Transition Steps to ISO 9001:2015

 

  • First step: Obtain a copy of the new ISO/DIS 9001:2015
  • Conduct a “Gap Analysis” imagesbetween 2008 and 2015 revision
  • Create a transition plan that maps out how we will manage the process to achieve ISO 9001:2015 certification
  • ISO9001:2008 vs 2015 comparison table.
  • Re-assess status of our QMS documentation
  • Presenting transition plan to  Pri-Registrar  during annual recertification
  • Completeness all changes in documentation and processes
  • Train/educate staff including your internal audit team those responsible for the about the changes
  • Internal audit process to validate changes.
  • Communicate to Pri-Registrar that the changes are occurring and the transition is being managed.
  • ISO recertification based on 2015 revision

download

By Source Management Systems Consulting

ISO 9001:2008 to ISO/DIS 9001 (2015 rev.) Correlation Matrix

The structure of the ISO 9001:2008 standard is changing:

  • The 2008 version has eight clauses and the 2015 version will have 10.
  • The structure of your current QMS does not have to change.

Image result for Iso 9001:2015 image

This below comparison chart will help, when the 2015 version is released, you when ensuring your QMS satisfies the requirments of the standard.

ISO-9001-2008-to-2015-Matrix

By Source Management Systems Consulting

FDA requirement: 21 CFR 820 and ISO 9001:2008

Compliance ISO 9001:2008 to requirement FDA: 21 CFR 820

21 CFR 820: Brief Description: ISO 9001:2008 clauses:
§ 820.1 – Scope.
§ 820.3 – Definitions.
§ 820.5 – Quality system.
General Provisions Scope: 1, 2, 3                                               4.1-General Requirement
§ 820.20 – Management responsibility.
§ 820.22 – Quality audit.
§ 820.25 – Personnel.
Quality System Requirements clause 5: Management Responsibilityclause 8.2.2: Internal Audit

clause 6.2 Human Resources

§ 820.30 – Design controls Design Controls clause  7.3 Design and Development
§ 820.40 – Document controls Document controls clause 4.2 Documentation Requirements
§ 820.50 – Purchasing controls. Purchasing controls. clause 7.4 Purchasing
§ 820.60 Identification.
§ 820.65 – Traceability.
Identification and Traceability clause 7.5.3 Identification and Traceability
§ 820.70 – Production and process controls.
§ 820.72 – Inspection, measuring, and test equipment.
§ 820.75 – Process validation.
Production and Process Controls clause 7.5 Production and service provision                                                  clause 7.6 Control of monitoring and measuring equipment
 § 820.80 – Receiving, in-process, and finished device acceptance.
§ 820.86 – Acceptance status.
Acceptance Activities clause 7.4.3 Verification of purchased product  clause 7.1 Product realization
§ 820.90 – Nonconforming product. Nonconforming product. clause 8.3 Control of noncoforming product
§ 820.100 – Corrective and preventive action. Corrective and preventive action. cluase 8.5.2 Corrective Actionclause 8.5.3 Preventive action
§ 820.120 – Device labeling.
§ 820.130 – Device packaging.
Labeling and Packaging Control

§ 820.140 – Handling.
§ 820.150 Storage.           § 820.160-Distribution

Handling, Storage, Distribution, and Installation 7.5.5 Preservation of product
§ 820.180 – General requirements.
§ 820.186 – Quality system record.
§ 820.198 – Complaint files.
Records clause 4.3 Control of records
§ 820.250 – Statistical techniques. Statistical Techniques clause 8.4 Analysis of data

Role of Quality Manager

  1. Quality Standards.  Documents and records are used all throughout the company.  Nobody should know more about quality, compliance and processes than the Quality Manager.  Your experience with Good Manufacturing Practices (GMP), ISO standards (i.e. ISO 9001), or 21 CFR 820 within a regulated industry are important to managing and controlling documents and records.
  2. Quality Project Management.  A Quality Manager is also a project manager managing corrective action, process improvement, and auditing projects.  One must have strong self-motivation, the ability to work independently, and within a team environment with strong follow up, organization and prioritization skills and excellent attention to detail helps too.  Perhaps most important of all is understanding the financial – risk-reward – trade-offs in good project management.
  3. Business Process Documentation.  A Quality Manager must be able to understand, comply, and improve established company policies and procedures.  Developing standard work, policies, procedures, job aids, and business process communications are a part of the job.  A Quality Manager is also a technical writer.  Familiarity with policy and procedure writing will help you to succeed.  Technical writing conveys technical information using active voice construction, instructional design, and desktop publishing methods to transfer information into understandable and useful information.
  4. Document Control.  As the Quality Manager, your Knowledge of the Quality documentation process, Document Control practices, and managing documents, records, forms, and work instructions is vital to maintaining your company’s compliance program.  A Quality Manager may be the Document Control Manager responsible for organizing documents into an easy to use and fast retrieval system.  Users need their policies and procedures to conform to requirements.  If they cannot find them, then they cannot follow them… Document control is an important priority.
  5. quality managerQuality Communications.  It might go without saying but explaining business process compliance to others is what a Quality Manager has to do.  Being able to understand a variety of instructions furnished in written, oral, diagram, or schedule form helps others to follow and conform to the established best practice.  Communicating compliance and conformance is done using software such as Microsoft Word and Excel, training using PowerPoint, process mapping using Visio, Statistical Process Control (SPC) using statistics, as well as document revision control software for policies and procedures management.
  6. People Management.  A Quality Manager should not be afraid of asking questions, collecting business process information, and working with others in a positive and collaborative manner.  Business processes include sensitive accounting and financial processes too.  So, you must be comfortable speaking effectively and communicating directly with all levels of personnel.
  7. Quality Auditing.  A Quality Manager performs some of the quality audits.  Supply chain audits, process audits, and may even lead ISO audits an act as a Lead Auditor managing teams of auditors.  Clearly understanding the compliance requirements, collecting objective evidence, and writing up audit reports ensure the quality management system is operating effectively.
  8. Problem Solving.  The Quality Manager solves problems, typically in situations where general standardization should exist, but may not be operating effectively.  Using process mapping techniques, lean, or Six Sigma process improvement methodology is essential to reducing waste and being effective in the Quality role.   A delicate balance exists between resolving problems yourself and identifying those situations that require management intervention for a solution.  Good political judgment is required where quality and compliance are concerned.
  9. Team Player.  The Quality Manager is involved in teams and meetings at every level of the organization.  Management reviews, material reviews, supplier reviews, corrective action reviews, process improvement teams, audits, customer visits and strategy discussions.  A good Quality Manager is involved with many areas of the company.
  10. Quality “Go To” Guy.  The Quality Manager is the person that everybody goes to to get answers about quality.  Product specifications, supplier requirements, testing, inspections, part verification, equipment calibration, corrective actions, non-conformances, workers compensation, benchmarking, voice of the customer, and on and on.  The buck stops here at Quality.

 

Source: www.bizmanualz.com

Customer Focus – Quality Principle

Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and
strive to exceed customer expectations.
• Increased revenue and market share obtained through flexible and fast  responses to market          opportunities

• Increased effectiveness in the use of the organization’s resources to enhance
customer satisfaction
• Improved customer loyalty leading to repeat business.
• Researching and understanding customer needs and expectations
• Ensuring that the objectives of the organization are linked to customer needs and expectations
• Communicating customer needs and expectationscustomer
throughout the organization
• Measuring customer satisfaction and acting
on the results
• Systematically managing customer relationships
• Ensuring a balanced approach between satisfying customers and other interested parties (such as owners, employees, suppliers, financiers, local
communities and society as a whole).

http://www.iso.org

Image

Continued Self-Development Skills:

future

Continued Self-Development Skills:
This is the most important personal management skill of them all. Without the ability to continue moving forward with personal development you will be unable to recognize the areas that need to be corrected in order to increase your time, financial, communication, and organization skills.

A few ways to increase your continued self-development skills are:
• Schedule a weekly appointment with yourself in order to evaluate your progress and your setbacks
• Spend time each morning focusing on what it is you’re going to accomplish for the day
• Review your day at its closing and accept the areas that need work and praise yourself for the day’s victories
• Remain open-minded and flexible. Remember, change is inevitable.
• Create goals and long term objectives
• No matter what, continue moving forward

By Source Management Systems Consulting

10 Guiding Principles for Leading Change Management

10 Guiding Principles for Leading Change Management

According to a 2013 Strategy&/Katzenbach Center survey of global senior executives on culture and change management, the success rate of major change initiatives is only 54%. This is far too low. The costs are high when change efforts go wrong—not only financially but in confusion, lost opportunity, wasted resources, and diminished morale. When employees who have endured real upheaval, and put in significant extra hours for an initiative that was announced with great fanfare, see it fizzle out, cynicism sets in.

The following is a list of 10 guiding principles for change that can help executives navigate the treacherous shoals of transformation in a systematic way—and help ensure that critical changes last for the long haul.

  1. Lead with the culture.In the Katzenbach Center survey, 84%  of executives surveyed said their organization’s culture was critical to the success of change management, and 64% saw it as more critical than strategy or the company’s operating model. Yet change leaders often fail to address culture—in terms of either overcoming cultural resistance or making the most of cultural support.Instead of trying to change the existing culture itself, skilled change managers draw emotional energy from it. They tap into the way people already think, behave, work, and feel to provide a boost to the change initiative. To use this emotional energy, leaders must look for the elements of the culture that are aligned to the change, bring them to the foreground, and attract the attention of the people who will be affected by the change.
  2. Start at the top.Although it’s important to engage employees at every level early on, all successful change management initiatives start at the top, with a committed and well-aligned group of executives strongly supported by the CEO. This alignment can’t be taken for granted. Rather, work must be done in advance to ensure that everyone agrees about the case for the change and the particulars for implementing it. This means top executives must engage in discussion, listen closely to one another, and weigh conflicting points of view in order to agree on a coherent vision for the goals of any major change initiative. Leadership, as the drivers of change, must act as a collaborative and committed team throughout the process.
  3. Involve every layer.Strategic planners often fail to take into account the extent to which midlevel and frontline people can make or break a change initiative. The path of rolling out change is immeasurably smoother if these people are tapped early for input on issues that will affect their jobs. Frontline people tend to be rich repositories of knowledge about where potential glitches may occur, what technical and logistical issues need to be addressed, and how customers may react to changes. In addition, their full-hearted engagement can smooth the way for complex change initiatives, whereas their resistance will make implementation an ongoing challenge.
  4. Make the rational and emotional case together.Leaders will often make the case for major change on the sole basis of strategic business objectives such as “we will enter new markets” or “we will grow 20% a year for the next three years.” Such objectives are fine as far as they go, but they rarely reach people emotionally in a way that ensures genuine commitment to the cause.Human beings respond to calls to action that engage their hearts as well as their minds, making them feel as if they’re part of something consequential.  By drawing directly on the company’s cultural history and traditions, leaders can activate a strong personal connection between the company and its employees.
  5. Act your way into new thinking.Many change initiatives seem to assume that people will begin to shift their behaviors once formal elements like directives and incentives have been put in place. Yet far more critical to the success of any change initiative is ensuring that people’s daily behaviors reflect the imperative of change. Start by defining a critical few behaviors that will be essential to the success of the initiative. Then conduct everyday business with those behaviors front and center. Senior leaders must visibly model these new behaviors themselves, right from the start, because employees will believe real change is occurring only when they see it happening at the top of the company.
  6. Engage, engage, engage.Leaders often make the mistake of imagining that if they convey a strong message of change at the start of an initiative, people will understand what to do. Nothing could be further from the truth. Powerful and sustained change requires constant communication, not only throughout the rollout but after the major elements of the plan are in place. The more kinds of communication employed, the more effective they are. Symbolic actions reinforce the impact of words.
  7. Lead outside the lines.Change has the best chance of cascading through an organization when everyone with authority and influence is involved. In addition to those who hold formal positions of power—the company’s recognized leaders—this group includes people whose power is more informal and is related to their expertise, to the breadth of their network, or to personal qualities that engender trust.We call these informal leaders “special forces.” They might include a well-respected field supervisor, an innovative project manager, or a receptionist who’s been at the firm for 25 years. Companies that succeed at implementing major change identify these people early and find ways to involve them as participants and guides. Informal leaders must be identified before they can be engaged. The best way to do this in a large organization is to run a network analysis. By mapping out connections and seeing who people talk to, you can complement the formal org chart with one that enables you to lead outside the lines.
  8. Leverage formal solutions.Persuading people to change their behavior won’t suffice for transformation unless formal elements—such as structure, reward systems, ways of operating, training, and development—are redesigned to support them. Many companies fall short in this critical area.After a strong start, a mentoring program for associates at a law firm faltered because no formal mechanisms were in place to support or reward this participation. Calculations for bonuses left development work out of the equation, and although senior partners paid lip service to the “wonderful work” the development committee was doing, they seemed to regard its members as internal volunteers. Once they recognized this problem, the firm’s leaders enacted substantial policy changes, starting with a mechanism the compensation committee could use to take into account the contributions made by those who trained others.
  9. Leverage informal solutions.Even when the formal elements needed for change are present, the established culture can undermine them if people revert to long-held but unconscious ways of behaving. This is why formal and informal solutions must work together. A top-tier technology company was trying to inculcate a more customer-centric mind-set after a decade focused on relentlessly cutting costs. A set of new procedures was put in place, but one of the most powerful solutions was purely cultural and informal—changing the informal motto that governed frontline decision making. By asking people at every level to be responsible for quality—and by celebrating and rewarding improvements—change leaders were able to create an ethic of ownership in the product.
  10. Assess and adapt.The Strategy&/Katzenbach Center survey revealed that many organizations involved in transformation efforts fail to measure their success before moving on. Leaders are so eager to claim victory that they don’t take the time to find out what’s working and what’s not, and to adjust their next steps accordingly. This failure to follow through results in inconsistency and deprives the organization of needed information about how to support the process of change throughout its life cycle.

These 10 guiding principles offer a powerful template for leaders committed to effecting sustained transformational change. The work required can be arduous and exacting. But the need for major change initiatives is only going to become more urgent. It behooves us all to get it right.

source: http://www.industryweek.com

By Source Management Systems Consulting

Customer in Defining Quality

The Growing Role of the Customer in Defining Quality

Four key factors drive the intersection of customer and quality:

• The role of quality within an organization

• Integration of goals in strategic planning

• Level of transparency on quality goals and reporting

• How the quality measures are used.

It is clear that many organizations are becoming true partners with their customers in order to maximize the value for both stakeholders. Organizations’ definition of quality, the actual quality processes, and using quality measures to drive performance and culture are all closely tied to customers. Because quality and customers are so closely aligned in successful organizations, the two concepts are intersecting into a customer-centric quality culture.

While manufacturing organizations tend to use mature quality practices—in regards to governance models, availability and use of metrics, quality management frameworks and certifications, and training—do their practices include a focus on the customer? What defines a customer-centric, quality culture and what are the driving factors of its success?

To answer these questions APQC(American Productivity and Quality Center) conducted correlation analysis on data, specifically for the manufacturing industries, from American Society for Quality – The Global Sate of Quality survey conducted by APQC for ASQ. The customer-centric quality culture can be defined by four statements that elucidate the organization’s relationship with its customer around quality:

Most of the survey respondents indicated they agree with the statements. However all cultural attributes were not weighted equally. The emphasis was placed on customer service and product performance, rather than two-way engagement or quality and what it means to the customer.

source: http://www.industryweek.com

The Role of Quality

The Role of Quality

 As organizations evolve quality from merely being a ‘checking the compliance boxes’ to really using quality practices to impact and empower staff to make improvements and address customer needs, there is opportunity for a greater return on investment and improved customer satisfaction. Organizations that use quality as a source of competitive advantage, operational excellence, or as a continuous improvement activity are much more likely to embrace the customer-centric, quality culture.

For example organizations that use quality as a source of competitive advantage are more likely to make their quality measures transparent to their customers (76.4%) than those who use it as a compliance activity (46.6%). This is particularly true for understanding what defines culture from the customer’s perspective.

Integration in Strategic Planning

To understand what’s truly valuable to the organization, one has to look at what makes it into the strategic plan. Although there is always intrinsic value in the use of quality goals and measures within an organization, it is when these goals are established across the organization—corporate, management and support services, and operational businesses and functional units—that quality can have the greatest impact on overall performance.

Level of Transparency

Transparency on quality measures helps create buy-in on quality management and enables employees to understand what role quality plays in how they do work, how they can impact quality, and its effects on their customers’ satisfaction. Transparency breeds accountability at the most basic level and even drives a healthy competition between business units. It also tends to increase knowledge-sharing opportunities (e.g., best practices or lessons learned), as managers with lower performance often reach out to managers in groups with higher performance, even across diverse products and services within the same organization.

Use of Quality Measures

The majority of respondents use quality measures to set goals that will drive higher performance throughout the organization (76%), for predictive analysis to identify potential opportunities or issues in their operations and business process (66%), and as part of their variable-performance compensations (61%). However organizations that include quality measures to drive higher performance or for operational improvement are more likely to agree with the customer-centric, quality cultural statements. This adoption indicates that the organization has embraced the quality culture and it’s simply now how they do business.

source: http://www.industryweek.com

Requirements of Quality Management System

What are Requirements of ISO 9001 Quality Management Systems?

audited image1The ISO offers one among the known management systems within the world. Overall, the systems are enforced by quite one million organizations in many countries. The ISO 9001 certified company follows tips set by the organization. The standards represent the foremost comprehensive existing nowadays, and are a tried and tested framework for firms to higher make sure that they’re meeting the wants of their several purchasers.

Requirements – Documentation

In order to be ISO 9001 compliant, an authorized company giving services or product should be in possession of documented statements of a top quality policy that delineates the standard objectives.

Quality Manual

A company seeking ISO 9001 certification should possess a top ISO 9001 quality manual that sets forth the scope of the standard management system and documented procedures for addressing quality problems.

Control of Documentation

Documentation should be controlled therefore on make sure the documents are approved before being issued. Additionally, all documentation should be unbroken up-to-date. Revisions should be resubmitted for approval once an amendment is formed.

Management Responsibility

Although the ISO 9001 produces the management standards, it’s the responsibility of the corporate to self-audit. Additionally, the corporate might permit customers to perform an audit likewise. To be certified as compliant, businesses management practices should be reviewed by a freelance ISO 9001 quality system certification company.

Measurement and Analysis

Per Section eight of the ISO standards, an organization should set up and implement “the watching, measure, analysis and improvement processes” that are required to demonstrate conformity to product necessities, guarantee conformity of the standard management system, and to supply continual improvement of the standard management necessities.

Continual Improvement

In order to stay compliant with the ISO standards, an organization should frequently develop and improve its own tips to make sure corrective and preventative measures are in situ to contend with any nonconformity that will arise.

source: qms9001certificationprocedures.wordpress.com

%d bloggers like this: