to the planned arrangements to the requirements of the ISO 9001:2015 QMS standard and the quality management system requirements established by the organization. The other purpose of the internal audit is to ensure that the quality management system is effectively implemented and maintained by the organization. I had posted an article 'Adding Value to Internal QMS Audit' in my blog on 'ISO 9001:2008 QMS Awareness'. The article is relevant, however to further improve internal audit, top management of the organization should consider outside auditor to internal audit the organization's QMS as an added improvement action. It is observed that internal auditors, selected within the organization, generally leave auditing leadership requirements of ISO 9001:2015 QMS. Internal auditors, selected within the organization, are working in the position below the top management, they do not report non-compliances of clause 5 of ISO 9001:2015 QMS standard and avoid auditing leadership requirements due to interpersonal organizational relationship. Bringing an outside auditor will bring transparency, fairness and impartiality.

Best wishes,

Keshav Ram Singhal

Organize training programmes for effective implementation of ISO 9001:2015 QMS in your organization

Organize training programmes for effective implementation of ISO 9001:2015 QMS in your organization

Staff awareness, towards ISO 9001:2015 QMS, is necessary for effective implementation of ISO 9001:2015 QMS in an organization. For creating general staff awareness towards ISO 9001:2015 QMS, organizations should conduct 'ISO 9001:2015 QMS Awareness' programme to communicate to the employees the aim of ISO 9001:2015 QMS,the advantages it offers to employees, customers and organizations, how it will work, and employees' role and responsibilities within the quality management system. The training programme should be conducted by a trainer, who can be an internal or outsider. If a lead auditor trained person is available in the organization, he may be able to conduct such programme. In case internal trainer is not available, then the organization may engage an outside trainer. The duration of 'ISO 9001:2015 QMS Awareness' programme should be four to eight hours depending upon the organization's needs and the level of knowledge its employees possess.

Leadership and active involvement of the top management facilitate proper implementation of ISO 9001:2015 QMS. The top management must be convinced that implementation and certification will enable the organization to demonstrate a visible commitment to quality and continual improvement. The top management must be aware of the overview of ISO 9001:2015 QMS. For the top management awareness, a meeting should be organized covering the following issues:
- Overview of ISO 9001:2015 QMS,
- Identification of goals and expectations,
- Role of the top management within iSO 9001:2015 QMS,
- Formulation of quality policy,
- Formulation of quality objectives,
- Organizational roles, responsibilities and authorities,
- Establishing a steering committee and a task force,
- Why appoint a consultant,
- Step-by-step process for implementation and certification.

Training programmes will provide necessary knowledge to people involved in ISO 9001:2015 QMS implementation, so these should be organized for different categories, such as managers, supervisors, workers, task force, steering committee members etc. In addition, training may also be necessary for creating and updating documented information, auditing and its principles, laboratory management techniques, calibration, testing procedures etc.

An in-depth training programme covering the following areas should be organized for members of task force, steering committee and employees selected for internal auditing, as necessary:
- ISO 9001:2015 QMS and its requirements,
- Internal quality audit,
- Statistical tools,
- Creating and updating documented information,
- Risk-based thinking.

The organization can organize such trainings as in-house programmes. The consultant (if appointed), an outside trainer or an external training institution could be invited to conduct in-house training programmes. When in-house capacilty, to carry out such training programmes, is not available, the organization should depute its personnel to external training programmes organized by professional training organizations.

- Keshav Ram Singhal

Seven Signs of a Strong Culture of Quality

Seven Signs of a Strong Culture of Quality

I read an article 'Seven Signs of a Strong Culture of Quality' written by Rachel Beavins Tracy that looked to seven signs of a strong quality culture: (i) Quality starts at design, (ii) Monitoring and measurement are priorities, (iii) Risk is part of decision-making criteria, (iv) The goal is not compliance, (v) Accountability is built-in, (vi) Leadership is clearly supportive, and (vii) People take ownership of problems.

The article is published at EtQ blog. Please CLICK HERE to read the article.

Thanks,

Keshav Ram Singhal

Quality Concepts and ISO 9001:2008 QMS Awareness: Understanding the meaning – Continual improvement ...

Quality Concepts and ISO 9001:2008 QMS Awareness: Understanding the meaning – Continual improvement ...: I was addressing a group of participants in a training programme on ‘ISO 9001 QMS Awareness’, while discussing and telling requirements r...

Difference between 7.1.6 and 7.2

Difference between 7.1.6 and 7.2

One of the readers asked difference between 7.1.6 and 7.2.

Clause 7.1.6 of ISO 9001:2015 QMS standard deals with the requirements related to the knowledge specific to the organization, which is a support resource for an organization. Clause 7.2 of ISO 9001:2015 QMS standard deals with the requirements related to the comptence of persons. Competence is the ability to apply knowledge and skills to achieve desired results. Competent person is also a resource for an organization.

Clause 7.1.6 requires determining organizational knowledge (necessary for the operation of its processes), maintaining it and making it available. When addressing changes, it requires considering current knowledge and determining the ways to acquire/access necessary knowledge/updates.

Clause 7.2 requires determining necessary competence of persons, ensuring competent persons doing the job, taking necessary actions to acquire necessary competence, evaluating the effectiveness of the actions taken and retaining documented information.

Clause 7.2 appears compliment to clause 7.1.6.

With best wishes,

KRS

New Blog on ISO 45001:2018 OH&SMS Awareness

Dear friends,

A new blog has been created to increase awareness on ISO 45001:2018, Occupational health and safety management system standard.

I seek your blessings.

Please CLICK HERE to visit the blog.

Thanks,

Keshav Ram Singhal

Resource Validation

Resource Validation

Resource = A stock or supply of money, materials, staff, and other assets that can be drawn on by a person or organization in order to function effectively.

Resources in ISO 9001:2015 QMS standard refers to people (human resources), infrastructure, environment, monitoring and measuring resources (such as monitoring and measuring equipment) and organizational knowledge, necessary for the effective implementation of organization's QMS, operation and control of organization's processes, so that product/service conformity is achieved.

Someone asked me about resource validation in ISO 9001:2015 QMS. I just thought what is the purpose of resources in the QMS. Resources are necessary for the effective implementation of organization's QMS, operation and control of organization's processes, so that product/service conformity is achieved. The second thought that drive my attention is the term validation. Validation is a term that is used for confirmation, through the provision of objective evidence that the requirements for a specific intended use or application have been fulfilled (3.8.13 - ISO 9000:2015).

Validation = the action of checking or proving the validity, fitness or accuracy of something
Validation = the action of making or declaring something legally or officially acceptable
Validation = Recognition or affirmation that a person or their opinions are worthwhile

Although the term 'resource validation' does not appear in clause 7 of the ISO 9001:2015 QMS standard, however we need to carry out resource validation by ensuring specifically that (i) human resources are competent for which we need to fulfill the requirements mentioned in clause 7.2 of ISO 9001:2015 QMS standard, and (ii) monitoring and measuring resources are suitable for their purpose for which we need to carry out calibration/verification as per clause 7.1 of ISO 9001:2015 QMS standard.

- Keshav Ram Singhal

Workshop on ISO 9001:2015 QMS Transition Auditor's Training

*Workshop on ISO 9001:2015 QMS Transition Auditor's Training*

Two days workshop on 'ISO 9001:2015 Transition Auditors’ Certificate Course' is being organized on January 22 - 23, 2018 by National Centre for Quality Management (NCQM), Mumbai NCQM Learning Centre, G-501, Kailas Industrial Complex, Vikhroli-Hiranandani Link Road, Vikhroli (W), Mumbai 400 079. the course contents are as under:

1. Evolution of ISO and subtle differences in terminology used in ISO
2. Overview on ISO 9000: 2000 series of Standards
3. Overview on ISO 9000: 2008 series of Standards
4. Major changes in ISO 9001:2015 over ISO 9001:2008
5. Understanding requirements of ISO 9001:2015 Standard
6. Exercises
6.1. Exercise 1: QMS terms and definitions
6.2. Exercise 2 : ISO 9001 Quiz
6.3. Exercise 3 : fact or Inference
6.4. Exercise 4: Identifying Clause/sub clause of certain non conformities.
6.5. Exercise 5: Identifying NCs, writing nonconformity report (NCR) an audior closing an NCR as an Auditee
7. Written test
8. Workshop evaluation
9. Feedback and follow-up plan

Successful candidates will be awarded a certificate from NCQM. Others will get certificate of attendance.

*More information* about the registration, fees and other details may be obtined from: National Centre for Quality Management
G - 503, Kailas Industrial Complex,
Vikhroli - Hiranandani Link Road ,
Vikhroli (W), Mumbai 400 079.
Tel: (022) 4011 1962 / 2517 0483 / 69
Email: drr@ncqm.com; ncqmmumbai@yahoo.co.in
Website: www.ncqm.com

Courtesy Source: NCQM Email dated 01 January 2018

*Please share information among interested people.*

Thanks,

Keshav Ram Singhal
http://profile-keshavramsinghal.blogspot.in/
Email - keshavsinghalajmer@gmail.com

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